A fixed-dose combination (FDC) medication used for the treatment of symptomatic Benign Prostatic Hyperplasia (BPH). Tamsulosin is a selective alpha-1A adrenergic receptor antagonist that relaxes smooth muscle in the prostate and bladder neck, improving urine flow. Finasteride is a 5-alpha-reductase inhibitor that reduces prostate volume by blocking the conversion of testosterone to dihydrotestosterone (DHT). This combination provides rapid symptomatic relief (from tamsulosin) and long-term disease modification by reducing prostate size and risk of complications (from finasteride).
Adult: One tablet (Tamsulosin 0.4mg + Finasteride 5mg) orally once daily, preferably 30 minutes after the same meal each day.
Note: Swallow the tablet whole with a glass of water. Do not crush, chew, or break the tablet. Should be taken after a meal (preferably breakfast or dinner) to ensure consistent absorption and reduce the risk of dizziness/orthostasis. The capsule/tablet should be handled with care; pregnant women should avoid contact with crushed or broken tablets due to finasteride absorption risk.
The combination works via two complementary pathways. Tamsulosin selectively blocks alpha-1A adrenoceptors located in the smooth muscle of the prostate, prostatic capsule, and bladder neck. This inhibition prevents norepinephrine-induced contraction, leading to muscle relaxation, reduced dynamic obstruction, and improved urinary flow. Finasteride is a competitive and specific inhibitor of Type II 5-alpha-reductase, the intracellular enzyme that converts testosterone to the more potent androgen dihydrotestosterone (DHT). DHT is the primary androgen responsible for prostate growth. By reducing intraprostatic DHT levels by up to 70-90%, finasteride induces epithelial apoptosis, leading to a significant reduction in prostate volume over time, thus addressing the static component of obstruction.
Pregnancy: CONTRANDICATED in women who are or may become pregnant. Finasteride is Pregnancy Category X. It can be absorbed through the skin. Exposure during pregnancy (via handling crushed/broken tablets or semen of a treated male) may cause abnormalities of the external genitalia in a male fetus. Women of childbearing potential should avoid handling broken tablets.
Driving: May cause dizziness, vertigo, or asthenia, which can impair the ability to drive or operate machinery. Patients should be cautioned, especially at initiation of therapy or after a dose increase.
| Other Alpha-blockers (e.g., Prazosin, Doxazosin) | Additive hypotensive effects, increased risk of orthostasis and syncope. | Major |
| Phosphodiesterase-5 Inhibitors (e.g., Sildenafil, Tadalafil) | Additive vasodilatory and hypotensive effects. | Major |
| Strong CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin) | May significantly increase tamsulosin plasma concentrations, increasing risk of adverse effects like hypotension. Contraindicated or requires close monitoring. | Major |
| Antihypertensives (Beta-blockers, ACE Inhibitors, Calcium channel blockers, Diuretics) | Potential additive blood pressure lowering effect. | Moderate |
| Warfarin | Finasteride has been reported to potentially enhance the anticoagulant effect; monitor INR closely. | Moderate |
| Herbal supplements (e.g., Saw Palmetto) | Theoretical additive effect; clinical significance unknown. | Minor |
Same composition (Tamsulosin (0.4mg) + Finasteride (5mg)), different brands: