Semaglutide / Methylcobalamin ODT

Semaglutide

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.

Methylcobalamin

Methylcobalamin is a form of vitamin B12.

ODTs

Orally disintegrating tablets (ODT) are designed to rapidly dissolve in the mouth, which may assist with patient compliance, particularly for individuals who experience difficulty swallowing.

This product is a compounded drug that is not FDA-approved. FDA has made no determination concerning its safety or efficacy. These ingredients carry risks. This compounded drug product is available only pursuant to a valid prescription from your healthcare provider.

Semaglutide

Patients should not take this medication if they are allergic to any components of this product. Patients should be advised to stop taking this medicine and seek immediate medical attention if they have any signs of a severe allergic reaction such as rash or hives spreading across the body, any swelling of the face, tongue, or throat, or any signs of trouble breathing. This is not a complete list of key warnings and precautions.

Methylcobalamin

Methylcobalamin may not be suitable for individuals with hypersensitivity to cobalamin or cobalt. Vitamin B12 may cause side effects such as headache, nausea, and diarrhea. Use should be monitored to avoid potential interactions with other medications, such as metformin, which may reduce B12 absorption.

Patients should not take this medication if they are allergic to any components of this product. Patients should be advised to stop taking this medicine and seek immediate medical attention if they have any signs of a severe allergic reaction such as rash or hives spreading across the body, any swelling of the face, tongue, or throat, or any signs of trouble breathing. This is not a complete list of key warnings and precautions.

Semaglutide Interactions

Drug-Drug Interactions: Semaglutide, a GLP-1 receptor agonist, may interact with several medications. Caution is advised when semaglutide is used concomitantly with insulin, metformin, or warfarin, potentially necessitating dose adjustments. Semaglutide may delay gastric emptying, which may affect the absorption of orally administered medications.

Drug-Supplement Interactions: While specific interactions between semaglutide and common supplements have not been definitively established, caution is generally advised when introducing any new supplement while taking semaglutide and should be discussed with a healthcare provider.

Patients should be instructed to give their health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements they use. Patients should also inform their healthcare provider if they smoke, drink alcohol, or use illegal drugs. Some items may interact with this medicine. This is not a complete list of potential interactions.

Methylcobalamin Interactions

Drug-Drug Interactions: Methylcobalamin, a form of vitamin B12, may interact with metformin, which may reduce vitamin B12 absorption. Interactions may also occur with proton pump inhibitors and colchicine.

Drug-Supplement Interactions: Concurrent intake of vitamin C may reduce the amount of vitamin B12 available in the body.

Patients should be instructed to give their health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements they use. Patients should also inform their healthcare provider if they smoke, drink alcohol, or use illegal drugs. Some items may interact with this medicine. This is not a complete list of potential interactions.

Like many medications, Semaglutide / Methylcobalamin ODT may cause adverse reactions. It is important to be aware of potential side effects and for patients to discuss any concerns with their healthcare provider.

Semaglutide Potential Adverse Effects

• Patients using semaglutide may experience nausea, vomiting, diarrhea, constipation, bloating, or abdominal pain.
• Semaglutide may cause blurred vision, anxiety, or chest tightness.
• In some cases, semaglutide has been associated with thyroid tumors, pancreatitis, and kidney problems.
• Respiratory side effects of semaglutide may include cough.

Patients should be advised to stop taking this medicine and seek immediate medical attention if they have any signs of a severe allergic reaction such as rash or hives spreading across the body, any swelling of the face, tongue, or throat, or any signs of trouble breathing. This is not a complete list of potential side effects. Patients should be advised to call their healthcare provider if they experience any unusual side effects or have any questions.

Methylcobalamin Potential Adverse Effects

• Side effects of methylcobalamin may include headache, nausea, and vomiting.
• Other side effects of methylcobalamin may include diarrhea or skin rash.
• Vitamin B-12 may cause allergic reactions in certain patients.

Patients should be advised to stop taking this medicine and seek immediate medical attention if they have any signs of a severe allergic reaction such as rash or hives spreading across the body, any swelling of the face, tongue, or throat, or any signs of trouble breathing. This is not a complete list of potential side effects. Patients should be advised to call their healthcare provider if they experience any unusual side effects or have any questions.

Potential Risk Factors

Semaglutide

• Risk Factors: A history of thyroid cancer, pancreatitis, or kidney disease may increase the risk of certain adverse effects with semaglutide. Semaglutide should not be used in patients with a personal or family history of thyroid cancer.
• Variability: Elderly patients may be more sensitive to the potential effects of semaglutide.

Methylcobalamin

• Risk Factors: Allergies to cobalamin may increase the risk of adverse effects with Vitamin B-12.
• Dose-Related Effects: Vitamin B-12 may cause side effects like headache.
• Variability: Individual response to Vitamin B-12 may vary, especially in patients with preexisting conditions like kidney disease or diabetes mellitus.

Semaglutide and Pregnancy

Semaglutide, a GLP-1 receptor agonist, should not be used during pregnancy due to potential risks. There are no adequate human studies on semaglutide or compounded semaglutide with methylcobalamin use during pregnancy to determine risk.

Methylcobalamin (Vitamin B12) and Pregnancy

There is limited information regarding vitamin B-12 supplementation during pregnancy. Healthcare providers should carefully weigh potential benefits of supplementation versus potential risks with patients and, if appropriate, which vitamin B-12 formulation best suits the patient’s needs.

Semaglutide and Breastfeeding

There is no sufficient data regarding semaglutide or its metabolites in human milk and the possible risk to breastfed infants.

Methylcobalamin and Breastfeeding

Vitamin B12 is naturally present in breast milk. Healthcare providers should carefully consider the potential benefits of vitamin B-12 supplementation versus potential risks in lactating mothers and, if appropriate, which vitamin B-12 formulation best suits the patient’s needs.

Store between 68°F to 77°F (20°C – 25°C). Properly discard any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain. Keep all medicine out of the reach of children and pets.