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Audeotherapy.com

Disclaimer

General Disclaimer

The information provided by AudeoTherapy regarding its products is strictly for informational purposes and does not constitute an FDA-approved label or endorsement. All formulations and recommendations are based on scientific research and are not intended to replace professional medical guidance. Products offered by AudeoTherapy, including compounded formulations, are not FDA-approved, and the company does not guarantee their safety or efficacy for specific uses or conditions.

 

The decision to use these formulations should be made by a licensed healthcare professional, taking into account the individual’s unique health circumstances and specific needs. AudeoTherapy disclaims any responsibility for harm or adverse effects resulting from misuse, improper application, or use of its products beyond their intended purpose.

 

Any licensed pharmacies partnered with AudeoTherapy adhere to all applicable legal and regulatory requirements, including Section 503A of the Food, Drug, and Cosmetic Act. This ensures that compounded products are dispensed only with a valid prescription for an identified patient. Additionally, all ingredients used must comply with regulatory standards and must not appear on the FDA’s prohibited substances list.

 

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Safety Information

Critical Details About Compounded Semaglutide

Compounded medications are legally allowed to be prescribed under federal law; however, they are not FDA-approved and do not undergo FDA evaluation for safety, efficacy, or production standards. At AudeoTherapy, compounded semaglutide is prescribed based on an individualized medical assessment.

WARNING: Potential Risk of Thyroid C-Cell Tumors
Research in animals has linked semaglutide, the active ingredient in some GLP-1 receptor agonists, to thyroid tumors, including medullary thyroid carcinoma (MTC). It is unclear if semaglutide causes similar tumors in humans. Notify your healthcare provider immediately if you notice symptoms of thyroid cancer, such as neck lumps or swelling, hoarseness, swallowing difficulties, or shortness of breath. Compounded semaglutide is not suitable for individuals with personal or family histories of MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Uses of Compounded Semaglutide
Compounded semaglutide is intended for use alongside a reduced-calorie diet and increased physical activity to manage chronic weight in adults who meet the following criteria:

  • A body mass index (BMI) of 30 kg/m² or higher (classified as obesity), or
  • A BMI of 27 kg/m² or higher (overweight) with at least one weight-related condition, such as type 2 diabetes, hypertension, or abnormal cholesterol levels.

Usage Restrictions

  • Do not use compounded semaglutide in combination with other GLP-1 receptor agonists or semaglutide-containing products.
  • Its safety and effectiveness when combined with other weight management medications have not been established.
  • Patients with a history of pancreatitis or gastroparesis have not been studied for this treatment.

Avoid Use If You:

  • Have a personal or family history of medullary thyroid carcinoma (MTC) or MEN 2.
  • Are diagnosed with type 1 diabetes, pancreatitis, or gastroparesis.
  • Are allergic to semaglutide or any inactive ingredients.
  • Have a history of suicidal thoughts or behavior.

Precautions and Warnings:

  • Acute Pancreatitis: Stop using the medication if pancreatitis is suspected.
  • Gallbladder Issues: Monitor for symptoms of gallbladder disease, including gallstones, and seek medical advice as needed.
  • Low Blood Sugar: When combined with insulin or similar medications, there is an increased risk of hypoglycemia. Regularly monitor blood sugar and adjust doses as recommended by your provider.
  • Kidney Health: Monitor kidney function, particularly in patients with renal impairment or those experiencing severe gastrointestinal effects.
  • Mental Health Concerns: Watch for mood changes, depression, or suicidal thoughts, and discontinue use if these symptoms occur.

Pregnancy and Fertility Considerations
Semaglutide may harm an unborn child. Avoid use during pregnancy or if planning to become pregnant. Stop treatment at least two months before attempting to conceive.

Common Side Effects:
Frequently reported side effects include nausea, vomiting, diarrhea, constipation, abdominal pain, fatigue, headaches, and low blood sugar in patients with type 2 diabetes.

Potential Drug Interactions:
Compounded semaglutide slows gastric emptying, which could impact the absorption of oral medications. Consult your healthcare provider to manage potential interactions effectively.

Medication Disclaimer

Essential Information on Medications: Saxenda®, Victoza®, Wegovy®, and Ozempic® are patented products of Novo Nordisk™, while Eli Lilly and Company™ produce Mounjaro™ and Zepbound. This website is not affiliated with, endorsed by, or connected to these companies or their products in any capacity. While these FDA-approved medications may be available through other sources, we do not provide them, and they are currently experiencing supply shortages. During such shortages, pharmacies might prepare compounded versions of these drugs, provided they comply with the Federal Food, Drug, and Cosmetic Act’s requirements. Compounded medications are valuable for patients with unique medical needs that FDA-approved drugs cannot address. However, it is important to note that compounded drugs are not FDA-approved, nor do they undergo premarketing evaluations for safety, effectiveness, or quality. The FDA has not assessed these medications for their intended uses, nor has the manufacturing process for compounded drugs been reviewed by the FDA.