Tamdutor 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

Per 500 mcg/400 mcg cap Dutasteride 500 mcg, tamsulosin HCl 400 mcg

Indications/Uses

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

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Dosage/Direction for Use

Adult (including the elderly) 1 cap once daily.

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Overdosage

View Tamdutor overdosage for action to be taken in the event of an overdose.

Administration

Should be taken on an empty stomach: Take approx 30 min after the same time of meal each day. Swallow whole, do not chew/open.

Contraindications

Hypersensitivity to dutasteride, other 5-α reductase inhibitors, tamsulosin (including tamsulosin-induced angioedema), soya, or peanut. Patients w/ history of orthostatic hypotension. Severe hepatic impairment. Women, childn, & adolescents <18 yr.

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Special Precautions

CV adverse events. Intraoperative floppy iris syndrome. Combination therapy should be prescribed after careful benefit-risk assessment & after consideration of alternative treatment including monotherapies. Regularly evaluate for prostate cancer. Promptly report any changes in breast tissue eg, lumps or nipple discharge. Sit or lie down at 1st signs of orthostatic hypotension (eg, dizziness, weakness) until symptoms have resolved. Co-administration w/ PDE5 inhibitors eg, sildenafil, tadalafil, vardenafil. Discontinue use 1-2 wk prior to cataract surgery. Patients w/ mild to moderate hepatic impairment & severe renal impairment. Avoid exposure of patient's partner who is or may potentially be pregnant to semen by use of condom. No studies on effect on pregnancy, lactation & fertility. Women, childn, & adolescents must avoid contact w/ leaking cap.

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Use In Pregnancy & Lactation

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Adverse Reactions

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

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Drug Interactions

Dutasteride: Serum conc may be increased in long term combination w/ potent CYP3A4 inhibitors eg, ritonavir, indinavir, nefazodone, itraconazole, ketoconazole. Tamsulosin: Enhanced hypotensive effects w/ drugs that can reduce BP including anesth agents, PDE5 inhibitors, & other α₁-adrenoceptor antagonists. Increased C_max & AUC w/ ketoconazole & paroxetine. Decreased clearance & increased AUC w/ cimetidine. Elimination rate may be increased w/ diclofenac & warfarin.

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Storage

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Description

View Tamdutor description for details of the chemical structure and excipients (inactive components).

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

Tamdutor 500 mcg/400 mcg cap

Packing/Price

30's (P1,170/box)

Tamdutor

dutasteride + tamsulosin

Manufacturer:

Pell Tech Healthcare

Distributor:

Torrent