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Dutasteride information from DrugsUpdate  

See Available Brands of Dutasteride in India

P - Contraindicated in pregnancy
LI - Lab*

Dutasteride is a 5-alpha-reductase inhibitor, a drug which inhibits the conversion of testosterone into dihydrotestosterone (DHT). It is used to treat conditions caused by DHT, such as benign prostatic hyperplasia (BPH).

Pharmacodynamics

Pharmacokinetics

Dutasteride has antiandrogenic properties. It inhibits 5α-reductase, thus preventing the conversion of testosterone to 5α-dihydrotestosterone which is the main androgen involved in causing prostate enlargement.
Absorption: Absorbed from the GI tract, reaching peak serum concentration in 1-3 hr. Bioavailability: About 60%.
Distribution: Highly bound to plasma proteins.
Metabolism: Metabolised by CYP3A4 and CYP3A5.
Excretion: Mainly excreted as metabolites in faeces. Elimination half-life: About 3-5 wk.

Dutasteride Indications / Dutasteride Uses

Information Not Available

Dutasteride Adverse Reactions / Dutasteride Side Effects

Impotence; decreased libido; ejaculation disorders; breast tenderness and enlargement.

Precautions

Monitor
Perform digital rectal exams, as well as other evaluations for prostate cancer prior to starting therapy and periodically thereafter. Assess patient to rule out other urologic diseases prior to treatment. Carefully monitor patients with large residual urine volume or severely diminished urinary flow for obstructive uropathy.
Hepatic Function
Use with caution.
Blood donation
Men should not donate blood until at least 6 mo after the last dose of dutasteride.
Handling capsules
Women who are pregnant or may be pregnant should not handle the capsules. Women who are not pregnant should use caution whenever handling the capsules. If contact is made with leaking capsules, wash the contacted area immediately with soap and water.
Obstructive uropathy
Patients with large residual urine volume or severely diminished urinary flow may not be good candidates for therapy.
Reproductive function
Sperm count may be reduced in some patients.
Overdosage
Symptoms
Single doses of dutasteride 40 mg for 7 days have not produced safety concerns.

Special Precautions

Excreted in semen therefore use of condom is recommended. Women of childbearing potential should avoid handling dutasteride capsules. Advisable to exclude other causes of benign prostatic hypertrophy (e.g. prostate cancer, infection) before initiating therapy.

Other Drug Interactions

Concurrent use with CYP3A4 inhibitors such as diltiazem and verapamil may increase serum levels of dutasteride.

Other Interactions

Information Not Available

Dosage

Oral
Benign prostatic hyperplasia
Adult: 500 mcg daily (treatment for 6 mth may be required before benefit is obtained).

Food(before/after)

May be taken with or without food

List of Contraindications

Dutasteride and Pregnancy

Contraindicated in pregnancy

Dutasteride and Lactation

Undetermined

Dutasteride and Children

Safety and efficacy not established

Dutasteride and Geriatic

Information Not Available

Dutasteride and Other Contraindications

Severe liver impairment; pregnant women, children, adolescent

Storage

Oral: Store at 25°C

Lab interference

Oral: Store at 25°C

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