Indications
Tamsulosin Hydrochloride & Dutasteride Capsules are indicated for:
- Management of moderate to severe benign prostatic hyperplasia (BPH) and risk reduction of acute urinary retention and surgical intervention in patients with significant BPH symptoms.
Pharmacology
This combination features Tamsulosin, an alpha-1 adrenergic antagonist, and Dutasteride, a dual 5-alpha reductase inhibitor (5ARI). Together, they enhance urinary flow and alleviate BPH symptoms:
- Tamsulosin selectively blocks alpha-1A and alpha-1D receptors, relaxing smooth muscles in the prostate and bladder neck.
- Dutasteride inhibits both Type I and Type II 5-alpha reductase isoenzymes, reducing dihydrotestosterone (DHT) levels and decreasing prostatic volume.
Dosage & Administration
Recommended Dosage for Adults: One capsule (0.4 mg Tamsulosin & 0.5 mg Dutasteride) taken orally about 30 minutes after a meal. Swallow capsules whole; do not chew or open. No dosage adjustment is necessary for renal impairment; caution is advised for mild to moderate hepatic impairment.
Interactions
No specific drug interaction studies have been conducted for the Tamsulosin-Dutasteride combination. Use caution with CYP3A4 inhibitors and drugs that may lower blood pressure.
Contraindications
Not suitable for women, children, or adolescents, and contraindicated in individuals with hypersensitivity to Dutasteride, other 5-alpha reductase inhibitors, or Tamsulosin.
Side Effects
Common side effects include impotence, decreased libido, breast disorders, ejaculation issues, and dizziness, with higher incidence in combination therapy.
Pregnancy & Lactation
Contraindicated for women due to potential risks to male fetuses and lack of studies on effects during pregnancy or lactation.
Precautions & Warnings
Regular PSA testing is necessary, as treatment can reduce PSA levels significantly. Patients should be cautious about potential blood pressure drops, especially when combining with other vasodilators.
Overdose Effects
No specific data exist for Tamsulosin-Dutasteride overdose; however, high doses of Dutasteride have shown no significant adverse effects, while Tamsulosin overdose may cause acute hypotension.
Therapeutic Class
BPH / Urinary Retention / Urinary Incontinence
Storage Conditions
Store in a cool, dry place, protected from light.
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