Creobic Double Action

Creobic Double Action

betamethasone + clotrimazole

Manufacturer:

Kotra Pharma

Distributor:

Kotra Pharma
Full Prescribing Info
Contents
Clotrimazole 1% w/w, betamethasone dipropionate 0.05% w/w.
Description
Clotrimazole 1.0% w/w, Betamethasone (as dipropionate) 0.05% w/w, Benzyl Alcohol (as preservative) 1.0% w/w.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Creobic DA Cream combines the broad spectrum antifungal activity of clotrimazole with the sustained anti-inflammatory, anti-pruritic and vasoconstrictive actions of betamethasone dipropionate. Clotrimazole appears to act on the fungal cell membrane, causing leakage of cell contents.
Pharmacokinetics: Creobic DA Cream is intended for treatment of skin conditions and is applied topically. There are minimal pharmacokinetic aspects related to bioavailability at the site of action. Clotrimazole penetrates the epidermis after topical administration but there is little, if any, systemic absorption. 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. Inflammation and / or other disease processes in the skin may increase percutaneous absorption of topical corticosteroids. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Once absorbed through the skin, the pharmacokinetics of topical corticosteroids are similar to systemically administered corticosteroids. Corticosteroids are bound to plasmaproteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Indications/Uses
All fungal skin infections due to dermatophytes (e.g. Indicated for the topical treatment of the following dermal infections: Tinea pedis, tinea cruris and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis due to Candida albicans.
Dosage/Direction for Use
Directions for Use: For external use only. Gently massage sufficient quantity into the affected and surrounding skin areas twice daily, in the morning and evening, for two weeks in tinea cruris, tinea corporis and candidiasis, and for four weeks in tinea pedis.
Duration of therapy: Clinical improvement usually occurs within the first three to five days of treatment, with relief of erythema and pruritus. The diagnosis should be reviewed if a patient with tinea cruris, tinea corporis, or candidiasis shows no clinical improvement after one week of treatment with Creobic DA Cream. In tinea pedis, the treatment should be applied for two weeks prior to making that decision. Treatment with Creobic DA Cream should be discontinued, if the condition persist after two weeks in tinea cruris and tinea corporis, and after four weeks in tinea pedis. Alternate therapy may then be instituted with an appropriate antifungal agent only. It is not recommended to use Creobic DA Cream for longer than four weeks.
Overdosage
Excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency, and produce manifestations of hypercorticism, including Cushing's disease. Appropriate symptomatic treatment is indicated for overdosage. Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In case of chronic toxicity, slow withdrawal of corticosteroids is advised.
Contraindications
Contraindicated in those patients with a history of sensitivity reactions to any of its components or to other corticosteroids or imidazoles.
Special Precautions
Creobic DA Cream should not be used with adhesive dressing as well as occlusive dressings. Treatment should be discontinued and appropriate therapy instituted, if irritation or sensitization develops with the use of this cream. An appropriate antibacterial agent should be administered concomitantly, in the presence of a bacterial infection. Creobic DA Cream therapy should be discontinued if a favourable response does not occur promptly, until the infection has been controlled adequately. If there is a lack of response to Creobic DA Cream, appropriate microbiological studies should be repeated to confirm the diagnosis and rule out other pathogens before instituting another course of antimycotic therapy. Any of the side effects that are reported following systemic use of corticosteroids may also occur with topical corticosteroids, including adrenal suppression, manifestations of Cushing's syndrome, hyperglycemia and glycosuria. The use of more potent corticosteroid agents will increase the systemic absorption of topical corticosteroids, 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 hypothalamic-pituitary- adrenal (HPA) axis suppression. If hypothalamic- pituitary-adrenal (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. Upon discontinuation of the drug, the recovery of hypothalamic-pituitary-adrenal (HPA) axis function is generally prompt and complete. Infrequently signs and symptoms of corticosteroids withdrawal may occur, requiring supplemental systemic corticotherapy. Not for ophthalmic use.
Use in Pregnancy & Lactation: The safety of topical corticosteroid use in pregnant women has not been established. Hence, drugs of this class should not be used during pregnancy, unless the potential benefit justifies the potential risk to the fetus and such use should not be extensive i.e. in large amounts or for prolonged periods of time. As it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Use in Children: Compared to mature patients, pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and to exogenous corticosteroid effects because of greater absorption due to a large skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include a bulging fontanelle, headaches and bilateral papilledema. The use of Creobic DA Cream in diaper dermatitis is not recommended.
Use In Pregnancy & Lactation
Use in Pregnancy & Lactation: The safety of topical corticosteroid use in pregnant women has not been established. Hence, drugs of this class should not be used during pregnancy, unless the potential benefit justifies the potential risk to the fetus and such use should not be extensive i.e. in large amounts or for prolonged periods of time. As it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
The following adverse reactions have been reported infrequently with clotrimazole and betamethasone dipropionate when used in combination: paraesthesia, maculopapular rash, edema and secondary infection. Reported adverse reactions to clotrimazole include erythema, stinging, blistering, peeling, edema, pruritus, urticarial and general irritation of the skin. The following local adverse reactions have been reported with the use of topical corticosteroids: 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. 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.
Drug Interactions
Not known.
Storage
Keep container well closed. Store below 30°C. Protect from light.
ATC Classification
D07CC01 - betamethasone and antibiotics ; Belongs to the class of potent (group III) corticosteroids, in combination with antibiotics. Used in the treatment of dermatological diseases.
Presentation/Packing
Cream (white to off white coloured, water miscible) 5 g, 15 g.
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