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TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE is a brand name for Betamethasone, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE (clotrimazole and betamethasone dipropionate) is indicated for: the topical treatment of the following fungal dermal infections complicated by inflammatory pruritus: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes,…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE should not be used with occlusive dressings. 2 Recommended Dose and Dosage Adjustment Based on the available data, Health Canada has not authorized the use of betamethasone dipropionate and clotrimazole in children below 12 years of age (See INDICATIONS).
3 Administration A thin film of TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE should be applied to cover completely the affected and surrounding skin areas twice daily, in the morning and at night, for two weeks in tinea cruris and tinea corporis, and for four weeks in tinea pedis.
The use of TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE for longer than four weeks is not recommended. Clinical improvement, with relief of erythema and pruritus, usually occurs within three to five days of treatment. If a patient with tinea cruris and tinea corporis shows no clinical improvement after one week of treatment with TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE, the diagnosis should be reviewed.
In tinea pedis, the treatment should be applied for two weeks prior to making that decision. Treatment with TARO-CLOTRIMAZOLE/ BETAMETHASONE DIPROPIONATE should be discontinued if the condition persists after two weeks in tinea cruris and tinea corporis and after four weeks in tinea pedis.
Alternate therapy may then be instituted, if indicated, with an appropriate antifungal preparation. 4 MISSED DOSE If a dose is missed, the patient can resume treatment with the next scheduled application.
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37%) patients. Adverse reactions reported with the use of clotrimazole are as follows: erythema, stinging, blistering, peeling, edema, pruritis, urticaria, and general irritation of the skin. The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended.
These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.
Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids. Page 8 of 17
General Patients should be advised to inform subsequent physicians of the prior use of corticosteroids. Occlusive dressings should not be used, as this may result in an increase in the systemic absorption of topical corticosteroids or clotrimazole.
If irritation or hypersensitivity develops with the use of TARO-CLOTRIMAZOLE/ BETAMETHASONE DIPROPIONATE (clotrimazole and betamethasone dipropionate), treatment should be discontinued, and appropriate therapy instituted. Endocrine and Metabolism Systemic absorption of topical corticosteroids has produced reversible hypothalamic- pituitary- adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Systemic absorption of topical corticosteroid agents will be increased with the use of more potent corticosteroid agents, with prolonged usage or if extensive body surface areas are treated. Therefore, patients receiving large doses of potent topical corticosteroids, applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression.
If HPA axis suppression occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute with a less potent corticosteroid agent. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.
Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticotherapy. Page 6 of 17 Monitoring and Laboratory Tests If there is a lack of response to TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE, appropriate microbiological studies should be repeated to confirm the diagnosis and rule out other pathogens before instituting another course of antimycotic therapy.
The following tests may be helpful in evaluating HPA axis suppression due to the corticosteroid component: Urinary free cortisol test ACTH stimulation test Ophthalmologic TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE should not be used in or near the eyes since this preparation is not formulated for ophthalmic use.
Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Skin Suitable precautions should be taken in using topical corticosteroids in patients with stasis dermatitis and other skin diseases with impaired circulation. Prolonged use of corticosteroid preparations may produce striae or atrophy of the skin or subcutaneous tissue.
If this occurs, treatment should be discontinued. 1 Pregnant Women There are no adequate and well-controlled studies in pregnant women on teratogenic effects of a topically applied combination of clotrimazole and betamethasone dipropionate.
Therefore, TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs containing corticosteroids should not be used extensively on pregnant patients in large amounts or for prolonged periods of time.
2 Breast-feeding Since it is not known whether the components of TARO-CLOTRIMAZOLE/ BETAMETHASONE DIPROPIONATE are excreted in human milk, caution should be exercised when this product is administered to a nursing woman. 3 Pediatrics Safety and effectiveness in children below the age of 12 have not been established with clotrimazome and betamethasone dipropionate.
The use of TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE in diaper dermatitis is not recommended. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of greater absorption due to a larger skin surface area to body weight ratio.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical dermatologics containing a corticosteroid to children should be limited to the least amount compatible with an effective therapeutic regimen.
Chronic corticosteroid therapy may interfere with the growth and development of children.
TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE is contraindicated in: patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.
patients who are sensitive to other corticosteroids or imidazoles. untreated bacterial and tubercular infections involving the skin and in certain viral diseases such as herpes simplex, chicken pox and vaccinia.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.