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Compounded Semaglutide
*Compounded medications may be prescribed by physicians but have not been FDA regulated for safety, effectiveness, or quality. FDA-approved medicines containing semaglutide are available.
WARNING
Please contact your doctor ASAP and seek in-person care immediately if a side effect becomes problematic or you experience:
- Severe nausea and/or vomiting resulting in dehydration—it is important to stay well hydrated and drink plenty of fluids while on this medication
Kidney problems/kidney failure - vomiting, nausea, diarrhea can cause dehydration and kidney issues and make kidney problems worse in individuals who have pre-existing kidney conditions; may sometimes lead to the need for hemodialysis - Thyroid C-Cell Tumor: Trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath (see black box warning below)
- Pancreatitis: Severe pain in your abdomen or back that will not go away
- Acute gallbladder disease - Pain in the middle or right upper stomach, fever, white parts of your eyes turn yellow or skin turns yellow, nausea/vomiting. If gallstones or inflammation of the gallbladder is suspected further studies are needed.
- Hepatitis/Elevated liver enzymes/Jaundice
- Diabetic retinopathy problems: Changes in vision in those with type II diabetes, particularly vision problems may worsen in those with a history of diabetic retinopathy
- Severe gastrointestinal disease - may cause gastrointestinal disease; do not use if you have a history of severe gastrointestinal disease
- Signs of low blood sugar (for example, dizziness, weakness, shakiness, jitteriness, headache, anxiety/mood changes, rapid heartbeat, confusion, slurred speech, sweating, or lightheadedness). While this is rare with GLP-1s, if it occurs, please seek in-person care immediately. If you have these symptoms, try having liquid or food containing sugar (around 15-20 grams) —drinking juice, having regular soda, or eating some hard candies right away, as this will help raise your blood sugar quickly. If taken with insulin or an insulin secretagogue (i.e. sulfonylurea such as Glipizide, glimepiride, and glyburide) it is best to talk to your healthcare provider about possibly lowering the dose of these medications to lower the risk of hypoglycemia.
- Increasing heart rate
- Worsening depression, behavior changes, or suicidality
Never share the semaglutide with other people
Drug Interactions
As with other medications, compounded semaglutide can interact with alcohol and certain prescription and non-prescription medications and herbal products. The risk of hypoglycemia is increased when combined with insulin or insulin secretagogues such as sulfonylureas. Compounded semaglutide delays gastric emptying and may impact the absorption of oral medications. If you are on papillary hormone medication, prior to starting compounded semaglutide, please review the timing of taking your papillary hormone medication with the doctor who prescribes it as it may need to be adjusted. The drug levels of medications with narrow therapeutic windows (ie warfarin) should be monitored closely while on compounded semaglutide.
Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions and additional information.
To report suspected adverse reactions to compounded semaglutide, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
In case of emergencies, please call 911 or go to the nearest emergency room.
Note: The above statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
BLACK BOX WARNING
GLP-1s are contraindicated in individuals with a history of medullary thyroid carcinoma, a family history of such, or in patients with multiple endocrine neoplasia syndrome type 2. Do not take them if you have ever had thyroid cancer. In studies with rodents, GLP-1s caused thyroid tumors, including thyroid cancer; it is not known if they will cause thyroid tumors or cancer in humans. Please notify your doctor ASAP if you develop trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath.
If you experience a medical emergency, call 911 or go to the nearest emergency room.
Tell your healthcare provider about your medical history prior to taking semaglutide.
Avoid alcohol while taking this medication. If you’re taking diabetes medications, please discuss this with your prescribing doctor before starting semaglutide, as your diabetes medications may need to be adjusted as you lose weight.
Use adequate contraception while taking this medication. Do not take this medication if pregnant, trying to get pregnant or breastfeeding. If you plan to become pregnant, this medication needs to be stopped at least 2 months before trying. This medication may cause fetal harm.
Notify your doctor if you have kidney, liver, or pancreas problems.
Stop using semaglutide and call your healthcare provider immediately if you have severe stomach or abdomen pain that will not go away, with or without vomiting.
Stop using semaglutide and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.
Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue semaglutide if suspected and promptly seek medical advice.
Compounded Tirzepatide
*Compounded medications may be prescribed by physicians but have not been FDA regulated for safety, effectiveness, or quality. FDA-approved medicines containing tirzepatide are available.
WARNING
Compounded tirzepatide usage has been associated with the potential development of thyroid tumors, including thyroid cancer. Watch for any potential symptoms, such as neck lumps or swelling, hoarseness, difficulty swallowing, or breathlessness. Should any of these symptoms arise, it is imperative to inform your healthcare provider promptly.
Avoid using compounded tirzepatide if you or any family members have a history of medullary thyroid carcinoma (MTC), a specific type of thyroid cancer. Similarly, refrain from its use if diagnosed with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or if you've previously experienced a severe allergic reaction to tirzepatide or any of its components.
Serious Side Effects
Compounded tirzepatide carries the risk of severe side effects, which include:
- Gastrointestinal Issues: Reports indicate the possibility of severe stomach problems associated with compounded tirzepatide usage. Notify your healthcare provider if you experience persistent or severe stomach discomfort.
- Kidney Complications: Diarrhea, nausea, and vomiting may lead to dehydration, potentially resulting in kidney problems. Adequate fluid intake is crucial to mitigate this risk.
- Gallbladder Concerns: Some individuals may encounter gallbladder problems while using compounded tirzepatide. Seek immediate medical attention if symptoms such as upper abdominal pain, fever, jaundice, or changes in stool color occur.
- Pancreatitis: Discontinue use and contact your healthcare provider if you experience persistent abdominal pain, with or without vomiting, as it could indicate inflammation of the pancreas.
- Allergic Reactions: Cease compounded tirzepatide usage and seek urgent medical assistance if you develop symptoms of a severe allergic reaction, including facial swelling, breathing difficulties, rash, or rapid heartbeat.
- Hypoglycemia: The risk of low blood sugar may increase when using compounded tirzepatide alongside medications that lower blood sugar levels. Recognizable symptoms include dizziness, sweating, confusion, and rapid heartbeat.
- Vision Changes: Notify your healthcare provider of any alterations in vision observed during tirzepatide treatment.
- Depression or Suicidal Thoughts: Pay close attention to changes in mood or mental state while using tirzepatide, and promptly report any concerns to your healthcare provider.
Common Side Effects
The most frequently reported side effects of compounded tirzepatide include:
- Nausea
- Diarrhea
- Vomiting
- Constipation
- Abdominal pain
- Indigestion
- Injection site reactions
- Fatigue
- Allergic reactions
- Belching
- Hair loss
- Heartburn
These side effects are not exhaustive. Should you experience any persistent or bothersome side effects, discuss them with your healthcare provider for appropriate management.
Tell your healthcare provider if you have any side effects.
To report suspected severe side effects or adverse reactions to compounded trizepatide, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. In case of emergencies, please call 911 or go to the nearest emergency room.
Drug Interactions
As with other medications, compounded trizepatide can interact with alcohol and certain prescription and non-prescription medications and herbal products. The risk of hypoglycemia is increased when combined with insulin or insulin secretagogues such as sulfonylureas. Compounded trizepatide delays gastric emptying and may impact the absorption of oral medications. If you are on papillary hormone medication, prior to starting compounded trizepatide, please review the timing of taking your papillary hormone medication with the doctor who prescribes it as it may need to be adjusted. The drug levels of medications with narrow therapeutic windows (ie warfarin) should be monitored closely while on compounded trizepatide.
Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions and additional information.
Tirzepatide may alter the efficacy of birth control pills. Talk with your doctor before starting tirzepatide if you are on birth control. Your healthcare provider may recommend another type of birth control for 4 weeks after you start tirzepatide and for 4 weeks after each increase in your dose.
Note: The above statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Compounded Semaglutide
*Compounded medications may be prescribed by physicians but have not been FDA regulated for safety, effectiveness, or quality. FDA-approved medicines containing semaglutide are available.
WARNING
Please contact your doctor ASAP and seek in-person care immediately if a side effect becomes problematic or you experience:
- Severe nausea and/or vomiting resulting in dehydration—it is important to stay well hydrated and drink plenty of fluids while on this medication
Kidney problems/kidney failure - vomiting, nausea, diarrhea can cause dehydration and kidney issues and make kidney problems worse in individuals who have pre-existing kidney conditions; may sometimes lead to the need for hemodialysis - Thyroid C-Cell Tumor: Trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath (see black box warning below)
- Pancreatitis: Severe pain in your abdomen or back that will not go away
- Acute gallbladder disease - Pain in the middle or right upper stomach, fever, white parts of your eyes turn yellow or skin turns yellow, nausea/vomiting. If gallstones or inflammation of the gallbladder is suspected further studies are needed.
- Hepatitis/Elevated liver enzymes/Jaundice
- Diabetic retinopathy problems: Changes in vision in those with type II diabetes, particularly vision problems may worsen in those with a history of diabetic retinopathy
- Severe gastrointestinal disease - may cause gastrointestinal disease; do not use if you have a history of severe gastrointestinal disease
- Signs of low blood sugar (for example, dizziness, weakness, shakiness, jitteriness, headache, anxiety/mood changes, rapid heartbeat, confusion, slurred speech, sweating, or lightheadedness). While this is rare with GLP-1s, if it occurs, please seek in-person care immediately. If you have these symptoms, try having liquid or food containing sugar (around 15-20 grams) —drinking juice, having regular soda, or eating some hard candies right away, as this will help raise your blood sugar quickly. If taken with insulin or an insulin secretagogue (i.e. sulfonylurea such as Glipizide, glimepiride, and glyburide) it is best to talk to your healthcare provider about possibly lowering the dose of these medications to lower the risk of hypoglycemia.
- Increasing heart rate
- Worsening depression, behavior changes, or suicidality
Never share the semaglutide with other people
Drug Interactions
As with other medications, compounded semaglutide can interact with alcohol and certain prescription and non-prescription medications and herbal products. The risk of hypoglycemia is increased when combined with insulin or insulin secretagogues such as sulfonylureas. Compounded semaglutide delays gastric emptying and may impact the absorption of oral medications. If you are on papillary hormone medication, prior to starting compounded semaglutide, please review the timing of taking your papillary hormone medication with the doctor who prescribes it as it may need to be adjusted. The drug levels of medications with narrow therapeutic windows (ie warfarin) should be monitored closely while on compounded semaglutide.
Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions and additional information.
To report suspected adverse reactions to compounded semaglutide, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
In case of emergencies, please call 911 or go to the nearest emergency room.
Note: The above statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
BLACK BOX WARNING
GLP-1s are contraindicated in individuals with a history of medullary thyroid carcinoma, a family history of such, or in patients with multiple endocrine neoplasia syndrome type 2. Do not take them if you have ever had thyroid cancer. In studies with rodents, GLP-1s caused thyroid tumors, including thyroid cancer; it is not known if they will cause thyroid tumors or cancer in humans. Please notify your doctor ASAP if you develop trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath.
If you experience a medical emergency, call 911 or go to the nearest emergency room.
Tell your healthcare provider about your medical history prior to taking semaglutide.
Avoid alcohol while taking this medication. If you’re taking diabetes medications, please discuss this with your prescribing doctor before starting semaglutide, as your diabetes medications may need to be adjusted as you lose weight.
