Avodart

Drug overview for AVODART (dutasteride):

Generic name: dutasteride (due-TAST-er-ide)
Drug class: 5 Alpha-Reductase Inhibitors
Therapeutic class: Genitourinary Therapy

Dutasteride is a selective inhibitor of steroid 5alpha-reductase isoenzymes types 1 and 2, which are necessary for conversion of testosterone to 5alpha-dihydrotestosterone (DHT). DHT appears to be the principal androgen responsible for stimulation of prostatic growth.

No enhanced Uses information available for this drug.

DRUG IMAGES

AVODART 0.5 MG SOFTGEL

The following indications for AVODART (dutasteride) have been approved by the FDA:

Indications:
Benign prostatic hyperplasia with lower urinary tract symptom

Professional Synonyms:
Symptomatic benign prostatic hyperplasia
Symptomatic benign prostatic hypertrophy
Symptomatic BPH
Symptomatic prostatic hypertrophy

Dosing information for AVODART
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
AVODART 0.5 MG SOFTGEL	Maintenance	Adults take 1 capsule (0.5 mg) by oral route once daily

Generic dosing information for DUTASTERIDE
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
DUTASTERIDE 0.5 MG CAPSULE	Maintenance	Adults take 1 capsule (0.5 mg) by oral route once daily

Contraindication List
Lactation
Pregnancy

Moderate List
Disease of liver
High-grade prostate cancer

The following adverse reaction information is available for AVODART (dutasteride):

Overview
Severe
Less Severe

Adverse reaction overview.

Adverse effects reported in at least 1% of patients receiving dutasteride and more frequently than with placebo include impotence, decreased libido, ejaculation disorder, and breast disorders (including breast tenderness and enlargement). Ejaculation disorders have been reported more frequently with combined therapy with dutasteride and tamsulosin than with either drug alone.

There are 7 severe adverse reactions.

More Frequent	Less Frequent
None.	High-grade prostate cancer

Rare/Very Rare
Angioedema Gynecomastia Hypersensitivity drug reaction Localized edema Malignant tumor of male breast Skin rash

There are 13 less severe adverse reactions.

More Frequent	Less Frequent
Disorder of ejaculation Erectile dysfunction Libido changes	Asthenozoospermia Oligospermia

Rare/Very Rare
Decrease ejaculate volume Depression Dizziness Mastalgia Pruritus of skin Testicular pain Testicular swelling Urticaria

The following precautions are available for AVODART (dutasteride):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy not established in children; the drug is not indicatedfor use in children.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Dutasteride is not indicated for use in women and is contraindicated in women who are pregnant. If used during pregnancy or if pregnancy occurs, apprise the pregnant woman of potential fetal hazard to a male fetus. Because 5alpha-reductase inhibitors inhibit the conversion of testosterone to DHT, dutasteride may cause abnormalities of the external genitalia of male fetuses exposed to the drug during pregnancy.

In animal reproduction studies, dutasteride inhibited normal development of externalgenitalia in male offspring when given to rats or rabbits during organogenesis at doses lessthan the maximum recommended human dose (MRHD) of 0.5 mg daily, in the absenceof maternal toxicity. Because of the possibility of absorption through the skin and subsequent risk to a male fetus, women who are pregnant or who potentially may be pregnant should not handle dutasteride capsules; if contact with a leaking dutasteride capsuleoccurs during pregnancy, the affected area should be washed immediately with soap and water.

Not known whether dutasteride is distributed into milk in humans or if the drug has any effects on the breastfed infant or on milk production. Dutasteride is not indicated for use in women.

No substantial differences in safety and efficacy relative to younger men in clinical studies or experience to date, but increased sensitivity cannot be ruled out.

Benign prostatic hyperplasia with lower urinary tract sx
N40.1	Benign prostatic hyperplasia with lower urinary tract symptoms