NIKP-Dutasteride: Dosing, Side Effect & Interaction

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 Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Dutasteride

Indications/Uses

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

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Dosage/Direction for Use

Adult male (including elderly) 0.5 mg once daily. May be administered alone or in combination w/ tamsulosin 0.4 mg.

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Overdosage

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Administration

May be taken with or without food: Swallow whole, do not chew/open.

Contraindications

Hypersensitivity to dutasteride or other 5-α-reductase inhibitors. Severe hepatic impairment. Women, childn & adolescents.

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Special Precautions

CV adverse events, primarily in combination w/ tamsulosin. Patients w/ high risk of prostate cancer & high grade tumours. Perform digital rectal exam & other prostate cancer evaluations prior to initiating therapy & periodically thereafter. Decreased mean serum PSA level by approx 50% after 6 mth of treatment. Establish new PSA baseline after 6 mth of treatment; regularly monitor PSA values thereafter. Carefully evaluate any confirmed increase from lowest PSA level. Possible breast cancer in men; promptly report any changes in breast tissue eg, lumps or nipple discharge. Decrease in mean serum PSA levels after 6 mth of treatment; establish new PSA baseline after 6 mth of treatment. Mild to moderate hepatic impairment. Women, childn & adolescents should avoid contact w/ leaking cap; immediately wash contact area w/ soap & water if contact is made w/ leaking cap.

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Use In Pregnancy & Lactation

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Adverse Reactions

Impotence, altered (decreased) libido, ejaculation & breast disorders. In combination w/ tamsulosin: Dizziness; cardiac failure.

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Drug Interactions

Increased serum conc w/ long-term use of potent CYP3A4 inhibitors (eg, ritonavir, indinavir, nefazodone, itraconazole, oral ketoconazole).

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view NIKP-Dutasteride detailed prescribing information

Storage

View NIKP-Dutasteride storage conditions for details to ensure optimal shelf-life.

Description

View NIKP-Dutasteride 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

G04CB02 - dutasteride ; Belongs to the class of testosterone-5-alpha reductase inhibitors. Used in the treatment of benign prostatic hypertrophy.

Thai FDA Category

Presentation/Packing

Form

NIKP-Dutasteride soft-gelatin cap 0.5 mg

Packing/Price

3 × 10's

NIKP-Dutasteride

dutasteride

Manufacturer:

Nichi-Iko

Distributor:

DKSH

Marketer:

Nichi-Iko