COMPOSITION: Each 1 gm cream contains: Active ingredients: Gentamycin sulphate 1.6949 mg (Equivalent to 1mg Gentamycin base) Mometasone furoate micronized 1 mg Miconazole nitrate micronized 20mg Excipients: Chlorocresol, White Soft Paraffin, Cetostearyl Alcohol, Cetomarogol 1000, Propylene Glycol, Sodium Phosphate Dibasic, Purified Water. PHARMACEUTICAL FORM: Topical cream. White, smooth homogenous cream, free from lumps & foreign matter. Clinical particulars Pharmacology Gentamicin Plus is a topical cream which contains Mometasone furoate, Gentamycin, Miconazole nitrate as active ingredients. Mometasone It is a synthetic medium potency corticosteroid, used topically for its glucocorticoid activity in the treatment of various skin disorders. It exhibits anti-inflammatory, anti-pruritic and anti- allergic actions. Gentamycin: Gentamycin topically is a broad-spectrum anti-bacterial agent against Gentamycin sensitive bacterial skin infections, which provides highly effective topical treatment in primary and secondary bacterial infections of the skin. It has been applied topically for skin infections in concentrations of 0.1%, but such use may lead to the emergence of resistance and is considered inadvisable. Concentrations of 0.3% are used in preparations for topical application to the eyes and ears. Gentamycin Sulfate 0.1% may clear infections that have not responded to other topical antibiotic agents. A liposomal formulation of gentamycin is under investigation. In primary skin infections such as impetigo contagiosa, treatment three or four times daily with Gentamycin Sulfate 0.1% usually clears the lesions promptly. In secondary skin infections, Gentamycin Sulfate 0.1% aids in the treatment of the underlying dermatosis by controlling the infection. Bacteria susceptible to the action of Gentamycin sulfate include sensitive strains of Streptococci (group A beta-hemolytic, alpha-hemolytic), Staphylococcus aureus (coagulase positive, coagulase negative, and some penicillinase producing strains), and the gram-negative bacteria, Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae. Miconazole: Miconazole nitrate is a broad-spectrum antifungal against pathogenic fungi including yeasts and dermatophytes. It is usually applied twice daily as a 2% cream, lotion, or powder in the treatment of fungal infections of the skin including candidiasis, dermatophytosis, and pityriasis versicolor. THERAPEUTIC INDICATIONS: Gentamicin Plus is indicated in mixed infections of the skin with fungi and bacteria. These include: • Atopic eczema, contact eczema, follicular eczema, infantile eczema. • Otitis externa, anogenital pruritis (pruritis ani/vulvae), nummular eczema, post traumatic infective eczema, seborrhoeic or flexural eczema, neurodermatitis, and psoriasis. • Infected superficial burns, paronychia, infected insect bites and stings, infected lacerations and abrasions, and wounds from minor surgery. • Mycotic infections of the skin and nails and superinfections due to Gram-positive bacteria. Topical preparations containing an imidazole such as ketoconazole or miconazole, usually with hydrocortisone, are used in the management of seborrhoeic dermatitis. DOSAGE AND ADMINISTRATION: Route of Administration: Cutaneous use. Dosage: ADULTS, INCLUDING ELDERLY PATIENTS AND CHILDREN: - Apply a thin film of Gentamicin Plus to the affected areas of skin once or twice daily. - The area treated may be covered with a gauze dressing if desired. Care should be exercised to avoid further contamination of the infected skin. • Use of topical corticosteroid in children or on the face should be limited to the least amount compatible with an effective therapeutic regimen and duration of treatment should be no more than 5 days. It has been suggested that a "steroid holiday " of at least 2 weeks be considered in children after each 2 or 3 weeks of daily topical therapy to allow thinned epidermis to restore itself and maintain its barrier function. Care is also necessary in applying corticosteroids to certain anatomical sites such as the face and flexures. Advice should be given that topical corticosteroids should be applied sparingly in thin layers by smoothing gently into the skin preferably after a bath, and that no benefit is gained from more frequent than twice daily application or by vigorous rubbing.
