DUTASTERIDE (dutasteride)

There are 2 contraindications. Absolute contraindication.

Contraindication List
Lactation
Pregnancy

There are 0 severe contraindications.

There are 2 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Disease of liver
High-grade prostate cancer

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

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.