PROSNORM 5 MG 30 TAB

Indications

Approved Uses

Benign prostatic hyperplasia (BPH) in men with an enlarged prostate: improves symptoms and reduces the risk of acute urinary retention and the need for BPH-related surgery.

Off-Label Uses

Androgenetic alopecia in men (typically 1 mg daily; different strength/product). Other off‑label uses sometimes include hirsutism in women (specialist use; contraindicated in pregnancy) and limited/controversial use in prostate cancer risk modification.

Dosage & Administration

Dosing by Condition

BPH: 5 mg orally once daily (monotherapy or with an alpha‑blocker); assess benefit after ~6 months of therapy.

Initial Dose

5mg orally once daily.

Maintenance Dose

5mg orally once daily.

Maximum Dose

5mg orally once daily.

Children's Dosage

Not approved for children.

How to Take

Swallow the 5 mg film‑coated tablet whole with water; may be taken with or without food, preferably at the same time each day. Do not crush or split; women who are pregnant or may become pregnant should not handle crushed/broken tablets.

Side Effects

Common Side Effects

Erectile dysfunction, decreased libido, ejaculation disorder (including decreased ejaculate volume), breast tenderness, rash.

Side Effect Frequency

Common (≈1-10%): decreased libido, erectile dysfunction, ejaculation disorder (including decreased ejaculate volume). Breast tenderness/enlargement (gynecomastia) can occur but is generally less common than sexual AEs. Uncommon/rare: hypersensitivity reactions (rash, pruritus, urticaria, angioedema), depression/mood changes, testicular pain; rare reports include male breast cancer-advise reporting breast changes.

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to finasteride/excipients; pregnancy (and women who are or may become pregnant-should not use/handle crushed or broken tablets); use in women; pediatric patients.

Warnings & Precautions

Key warnings/precautions: reduces PSA by ~50%-adjust interpretation and investigate any rise from nadir; evaluate for prostate cancer before and during therapy; possible high-grade prostate cancer signal; women who are or may become pregnant must not handle crushed/broken tablets (fetal risk); monitor for depression/suicidal ideation; counsel to report breast changes.

Age Restriction

Not approved/recommended for use in patients <18 years; indicated for adult men only (BPH).

Driving Warning

Safe

Drug Interactions

Interaction Severity

No clinically significant drug-drug interactions are generally identified; CYP3A4 modulators may change levels slightly but typically without clinical relevance.

Food Interaction

No clinically meaningful food interaction; may be taken with or without food.

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

Not approved for children.

Elderly

Standard adult dosing; no dose adjustment required, although half-life may be slightly prolonged in men ≥70 years without clinical significance

Kidney Impairment

No adjustment needed.

Liver Impairment

No specific dose adjustment is provided; use with caution in hepatic impairment (especially severe) due to hepatic metabolism.

Storage & Patient Advice

Missed Dose

If a dose is missed, skip it and take the next dose at the usual time; do not take a double dose.

Stopping the Medicine

Can be stopped without taper; after discontinuation, BPH benefits (symptom improvement and reduced prostate volume) gradually diminish and symptoms/prostate size tend to return toward baseline within ~6-12 months.

Overdose

No specific overdose symptoms or antidote identified; single doses up to 400 mg and multiple doses up to 80 mg/day for ~3 months have been given without significant adverse effects; manage with supportive/symptomatic care and medical evaluation.

Patient Counseling

Take 1 tablet (finasteride 5 mg) by mouth once daily, with or without food, at the same time each day; benefit for BPH may take ~3-6 months and therapy should be continued as prescribed. If a dose is missed, take it when remembered the same day; if it is close to the next dose, skip-do not double. Tell clinicians/labs you take finasteride because it lowers PSA (PSA values are typically interpreted as ~doubled after ≥6 months of therapy). Women who are pregnant or may become pregnant must not handle crushed/broken tablets (risk to male fetus). Seek medical advice promptly for breast changes (lump, pain, nipple discharge), allergic reaction, mood changes/depression, or bothersome/persistent sexual adverse effects.

Monitoring Requirements

Baseline and periodic PSA and digital rectal exam per prostate cancer screening standards; interpret PSA by accounting for ~50% reduction after ~6 months on finasteride; monitor symptom response (e.g., IPSS) and adverse effects.

Pharmacology

Mechanism of Action

Selective inhibition of Type II 5‑alpha‑reductase, blocking conversion of testosterone to dihydrotestosterone (DHT), thereby lowering serum/intraprostatic DHT and reducing prostate volume over time.

Onset of Action

Biochemical DHT reduction occurs within hours to days, but BPH symptom improvement typically requires ~3-6 months, with maximal benefit often by 6-12 months.

Duration of Effect

DHT suppression is maintained over the 24‑hour dosing interval with once‑daily dosing; prostate volume/symptom benefits persist only with continued therapy and gradually reverse after discontinuation.

Excretion

Excretion is mainly as metabolites: ~57% in feces and ~39-40% in urine.

Protein Binding

Approximately 90%.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 5 mg finasteride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Urological Condition

BPH

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 19-07-2026