|Drug Name:||Clotrimazole and Betamethasone Dipropionate|
|Manufacturer:||E. FOUGERA and CO.|
Pregnancy Category C: There have been no teratogenic studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate.A Segment II (teratology) study in pregnant rats with intravaginal doses up to 100 mg/kg clotrimazole have revealed no evidence of harm to the fetus.
This dose is approximately 17-fold the human dose based on a mg/m2 comparison.Segment II (teratology) studies of clotrimazole were conducted by the oral (gavage) route in rats, mice, and rabbits.
In rats administered 25, 50, 100, or 200 mg/kg/day, no increase in malformations was seen at doses up to 200 mg/kg.
Doses of 100 and 200 mg/kg were embryotoxic (increased resorptions) as well as maternally toxic, while doses of 25 and 50 mg/kg were well tolerated by both the dams and the fetuses.
These doses were approximately 4-, 8-, 17- and 34-fold the human dose based on a mg/m2 comparison, respectively.In pregnant mice, clotrimazole at oral doses of 25, 50, 100, or 200 mg/kg/day was not teratogenic and was well tolerated by both the dams and the fetuses.
These doses were approximately 2-, 4-, 8-, and 17-fold the human dose based on a mg/m2 comparison, respectively.
No evidence of maternal toxicity or embryotoxicity was seen in pregnant rabbits dosed orally with 60, 120, or 180 mg/kg/day.
These doses were approximately 20-, 40-, and 61-fold the human dose based on a mg/m2 comparison, respectively.Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg.
This dose is approximately one-fifth the human dose based on a mg/m2 comparison.
The abnormalities observed included umbilical hernias, cephalocele and cleft palates.Betamethasone dipropionate has not been tested for teratogenic potential by the dermal route of administration.
Other corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels.Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.
Clotrimazole and Betamethasone Dipropionate Cream is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes , and Trichophyton rubrum in patients 17 years and older.
Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections.The efficacy of Clotrimazole and Betamethasone Dipropionate Cream for the treatment of infections caused by zoophilic dermatophytes (e.g., Microsporum canis) has not been established.Several cases of treatment failure of Clotrimazole and Betamethasone Dipropionate Cream in the treatment of infections caused by Microsporum canis have been reported.