Important Safety Information: Finasteride, Biotin, Vitamin C | Compounded

What is this?

This Important Safety Information summarizes key warnings and precautions for Finasteride, Biotin, and Vitamin C in a customized compounded formulation. Finasteride is commonly used to support hair health and hormone-related conditions. Biotin and Vitamin C are vitamins that support hair, skin, and overall cellular health. This compounded formulation is not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy and should only be used exactly as directed by a licensed healthcare provider. This summary does not include all available information. Always read your medication label and follow your provider’s instructions. 

Most Serious Warnings

Product can cause:

• Severe allergic reactions, including swelling of the face, lips, tongue, or throat

• Hormonal changes related to finasteride use

• Sexual side effects such as decreased libido or erectile dysfunction

• Mood changes or depressive symptoms

• Breast tenderness or enlargement

• Potential risk to a male fetus if exposed during pregnancy

Compounded formulations may carry sterility or formulation risks due to limited FDA oversight.

Who Should NOT Take This Medication

Do not take this medication if you:

• Have a known allergy to finasteride, biotin, vitamin C, or any ingredient in the formulation

• Are pregnant or may become pregnant, especially if carrying a male fetus

• Have been advised by your provider to avoid 5-alpha reductase inhibitors

• Have a history of serious hypersensitivity reactions to similar medications

Before Taking This Medication, Tell Your Healthcare Provider if You:

• Have liver disease or abnormal liver function tests

• Have a history of depression or mood disorders

• Have prostate conditions or elevated PSA levels

• Are taking prescription medications, over the counter drugs, supplements, or herbal products

• Smoke, drink alcohol, or use recreational drugs

• Have any known allergies to medications, foods, or substances

Possible Side Effects

Common (mild to moderate):

• Decreased libido

• Erectile dysfunction

• Reduced semen volume

• Breast tenderness

• Mild skin reactions

Serious (seek medical care immediately):

• Swelling of the face, lips, tongue, or throat

• Difficulty breathing

• Severe rash or hives

• Persistent mood changes, depression, or suicidal thoughts

• New breast lumps, pain, or nipple discharge

While Taking This Medication

Tell your healthcare provider if:

• Your symptoms do not improve in a timely manner

• You develop new or worsening symptoms

• You experience sexual side effects that persist

• You notice breast changes or mood changes

It may take time for this medication to begin working and for noticeable changes to occur.

Overdose

If overdose is suspected, seek emergency medical attention or contact Poison Control immediately.

Missed Dosage

If you miss a scheduled dose:

• Take the missed dose when you remember, unless it is near the time for your next dose

• If it is near the next scheduled dose, skip the missed dose

• Do not double doses

Storage

• Store according to the instructions listed on your pharmacy label

• Keep out of reach of children and pets

Medication Disposal

Dispose of unused or expired medication according to local medication disposal guidelines. Do not flush medication or dispose of it in household drains.

Provider Oversight and Order Review

This compounded medication requires review and oversight by a licensed Superior Health and Wellness provider. Dosing and therapy schedules must be discussed directly with your provider to ensure safety and clinical appropriateness. Orders may be adjusted based on labs, response, or treatment goals.

Telemedicine Disclosure

This prescription may be issued via telemedicine. If you experience any concerning or severe symptoms, contact your prescribing clinician immediately or seek emergency medical care.

Disclaimer

This summary does not include all information about this compounded formulation and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment recommendations. This compounded medication has not been evaluated or approved by the FDA for safety or efficacy.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.