DUTAMAX

Dutasteride INN

 Composition : Dutasteride INN 0.5mg Capsule.

 Indication : It is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to; 1. Improve symptoms, 2. Reduce the risk of acute urinary retention, 3. Reduce the risk of the need for BPH-related surgery.

 Dosage and administration : The recommended dose of Dutasteride is one capsule (0.5mg) taken orally once a day. Dutasteride may be administered with or without food. No dosage adjustment is necessary for subjects with renal impairment or for the elderly patients. Or, as directed by the registered physician.

 Packing :Dutamax : 3 x 7’s soft capsules in blister pack.

PRESCRIBING DESCRIPTION

Composition : Dutasteride 0.5mg Capsule. Indications : It is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to; 1. Improve symptoms, 2. Reduce the risk of acute urinary retention, 3. Reduce the risk of the need for BPH-related surgery. Dosage and administration : The recommended dose of Dutasteride is one capsule (0.5mg) taken orally once a day. Dutasteride may be administered with or without food. No dosage adjustment is necessary for subjects with renal impairment or for the elderly patients. Or, as directed by the registered physician. Contraindications : This medicine is contraindicated in-patients with a history of hypersensitivity to Dutasteride, other 5a-reductase inhibitors, or any component of the preparation. It is also contraindicated for use in women and children. Side effects : Most adverse reactions were mild or moderate. Most common adverse effects are: Impotence, decreased libido, Ejaculation disorder, Gynecomastia. Precautions : Lower urinary tract symptoms of BPH can be indicative of other urological diseases, including prostate cancer. Patients should be assessed to rule out other urological diseases prior to treatment with Dutasteride. Drug interactions : Care should be taken when administering Dutasteride to patients taking potent, chronic CYP3A4 inhibitors. Dutasteride do not alter the steadystate pharmacokinetics of Digoxin & S- or-R- Warfarin isomers when administered concomitantly at a dose of 0.5mg/day for 3 weeks. Packing : Dutamax : 3 x 7’s soft capsules in blister pack.