Polyderm 4

Tolnaftate, clioquinol, gentamicin sulfate, betamethasone valerate.

Off-white to yellowish brown, glossy, viscous cream.
Each gram contains: Tolnaftate 10 mg, Clioquinol 10 mg, Gentamicin (as Sulfate) 1 mg, Betamethasone (as Valerate) 500 mcg.

Pharmacology: Clinical studies have demonstrated the efficacy of betamethasone valerate in the treatment of corticosteroid-responsive dermatoses. When betamethasone valerate was subjected to the Draize patch test, no primary irritation or potential for allergic contact dermatitis occurred.
In vitro antibacterial activity of gentamicin showed it to be bactericidal against a wide variety of gram-positive and gram-negative bacteria. At concentrations 4 mcg/mL or less, gentamicin inhibited 95% strains of Staphylococcus aureus and 70-90% of strains of Escherichia coli and Aerobacter aerogenes. Toxicity studies animals and man revealed no evidence of skin irritation after local application of gentamicin in concentrations higher than that formulated for therapeutic use. Results of the Draize cutaneous patch test in 100 patients indicated that gentamicin was not primary irritant; furthermore, gentamicin has a low index of skin irritation sensitization. Tolnaftate is a potent fungicidal agent against Trychophyton mentagrophyes, Trichophyton rubrum, Microsporum canis, Epidermophyton occosum and Malassezia furfur. Clinical studies have shown the excellent fungicidal effect of tolnaftate in large number of patients with superficial fungal infections. Therapy with tolnaftate has been notable for lack of recurrence. Test of skin sensitivity have shown no signs of local irritation 24 and 48 hours after medication was applied. Clioquinol is effective topical therapy for bactericidal and/or candidial (monilial) infections. Inhibition of candida labicans was obtained with concentrations of 25 mcg/mL. At concentrations of 50 mcg/mL clioquinol completely/inhibited all our four strains of Candida albicans tested. Each component of cream makes a significant contribution to the efficacy of the product in treating infections of mixed etiology.

Used in the treatment of a wide variety of eczemas and other allergic and inflammatory dermatoses where secondary bacterial and/or fungal infection is present. It includes tinea infections, chronic dermatitis, contact dermatitis. Parakeratosis, paronychia, anal pruritus, impetigo and photosensitivity dermatitis.

Apply completely on affected area 2-3 times a day for 5-10 days or as prescribed by physician.

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 antibiotics may lead to over-growth of lesions by non-susceptible 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 non-susceptible organisms occurs, stop treatment with cream and institute appropriate therapy.

Contraindicated in those patients with a history of sensitivity reactions to any of its components.

The cream is contraindicated for TB lesion on skin, acute herpes simplex, vacinnia or varicella.
Avoid use in or near the eyes.

Since safety of topical corticosteroid use in pregnant women has not been established, drugs of this class 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.
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 discontinue the drug, taking into account the importance of the drug to the mother.

May cause irritation, skin atrophy, striae, folliculitis, superinfection due to non-susceptible organism, miliaria and dryness.

Store at temperatures not exceeding 30°C.

Topical Anti-Infectives with Corticosteroids

D07CC01 - betamethasone and antibiotics ; Belongs to the class of potent (group III) corticosteroids, in combination with antibiotics. Used in the treatment of dermatological diseases.

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