Mixderm cream is indicated for the relief of the inflammatory manifestations of corticosteroid-responsive dermatoses when complicated by secondary infection caused by organisms sensitive to the components of this dermatologic preparation, or when the possibility of such infections is suspected.
Such disorders include: inguinal dermatosis, chronic dermatitis of extremities, erythrasma, balanoposthitis, herpes zoster, eczematoid dermatitis, contact dermatitis, follicular dermatitis, dyshidrosis, paronychia, anal pruritus, seborrheic eczema, intertrigo, seborrheic dermatitis, pustular acne, impetigo, neurodermatitis, angular stomatitis, photosestivity dermatitis, lichenified Inguinal dermatophytosis and tinea infections such as tinea pedis, tinea cruris and tinea corporis.
Dosage And Administration
- A thin film of Mixderm cream should be applied to cover completely the affected area two or three times daily, or as prescribed by the physician.
- Frequency of application should be determined according to severity of the condition.
- Duration of therapy should be determined by patient response. In cases of tinea pedis longer therapy (2-4 weeks) may be necessary.
Composition
Each 1 gram contains active ingredients: 0.6 mg Betamethasone valerate (equivalent to 0.5 mg betamethasone), 1.7 mg Gentamicin sulphate (equivalent to 1.0 mg gentamicin), 10 mg Tolnaftate, 10 mg Clioquinol (lodochlorhydroxyquin).
Inactive ingredients: Chlorocresol, Texofor AIP, Cetostearyl alcohol, White petrolatum, Sodium biphosphate, Mineral oil, Sodium hydroxide and Purified water.
Pharmaceutical form
Topical cream (for external use only).
Pharmacological action
Mixderm is a topical cream, it combines:
- Betamethasone valerate: anti-inflammatory, anti-pruntic and vasoconstrictive agent.
- Gentamicin sulphate: wide spectrum antibiotic that provides highly effective topical treatment in primary and secondary bacterial infections of the skin.
- Tolnaftate: fungicidal agent.
- Clioquinol: antibacterial and antifungal agent.
Overdosage
Symptoms
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. A single overdose of gentamicin would not be expected to produce symptoms.
Excessive or prolonged use of topical antibiotics may lead to overgrowth of lesions by nonsusceptible organisms. Systematically, tolnaftate is pharmacologically inactive. Clioquinol rarely produces iodism.
Treatment
- Appropriate symptomatic treatment is indicated.
- Acute hypercorticoid symptoms are usually reversible.
- Treat electrolyte imbalance, if necessary. In case of chronic toxicity, slow withdrawal of corticosteroids is advised.
- If overgrowth by nonsusceptible organisms occurs, stop treatment with Mixderm Cream and institute appropriate therapy.
Contraindications
Mixderm cream is contraindicated in patients with a history of sensitivity reactions to any of its components.
Side Effects
Local side effects reported with the use of topical corticosteroids, especially, under occlusive dressings, include: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, stria and miliarie.
Rash, imitation and hypersensitivity have been reported with the topical usage of gentamicin sulfate, clioquinol and rarely with tolnaftate.
Pregnancy And Lactation
Pregnancy
Since safety of topical corticosteroid use in pregnant women has not been established, topical creams containing corticosteroid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Drugs of this class should not be used extensively in large amounts or for prolonged periods of time in pregnant patients.
Lactation
Since 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.
Precautions And Warnings
Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children.
Prolonged use of topical antibiotics occasionally may result in overgrowth of non-susceptable organisms. If this occurs, or if imitation, sensitization or superinfection develops, treatment with Mixderm cream should be discontinued and appropriate therapy instituted.
Systemic absorption of clioquinol may interfere with thyroid function tests. The femic chloride test for phenylketonuria can yield a false-positive result if cloquinol is present in the urine.
Pediatric use
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and to exogenous corticosteroid effects than mature patients because of greater absorption due to a large skin surface area to body weight ratio.
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 buiging fontanelle, headaches and bilateral papilledema.
Patient Instructions
- Mixderm cream is for external use only.
- Mixderm cream contains clioquinol, which may stains skin and clothing Do not apply to irritated skin or if excessive imitation develops.
- Mixderm cream is not for ophthalmic use, if eye contact occurs, immediately wash out the eye with water or saline. Keep out of reach of children.
other information
Generic name
Betamethasone valerate, Gentamicin sulphate, Tolnaftate and Clioquinol.
Package and storage
A carton box containing Aluminum collapsible tube of 15 g. cream, fitted with plastic cap. Store at temperature not exceeding 30°C.
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