DUODART Capsules 0.5Mg/0.4Mg (1 Box = 30 Capsules)

Requires Prescription (YES/NO)

Yes

Generics

Tamsulosin HCl + Dutasteride

Used For

Benign Prostatic Hyperplasia

How it works

Tamsulosin HCl inhibits a1a and a1d adrenergic receptors in the stromal prostatic smooth muscle and bladder neck. Blockade of these adrenoceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH. Dutasteride is a competitive and specific inhibitor of both type 1 and type 2, 5 alpha-reductase isoenzymes, with which it forms a stable enzyme complex. Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT). DHT is the androgen primarily responsible for the initial development and subsequent enlargement.of the prostate gland. Testosterone is converted to DHT by the enzyme 5 alpha-reductase, which exists as 2 isoforms, type 1 and type 2. The type 2 isoenzyme is primarily active in the reproductive tissues, while the type 1 isoenzyme is also responsible for testosterone conversion in the skin and liver.

Dosage

Tamsulosin HCl + Dutasteride

Side Effects

Common : Dizziness, Impotence, Altered (decreased) libido, Ejaculation disorders and Breast disorders.Uncommon : Cardiac failure.

Drug Interactions

Strong CYP3A4 inhibitors (e.g., ketoconazole) , inhibitors of CYP3A4 (e.g., erythromycin), strong (e.g., paroxetine) or moderate (e.g., terbinafine) , Cimetidine , Phosphodiesterase-5 Inhibitors (PDE-5 Inhibitors) , Warfarin.

Indication

Tamsulosin HCl + Dutasteride treats and prevents progression of benign prostatic hyperplasia (BPH) through alleviating symptoms, reducing prostate size (volume), improving urinary flow rate and reducing the risk of acute urinary retention (AUR) and the need for BPH-related surgery.

When not to Use

Tamsulosin HCl + Dutasteride is contraindicated in: • Patients with known hypersensitivity to dutasteride, tamsulosin HCl (including tamsulosin induced angio-edema), soya, peanut or to any excipient of the product.• Women, children and adolescents. • Patients with a history of orthostatic hypotension. • Patients with severe hepatic impairment.

Precaution

Combination therapy should be prescribed after careful benefit risk assessment due to the potential increased risk of adverse events (including cardiac failure) and after consideration of alternative treatment options including monotherapies .

Warning 1

Men taking Tamsulosin HCl + Dutasteride should be regularly evaluated for prostate cancer.

Warning 2

The treatment of patients with severe renal impairment (creatinine clearance of less than 10 ml/min) should be approached with caution.

Warning 3

Patients should be informed about the possible occurrence of symptoms related to orthostatic hypotension such as dizziness when taking Tamsulosin HCl + Dutasteride.

Pregnancy category

Always consult your physician before using any medicine.

Storage (YES/NO)

Store this medicine at room temperature, away from direct light and heat.