Tamduet Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Dutasteride 500 mcg, tamsulosin HCl 400 mcg

Indications/Uses

Moderate to severe symptoms of benign prostatic hyperplasia (BPH). Risk reduction of acute urinary retention & surgery in patients w/ moderate to severe symptoms of BPH.

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Dosage/Direction for Use

Adult male (including elderly) 1 cap once daily.

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Overdosage

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Administration

Should be taken with food: Take approx 30 min after the same meal each day. Swallow whole, do not chew/open.

Contraindications

Hypersensitivity to dutasteride, other 5α-reductase inhibitors, tamsulosin (including tamsulosin-induced angioedema), soya, peanut. History of orthostatic hypotension. Severe hepatic impairment. Women. Childn & adolescents <18 yr.

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Special Precautions

Regularly evaluate men taking dutasteride for prostate cancer. Higher incidence of cardiac failure. Breast neoplasia, reports of male breast cancer in men taking dutasteride. Instruct patients to promptly report any changes in breast tissue eg, lumps or nipple discharge. Orthostatic/symptomatic hypotension. Concomitant use w/ PDE5 inhibitors (eg, sildenafil, tadalafil, vardenafil) can potentially cause symptomatic hypotension. Intraoperative floppy iris syndrome. Not recommended in patients for whom cataract surgery is scheduled. Discontinue therapy 1-2 wk prior to cataract surgery. Severe renal impairment (CrCl <10 mL/min). Patients w/ liver disease; mild to moderate hepatic impairment. Use a condom to avoid exposure to semen. Pregnancy & lactation. Avoid contact w/ leaking cap in women, childn, & adolescents.

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Use In Pregnancy & Lactation

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Adverse Reactions

Dizziness; impotence, altered (decreased) libido, ejaculation disorders, breast disorders. Cardiac failure.

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Drug Interactions

Dutasteride: Greater serum conc w/ verapamil or diltiazem (moderate inhibitors of CYP3A4 & inhibitors of P-gp). Serum conc may be increased w/ long-term combination w/ drugs that are potent inhibitors of enzyme CYP3A4 (eg, ritonavir, indinavir, nefazodone, itraconazole, ketoconazole administered orally). Tamsulosin: Enhanced hypotensive effects w/ drugs that can reduce BP, including anesth agents, PDE5 inhibitors, & other α₁-adrenoreceptor antagonists. Increased C_max & AUC w/ ketoconazole (a strong CYP3A4 inhibitor); & paroxetine (a strong CYP2D6 inhibitor). Decreased clearance & increased AUC w/ cimetidine. Elimination rate may be increased w/ diclofenac & warfarin.

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Storage

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Description

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Action

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MIMS Class

Drugs for Bladder & Prostate Disorders

ATC Classification

G04CA52 - tamsulosin and dutasteride ; Belongs to the class of alpha-adrenoreceptor antagonists. Used in the treatment of benign prostatic hypertrophy.

Regulatory Classification

Presentation/Packing

Form

Tamduet cap

Packing/Price

30's (P45/cap)

Tamduet

dutasteride + tamsulosin

Manufacturer:

Ajanta Pharma Phil

Distributor:

Ajanta Pharma Phil