ATHLETE'S FOOT (terbinafine hcl)

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 9 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anaphylaxis Angioedema Blistering skin Erythema Paresthesia Pruritus of skin Skin inflammation Skin irritation Skin rash

There are 14 less severe adverse reactions.

More Frequent	Less Frequent
Pruritus of skin Skin inflammation Skin irritation	None.

Rare/Very Rare
Abnormal hair texture Alopecia Cheilitis Dermatitis due to topical drug Dry skin Erythema Hair discoloration Paresthesia Skin irritation Skin rash Stinging of skin

There are no adequate and controlled studies to date using tolnaftate in pregnant women, and the drug should be used during pregnancy only when clearly needed. Because small amounts of miconazole nitrate are absorbed from the vagina, Category B. 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 tolnaftate is distributed into milk. Safe use of tolnaftate in nursing women has not been established. It is not known whether miconazole nitrate is distributed into milk.

Terbinafine is distributed into milk following oral administration. A decision should be made to discontinue nursing or the drug. Miconazole nitrate should be used with caution in nursing women.

No enhanced Geriatric Use information available for this drug.