Use adequate contraception while taking this medication. Do not take this medication if pregnant, trying to get pregnant or breastfeeding. If you plan to become pregnant, this medication needs to be stopped at least 2 months before trying. This medication may cause fetal harm.
Notify your doctor if you have kidney, liver, or pancreas problems.
Stop using semaglutide and call your healthcare provider immediately if you have severe stomach or abdomen pain that will not go away, with or without vomiting.
Stop using semaglutide and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.
Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue semaglutide if suspected and promptly seek medical advice.
Lipotropic (MIC) & B12 Injection: Important Safety Information
1. Introduction
- What Are Lipotropic (MIC) Injections?
Lipotropic injections often contain a combination of Methionine, Inositol, and Choline (MIC). These components may support liver function, metabolism, and fat processing when used alongside a proper diet and exercise regimen. - B12 Supplementation
Vitamin B12 (commonly cyanocobalamin or methylcobalamin) is frequently added to lipotropic injections to support energy metabolism and red blood cell formation. - Regulatory Status
Certain formulations of MIC and B12 injections may not be evaluated or approved by the U.S. Food and Drug Administration (FDA) for weight loss or other off-label uses. If you prefer only FDA-approved treatments, please consult your healthcare provider about alternatives.
2. Potential Uses & Benefits
- Weight-Management Support
MIC injections are sometimes used as an adjunct to lifestyle interventions (diet and exercise) for individuals seeking to support healthy metabolism. - Nutritional Support
B12 supplementation may help address or prevent deficiency, supporting energy levels and proper red blood cell production. - Limitations
This product is not intended to diagnose, treat, cure, or prevent any disease and is typically part of a broader health or weight-management plan. Efficacy for weight loss varies among individuals and has limited clinical trial data.
3. Contraindications
You should not receive MIC+B12 injections if you:
- Have a known allergy or hypersensitivity to any of the ingredients (e.g., methionine, inositol, choline, vitamin B12) or their preservatives.
- Are pregnant, trying to conceive, or breastfeeding, unless your healthcare provider has deemed it safe.
- Have severe or unstable medical conditions (e.g., advanced liver or kidney disease) without consulting a qualified healthcare professional.
4. Warnings & Precautions
- Not FDA-Approved for Weight Loss
- While sometimes used in weight-management protocols, lipotropic injections have not been formally evaluated or approved by the FDA for weight loss.
-
- Consult Your Healthcare Provider
- Discuss your full medical history, including any chronic conditions, allergies, or autoimmune disorders.
- Inform your provider about all medications, supplements, and herbs you currently take, as these can interact with MIC or B12.
-
- Pre-Existing Conditions
- Use caution if you have a history of cardiovascular disease, diabetes, or hormone-related conditions.
- Lab monitoring (e.g., liver function, B12 levels) may be recommended depending on your clinical situation.
-
- Pediatric or Geriatric Use
- Safety and efficacy in children or the elderly have not been fully established for weight-management or off-label indications.
- Use only under professional guidance in these populations.
5. Potential Side Effects
While many individuals tolerate MIC+B12 injections well, side effects can occur. Contact your healthcare provider if any of the following become severe or persist:
- Injection Site Reactions
- Redness, swelling, tenderness, or bruising at the injection site.
- If signs of infection (e.g., pus, warmth, significant redness) develop, seek medical attention.
-
- Gastrointestinal Discomfort
- Nausea, upset stomach, or mild diarrhea.
- Severe or persistent GI symptoms should be evaluated by a healthcare professional.
-
- Allergic Reactions
- Rash, itching, hives, swelling of the face or throat, difficulty breathing (possible anaphylaxis).
- Discontinue use and seek immediate medical help if you suspect a serious allergic reaction.
-
- Headache, Dizziness, or Fatigue
- Some individuals may experience mild headaches, dizziness, or fatigue following the injection.
- Stop use and consult your provider if these symptoms are severe or prolonged.
-
- Unusual Urine Odor
- Methionine can sometimes cause a distinct odor in urine; generally not harmful but discuss with your provider if concerning.
6. Drug Interactions
- Other Medications and Supplements
- Lipotropic agents and high-dose B12 may interact with certain prescription drugs (e.g., levodopa, methotrexate) or other supplements.
- Always inform your healthcare provider of all medications, supplements, or herbal products you take.
7. Administration & Dosage
- Administration Method
- Injections are typically administered intramuscularly (IM) or subcutaneously (SQ).
- A qualified healthcare professional or a person trained in proper injection technique should administer.
-
- Dosage & Frequency
- Dosage and frequency can vary widely, depending on individual health status and goals.
- Follow your provider’s specific instructions and do not exceed the recommended dose without medical guidance.
-
- Monitoring
- Your provider may recommend periodic blood work (e.g., vitamin B12 levels, liver function tests) to assess effectiveness and detect potential issues.
8. Storage & Handling
- Proper Storage
- Refrigeration may be required for certain lipotropic formulations (check label or pharmacy instructions).
- Protect from direct sunlight or extreme temperatures.
- Sterility
- Use sterile, unexpired products. Do not reuse needles or syringes.
- Dispose of injection materials in approved sharps containers.
9. Adverse Event Reporting
- Severe Reactions
- If you experience any severe or life-threatening symptoms, discontinue use and seek emergency medical care.
- FDA Reporting
- You or your healthcare provider can report suspected adverse reactions to the FDA’s MedWatch Program at 1-800-FDA-1088 or online at www.fda.gov/medwatch.
10. Disclaimer
- Not Evaluated by the FDA
- These statements have not been evaluated by the FDA, and MIC+B12 injections are not approved to diagnose, treat, cure, or prevent any disease beyond recognized indications.
- Consult a Professional
- This information is intended for educational purposes only and does not replace professional medical advice.
- Individual Variation
- Responses to lipotropic injections vary; results are not guaranteed. Always follow healthcare professional guidance regarding dosage, follow-ups, and any complementary dietary or lifestyle adjustments.
Questions or Concerns?
If you have any questions about Lipotropic (MIC) and B12 injections, including their potential benefits, side effects, or dosage, please consult your qualified healthcare provider.
Important Safety Information for Ozempic (semaglutide) injection
Warning: Risk of Thyroid C-Cell Tumors
- In studies with mice and rats, semaglutide (the active ingredient in Ozempic and Wegovy) caused thyroid tumors, including thyroid cancer. It is not known if Ozempic will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
- Do not use Ozempic if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
What is the FDA-approved use of Ozempic?
Ozempic is a glucagon-like peptide-1 (GLP-1) receptor agonist that is used:
- with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
- to reduce the risk of major adverse cardiovascular events in patients with type 2 diabetes mellitus and established cardiovascular disease.
Limitations of Use:
- Ozempic has not been studied in patients with a history of pancreatitis.
- Ozempic is not for treatment of type 1 diabetes mellitus.
Your provider may recommend the use of Ozempic as treatment for chronic weight management (obesity or overweight).
Who should not use Ozempic?
Do not use Ozempic if:
- You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- You have a known allergic reaction to semaglutide (the active ingredient in Wegovy or Ozempic).
How should Ozempic be administered?
You can take Ozempic with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your provider will guide you on a treatment regimen that may include an increase in dose every four weeks.
You should not change your dosing regimen or stop taking Ozempic as prescribed without discussing with your provider first.
What should I tell my provider before using Ozempic?
- Ozempic has certain drug interactions. It’s important to tell your provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.
Some medications to watch out for include:
- Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL)
- Ozempic causes a delay in gastric emptying so it has the potential to impact the absorption of medications that are taken by mouth at the same time. Your provider can guide you on how to schedule your medications.
- Other GLP-1 medications, including Wegovy, Saxenda, Victoza, Byetta, or Bydureon
- If you’re using other products for weight loss, including dietary supplements
It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:
- Type 1 or type 2 diabetes
- Thyroid cancer
- Pancreatitis
- Kidney disease
- Diabetic retinopathy
- Depression
- Suicidal thoughts or behavior
Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.
- If you are pregnant: Ozempic should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Ozempic during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.
- If you are a female or male of reproductive potential: Discontinue Ozempic at least 2 months before a planned pregnancy since the drug can stay in the bloodstream for a long time.
- If you are breastfeeding: Ozempic was found in the milk of lactating rats. Tell your provider if you are breastfeeding before you start Ozempic.
Pregnancy registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide (the active ingredient in Ozempic and Ozempic) during pregnancy. Pregnant women exposed to semaglutide and healthcare providers are encouraged to contact Novo Nordisk at 1-800-727-6500.
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
What are the most serious side effects that I or a caregiver should monitor for when taking Ozempic?
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
These serious side effects can occur with Ozempic. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.
- Thyroid C-Cell Tumors: In mice and rats, semaglutide (the active ingredient in Ozempic and Ozempic) caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether Ozempic causes thyroid C-cell tumors in humans. There were cases of MTC reported in patients who took liraglutide (the active ingredient in Victoza and Saxenda) after the drug was put on the market. Ozempic is contraindicated in patients with a family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
- Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.
- Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: If you have type 2 diabetes, tell your provider right away if you experience changes in vision.
- Never Share a Pen: Pen-sharing poses a risk of infection.
- Low Blood Sugar (hypoglycemia): Ozempic lowers blood glucose. It can cause too low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.
- Acute Kidney Injury: In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. It is important for you to drink plenty of water to help reduce your chance of dehydration.
- Serious Allergic Reactions: Stop using Ozempic right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.
- Acute Gallbladder Disease: Ozempic may cause gallbladder problems, including gallstones. Some gallbladder problems require surgery. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.
- Increase in Heart Rate: Tell your provider right away if you have a racing heartbeat while at rest.
- Suicidal Behavior and Ideation: You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
What are the most common side effects of Ozempic?
- Nausea
- Vomiting
- Diarrhea
- Stomach pain
- Constipation
You are encouraged to report negative side effects of prescription products:
- Contact Novo Nordisk Inc. at 1-833-934-6891
- Contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch
This information is not comprehensive. Please see the full Prescribing Information for complete safety information.
Important Safety Information for Mounjaro® (tirzepatide) Injection
Warning: Risk of Thyroid C-Cell Tumors
Mounjaro® (tirzepatide) injection may cause thyroid tumors, including thyroid cancer. Watch for symptoms such as a lump or swelling in the neck, hoarseness, difficulty swallowing, or shortness of breath. If you experience any of these symptoms, inform your healthcare provider immediately.
- Do not use Mounjaro® (tirzepatide) injection if you or any family members have a history of medullary thyroid carcinoma (MTC).
- Do not use if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
What is the FDA-approved use of Mounjaro® (tirzepatide) injection?
Mounjaro® (tirzepatide) is an injectable medication approved for adults with type 2 diabetes. It is used alongside diet and exercise to improve blood sugar (glucose) control.
Limitations of Use:
- It is not known if Mounjaro® can be used in people with a history of pancreatitis.
- It is not approved for type 1 diabetes or for use in children under 18 years of age.
Who should not use Mounjaro® (tirzepatide) injection?
Do not use Mounjaro® if:
- You or a family member has a history of medullary thyroid carcinoma (MTC) or MEN 2.
- You are allergic to Mounjaro® or its ingredients.
How should I take Mounjaro® (tirzepatide) injection?
- Take Mounjaro® once weekly, on the same day each week, with or without food.
