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UROCAP D

TAMSULOSIN HCL USP & DUTASTERIDE INN


NAME STRENGTH PACK SIZE DOSAGE FORM
UROCAP D 0.4 MG + 0.5 MG 0.4 MG + 0.5 MG 30 S CAPSULE

Each capsule contains Tamsulosin Hcl 0.4 mg and Dutasteride 0.5 mg.

Combination of Tamsulosin Hydrochloride and Dutasteride improve symptoms in patients with Benign Prostatic Hyperplasia (BPH). Dutasteride, a dual 5 alpha-reductase inhibitor (5 ARI) and Tamsulosin Hydrochloride, an antagonist of alpha1 A-adrenoreceptors. Treatment of BPH with 5 ARIs and alpha1-adrenoreceptor blocking agents results in an improvement in urine flow rate and a reduction in symptoms of BPH.

For the treatment of moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH) in men with enlarged prostates. Dutasteride in combination with Tamsulosin has been shown to reduce symptoms of BPH, improve urinary flow and reduce prostate size and was statistically significant to Tamsulosin monotherapy.

The recommended dose is one capsule approximately 30 minutes after meal daily.

• For women and children • Patients with known hypersensitivity to Dutasteride, other 5 alpha-reductase inhibitors, Tamsulosin Hydrochloride (including Tamsulosin induced angioedema) or to any ingredient in the formulation.

• This drug is for use in men only. • Dutasteride is absorbed through the skin. Therefore, women who are pregnant or may be pregnant should not handle such capsules.

The most common (1-10%) side effects are-decreased sex drive, breast swelling or tenderness, dizziness.

Not applicable.

There have been no drug interaction studies for Dutasteride-Tamsulosin combination.

No data is available with regard to over dosage of Tamsulosin-Dutesteroid combination.

There have been no drug interaction studies for Dutasteride-Tamsulosin combination.

Urocap-D: Each box contains 3x10 capsules in Alu-Alu blister pack.