Dusorac 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). Reduction in 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 elderly) 1 cap once daily.

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Overdosage

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Administration

May be taken with or without food: Swallow whole, approx 30 min after the same time of meal each day. Do not chew or open cap.

Contraindications

Hypersensitivity to dutasteride, other 5-α 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

Increased CV adverse events/risks. Not recommended in patients w/ scheduled cataract surgery. May cause orthostatic & symptomatic hypotension. Avoid contact w/ leaking cap. Patient w/ liver disease. Severe renal impairment (CrCl <10 mL/min) & mild to moderate hepatic impairment. Avoid exposure of semen to a partner w/ potential to be pregnant. Dutasteride: Regularly evaluate men for prostate cancer. Breast neoplasia. Tamsulosin: Coadministration w/ PDE5 inhibitors (eg, sildenafil, tadalafil, vardenafil). Discontinue 1-2 wk prior to cataract surgery. Intraoperative floppy iris syndrome.

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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: Increased serum conc w/ verapamil or diltiazem, ritonavir, indinavir, nefazodone, itraconazole, ketoconazole. Tamsulosin: May potentially cause symptomatic hypotension w/ PDE5 inhibitors eg, sildenafil, tadalafil, vardenafil. 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. Increased elimination rate 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

Dusorac cap

Packing/Price

100's;30's

Dusorac

dutasteride + tamsulosin

Manufacturer:

Pell Tech Healthcare

Distributor:

Altomed Pharma

Marketer:

Ambica