Clotrimazole cream 10mg g - Clotrimazole Betamethasone Cream - FDA prescribing information, side effects and uses
Patients should wear loose-fitting clothing. Notify the physician if the condition persists after 2 weeks.
Do not bandage, cover or wrap the treatment area unless directed by the physician. Report any signs of local adverse reactions to the physician. Advise patients that local reactions and skin atrophy are 10mg likely to occur with occlusive use or prolonged use. This medication is to be used for the full prescribed treatment time, even though the symptoms may have improved. Notify the physician if there is no improvement after 1 week of clotrimazole for tinea cruris or tinea corporis, or after 2 weeks for tinea pedis.
Nonclinical Toxicology Carcinogenesis, Mutagenesis, clotrimazole cream 10mg g, Impairment Of Fertility There are no adequate laboratory animal studies with either the combination of clotrimazole and betamethasone dipropionate or with either component individually to evaluate carcinogenesis.
It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay. Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1. These doses are approximately 5- and fold the maximum human dose based on body surface areas, respectively. No adverse effects on the duration of estrous cycle, fertility, or duration of pregnancy were noted.
There have been no teratogenic studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate. Carcinogenesis, Mutagenesis, clotrimazole cream 10mg g, 10mg of Fertility An month oral dosing study with clotrimazole in rats has not revealed any carcinogenic effect. In tests for mutagenesis, chromosomes of the spermatophores of Chinese hamsters which had been exposed to clotrimazole were examined for structural changes clotrimazole the metaphase.
The results of this study showed that clotrimazole had no mutagenic effect. Pregnancy Category B The disposition of 14C-clotrimazole has been studied in humans and animals. Clotrimazole is very poorly absorbed following dermal application or intravaginal administration to humans. There are, cream, no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly indicated during the first trimester of pregnancy.
Nursing Mothers It is not known whether this drug is excreted in human milk, caution should be exercised when clotrimazole is used by a nursing woman. Pediatric Use Safety and effectiveness in children have been established for clotrimazole when used as cream and in the recommended dosage. Adverse Reactions The following adverse reactions have been reported in connection with the use of this product: Clinical improvement, with relief of pruritis, coupon for actoplus occurs within the first week of treatment with Clotrimazole Cream.
If the patient shows no clinical improvement after four weeks of treatment with Clotrimazole Cream, the diagnosis should be reviewed. NDC 15 g. Clotrimazole, USP is an odorless, white crystalline powder, insoluble in water and soluble in ethanol.
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Betamethasone dipropionate, USP is a white to creamy-white, odorless crystalline powder, insoluble in water. Ceteareth, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic monohydrate, stearyl alcohol and white petrolatum; benzyl alcohol as preservative.
Betamethasone dipropionate is a corticosteroid. Corticosteroids play a role in cellular signaling, cream 10mg, inflammation, clotrimazole cream 10mg g, and protein regulation; however, the precise mechanism of action for the treatment of tinea pedis, tinea cruris and tinea corporis is unknown.
However, similar blanching scores do not necessarily imply clotrimazole equivalence.
Clotrimazole Betamethasone Cream
Pharmacokinetics Skin penetration and systemic absorption of clotrimazole and betamethasone dipropionate following topical application of clotrimazole and betamethasone dipropionate cream has not been studied. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin.
Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids [see Dosage and Administration 2 ]. Once absorbed through the skin, the pharmacokinetics of topical corticosteroids are similar to systemically administered corticosteroids, clotrimazole cream 10mg g. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are clotrimazole excreted by the kidneys.
Some of the topical corticosteroids and their metabolites are also excreted into the bile. The methylsterols may affect the electron transport system, thereby inhibiting growth of fungi. Activity In Vitro and In Vivo Clotrimazole has been shown to be active against most strains of the following dermatophytes, both in vitro and in clinical infections, clotrimazole cream 10mg g, Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum [see Indications and Usage 1 ].
Drug Resistance Strains of dermatophytes having a natural resistance to clotrimazole have not been cream. Resistance to azoles, including clotrimazole, has been reported in some Candida species.
No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Trichophyton mentagrophytes. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility There are no adequate laboratory animal studies with either the combination of clotrimazole and betamethasone dipropionate or with either component individually to evaluate carcinogenesis.
It was positive in the in vitro human lymphocyte chromosome aberration 10mg, and equivocal in the in vivo mouse bone marrow micronucleus assay.
These doses are approximately 5- and fold the maximum human dose based on body surface areas, respectively. No adverse effects on the duration of estrous cycle, fertility, or duration of pregnancy were noted. Clinical Studies In clinical trials of tinea corporis, tinea cruris, and tinea pedis, subjects treated with clotrimazole and betamethasone dipropionate cream showed a better clinical response at the cream return visit than subjects treated with clotrimazole cream, clotrimazole cream 10mg g.
In tinea corporis and tinea cruris, the subject returned 3 to 5 days after starting treatment, and in tinea pedis, after 1 week. Mycological cure rates observed in subjects treated with clotrimazole and betamethasone dipropionate cream were as good as, or better than, 10mg those subjects treated with clotrimazole cream.
In these same clinical studies, clotrimazole cream 10mg g, patients treated with clotrimazole and betamethasone dipropionate cream showed better clinical responses and mycological cure rates when compared with subjects treated with betamethasone dipropionate cream.
Use clotrimazole and betamethasone dipropionate cream as directed by the physician. It is for external use only. Avoid contact with the eyes, the mouth, or intravaginally. Do not use clotrimazole and betamethasone dipropionate cream on the face or underarms.
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