- Use the pre-filled injector pen as a subcutaneous injection in your stomach, thigh, or upper arm. Rotate injection sites weekly.
- Follow the dosing regimen provided by your WeightMeds provider, which may include dose increases every four weeks.
Do not change or stop your prescribed regimen without consulting your WeightMeds provider. If you take too much Mounjaro®, contact your healthcare provider immediately.
What should I discuss with my WeightMeds provider before starting Mounjaro®?
- Share your full medical history, including any thyroid, gastrointestinal, pancreatic, kidney, or vision issues.
- Discuss all medications, including over-the-counter drugs, supplements, and vitamins, as Mounjaro® may interact with some medications.
- Inform your provider if you are pregnant, planning to become pregnant, or breastfeeding.
- If using oral birth control, switch to a non-oral method or use a barrier method for 4 weeks after starting or increasing your dose of Mounjaro®.
Most Serious Side Effects to Monitor For:
- Thyroid C-Cell Tumors
- Severe Gastrointestinal Issues: Nausea, vomiting, or diarrhea that may worsen pre-existing conditions.
- Pancreatitis: Severe abdominal pain that may radiate to the back.
- Low Blood Sugar (Hypoglycemia): Symptoms include dizziness, sweating, confusion, or rapid heartbeat.
- Allergic Reactions: Swelling, rash, or difficulty breathing.
- Kidney Problems: Dehydration may worsen kidney function.
- Gallbladder Issues: Look for abdominal pain, fever, jaundice, or unusual stools.
- Vision Changes: Particularly if you have diabetic retinopathy.
- Mental Health Changes: Report any suicidal thoughts or mood changes immediately.
Common Side Effects:
- Nausea, vomiting, or diarrhea
- Constipation or indigestion
- Injection site reactions
- Tiredness
- Belching or heartburn
For a full list of side effects and complete safety information, consult the prescribing information.
Disclaimer:
WeightMeds has no affiliation with Novo Nordisk, Eli Lilly, or Amylin Pharmaceuticals. Medications offered by WeightMeds are not manufactured by these companies. Trademarks such as Ozempic®, Wegovy®, and Mounjaro® are owned by their respective manufacturers.
For more information, contact WeightMeds or your healthcare provider.
Metformin (Off-Label Use for Anti-Aging & Weight Loss): Important Safety Information
1. Introduction
- FDA-Approved Use
Metformin is an oral medication primarily approved by the U.S. Food and Drug Administration (FDA) for the management of type 2 diabetes mellitus. It helps improve blood glucose control by decreasing glucose production in the liver and increasing insulin sensitivity. - Off-Label Use
Metformin has garnered interest as a potential agent for anti-aging and weight management, but it is not FDA-approved for these purposes. Efficacy and safety data for these off-label uses are still under investigation in clinical and observational studies.
2. Potential Benefits & Limitations
- Possible Benefits (Off-Label)
- Anti-Aging: Some researchers hypothesize metformin may have protective effects on metabolic and cellular processes related to aging.
- Weight Management: Metformin can help reduce appetite or modestly aid weight reduction in certain individuals, especially those with insulin resistance.
- Limitations
- There is no guarantee of anti-aging or weight-loss results, as evidence is not conclusive for these off-label indications.
- Metformin does not replace lifestyle interventions such as a healthy diet, regular exercise, and balanced sleep.
- This product is not intended to diagnose, treat, cure, or prevent any disease in the context of anti-aging.
3. Contraindications
You should not take metformin if you:
- Have a severe renal impairment or significantly reduced kidney function (e.g., eGFR below certain thresholds—consult your healthcare provider for details).
- Have a known hypersensitivity to metformin or its inactive ingredients.
- Have acute or chronic metabolic acidosis (including diabetic ketoacidosis).
- Are undergoing imaging studies with iodinated contrast (your provider may advise temporarily stopping metformin around the time of the procedure to reduce risk of kidney issues).
- Have any condition associated with hypoxemia or significantly compromised circulation (e.g., heart failure or recent myocardial infarction), which can increase the risk of lactic acidosis.
4. Black Box Warning: Lactic Acidosis
- Serious Risk
Metformin can cause lactic acidosis (a dangerous build-up of lactic acid in the blood). Although rare, it can be fatal. - Risk Factors
- Poorly functioning kidneys.
- Excessive alcohol intake.
- Severe dehydration or infections.
- Use of certain medications (e.g., carbonic anhydrase inhibitors) or conditions reducing tissue perfusion.
- Symptoms
- Rapid breathing, muscle pain, abdominal discomfort, unusual fatigue, dizziness, or feeling cold.
- Seek immediate medical attention if you suspect lactic acidosis.
5. Warnings & Precautions
- Off-Label Status
- Metformin’s benefits for anti-aging or weight loss are not confirmed by large-scale randomized trials. Use under medical supervision if considering for off-label purposes.
- Renal & Liver Function
- Periodic kidney function checks (e.g., eGFR) are essential.
- Caution in patients with hepatic (liver) impairment, as it may increase the risk of lactic acidosis.
- Vitamin B12 Deficiency
- Long-term metformin use may reduce vitamin B12 absorption. Your provider may recommend periodic B12 monitoring and supplementation if needed.
- Hypoglycemia Risk (Low Blood Sugar)
- While metformin alone rarely causes hypoglycemia, the risk may increase if you combine metformin with other anti-diabetic agents (e.g., insulin, sulfonylureas).
- Pregnancy & Breastfeeding
- Safety in pregnant or breastfeeding individuals for anti-aging or weight-loss purposes is not established. Discuss with a qualified healthcare professional before use.
6. Common Side Effects
You may experience mild to moderate side effects when starting or adjusting metformin dosage. Contact your healthcare provider if symptoms become severe or persist.
- Gastrointestinal (GI) Distress
- Nausea, diarrhea, abdominal cramping, bloating, or gas.
- Taking metformin with meals can often help reduce GI side effects.
- Metallic Taste
- A harmless yet noticeable metallic or bitter taste in the mouth.
- Weakness or Fatigue
- May occur initially; consult your provider if persistent or severe.
- Vitamin B12 Deficiency
- Can manifest as numbness, tingling in extremities, or fatigue over long-term use.
7. Drug Interactions
- Other Medications
- Some drugs (e.g., diuretics, corticosteroids, antihypertensives, carbonic anhydrase inhibitors, etc.) can affect metformin’s safety and effectiveness.
- Always inform your healthcare provider of all prescription, over-the-counter medications, vitamins, and herbal supplements you take.
- Alcohol
- Excessive alcohol consumption increases the risk of lactic acidosis and should be avoided or limited while on metformin.
8. Administration & Dosage
- Prescribed Dosage
- Doses vary based on clinical factors such as body weight, kidney function, and potential diabetic risk.
- Do not exceed the recommended dose without medical advice.
- Timing
- Usually taken with meals to reduce GI discomfort.
- Extended-release forms (XR) may be taken once daily, often with the evening meal.
- Monitoring
- Your healthcare provider may recommend periodic blood tests to monitor kidney function, vitamin B12 levels, and overall metabolic health.
9. Storage & Handling
- Storage
- Store at room temperature away from moisture and direct sunlight.
- Keep out of reach of children and pets.
- Integrity
- Check expiration dates. Do not use expired metformin.
- Store tablets in their original packaging whenever possible.
10. Adverse Event Reporting
- Severe Reactions
- Stop taking metformin and seek immediate medical attention if you experience symptoms of lactic acidosis or a severe allergic reaction (e.g., hives, swelling, difficulty breathing).
- FDA Reporting
- Patients or healthcare providers can report suspected adverse reactions to the FDA’s MedWatch Program at 1-800-FDA-1088 or online at www.fda.gov/medwatch.
11. Disclaimer
- Off-Label Use
- Metformin’s use for anti-aging or weight-loss support is not FDA-approved, and scientific consensus on these off-label benefits is still evolving.
- Not a Replacement
- Metformin is not a replacement for a healthy diet, regular exercise, and routine health monitoring.
- Consult a Professional
- This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
Questions or Concerns?
If you have any questions about metformin’s off-label use for anti-aging or weight loss, including potential benefits, side effects, or dosage, please consult a qualified healthcare professional.
Live Longer
NAD+ Injection: Important Safety Information
1. Introduction
Nicotinamide Adenine Dinucleotide (NAD+) is a coenzyme found in all living cells, involved in critical metabolic processes. NAD+ injections are sometimes used for various wellness purposes. Please note that NAD+ injections may not be evaluated or approved by the U.S. Food and Drug Administration (FDA) for safety, effectiveness, or quality. If you have any questions about NAD+ therapy, consult a qualified healthcare professional.
2. Purpose & Benefits
- NAD+ may be administered for potential support of energy metabolism, cellular repair, or other wellness goals.
- This information does not constitute medical advice regarding indications or dosage and is provided for educational purposes only.
3. Contraindications
You should not receive NAD+ injections if you:
- Have a known allergy or hypersensitivity to NAD+ or any of the injection components.
- Are pregnant, planning to become pregnant, or breastfeeding, unless specifically advised by your healthcare provider.
- Have severe or unstable medical conditions (e.g., uncontrolled diabetes, end-stage renal disease, significant heart or liver disease) without first consulting a physician.
4. Potential Risks & Side Effects
While many individuals tolerate NAD+ injections well, side effects can occur. Contact your healthcare provider immediately if any symptoms worsen or become unmanageable. Potential side effects include:
- Injection Site Reactions
- Redness, swelling, or pain at the injection site.
- Bruising or minor bleeding.
-
- Gastrointestinal Disturbances
- Nausea, vomiting, or diarrhea.
- Abdominal discomfort or cramping.
-
- Headache or Dizziness
- May occur shortly after injection.
- If severe or persistent, seek medical attention.
-
- Changes in Energy Levels
- Some individuals report fatigue or jitteriness, especially if combined with other stimulants.
-
- Allergic Reactions
- Rash, itching, swelling (including of the face, lips, tongue, or throat), or difficulty breathing.
- Seek emergency care if you suspect a serious allergic reaction (anaphylaxis).
5. Warnings & Precautions
- Not FDA-Approved
-
- NAD+ injections have not been evaluated by the FDA for safety or efficacy.
- If you prefer FDA-approved treatments, discuss alternatives with your healthcare provider.
-
- Medical Supervision Required
- NAD+ injections should be administered by a qualified healthcare professional or under professional guidance, following all recommended safety protocols.
-
- Pre-Existing Conditions
- Inform your healthcare provider of any heart, kidney, liver, or other medical conditions.
- Discuss any concerns regarding potential interactions with existing medications or supplements.
-
- Use in Specific Populations
- Safety and effectiveness in children have not been established.
- Pregnant or nursing women should consult a physician before use.
-
- Monitor for Unusual Symptoms
- Report any unexpected changes in mood, behavior, or physical health (e.g., extreme fatigue, chest pain, shortness of breath).
6. Drug Interactions
- NAD+ may interact with certain prescription or over-the-counter medications, herbal supplements, or dietary regimens.
- Tell your healthcare provider about all medications and supplements you take before starting NAD+ injections.
- Watch for potential changes in how other medications work, as NAD+ could theoretically affect metabolic pathways.
7. Administration & Dosage
- Administration Method
- Typically administered intramuscularly (IM) or Subcutaneous (SUBQ) under medical supervision.
