PROPECIA 1/MG FC TAB 28/FC TAB

Indications

Approved Uses

Treatment of male pattern hair loss (androgenetic alopecia) in men only.

Dosage & Administration

Dosing by Condition

Male androgenetic alopecia: 1 mg orally once daily.

Initial Dose

1mg once daily orally

Maintenance Dose

1mg once daily orally (continuous long-term use required)

Maximum Dose

1 mg once daily for androgenetic alopecia.

Children's Dosage

Not approved for children or adolescents under 18 years

How to Take

Swallow 1 mg tablet whole with water once daily; may be taken with or without food; take at the same time each day. Women who are pregnant or may become pregnant should not handle crushed or broken tablets.

Side Effects

Common Side Effects

Decreased libido, erectile dysfunction, ejaculation disorder (including decreased ejaculate volume).

Side Effect Frequency

Common (≈1-10%): decreased libido, erectile dysfunction, ejaculation disorder (including decreased ejaculate volume). Uncommon/rare: breast tenderness/gynecomastia and testicular pain; hypersensitivity reactions (rash, urticaria, angioedema); depression/mood changes (rare) and reports of suicidal ideation; male breast cancer is very rare.

Safety & Warnings

Contraindications

Contraindicated in pregnancy (and in women who are or may become pregnant) and in patients with hypersensitivity to finasteride or any excipients; not indicated for use in women or children.

Warnings & Precautions

For use in men only; women who are or may be pregnant must not handle crushed/broken tablets due to fetal risk; finasteride lowers PSA (approximately 50%) so PSA interpretation should be adjusted; monitor for mood changes (depression/suicidal ideation) and sexual adverse effects; counsel regarding possible high-grade prostate cancer signal.

Age Restriction

Not approved for use in patients <18 years; indicated for adult men only (typically ≥18 years).

Drug Interactions

Drug Interactions

No clinically significant drug interactions have been identified; finasteride does not meaningfully inhibit/induce CYP enzymes, and routine dose adjustment with CYP3A modulators is not recommended.

Food Interaction

No food restriction; may be taken with or without food.

Special Populations

Pregnancy

Contraindicated

Children

Not approved for children or adolescents under 18 years

Storage & Patient Advice

Stopping the Medicine

Can be stopped at any time without tapering; discontinuation leads to loss of hair-growth benefit with reversal typically within ~12 months.

Overdose

No specific overdose symptoms identified; single doses up to 400 mg and multiple doses up to 80 mg/day for 3 months were tolerated in studies; manage with symptomatic/supportive care and seek medical attention-no specific antidote.

Patient Counseling

Take 1 mg orally once daily, with or without food, consistently; expect onset after ~3 months and assess benefit by 6-12 months (continued use needed to maintain effect; stopping typically leads to loss of regrown hair within ~12 months). For men only: women who are pregnant or may become pregnant must not handle crushed/broken tablets. Inform clinicians about finasteride before PSA testing (PSA is reduced ~50%). Seek medical advice for sexual adverse effects, mood changes/depression, and report any breast changes (lumps, pain, nipple discharge).

Monitoring Requirements

No routine labs required for alopecia; if PSA testing is performed for prostate cancer screening, interpret with adjustment (finasteride lowers PSA ~50%). Monitor for sexual adverse effects and mood changes (including depression/suicidal ideation).

Pharmacology

Mechanism of Action

Competitive, specific inhibitor of Type II 5α-reductase, blocking conversion of testosterone to dihydrotestosterone (DHT) and thereby lowering serum/scalp DHT.

Onset of Action

At least 3 months of daily use is needed to see benefit; maximal effect typically requires 6-12 months (and may continue improving up to ~12-24 months).

Duration of Effect

Benefit is maintained only with continuous daily use; effects are lost and hair loss resumes within about 12 months after stopping.

Half-Life

Mean terminal half-life in plasma is approximately 4.5 hours (range 3.3-13.4 hours); age-specific variations are not detailed in the prescribing information

Bioavailability

Approximately 65%.

Protein Binding

Approximately 90%.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 1mg finasteride.

Generic Availability

Yes

Primary Use

Treatment of male androgenetic alopecia (male pattern hair loss) to slow hair loss and promote hair regrowth in adult men

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