Biotin 5mg | Dutasteride 0.4mg | Minoxidil 1mg

Route: Oral capsule for systemic administration.

• Swallow whole with water; may be taken with or without food.
• Take at the same time each day for consistent drug levels.
• Do not crush or open the capsule unless directed by the prescriber.
• If a dose is missed, take as soon as remembered that same day; do not double-dose.

Dosing is prescriber-determined. General reference parameters for the individual components:

• Dutasteride: FDA-approved dose for BPH is 0.5 mg once daily; off-label alopecia studies use 0.5 mg daily, and some protocols use lower doses. The 0.4 mg dose in this formulation is a prescriber-individualized amount.
• Minoxidil: Low-dose oral minoxidil (0.25–2.5 mg daily) is used off-label for alopecia; 1 mg daily is within the studied low-dose range.
• Biotin 5 mg: A commonly prescribed oral biotin supplementation dose for hair/nail concerns.
• As with all systemic therapies for alopecia, response requires at least 3–6 months of consistent use before assessment.

• Biotin: Essential coenzyme for acetyl-CoA carboxylase and propionyl-CoA carboxylase; deficiency causes hair loss through disrupted fatty acid and protein synthesis; supplementation restores keratin-building metabolic pathways. Not effective for hair loss in biotin-sufficient individuals beyond addressing deficiency.
• Dutasteride: Competitive inhibitor of all three 5-alpha-reductase isoforms (I, II, III); reduces conversion of testosterone to DHT in peripheral tissues, scalp, and prostate; achieves ~99% reduction in serum DHT levels vs. ~70% with finasteride, providing more complete androgen suppression in follicles prone to DHT-mediated miniaturization.
• Minoxidil (oral): Converted to minoxidil sulfate, which opens ATP-sensitive potassium channels in vascular smooth muscle and directly in follicular dermal papilla cells; systemic delivery provides consistent scalp follicular exposure independent of topical application technique; extends anagen phase and increases follicular caliber.

This combination capsule is indicated for patients with androgenetic alopecia where topical therapy is insufficient or poorly tolerated, or where systemic therapy is preferred. Dutasteride provides more complete DHT suppression than finasteride and is supported by multiple randomized controlled trials for male androgenetic alopecia. Low-dose oral minoxidil has been studied extensively in both male and female androgenetic alopecia.

Prescriber monitoring:

• Confirm that patient is not pregnant and will not become pregnant during treatment (both dutasteride and low-dose oral minoxidil carry teratogenicity and reproductive concerns).
• Monitor blood pressure and heart rate periodically, especially during the first 3 months; low-dose oral minoxidil can cause fluid retention and reflex tachycardia.
• Assess for edema, which may require diuretic cotherapy.
• Monitor PSA in men: dutasteride reduces PSA by ~50%; adjust interpretation accordingly.
• For men: counsel on potential sexual side effects (libido, ejaculation, gynecomastia) from dutasteride.

Contraindications:

• Pregnancy or women who may become pregnant (dutasteride and minoxidil are contraindicated; dutasteride is absorbed dermally from capsule contents)
• Known hypersensitivity to dutasteride, finasteride (cross-reactivity possible), minoxidil, or biotin
• Pericardial effusion or cardiac disease (precaution for oral minoxidil)

Warnings & Precautions:

• Dutasteride teratogenicity: Can be absorbed through skin from a broken/open capsule; women of childbearing potential should not handle crushed capsules. Dutasteride remains detectable in semen for up to 6 months after discontinuation.
• Oral minoxidil cardiovascular effects: Even at 1 mg, oral minoxidil may cause fluid retention, peripheral edema, pericardial effusion, and reflex tachycardia; use caution in patients with cardiac or renal comorbidities.
• PSA masking: Dutasteride suppresses PSA by approximately 50%; this must be accounted for in prostate cancer screening.
• Dutasteride has a long half-life (~5 weeks); effects and side effects may persist for months after discontinuation.

Drug Interactions:

• CYP3A4 inhibitors (ketoconazole, ritonavir) increase dutasteride plasma concentrations.
• Guanethidine combined with oral minoxidil may cause severe hypotension.
• Antihypertensives may have additive hypotensive effects with oral minoxidil.

Common Side Effects: Decreased libido, ejaculatory dysfunction, gynecomastia (dutasteride); hypertrichosis (generalized hair growth), peripheral edema, fluid retention, reflex tachycardia (low-dose oral minoxidil); biotin at 5 mg is generally well-tolerated but may interfere with biotin-based laboratory assay results (thyroid function tests, cardiac troponin).

Store at controlled room temperature (20–25°C / 68–77°F). Protect from moisture and excessive heat. Keep capsules in the original container with the lid tightly closed. Do not expose to moisture; avoid storing in bathrooms. Use before the beyond-use date assigned by Genesis Compounding. Women who are pregnant or may become pregnant should not handle this medication.

Why is dutasteride preferred over finasteride in this formulation?

Dutasteride inhibits all three isoforms of 5-alpha-reductase (types I, II, and III), reducing DHT by up to 99% compared to finasteride's ~70%. This more complete DHT suppression may be more effective for patients with androgenetic alopecia who have not responded adequately to finasteride.

Is 1 mg of oral minoxidil safe?

Low-dose oral minoxidil (0.25–2.5 mg daily) is increasingly used for hair loss and is generally well-tolerated at these doses. The most common adverse effects are mild hypertrichosis (unwanted hair growth elsewhere on the body), fluid retention, and mild tachycardia. Your prescriber will monitor you for these effects.

Can women use this capsule?

Women who are pregnant or may become pregnant must not use or handle this medication. Dutasteride is teratogenic and may be absorbed even through skin contact with broken capsules. Women without childbearing potential should discuss the risks and benefits with their prescriber before use.

Will biotin improve my hair growth?

Biotin supports keratin synthesis and is included as a nutritional cofactor. Clinical benefit from biotin supplementation is most apparent in individuals with biotin deficiency. In biotin-sufficient individuals, its contribution to hair growth is modest, but it is a safe and commonly used adjunct in hair health protocols.

Is this product FDA-approved?

This is a 503A compounded capsule prepared by Genesis Compounding for a specific patient based on a prescriber's order. It is not an FDA-approved combination product. Each active ingredient (dutasteride, minoxidil, biotin) is an established compound; dutasteride is FDA-approved for BPH and oral minoxidil for hypertension, with hair loss use being off-label.