Dutasteride

Dutasteride is a dual 5-alpha reductase inhibitor that inhibits both type 1 and type 2 5α-reductase isoenzymes, which are responsible for conversion of testosterone to 5α-dihydrotestosterone (DHT). It is indicated for symptomatic BPH in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of BPH-related surgery. The recommended dose is 0.5 mg orally once daily. Contraindicated in severe liver impairment, pregnant women, children, and adolescents.

• Benign prostatic hyperplasia (BPH)

Dutasteride is a dual inhibitor of 5α-reductase. It inhibits both type 1 and type 2 5α-reductase isoenzymes, which are responsible for the conversion of testosterone to 5α-dihydrotestosterone (DHT). DHT is the androgen primarily responsible for hyperplasia of glandular prostatic tissue.

Dutasteride has antiandrogenic properties. It inhibits 5alpha-reductase, preventing the conversion of testosterone to 5α-dihydrotestosterone which is the main androgen involved in causing prostate enlargement.

Adult Dose (Oral): 500 mcg once daily for at least 6 months.

Hepatic Dose: Severe: Contraindicated.

Renal Dose: Dose adjustment not necessary.

Oral capsule. Take in the dose and duration as advised by your doctor. Swallow whole. Do not chew, crush or break. May be taken with or without food, but better to take at a fixed time.

If you miss a dose of Dutasteride, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

Common Side Effects:

• Decreased sexual desire
• Impotence (trouble getting or keeping an erection)
• Decrease in amount of semen/sperm
• Testicle pain or swelling
• Increased breast size
• Breast tenderness
• Allergic reaction

• Dutasteride shrinks the enlarged prostate and reduces the risk of urinary retention.
• It may take 3 to 6 months to see full beneficial effect.
• Usually well tolerated but may produce mild sexual side effects.
• Do not donate blood for 6 months after the last dose (to prevent administration to pregnant transfusion recipients).
• Pregnant or potentially pregnant women should not handle dutasteride capsules.

• Severe liver impairment
• Pregnant women
• Children
• Adolescents
• Hypersensitivity to Dutasteride or other 5-alpha reductase inhibitors

Plasma concentrations may be increased when used concomitantly with moderate or potent CYP3A4 inhibitors.

It is not known whether it is safe to consume alcohol with Dutasteride. Please consult your doctor.

Dutasteride is highly unsafe during pregnancy. Studies have shown significant harmful effects to the developing baby.

Information regarding the use of Dutasteride during breastfeeding is not available. Please consult your doctor.

Safety and effectiveness in the pediatric population have not been established.

No overall differences in safety or efficacy observed between elderly and adult subjects.

Renal impairment: Probably safe in kidney disease. Dose adjustment may not be needed.

Hepatic impairment: Use with caution. Dose adjustment may be needed. Not recommended in severe liver disease.

Single doses up to 40 mg (80 times therapeutic dose) were safe in volunteer studies. No specific antidote.

Store below 30°C, away from light & moisture. Keep out of reach of children.

Dutasteride