- Proper aseptic technique is critical to minimize risks of infection or injection site complications.
- Dosage
- The appropriate dose varies based on individual factors (age, weight, underlying health conditions).
- Follow the dosage and schedule as prescribed by your healthcare provider.
- Do not self-adjust or discontinue injections without consulting your provider.
8. Reporting Adverse Events
- If you experience concerning side effects or a serious adverse event, seek immediate medical care.
- You can also report suspected adverse reactions to the FDA’s MedWatch Program at 1-800-FDA-1088 or at www.fda.gov/medwatch.
9. Additional Precautions & Tips
- Hydration: Staying well-hydrated may help mitigate some side effects like headaches or dizziness.
- Lifestyle Factors: Aim for a balanced diet, regular exercise, and healthy sleep to optimize any potential benefits of NAD+ therapy.
- Follow-Up: Schedule follow-up appointments or lab tests if your healthcare provider deems them necessary to monitor any changes while on NAD+ therapy.
10. Disclaimer
- These statements have not been evaluated by the Food and Drug Administration.
- NAD+ injections are not intended to diagnose, treat, cure, or prevent any disease.
- This document is for informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
For questions or concerns about NAD+ injections, potential benefits, or side effects, please consult a qualified healthcare provider.
NAD+ Nasal Spray: Important Safety Information
1. Introduction
- What is NAD+?
Nicotinamide Adenine Dinucleotide (NAD+) is a coenzyme found in every cell of the body, playing a key role in cellular metabolism, energy production, and other physiological processes. - Regulatory Status
NAD+ nasal spray has not been evaluated or approved by the U.S. Food and Drug Administration (FDA) for safety, effectiveness, or quality. If you prefer only FDA-approved treatments, please discuss alternatives with your healthcare provider.
2. Purpose & Potential Benefits
- Uses
Some practitioners provide NAD+ nasal spray for potential support of energy levels, cognitive function, or general well-being. - Limitations
Evidence for these uses is primarily anecdotal or based on limited research. This product is not intended to diagnose, treat, cure, or prevent any disease.
3. Contraindications
You should not use NAD+ nasal spray if:
- You have a known allergy or hypersensitivity to NAD+ or any ingredient in the nasal spray formulation.
- You are pregnant, planning to become pregnant, or breastfeeding without first discussing the risks and benefits with a qualified healthcare professional.
- You have severe or unstable medical conditions (e.g., advanced heart disease, uncontrolled diabetes, end-stage renal disease) without medical supervision.
4. Warnings & Precautions
- Not FDA-Approved
- NAD+ nasal spray is not regulated by the FDA, and its safety/efficacy profile for any particular medical condition is not established.
-
- Consult a Healthcare Professional
- Before starting NAD+ nasal spray, inform your healthcare provider about your medical history, current medications, and supplements.
- Discuss potential benefits, risks, and any necessary monitoring.
-
- Pre-Existing Nasal or Sinus Conditions
- If you have chronic sinusitis, nasal polyps, or any nasal/sinus abnormalities, use NAD+ nasal spray with caution and under professional guidance.
-
- Use in Specific Populations
- Safety in children, pregnant or nursing mothers, or immunocompromised patients is not well established.
- Avoid use unless the benefits clearly outweigh risks, as determined by a healthcare professional.
5. Potential Side Effects
Although many people tolerate NAD+ nasal spray without major issues, side effects may include:
- Nasal Irritation
- Burning, itching, dryness, congestion, or sneezing.
- If discomfort persists or worsens, discontinue use and consult a healthcare provider.
-
- Headache or Dizziness
- May occur soon after application.
- If severe, stop use and seek medical advice.
-
- Nosebleeds (Epistaxis)
- Nasal mucosa irritation can sometimes lead to minor bleeding.
- If nosebleeds are frequent or severe, discontinue and consult your provider.
-
- Allergic Reactions
- Hives, itching, swelling of the face, lips, tongue, or throat; difficulty breathing.
- Seek emergency care if you suspect a serious allergic reaction.
-
- Other Possible Effects
- Fatigue, restlessness, or changes in mood.
- Report any unexpected or concerning symptoms to your healthcare professional.
6. Drug Interactions
- NAD+ may theoretically affect how other medications are metabolized, given its role in cellular processes.
- Tell your healthcare provider about all prescription and over-the-counter medications, vitamins, and herbal products you are taking.
- Avoid combining with other nasal sprays unless advised by a professional, as ingredient interactions or additive irritation could occur.
7. Administration & Dosage
- How to Use
- Typically administered via a nasal applicator.
- Follow the specific instructions provided by the pharmacist or healthcare provider (e.g., number of sprays per nostril, frequency of use).
-
- Dosage
- There is no standardized dosing guideline for NAD+ nasal spray. Your provider may suggest a specific protocol based on your individual needs.
- Do not exceed the recommended dose without medical guidance.
-
- Technique
- Gently blow your nose before each use.
- Keep the bottle upright, insert the nozzle into one nostril, and administer the prescribed number of sprays while gently inhaling.
- Repeat in the other nostril if directed. Avoid sharing nasal spray devices to prevent the spread of infection.
8. Storage & Handling
- Temperature: Store at the temperature specified on the product label.
- Avoid Contamination: Keep the spray nozzle clean. Wipe and recap after each use.
- Expiration: Do not use beyond the expiration date. Discard if the solution changes color or appears cloudy.
9. Adverse Event Reporting
- Report Side Effects: If you experience severe or unexpected reactions, seek medical attention immediately.
- Contact the FDA: You can report suspected adverse reactions to the FDA’s MedWatch Program at 1-800-FDA-1088 or online at www.fda.gov/medwatch.
10. Disclaimer
- Not Evaluated by the FDA: These statements have not been evaluated by the FDA, and NAD+ nasal spray is not approved to diagnose, treat, cure, or prevent any disease.
- Consult a Professional: This information is for educational purposes only and should not replace professional medical advice.
- No Guarantee: Individual results and experiences may vary.
Questions or Concerns?
If you have any questions regarding NAD+ nasal spray, its usage, potential benefits, or side effects, please consult your qualified healthcare professional.
Glutathione Injection: Important Safety Information
1. Introduction
- What is Glutathione?
Glutathione is a tripeptide (made from glutamate, cysteine, and glycine) naturally present in cells, where it plays a key role in antioxidant defense and various metabolic processes. - Regulatory Status
Glutathione injections are not evaluated or approved by the U.S. Food and Drug Administration (FDA) for specific medical indications, dosage, safety, or effectiveness. If you prefer only FDA-approved medications, please discuss alternatives with your healthcare provider.
2. Potential Benefits & Limitations
- Common Uses
Some practitioners may use glutathione injections for antioxidant support, skin health, or general wellness. - Limitations
The benefits are based on limited studies and anecdotal reports. Glutathione injections are not intended to diagnose, treat, cure, or prevent any disease.
3. Contraindications
You should not receive glutathione injections if you:
- Have a known allergy or hypersensitivity to glutathione or any component in the formulation.
- Are pregnant, planning to become pregnant, or breastfeeding without discussing the potential risks and benefits with a qualified healthcare professional.
- Have serious or unstable medical conditions (e.g., end-stage kidney disease, severe liver disease, or uncontrolled diabetes) without close medical supervision.
4. Warnings & Precautions
- Not FDA-Approved
- Glutathione injection is not FDA-approved, and its safety or efficacy profile for specific indications is not established.
-
- Consult a Healthcare Professional
- Before starting glutathione injections, discuss your entire medical history, current medications, and supplements with your healthcare provider.
- Talk about potential benefits, risks, and whether you need any follow-up lab tests or monitoring.
-
- Use in Specific Populations
- The safety in children, pregnant women, breastfeeding mothers, or immunocompromised patients is unknown.
- Use only under medical guidance if the potential benefits outweigh the risks.
-
- Allergies or Sensitivities
- Disclose any history of allergies or adverse reactions to medications, especially those administered via injection.
5. Potential Side Effects
While many individuals tolerate glutathione injections without major issues, some side effects may occur. Contact your healthcare provider if any symptoms persist or worsen.
- Injection Site Reactions
- Redness, swelling, pain, or bruising at the injection site.
- If you notice persistent or severe discomfort, discoloration, or infection-like symptoms (e.g., warmth, pus), consult your healthcare provider promptly.
-
- Allergic Reactions
- Itching, rash, hives, shortness of breath, or swelling of the face, lips, tongue, or throat.
- Seek immediate medical attention if you suspect a serious allergic reaction (anaphylaxis).
-
- Nausea or Gastrointestinal Distress
- Mild nausea, stomach upset, or diarrhea can occur.
- Report severe or persistent GI symptoms to your provider.
-
- Headache or Lightheadedness
- Might occur after injection; if severe, contact your healthcare provider.
-
- Other Possible Effects
- Changes in skin pigmentation, dizziness, fatigue, or other unanticipated symptoms.
- Discontinue and consult a professional if unusual or concerning effects arise.
6. Drug Interactions
- Medication and Supplement Considerations
- Glutathione may theoretically interact with certain prescription or over-the-counter medications, vitamins, or herbal products, especially those affecting oxidation-reduction or detoxification pathways.
- Always inform your healthcare provider of all medications and supplements you take to avoid potential interactions or complications.
7. Administration & Dosage
- Administration Method
- Glutathione injections are typically given subcutaneously (SUB-Q) or intramuscularly (IM).
- Administration should be performed by a qualified healthcare professional or under appropriate medical supervision.
-
- Dosage
- There is no universally accepted standard dosing protocol for glutathione injection.
- Your healthcare provider will determine the dosage and frequency based on your individual health status and treatment goals.
-
- Monitoring
- Depending on the reason for use, your provider may recommend regular lab tests (e.g., liver function, kidney function) to monitor safety and effectiveness.
8. Storage & Handling
- Temperature
- Store the product as indicated on the label or as instructed by your pharmacist (often in a refrigerator, protected from direct sunlight).
- Sterility
- Ensure vials or ampules are used in a sterile manner. Never reuse syringes or needles.
- Expiration
- Do not use beyond the expiration date. Inspect the product for discoloration or particulate matter before each use; discard if present.
9. Adverse Event Reporting
- If you experience a severe or unexpected reaction, discontinue use and seek immediate medical attention.
- You or your healthcare provider can report suspected adverse reactions to the FDA’s MedWatch Program at 1-800-FDA-1088 or online at www.fda.gov/medwatch.
10. Disclaimer
- Not Evaluated by the FDA: These statements have not been evaluated by the Food and Drug Administration, and glutathione injections are not FDA-approved to diagnose, treat, cure, or prevent any disease.
- Consult a Professional: This information is for educational purposes only and does not replace professional medical advice.
- No Guarantee: Individual responses and results may vary.
Questions or Concerns?
For any additional information regarding glutathione injections, including potential benefits, side effects, or dosage considerations, please consult your qualified healthcare provider.
Glutathione Nasal Spray: Important Safety Information
1. Introduction
- What is Glutathione?
Glutathione is a tripeptide composed of glutamate, cysteine, and glycine. It plays a crucial role in antioxidant defense and various metabolic processes within the body. - Regulatory Status
Glutathione nasal spray is not evaluated or approved by the U.S. Food and Drug Administration (FDA) for safety, effectiveness, or specific medical indications. If you prefer only FDA-approved medications, please consult your healthcare provider for alternatives.
