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Indications/Uses
Benign prostatic hyperplasia.
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Dosage/Direction for Use
Adult: PO Per tab contains tamsulosin 0.4 mg and dutasteride 0.5 mg: 1 tab once daily.
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Contraindications
Hypersensitivity, severe liver impairment. Pregnancy, lactation, child, adolescent.
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Special Precautions
Excreted in semen therefore use of condom is recommended. Women of childbearing potential should avoid handling leaking capsules of dutasteride. Prostate carcinoma should be ruled out before starting the therapy. Blood donation to be avoided during and at least 6 mths after discontinuance of drug.
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Adverse Reactions
Impotence, decreased libido, ejaculation disorders, breast tenderness and enlargement, postural hypotension, dizziness and vertigo, headache, infection, asthenia, back pain, chest pain, somnolence, insomnia, rhinitis, pharyngitis, cough, sinusitis, diarrhoea, nausea, tooth disorder, blurred vision.
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Drug Interactions
Concomitant admin with moderate or strong inhibitors of CYP2D6 (eg. fluoxetine) or CYP34A (eg. ketoconazole, cimetidine) increases tamsulosin serum concentration; increase in blood concentrations of dutasteride in the presence of inhibitors of CYP3A4/5 such as ritonavir, ketoconazole, verapamil, diltiazem, cimetidine, troleandomycin, and ciprofloxacin.
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CIMS Class
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ATC Classification
G04CB02 - dutasteride ; Belongs to the class of testosterone-5-alpha reductase inhibitors. Used in the treatment of benign prostatic hypertrophy.
G04CA02 - tamsulosin ; Belongs to the class of alpha-adrenoreceptor antagonists. Used in the treatment of benign prostatic hypertrophy. |
