Dutimax 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

Treatment & prevention of benign prostatic hyperplasia (BPH) progression by alleviating symptoms, reducing prostate size (vol), improving urinary flow rate & reducing risk of acute urinary retention & the need for BPH-related surgery.

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Dosage/Direction for Use

Adult male (including elderly) 1 cap once daily.

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Overdosage

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

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 or tamsulosin HCl. Women. Childn.

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Special Precautions

Regularly evaluate men on treatment for prostate cancer risk including PSA testing. Establish new PSA baseline after 6 mth of treatment. Monitor PSA values regularly thereafter. Perform digital rectal exam & other prostate cancer evaluations on BPH patients prior to initiating therapy & periodically thereafter. Risk of orthostatic/symptomatic hypotension. Risk of intraoperative floppy iris syndrome during cataract surgery. Concomitant use w/ PDE5 inhibitors; moderate CYP3A4 (eg, erythromycin) or strong (eg, paroxetine) or moderate CYP2D6 inhibitor, combination of both CYP3A4 & CYP2D6 inhibitor. Not recommended w/ strong CYP3A4 inhibitor (eg, ketoconazole). Poor CYP2D6 metabolisers. Patients w/ liver disease. May affect ability to drive & use machines as symptoms related to orthostatic hypotension eg, dizziness can possibly occur. Women & childn must avoid contact w/ leaking cap.

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Use In Pregnancy & Lactation

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Drug Interactions

Tamsulosin HCl: Increased exposure w/ strong CYP3A4 inhibitors (eg, ketoconazole); strong CYP2D6 inhibitors (eg, paroxetine).

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Storage

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Description

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

Action

View Dutimax mechanism of action for pharmacodynamics and pharmacokinetics details.

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

Dutimax 500 mcg/400 mcg cap

Packing/Price

30's

Dutimax

dutasteride + tamsulosin

Manufacturer:

Innovative Healthcare

Distributor:

ECE Pharma

Marketer:

4Life Healthcare