2. Purpose & Potential Benefits
- Potential Uses
Some practitioners may recommend glutathione nasal spray as a supplemental antioxidant therapy or for sinus/nasal health support. - Limitations
Current data on the efficacy of glutathione nasal spray is limited. This product is not intended to diagnose, treat, cure, or prevent any disease.
3. Contraindications
Avoid using glutathione nasal spray if you:
- Have a known allergy or hypersensitivity to glutathione or any ingredient in the nasal spray formulation.
- Are pregnant, planning to become pregnant, or breastfeeding without first consulting a qualified healthcare professional.
- Have severe or unstable medical conditions (e.g., uncontrolled diabetes, end-stage renal disease, severe respiratory disorders) without medical supervision.
4. Warnings & Precautions
- Not FDA-Approved
- Glutathione nasal spray has not been assessed or cleared by the FDA for medical use.
- Effectiveness and safety for any particular indication are not well established.
-
- Consult a Healthcare Professional
- Inform your healthcare provider of your entire medical history, current medications, and supplements before starting glutathione nasal spray.
- Discuss potential benefits, risks, and any necessary follow-up or lab work.
-
- Nasal or Respiratory Conditions
- Use caution if you have chronic sinusitis, nasal polyps, or other respiratory conditions.
- If you experience worsening congestion, difficulty breathing, or new-onset respiratory symptoms, discontinue use and seek medical advice.
-
- Use in Specific Populations
- Safety in children, pregnant/nursing women, and immunocompromised individuals is not established.
- Use only under medical supervision if benefits clearly outweigh potential risks.
5. Potential Side Effects
While many people tolerate glutathione nasal spray without significant issues, you may experience:
- Nasal Irritation
- Burning, itching, dryness, or sneezing.
- If irritation persists or becomes severe, stop using the spray and contact your healthcare provider.
-
- Headache or Dizziness
- May occur after application.
- Seek medical attention if these symptoms are severe or prolonged.
-
- Nosebleeds (Epistaxis)
- Nasal membrane irritation can occasionally lead to bleeding.
- Discontinue use if nosebleeds are frequent or severe and consult your healthcare provider.
-
- Allergic Reactions
- Signs may include hives, rash, swelling of the face, lips, tongue, or throat; difficulty breathing.
- Seek emergency medical help if you suspect anaphylaxis.
-
- Other Potential Reactions
- Altered taste, mild fatigue, or unexpected nasal discharge.
- Report any unusual or concerning symptoms to your healthcare professional.
6. Drug Interactions
- Medication and Supplement Interactions
- Glutathione may theoretically interact with certain medications or supplements that affect oxidative stress or metabolic pathways.
- Always inform your healthcare provider about prescription and over-the-counter medications, herbal products, and dietary supplements you are taking.
7. Administration & Dosage
- How to Use
- Typically administered via a nasal applicator.
- Follow specific instructions provided by your pharmacist or healthcare provider (e.g., how many sprays per nostril and how often).
-
- Dosage
- No standardized dosing protocol exists for glutathione nasal spray.
- Do not exceed the recommended dose provided by your healthcare professional.
-
- Technique
- Gently blow your nose before each application.
- Keep the bottle upright; insert the nozzle into one nostril and administer the prescribed number of sprays while breathing in gently.
- Repeat in the other nostril if directed.
- Avoid sharing nasal spray devices to prevent contamination or infection spread.
8. Storage & Handling
- Temperature
- Store at the temperature recommended on the product label or by your pharmacist (often refrigerated).
- Avoid Contamination
- Keep the spray nozzle clean. Wipe and recap after each use.
- Expiration
- Do not use beyond the expiration date. Discard if the solution appears discolored or cloudy.
9. Adverse Event Reporting
- If you experience a severe reaction or concerning symptoms, discontinue use and seek immediate medical care.
- You or your healthcare provider can report adverse reactions to the FDA’s MedWatch Program at 1-800-FDA-1088 or online at www.fda.gov/medwatch.
10. Disclaimer
- Not Evaluated by the FDA
- These statements have not been evaluated by the FDA, and glutathione nasal spray is not approved to diagnose, treat, cure, or prevent any disease.
- Consult a Professional
- This information is for educational purposes only and does not replace professional medical advice.
- No Guarantee
- Individual results and experiences may vary.
Questions or Concerns?
If you have any questions regarding glutathione nasal spray, including dosage, potential benefits, or side effects, please consult your qualified healthcare professional.
Methylcobalamin (Vitamin B12) Injection: Important Safety Information
1. Introduction
- What Is Methylcobalamin?
Methylcobalamin is a biologically active form of Vitamin B12. It is often prescribed or administered to individuals with Vitamin B12 deficiency, or for certain neurological and hematological conditions. - Regulatory Status
In some cases, compounded forms of methylcobalamin have not been evaluated or approved by the U.S. Food and Drug Administration (FDA) for all potential uses. If you prefer or require an FDA-approved product, please consult your healthcare provider for alternatives.
2. Potential Benefits & Uses
- Common Indications
- Treating or preventing Vitamin B12 deficiency (e.g., pernicious anemia).
- Providing support for neurological health in certain conditions (e.g., peripheral neuropathy).
- Assisting with red blood cell formation and overall energy metabolism.
- Limitations
While many individuals benefit from methylcobalamin injections, this product is not intended to diagnose, treat, cure, or prevent any disease beyond uses recognized by healthcare professionals. Always consult your provider to determine if this therapy is right for you.
3. Contraindications
You should not receive methylcobalamin injections if:
- You have a known allergy or hypersensitivity to Vitamin B12, cobalt, or any ingredient in the formulation.
- You have Leber’s disease (hereditary optic nerve atrophy), as high-dose B12 supplementation could potentially worsen the condition.
- You are pregnant or breastfeeding without first discussing risks and benefits with your healthcare provider.
4. Warnings & Precautions
- Not FDA-Approved for All Uses
- Certain forms or dosages of methylcobalamin may be compounded and not specifically reviewed by the FDA.
-
- Consult a Healthcare Professional
- Inform your provider about your medical history, including any allergies, kidney or liver disease, or blood disorders.
- Discuss any other medications or supplements you are taking, as these may interact with B12 therapy.
-
- Pre-Existing Conditions
- Use caution if you have a history of hematological disorders, as your provider may require regular lab work (e.g., complete blood counts).
-
- Use in Specific Populations
- Safety in pregnant or nursing women has not been fully established for high-dose methylcobalamin.
- Pediatric use should be supervised by a qualified medical professional.
5. Potential Side Effects
While most people tolerate methylcobalamin injections well, side effects can occur. Contact your healthcare provider if you experience any of the following symptoms, especially if they are severe or persistent:
- Injection Site Reactions
- Redness, swelling, tenderness, or mild pain at the injection site.
- If signs of infection (e.g., warmth, pus, significant redness) develop, seek medical attention.
-
- Allergic Reactions
- Itching, rash, hives, swelling of the face/lips/tongue, or difficulty breathing.
- If you experience these signs, discontinue use and seek emergency medical care.
-
- Gastrointestinal Symptoms
- Nausea, diarrhea, or upset stomach may occur.
- Report severe or persistent gastrointestinal issues to your provider.
-
- Dizziness or Headache
- Some individuals may experience mild dizziness or headaches.
- If severe, stop use and consult a healthcare professional.
-
- Hypokalemia (Low Potassium)
- Very rarely, rapid improvement in anemia can cause shifts in potassium levels.
- Symptoms might include muscle weakness, irregular heartbeat, or confusion. Inform your provider if you experience these.
6. Drug Interactions
- Medication and Supplement Considerations
- Metformin, proton pump inhibitors, and other drugs can affect or be affected by B12 status.
- Always inform your healthcare provider of all medications (prescription and over-the-counter), vitamins, or herbal supplements you are taking.
7. Administration & Dosage
- Administration Method
- Typically administered intramuscularly (IM) or subcutaneously (SQ).
- Should be administered by a qualified healthcare professional or according to instructions provided by your medical team.
-
- Dosage
- Dosage and frequency vary based on individual needs (e.g., underlying deficiency, condition severity).
- Follow your provider’s directions precisely. Do not adjust the dose without medical guidance.
-
- Monitoring
- Periodic blood tests (e.g., serum B12 levels, complete blood counts) may be recommended to ensure the therapy is effective and safe.
8. Storage & Handling
- Temperature
- Store as indicated by your pharmacist or on the product label (often refrigerated or at controlled room temperature).
- Sterility
- Use only sterile, unexpired products.
- Do not reuse needles or syringes; dispose of them in approved sharps containers.
9. Adverse Event Reporting
- Immediate Care
- If you experience severe side effects (e.g., difficulty breathing, significant swelling, severe pain), seek immediate medical attention.
- FDA Reporting
- You or your healthcare provider can report suspected adverse reactions to the FDA’s MedWatch Program at 1-800-FDA-1088 or online at www.fda.gov/medwatch.
10. Disclaimer
- Not Evaluated by the FDA for All Uses
- These statements may not be reviewed by the FDA, and methylcobalamin injections are not FDA-approved to diagnose, treat, cure, or prevent any disease beyond recognized indications.
- Consult a Professional
- This information is for educational purposes only and does not replace medical advice, diagnosis, or treatment from a qualified healthcare provider.
- Individual Variation
- Treatment response and side effects may vary. Always follow the advice of your healthcare professional regarding therapy, dosage, and monitoring.
Questions or Concerns?
If you have any questions regarding methylcobalamin (Vitamin B12) injections, including their potential benefits, side effects, or dosage, please consult a qualified healthcare professional.
Sermorelin: Important Safety Information
1. Introduction
- What is Sermorelin?
Sermorelin is a synthetic peptide analog of growth hormone–releasing hormone (GHRH). It works by stimulating the pituitary gland to produce and secrete natural growth hormone (GH). - Regulatory Status
Sermorelin may be prescribed or compounded by certain healthcare providers but may not be approved by the U.S. Food and Drug Administration (FDA) for all uses. If you prefer only FDA-approved medications for your condition, please consult your healthcare provider for alternatives.
2. Potential Benefits & Indications
- Common Uses
Some practitioners use sermorelin to help address growth hormone deficiencies, promote lean body mass, support energy levels, or assist with certain aspects of aging. - Limitations
The efficacy of sermorelin for anti-aging or athletic performance enhancement is not conclusively established in large-scale clinical trials. This product is not intended to diagnose, treat, cure, or prevent any disease beyond those conditions specifically recognized by your healthcare professional.
3. Contraindications
You should not use sermorelin if you:
- Have an active malignancy, especially related to the pituitary gland or hypothalamus.
- Have a known hypersensitivity or allergy to sermorelin or any of its components.
- Are pregnant, planning to become pregnant, or breastfeeding, unless advised otherwise by a qualified healthcare professional.
- Have severe or unstable medical conditions (e.g., uncontrolled diabetes, advanced kidney or liver disease) without close medical supervision.
4. Warnings & Precautions
-
- Not FDA-Approved for All Uses
- Sermorelin may be used off-label for certain conditions. Its safety and efficacy for those uses are not fully evaluated by the FDA.
-
- Consult a Healthcare Professional
- Provide your full medical history to your healthcare provider before starting sermorelin.
