FINASID 5MG TAB

Indications

Approved Uses

Benign prostatic hyperplasia (BPH) in men (including reduction in risk of acute urinary retention and need for BPH-related surgery); androgenetic alopecia is approved for finasteride 1 mg products, not for this 5 mg BPH product.

Dosage & Administration

Dosing by Condition

Benign prostatic hyperplasia (BPH): 5 mg orally once daily (with or without food); assess response after ~6 months; continue long term if effective.

Initial Dose

5mg orally once daily.

Maintenance Dose

5mg orally once daily.

Maximum Dose

5mg per day

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Renal impairment: no dosage adjustment required. Hepatic impairment: use caution (hepatic metabolism); no specific dose adjustment established.

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 break; women who are pregnant or may become pregnant must not handle crushed/broken tablets.

Side Effects

Common Side Effects

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

Side Effect Frequency

Common (1-10%): decreased libido, erectile dysfunction/impotence, ejaculation disorder (including decreased ejaculate volume); Uncommon (<1%): breast tenderness/enlargement (gynecomastia), rash/hypersensitivity

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). Not indicated for use in women or children.

Warnings & Precautions

Key warnings/precautions: evaluate for prostate cancer before/during therapy; PSA decreases ~50% after ~6 months-interpret PSA accordingly and investigate any rise; possible high‑grade prostate cancer signal; women who are or may become pregnant must not handle crushed/broken tablets; monitor for mood changes/depression/suicidal ideation.

Age Restriction

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

Driving Warning

Safe

Drug Interactions

Drug Interactions

No clinically significant drug interactions are generally identified; finasteride is metabolized by CYP3A4 but routine dose adjustment with CYP3A4 inhibitors is not required.

Interaction Severity

No major clinically significant drug-drug interactions are expected; monitor when combined with alpha‑blockers due to additive hypotension risk (common combination in BPH). Saw palmetto: avoid/monitor due to potential additive 5‑alpha‑reductase effects and confounding of response/PSA.

Food Interaction

No clinically significant 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, though half-life may be slightly prolonged in men over 70 years without clinical significance

Kidney Impairment

No adjustment needed.

Liver Impairment

No specific dose adjustment provided; use with caution in hepatic impairment.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered the same day; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Can be discontinued without taper; after stopping, BPH benefits (symptom control/prostate volume reduction) gradually diminish and may return toward baseline over months.

Overdose

No specific overdose syndrome; single doses up to 400 mg and multiple doses up to 80 mg/day have been tolerated-manage with symptomatic/supportive care and seek medical attention.

Patient Counseling

Take 1 tablet (5 mg) once daily at the same time each day, with or without food; benefits may take 3-6 months (or longer) and stopping can lead to symptom return. Tell clinicians you take finasteride before PSA testing (PSA is lowered ~50%). Do not crush/break tablets; pregnant or potentially pregnant women must not handle broken/crushed tablets. Report breast changes (lumps/nipple discharge), mood changes/depression, and persistent sexual adverse effects.

Monitoring Requirements

Baseline and periodic PSA (interpret by doubling the measured PSA after ≥6 months of therapy), clinical assessment of LUTS/urinary flow and need for ongoing therapy; routine DRE/prostate cancer evaluation per urology standards.

Pharmacology

Mechanism of Action

Competitive, selective inhibitor of type II 5‑alpha‑reductase, blocking conversion of testosterone to dihydrotestosterone (DHT) and thereby lowering serum/intraprostatic DHT and reducing prostate volume over time.

Onset of Action

BPH symptom improvement may begin after ~3 months, but at least 6 months is typically needed to assess meaningful clinical response; maximal benefit may take 6-12 months.

Duration of Effect

Pharmacodynamic effect persists with daily dosing; after discontinuation, DHT returns toward baseline within ~14 days, while prostate volume/symptom benefits gradually reverse over months.

Bioavailability

Approximately 65% (range ~63-80%)

Metabolism

Extensive hepatic metabolism, primarily via CYP3A4, to metabolites with minimal 5α-reductase inhibitory activity

Excretion

Primarily as metabolites: ~57% in feces and ~39-40% in urine

Protein Binding

Approximately 90% protein bound

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 5mg finasteride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Urological Condition

BPH

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