AZOLEN (miconazole nitrate)

There are 0 contraindications.

There are 0 severe contraindications.

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
No disease contraindications

There are 2 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Blistering skin Skin rash

There are 4 less severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Dermatitis due to topical drug Erythema Paresthesia Skin irritation

Because small amounts of miconazole nitrate are absorbed from the vagina, the manufacturer states that the vaginal preparations should not be used in the first trimester of pregnancy unless the drug is considered essential to the welfare of the patient. For self-medication, miconazole nitrate vaginal suppositories or vaginal cream should not be used in pregnant women unless otherwise instructed by a physician. Follow-up reports from clinical studies during which miconazole vaginal preparations were used for up to 14 days in pregnant women have revealed no adverse effects or complications attributable to therapy with the drug in infants born to these women.

Prolonged gestation has occurred in rats, but not in rabbits, receiving oral miconazole nitrate. In addition, fetotoxicity and embryotoxicity have occurred in rats and rabbits and dystocia in rats in reproduction studies using oral miconazole nitrate dosages of 80 mg/kg and higher; these effects were not observed in rats following intravaginal administration of the drug.

It is not known whether miconazole nitrate is distributed into milk. Miconazole nitrate should be used with caution in nursing women.

No enhanced Geriatric Use information available for this drug.