- Discuss any other medications, supplements, or therapies you are using, as these can impact sermorelin’s efficacy or risk profile.
-
- Pre-Existing Conditions
- If you have diabetes, thyroid disorders, or any endocrine-related condition, careful monitoring may be needed because sermorelin can affect hormone balance.
-
- Use in Specific Populations
- The safety of sermorelin in children, pregnant women, or nursing mothers has not been thoroughly established outside of specific medical indications.
- Use only under professional guidance if you belong to these populations.
5. Potential Side Effects
Contact your healthcare provider if any symptoms become severe or do not resolve:
- Injection Site Reactions
- Redness, pain, swelling, or itching at the site of injection.
- If signs of infection (e.g., warmth, pus, significant tenderness) occur, seek medical attention.
-
- Flushing or Headaches
- Some people may experience flushing, mild headaches, or lightheadedness.
- If headaches are persistent or severe, discontinue use and consult your healthcare provider.
-
- Nausea or Dizziness
- Occasional nausea or dizziness can occur.
- Discontinue and speak with a healthcare provider if these symptoms worsen or persist.
-
- Increased Hunger
- A change in appetite or mild GI discomfort may be noticed.
-
- Allergic Reactions
- Rash, hives, swelling of the face, lips, tongue, or throat, or difficulty breathing may signal a serious allergic reaction.
- Seek immediate medical care if anaphylaxis is suspected.
6. Drug Interactions
- Other Medications/Supplements
- Sermorelin may interact with medications that influence the endocrine system, glucose metabolism, or other peptides/hormones.
- Always inform your healthcare provider about all prescription, over-the-counter medications, and supplements you use.
7. Administration & Dosage
-
- Administration Method
- Typically administered as a subcutaneous (under the skin) injection.
- Injections should be performed as directed by a qualified healthcare professional or according to detailed instructions provided.
-
- Dosage
- Dosage and frequency vary based on individual factors such as age, body weight, and treatment goals.
- Do not exceed prescribed dosage without consulting your healthcare provider.
-
- Timing & Technique
- Your healthcare provider may advise specific timing (e.g., bedtime) to optimize the natural growth hormone cycle.
- Proper injection technique is essential to minimize side effects and ensure effectiveness.
8. Monitoring & Follow-up
- Lab Tests
- Your healthcare provider may recommend periodic blood tests (e.g., IGF-1 levels) to monitor hormone levels and treatment response.
- Physical Check-ups
- Regular check-ups may be necessary to track weight, body composition, or other health indicators.
9. Storage & Handling
- Storage
- Store sermorelin according to the temperature guidelines provided on the label or by your pharmacist (often refrigerated).
- Shelf Life
- Do not use beyond the expiration date. Discard if the product changes color or appears contaminated.
- Safety
- Keep all medications out of the reach of children.
- Never reuse needles or syringes; follow proper disposal instructions.
10. Adverse Event Reporting
- Severe Reactions
- Discontinue use and seek immediate medical attention if you experience severe or unusual side effects.
- FDA Reporting
- You or your healthcare provider can report suspected adverse reactions to the FDA’s MedWatch Program at 1-800-FDA-1088 or via www.fda.gov/medwatch.
11. Disclaimer
- Not Evaluated by the FDA
- These statements have not been evaluated by the Food and Drug Administration, and sermorelin is not FDA-approved to diagnose, treat, cure, or prevent any condition outside of recognized uses.
- Consult a Professional
- This information is for educational purposes only and should not replace professional medical advice, diagnosis, or treatment.
- Individual Variation
- Responses to sermorelin may vary. Always follow the advice of a qualified healthcare provider regarding initiation, continuation, or modification of therapy.
Questions or Concerns?
If you have any questions regarding sermorelin injections, dosage, benefits, or potential side effects, please consult your qualified healthcare provider.
Metformin (Off-Label Use for Anti-Aging & Weight Loss): Important Safety Information
1. Introduction
- FDA-Approved Use
Metformin is an oral medication primarily approved by the U.S. Food and Drug Administration (FDA) for the management of type 2 diabetes mellitus. It helps improve blood glucose control by decreasing glucose production in the liver and increasing insulin sensitivity. - Off-Label Use
Metformin has garnered interest as a potential agent for anti-aging and weight management, but it is not FDA-approved for these purposes. Efficacy and safety data for these off-label uses are still under investigation in clinical and observational studies.
2. Potential Benefits & Limitations
- Possible Benefits (Off-Label)
- Anti-Aging: Some researchers hypothesize metformin may have protective effects on metabolic and cellular processes related to aging.
- Weight Management: Metformin can help reduce appetite or modestly aid weight reduction in certain individuals, especially those with insulin resistance.
- Limitations
- There is no guarantee of anti-aging or weight-loss results, as evidence is not conclusive for these off-label indications.
- Metformin does not replace lifestyle interventions such as a healthy diet, regular exercise, and balanced sleep.
- This product is not intended to diagnose, treat, cure, or prevent any disease in the context of anti-aging.
3. Contraindications
You should not take metformin if you:
- Have a severe renal impairment or significantly reduced kidney function (e.g., eGFR below certain thresholds—consult your healthcare provider for details).
- Have a known hypersensitivity to metformin or its inactive ingredients.
- Have acute or chronic metabolic acidosis (including diabetic ketoacidosis).
- Are undergoing imaging studies with iodinated contrast (your provider may advise temporarily stopping metformin around the time of the procedure to reduce risk of kidney issues).
- Have any condition associated with hypoxemia or significantly compromised circulation (e.g., heart failure or recent myocardial infarction), which can increase the risk of lactic acidosis.
4. Black Box Warning: Lactic Acidosis
- Serious Risk
Metformin can cause lactic acidosis (a dangerous build-up of lactic acid in the blood). Although rare, it can be fatal. - Risk Factors
- Poorly functioning kidneys.
- Excessive alcohol intake.
- Severe dehydration or infections.
- Use of certain medications (e.g., carbonic anhydrase inhibitors) or conditions reducing tissue perfusion.
- Symptoms
- Rapid breathing, muscle pain, abdominal discomfort, unusual fatigue, dizziness, or feeling cold.
- Seek immediate medical attention if you suspect lactic acidosis.
5. Warnings & Precautions
- Off-Label Status
- Metformin’s benefits for anti-aging or weight loss are not confirmed by large-scale randomized trials. Use under medical supervision if considering for off-label purposes.
- Renal & Liver Function
- Periodic kidney function checks (e.g., eGFR) are essential.
- Caution in patients with hepatic (liver) impairment, as it may increase the risk of lactic acidosis.
- Vitamin B12 Deficiency
- Long-term metformin use may reduce vitamin B12 absorption. Your provider may recommend periodic B12 monitoring and supplementation if needed.
- Hypoglycemia Risk (Low Blood Sugar)
- While metformin alone rarely causes hypoglycemia, the risk may increase if you combine metformin with other anti-diabetic agents (e.g., insulin, sulfonylureas).
- Pregnancy & Breastfeeding
- Safety in pregnant or breastfeeding individuals for anti-aging or weight-loss purposes is not established. Discuss with a qualified healthcare professional before use.
6. Common Side Effects
You may experience mild to moderate side effects when starting or adjusting metformin dosage. Contact your healthcare provider if symptoms become severe or persist.
- Gastrointestinal (GI) Distress
- Nausea, diarrhea, abdominal cramping, bloating, or gas.
- Taking metformin with meals can often help reduce GI side effects.
- Metallic Taste
- A harmless yet noticeable metallic or bitter taste in the mouth.
- Weakness or Fatigue
- May occur initially; consult your provider if persistent or severe.
- Vitamin B12 Deficiency
- Can manifest as numbness, tingling in extremities, or fatigue over long-term use.
7. Drug Interactions
- Other Medications
- Some drugs (e.g., diuretics, corticosteroids, antihypertensives, carbonic anhydrase inhibitors, etc.) can affect metformin’s safety and effectiveness.
- Always inform your healthcare provider of all prescription, over-the-counter medications, vitamins, and herbal supplements you take.
- Alcohol
- Excessive alcohol consumption increases the risk of lactic acidosis and should be avoided or limited while on metformin.
8. Administration & Dosage
- Prescribed Dosage
- Doses vary based on clinical factors such as body weight, kidney function, and potential diabetic risk.
- Do not exceed the recommended dose without medical advice.
- Timing
- Usually taken with meals to reduce GI discomfort.
- Extended-release forms (XR) may be taken once daily, often with the evening meal.
- Monitoring
- Your healthcare provider may recommend periodic blood tests to monitor kidney function, vitamin B12 levels, and overall metabolic health.
9. Storage & Handling
- Storage
- Store at room temperature away from moisture and direct sunlight.
- Keep out of reach of children and pets.
- Integrity
- Check expiration dates. Do not use expired metformin.
- Store tablets in their original packaging whenever possible.
10. Adverse Event Reporting
- Severe Reactions
- Stop taking metformin and seek immediate medical attention if you experience symptoms of lactic acidosis or a severe allergic reaction (e.g., hives, swelling, difficulty breathing).
- FDA Reporting
- Patients or healthcare providers can report suspected adverse reactions to the FDA’s MedWatch Program at 1-800-FDA-1088 or online at www.fda.gov/medwatch.
11. Disclaimer
- Off-Label Use
- Metformin’s use for anti-aging or weight-loss support is not FDA-approved, and scientific consensus on these off-label benefits is still evolving.
- Not a Replacement
- Metformin is not a replacement for a healthy diet, regular exercise, and routine health monitoring.
- Consult a Professional
- This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
Questions or Concerns?
If you have any questions about metformin’s off-label use for anti-aging or weight loss, including potential benefits, side effects, or dosage, please consult a qualified healthcare professional.
Optimize
Sermorelin: Important Safety Information
1. Introduction
- What is Sermorelin?
Sermorelin is a synthetic peptide analog of growth hormone–releasing hormone (GHRH). It works by stimulating the pituitary gland to produce and secrete natural growth hormone (GH). - Regulatory Status
Sermorelin may be prescribed or compounded by certain healthcare providers but may not be approved by the U.S. Food and Drug Administration (FDA) for all uses. If you prefer only FDA-approved medications for your condition, please consult your healthcare provider for alternatives.
2. Potential Benefits & Indications
- Common Uses
Some practitioners use sermorelin to help address growth hormone deficiencies, promote lean body mass, support energy levels, or assist with certain aspects of aging. - Limitations
The efficacy of sermorelin for anti-aging or athletic performance enhancement is not conclusively established in large-scale clinical trials. This product is not intended to diagnose, treat, cure, or prevent any disease beyond those conditions specifically recognized by your healthcare professional.
3. Contraindications
You should not use sermorelin if you:
- Have an active malignancy, especially related to the pituitary gland or hypothalamus.
- Have a known hypersensitivity or allergy to sermorelin or any of its components.
- Are pregnant, planning to become pregnant, or breastfeeding, unless advised otherwise by a qualified healthcare professional.
- Have severe or unstable medical conditions (e.g., uncontrolled diabetes, advanced kidney or liver disease) without close medical supervision.
4. Warnings & Precautions
-
- Not FDA-Approved for All Uses
- Sermorelin may be used off-label for certain conditions. Its safety and efficacy for those uses are not fully evaluated by the FDA.
-
- Consult a Healthcare Professional
- Provide your full medical history to your healthcare provider before starting sermorelin.
