API

Silodosin (8mg) + Dutasteride (0.5mg)

Drug classification

Alpha-1 adrenergic antagonist (silodosin) and 5-alpha-reductase inhibitor (dutasteride) combination.

Dosage form

Hard gelatin capsule containing silodosin 8mg and dutasteride 0.5mg.

API strength per dosage

Dose

Avoprost D combines silodosin 8 mg and dutasteride 0.5 mg, typically taken once daily with a meal for adult males with benign prostatic hyperplasia. Not recommended in severe hepatic or renal impairment. Safety and efficacy in paediatric patients have not been established; use is not indicated in children or women. Always consult product-specific guidelines.

Mechanism of action

Silodosin selectively antagonizes alpha-1A adrenergic receptors in the prostate and bladder neck, relaxing smooth muscle and improving urine flow. Dutasteride inhibits type 1 and type 2 5-alpha reductase enzymes, reducing dihydrotestosterone (DHT) synthesis, leading to prostate shrinkage and symptom relief in benign prostatic hyperplasia.

Indications

Treatment of Benign prostatic hyperplasia

Side effects

Ejaculation disorder Impotence Headache Dizziness Decreased libido Orthostatic hypotension sudden lowering of blood pressure on standing Nausea Abdominal pain Breast enlargement in male Breast tenderness in male

Pregnancy category

Silodosin and dutasteride are not recommended in pregnancy; dutasteride is contraindicated due to potential risk of fetal harm, especially to male fetuses.

Precautions

Hypotension risk, monitor blood pressure, assess for urinary retention, monitor prostate-specific antigen (PSA) levels, evaluate liver function, caution in severe hepatic or renal impairment, potential sexual dysfunction, avoid in women and children, monitor for allergic reactions, inform patients about possible ejaculation disorders.

Contraindications

Hypersensitivity to silodosin, dutasteride, or excipients, severe hepatic impairment, women of childbearing potential, pregnancy, children, severe renal impairment, concomitant strong CYP3A4 inhibitors, history of orthostatic hypotension.