API

Finasteride, Tamsulosin hydrochloride

Drug classification

Finasteride: 5-alpha reductase inhibitor; Tamsulosin: Alpha-1 blocker; Urological combination.

Dosage form

Tablet

API strength per dosage

FINASTERIDE USP 5MG TAMSULOSIN HCL BP 400MG

Dose

Adults: One tablet daily (finasteride 5 mg and tamsulosin hydrochloride 0.4 mg) taken orally after the same meal each day. Not recommended for pediatric use. Use with caution in severe hepatic impairment; dose adjustment generally not required in renal impairment.

Mechanism of action

Finasteride inhibits type II 5α-reductase, blocking conversion of testosterone to dihydrotestosterone (DHT), reducing prostatic growth. Tamsulosin selectively antagonizes α1A-adrenergic receptors in prostatic and bladder neck smooth muscle, decreasing muscle tone and improving urinary flow.

Indications

Benign prostatic hyperplasia, lower urinary tract symptoms associated with benign prostatic hyperplasia.

Side effects

Erectile dysfunction, decreased libido, ejaculation disorders, breast tenderness, dizziness, orthostatic hypotension, headache, rhinitis, abnormal ejaculation, gynecomastia, allergic reactions, asthenia.

Pregnancy category

Category X

Precautions

Hypersensitivity to finasteride or tamsulosin, women and children contraindicated, risk of orthostatic hypotension, hepatic or severe renal impairment, history of sulfa allergy, potential for drug interactions, monitor for prostate cancer, caution in cataract surgery (IFIS risk), may affect PSA levels, not for use in pregnancy.

Contraindications

Hypersensitivity to finasteride or tamsulosin, pregnancy or women of childbearing potential, severe hepatic impairment, severe renal impairment, history of orthostatic hypotension, concurrent use with strong CYP3A4 inhibitors.