- Discuss any other medications, supplements, or therapies you are using, as these can impact sermorelin’s efficacy or risk profile.
-
- Pre-Existing Conditions
- If you have diabetes, thyroid disorders, or any endocrine-related condition, careful monitoring may be needed because sermorelin can affect hormone balance.
-
- Use in Specific Populations
- The safety of sermorelin in children, pregnant women, or nursing mothers has not been thoroughly established outside of specific medical indications.
- Use only under professional guidance if you belong to these populations.
5. Potential Side Effects
Contact your healthcare provider if any symptoms become severe or do not resolve:
- Injection Site Reactions
- Redness, pain, swelling, or itching at the site of injection.
- If signs of infection (e.g., warmth, pus, significant tenderness) occur, seek medical attention.
-
- Flushing or Headaches
- Some people may experience flushing, mild headaches, or lightheadedness.
- If headaches are persistent or severe, discontinue use and consult your healthcare provider.
-
- Nausea or Dizziness
- Occasional nausea or dizziness can occur.
- Discontinue and speak with a healthcare provider if these symptoms worsen or persist.
-
- Increased Hunger
- A change in appetite or mild GI discomfort may be noticed.
-
- Allergic Reactions
- Rash, hives, swelling of the face, lips, tongue, or throat, or difficulty breathing may signal a serious allergic reaction.
- Seek immediate medical care if anaphylaxis is suspected.
6. Drug Interactions
- Other Medications/Supplements
- Sermorelin may interact with medications that influence the endocrine system, glucose metabolism, or other peptides/hormones.
- Always inform your healthcare provider about all prescription, over-the-counter medications, and supplements you use.
7. Administration & Dosage
-
- Administration Method
- Typically administered as a subcutaneous (under the skin) injection.
- Injections should be performed as directed by a qualified healthcare professional or according to detailed instructions provided.
-
- Dosage
- Dosage and frequency vary based on individual factors such as age, body weight, and treatment goals.
- Do not exceed prescribed dosage without consulting your healthcare provider.
-
- Timing & Technique
- Your healthcare provider may advise specific timing (e.g., bedtime) to optimize the natural growth hormone cycle.
- Proper injection technique is essential to minimize side effects and ensure effectiveness.
8. Monitoring & Follow-up
- Lab Tests
- Your healthcare provider may recommend periodic blood tests (e.g., IGF-1 levels) to monitor hormone levels and treatment response.
- Physical Check-ups
- Regular check-ups may be necessary to track weight, body composition, or other health indicators.
9. Storage & Handling
- Storage
- Store sermorelin according to the temperature guidelines provided on the label or by your pharmacist (often refrigerated).
- Shelf Life
- Do not use beyond the expiration date. Discard if the product changes color or appears contaminated.
- Safety
- Keep all medications out of the reach of children.
- Never reuse needles or syringes; follow proper disposal instructions.
10. Adverse Event Reporting
- Severe Reactions
- Discontinue use and seek immediate medical attention if you experience severe or unusual side effects.
- FDA Reporting
- You or your healthcare provider can report suspected adverse reactions to the FDA’s MedWatch Program at 1-800-FDA-1088 or via www.fda.gov/medwatch.
11. Disclaimer
- Not Evaluated by the FDA
- These statements have not been evaluated by the Food and Drug Administration, and sermorelin is not FDA-approved to diagnose, treat, cure, or prevent any condition outside of recognized uses.
- Consult a Professional
- This information is for educational purposes only and should not replace professional medical advice, diagnosis, or treatment.
- Individual Variation
- Responses to sermorelin may vary. Always follow the advice of a qualified healthcare provider regarding initiation, continuation, or modification of therapy.
Questions or Concerns?
If you have any questions regarding sermorelin injections, dosage, benefits, or potential side effects, please consult your qualified healthcare provider.
BPC-157: Important Safety Information
1. Introduction
- What is BPC-157?
BPC-157 is a synthetic peptide derived from a fifteen-amino-acid sequence found in human gastric juice. It is theorized to promote angiogenesis (the development of new blood vessels), which may support increased blood flow and nutrient transport to tissues. - Mechanism of Action
Research suggests that BPC-157 regulates Vaso Endothelial Growth Factor (VEGF) and plays a role in promoting healing, offering cytoprotective properties, and potentially influencing the gut-brain axis and microbiota balance. - Regulatory Status
BPC-157 is not approved by the U.S. Food and Drug Administration (FDA) for any specific medical indication. If you require an FDA-approved therapy, please speak with your healthcare provider about alternative options.
2. Potential Uses & Research
- Regenerative Properties
Emerging literature (primarily from animal models) indicates BPC-157 may help support tissue regeneration, particularly in tendons, ligaments, and skeletal muscle recovery. - Gut-Brain Axis Support
Studies explore BPC-157’s potential role in regulating gut microbiota, influencing cognitive and emotional functioning via the gut-brain axis, and supporting the autonomic, hypothalamic-pituitary-adrenal (HPA), and gastrointestinal (GI) nerve connections. - Inflammation & CNS Disorders
Preliminary data suggest BPC-157 may reduce inflammation, support nerve recovery, and improve outcomes in central nervous system (CNS) disorders. - Limited Human Trials
While animal and preliminary in vitro research is promising, there are few well-controlled human clinical trials on BPC-157, and more data is needed to confirm safety, efficacy, and dosing parameters.
3. Contraindications & Precautions
You should not use BPC-157 if you:
- Are pregnant, planning to become pregnant, or breastfeeding without specific medical advice, as safety data in these populations are lacking.
- Have a known allergy or hypersensitivity to BPC-157 or any ingredient used in its formulation.
- Suffer from severe or unstable medical conditions (e.g., uncontrolled diabetes, advanced kidney/liver disease) without consulting a qualified healthcare professional.
Please consult your healthcare provider before using BPC-157 if you have:
- A history of autoimmune or chronic inflammatory disorders.
- Active malignancies or are undergoing cancer treatment.
- Any serious health conditions requiring ongoing medical management.
4. Possible Side Effects
Although formal human safety data is limited, potential side effects from anecdotal reports or small-scale studies include:
- Injection Site Reactions (if administered via injection)
- Redness, swelling, pain, or irritation at the site of injection.
- Seek medical attention if signs of infection (e.g., warmth, pus) develop.
-
- Gastrointestinal Upset
- Nausea, changes in bowel habits, or mild cramping.
- If GI symptoms are severe or persistent, consult a healthcare professional.
-
- Allergic Reactions
- Rash, itching, swelling of the face/lips/tongue, or difficulty breathing (possible anaphylaxis).
- Discontinue use and seek emergency care if you suspect a severe allergic reaction.
-
- Changes in Mood or Energy
- Some users report shifts in mood, energy levels, or sleep patterns.
- If significant, discuss with your healthcare provider.
Because of limited large-scale studies, other potential side effects may not yet be identified. Always report any unusual symptoms to a medical professional.
5. Administration & Dosage
- Route & Formulation
- BPC-157 may be compounded in various forms, including capsules, subcutaneous injections, or topical formulations.
- The appropriate route depends on the specific condition and medical guidance.
-
- Dosage
- There is no standardized dosing protocol for BPC-157 in humans.
- Your healthcare provider may recommend a customized regimen based on factors such as body weight, medical history, and treatment goals.
-
- Monitoring
- Regular follow-up appointments may be advised to assess tolerance, response, or any side effects.
- Notify your practitioner of any changes in health status during use.
6. Warnings & Limitations
- Off-Label and Experimental Use
BPC-157 is not FDA-approved for any indication; therefore, its use should be considered experimental or off-label. - Limited Human Data
Much of the evidence supporting BPC-157’s benefits comes from animal or in vitro models. Caution is advised until more robust human data is available. - Not a Substitute for Standard Medical Care
BPC-157 should not replace conventional therapies prescribed for medical conditions such as inflammatory diseases, tendon injuries, or gastrointestinal disorders. - Risk vs. Benefit
Discuss potential benefits and risks with your qualified healthcare provider before initiating therapy.
7. Drug Interactions
- Concomitant Medications
- Inform your healthcare provider about any prescription medications, over-the-counter drugs, supplements, or herbal products you are taking.
- Interactions or additive effects on inflammation, tissue repair, or vascular health remain poorly characterized.
8. Storage & Handling
- Temperature & Light
- Store in a cool, dry place, typically refrigerated if instructed by your compounder or pharmacist.
- Protect from direct sunlight and moisture.
- Expiration
- Do not use BPC-157 beyond its expiration date or if the product shows signs of contamination or degradation.
9. Reporting Adverse Events
- Seek Immediate Medical Attention
- If you experience severe adverse events such as difficulty breathing, chest pain, significant swelling, or sudden confusion, seek emergency care.
- Adverse Event Reporting
- Contact your healthcare professional to report any unexpected reactions.
- You can also file a report with the FDA’s MedWatch Program at 1-800-FDA-1088 or online at www.fda.gov/medwatch.
10. Disclaimer
- Not Evaluated by the FDA
- BPC-157 has not been approved by the FDA to diagnose, treat, cure, or prevent any disease.
- Informational Purposes Only
- This document provides general educational information and should not replace advice from a licensed medical professional.
- Individual Variation
- Response to BPC-157 may vary significantly; no outcomes are guaranteed.
Questions or Concerns?
If you have any questions regarding BPC-157, including its mechanism of action, safety profile, or potential off-label uses, please consult a qualified healthcare professional.
Nourish, Revive, Thrive
BPC-157: Important Safety Information
1. Introduction
- What is BPC-157?
BPC-157 is a synthetic peptide derived from a fifteen-amino-acid sequence found in human gastric juice. It is theorized to promote angiogenesis (the development of new blood vessels), which may support increased blood flow and nutrient transport to tissues. - Mechanism of Action
Research suggests that BPC-157 regulates Vaso Endothelial Growth Factor (VEGF) and plays a role in promoting healing, offering cytoprotective properties, and potentially influencing the gut-brain axis and microbiota balance. - Regulatory Status
BPC-157 is not approved by the U.S. Food and Drug Administration (FDA) for any specific medical indication. If you require an FDA-approved therapy, please speak with your healthcare provider about alternative options.
2. Potential Uses & Research
- Regenerative Properties
Emerging literature (primarily from animal models) indicates BPC-157 may help support tissue regeneration, particularly in tendons, ligaments, and skeletal muscle recovery. - Gut-Brain Axis Support
Studies explore BPC-157’s potential role in regulating gut microbiota, influencing cognitive and emotional functioning via the gut-brain axis, and supporting the autonomic, hypothalamic-pituitary-adrenal (HPA), and gastrointestinal (GI) nerve connections. - Inflammation & CNS Disorders
Preliminary data suggest BPC-157 may reduce inflammation, support nerve recovery, and improve outcomes in central nervous system (CNS) disorders. - Limited Human Trials
While animal and preliminary in vitro research is promising, there are few well-controlled human clinical trials on BPC-157, and more data is needed to confirm safety, efficacy, and dosing parameters.
3. Contraindications & Precautions
You should not use BPC-157 if you:
- Are pregnant, planning to become pregnant, or breastfeeding without specific medical advice, as safety data in these populations are lacking.
- Have a known allergy or hypersensitivity to BPC-157 or any ingredient used in its formulation.
- Suffer from severe or unstable medical conditions (e.g., uncontrolled diabetes, advanced kidney/liver disease) without consulting a qualified healthcare professional.
Please consult your healthcare provider before using BPC-157 if you have:
- A history of autoimmune or chronic inflammatory disorders.
- Active malignancies or are undergoing cancer treatment.
- Any serious health conditions requiring ongoing medical management.
4. Possible Side Effects
Although formal human safety data is limited, potential side effects from anecdotal reports or small-scale studies include:
- Injection Site Reactions (if administered via injection)
- Redness, swelling, pain, or irritation at the site of injection.
- Seek medical attention if signs of infection (e.g., warmth, pus) develop.
-
- Gastrointestinal Upset
- Nausea, changes in bowel habits, or mild cramping.
- If GI symptoms are severe or persistent, consult a healthcare professional.
-
- Allergic Reactions
- Rash, itching, swelling of the face/lips/tongue, or difficulty breathing (possible anaphylaxis).
- Discontinue use and seek emergency care if you suspect a severe allergic reaction.
-
- Changes in Mood or Energy
- Some users report shifts in mood, energy levels, or sleep patterns.
- If significant, discuss with your healthcare provider.
Because of limited large-scale studies, other potential side effects may not yet be identified. Always report any unusual symptoms to a medical professional.
5. Administration & Dosage
- Route & Formulation
- BPC-157 may be compounded in various forms, including capsules, subcutaneous injections, or topical formulations.
- The appropriate route depends on the specific condition and medical guidance.
-
- Dosage
- There is no standardized dosing protocol for BPC-157 in humans.
- Your healthcare provider may recommend a customized regimen based on factors such as body weight, medical history, and treatment goals.
-
- Monitoring
- Regular follow-up appointments may be advised to assess tolerance, response, or any side effects.
- Notify your practitioner of any changes in health status during use.
6. Warnings & Limitations
- Off-Label and Experimental Use
BPC-157 is not FDA-approved for any indication; therefore, its use should be considered experimental or off-label. - Limited Human Data
Much of the evidence supporting BPC-157’s benefits comes from animal or in vitro models. Caution is advised until more robust human data is available. - Not a Substitute for Standard Medical Care
BPC-157 should not replace conventional therapies prescribed for medical conditions such as inflammatory diseases, tendon injuries, or gastrointestinal disorders. - Risk vs. Benefit
Discuss potential benefits and risks with your qualified healthcare provider before initiating therapy.
7. Drug Interactions
- Concomitant Medications
- Inform your healthcare provider about any prescription medications, over-the-counter drugs, supplements, or herbal products you are taking.
- Interactions or additive effects on inflammation, tissue repair, or vascular health remain poorly characterized.
8. Storage & Handling
- Temperature & Light
- Store in a cool, dry place, typically refrigerated if instructed by your compounder or pharmacist.
- Protect from direct sunlight and moisture.
- Expiration
- Do not use BPC-157 beyond its expiration date or if the product shows signs of contamination or degradation.
9. Reporting Adverse Events
- Seek Immediate Medical Attention
- If you experience severe adverse events such as difficulty breathing, chest pain, significant swelling, or sudden confusion, seek emergency care.
- Adverse Event Reporting
- Contact your healthcare professional to report any unexpected reactions.
- You can also file a report with the FDA’s MedWatch Program at 1-800-FDA-1088 or online at www.fda.gov/medwatch.
10. Disclaimer
- Not Evaluated by the FDA
- BPC-157 has not been approved by the FDA to diagnose, treat, cure, or prevent any disease.
- Informational Purposes Only
- This document provides general educational information and should not replace advice from a licensed medical professional.
- Individual Variation
- Response to BPC-157 may vary significantly; no outcomes are guaranteed.
Questions or Concerns?
If you have any questions regarding BPC-157, including its mechanism of action, safety profile, or potential off-label uses, please consult a qualified healthcare professional.
GLP-1 Boost: Important Safety Information
1. Introduction
- What is GLP-1 Boost?
GLP-1 Boost is a dietary supplement designed to support healthy metabolism, inspired by mechanisms of glucagon-like peptide-1 (GLP-1). It is formulated with a proprietary blend of hops extract, beetroot powder, nicotinamide mononucleotide (NMN), and berberine, encapsulated in a vegetable capsule (HPMC). - Why GLP-1?
GLP-1 is a hormone known for its glucose-dependent insulin secretion, regulation of gastric emptying, and appetite modulation. It is also studied for its possible anti-inflammatory, cardio- and neuroprotective effects, as well as reduced apoptosis and potential support for learning and memory. - Regulatory Status
GLP-1 Boost is not an FDA-approved product. If you require an FDA-approved medication, such as prescription GLP-1 receptor agonists (e.g., semaglutide, tirzepatide), please consult your healthcare provider for alternatives.
2. Potential Benefits & Ingredients
- Hops Extract
- Known for its antioxidant (polyphenols), anti-inflammatory, and antimicrobial properties.
- May have positive impacts on digestion and relaxation/sleep.
-
- Beetroot Powder
- Rich in betalains (betanin) and nitrates, which can help support antioxidant pathways and potentially reduce LDL cholesterol.
- May contribute to improved exercise capacity and reduced muscle soreness.
-
- Nicotinamide Mononucleotide (NMN)
- A precursor to NAD+, essential for cellular energy and repair processes.
- Often discussed in the context of healthy aging, cellular metabolism, and pro-survival mechanisms.
-
- Berberine
- A plant alkaloid widely used in Eastern medicine for digestive disorders and skin conditions.
- Studies suggest it may help regulate glucose and lipid metabolism and may have hypoglycemic (blood sugar–lowering) properties.
Note on Research
- While some in vitro and animal studies (and small human trials for berberine) show promise for these individual ingredients, robust clinical data in humans on this exact combination (GLP-1 Boost) is currently limited.
- The blend is formulated to mimic or support processes linked to GLP-1 receptor agonists; however, it is not a substitute for prescribed medications.
3. Who Should Avoid or Use Caution
You should not take GLP-1 Boost if you:
- Are pregnant, trying to become pregnant, or breastfeeding, unless specifically advised by a qualified healthcare professional.
- Have a known allergy or hypersensitivity to any of the listed ingredients (hops, beetroot, NMN, berberine) or the capsule constituents.
- Have severe or unstable medical conditions (e.g., advanced liver disease, kidney disease, or heart failure) without close medical supervision.
Consult your healthcare provider before starting GLP-1 Boost if you:
- Have type 1 diabetes, uncontrolled type 2 diabetes, or require insulin therapy.
- Are on medications for blood sugar control (e.g., sulfonylureas, metformin) or other supplements that may interact with these ingredients.
- Have a history of severe gastrointestinal disorders or any condition affecting nutrient absorption.
- Have underlying conditions involving blood pressure, as beetroot nitrates may influence nitric oxide pathways.
4. Possible Side Effects
Although many individuals may tolerate GLP-1 Boost without incident, you could experience:
- Gastrointestinal Distress
- Mild bloating, gas, or changes in bowel habits.
- If persistent or severe, consult a healthcare professional.
-
- Allergic Reactions
- Itching, hives, swelling of the lips/tongue/face, or difficulty breathing (possible anaphylaxis).
- Discontinue immediately and seek medical attention if you suspect an allergic reaction.
-
- Headache or Dizziness
- May occur if you are sensitive to changes in blood sugar or blood pressure.
- If pronounced, discontinue and consult a qualified provider.
-
- Blood Sugar Fluctuations
- Possible for those who are on other hypoglycemic agents or have impaired glucose tolerance.
- Monitor blood sugar levels as advised by your physician.
-
- Low Blood Pressure
- Especially if combined with other blood pressure–lowering agents or if you are prone to hypotension.
5. Drug Interactions
- Medications for Diabetes
- Berberine and NMN may influence glucose metabolism and insulin sensitivity; combining them with anti-diabetic medications may increase the risk of hypoglycemia.
- Blood Pressure Medications
- Beetroot (and its nitric oxide effects) could influence blood pressure, requiring careful monitoring with antihypertensives.
- Other Supplements or Herbs
- Hops or berberine might potentiate or reduce the efficacy of other herbal therapies or supplements.
- Always Inform Your Healthcare Provider
- Disclose all prescription drugs, over-the-counter medications, vitamins, and herbal products you are taking before starting GLP-1 Boost.
6. Usage & Dosing
- Recommended Dosage
- Follow instructions provided on the label or as directed by your healthcare professional.
- Do not exceed the recommended serving size without professional guidance.
- Timing
- Some components may be better absorbed with meals. Check with a healthcare professional for best timing.
- Storage
- Store in a cool, dry place away from direct sunlight. Keep out of reach of children.
7. Additional Considerations
- Not a Substitute for Prescription Medications
- GLP-1 Boost is a dietary supplement, not a prescription GLP-1 receptor agonist (e.g., semaglutide, tirzepatide). It should not replace medications prescribed for metabolic disorders or diabetes.
- Lifestyle Factors
- For optimal results, combine this supplement with a balanced diet, regular exercise, proper hydration, and adequate rest.
- Individual Results May Vary
- Response to dietary supplements can differ significantly among individuals based on genetics, health status, and lifestyle factors.
8. Disclaimer
- Not Evaluated by the FDA
- These statements have not been evaluated by the U.S. Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
- Consult a Professional
- This information is provided for educational purposes only and does not replace professional medical advice.
- No Guaranteed Outcomes
- While some evidence supports the individual ingredients, results are not guaranteed, and research is still evolving.
9. Reporting Adverse Events
- Seek Medical Care
- If you experience severe side effects or adverse events (e.g., difficulty breathing, severe allergic reactions, acute hypoglycemia), discontinue use and seek immediate medical attention.
- FDA MedWatch
- You or your healthcare provider can report suspected adverse reactions to the FDA’s MedWatch Program by calling 1-800-FDA-1088 or visiting www.fda.gov/medwatch.
Questions or Concerns?
If you have any questions regarding GLP-1 Boost—whether about potential benefits, side effects, or interactions—please consult a qualified healthcare professional.
Ridiculously simple
Doctor-recommended treatment tailored to your needs for lasting results
Take the quiz to see which treatment is right for you.
A qualified professional will evaluate your answers.
We’ll ship the treatment right to your door, for free.
Frequently asked questions
What if I need to cancel?
We understand that circumstances may change, and there are no long-term contracts or cancellation fees involved. Just log into our patient portal to manage or cancel your appointment. It’s quick, easy, and hassle-free.
Do I need insurance?
No, IVY RX does not require insurance. We keep things simple with transparent pricing, straightforward billing, and affordable generic options—making it easier than ever to take care of yourself.
Can I talk to a doctor?
Absolutely! You can quickly and securely message your care providers through our patient portal. Simply log in, choose your provider, and send them a message. It’s that easy!
Do your treatments include prescriptions and medications?
Yes! IVY RX covers the cost of the doctor’s visit, prescription medications, and free shipping—no hidden or extra fees. Medications are provided only after a qualified physician determines they’re right for you. Plus, Eden’s comprehensive package includes ongoing support and regular check-ins to help you get the most out of your treatment.
Is shipping included with each order?
Yes! Shipping is included with every order, so you’ll never have to worry about extra fees or hidden costs. Your treatment ships directly to your door—free of charge.
Still have questions?
