TRADE NAME:GARAMYCIN CREAM GENERIC NAME: Gentamicin (as sulfate) COMPOSITION: Each 1 gm cream contains: Gentamicin (as sulfate) 1 mg Excipients: Chlorocreasol, monocetyl ether of polyethylene glycol, cetostearyl alcohol, white petrolatum, liquid petrolatum, sodium dihydrogen phosphate. PHARMACEUTICAL FORM: Cream. PHARMACOLOGICAL ACTION: Gentamicin sulfate is a wide spectrum antibiotic that provides highly effective topical treatment in primary and secondary bacterial infections of the skin. Garamycin cream may clear infections that have not responded to treatment with other topical antibiotic agents. In primary skin infections such as impetigo contagiosa, treatment 3 or 4 times daily with Garamycin cream usually clears the lesions promptly. In secondary skin infections, Garamycin cream aids in the treatment of the underlying dermatoses by controlling the infection. Bacteria susceptible to the action of gentamicin 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. INDICATIONS: - Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyodermagangrenosum. -Secondary skin infections: Infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, and bacterial super-infections of fungal or viral infections. Please Note: Gentamicin sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections. -Gentamicin sulfate is useful in the treatment of infected skin cysts and certain other skin abscesses when preceded by incision and drainage to permit adequate contact between the antibiotic and the infecting bacteria. -Good results have been obtained in the treatment of infected stasis and other skin ulcers, infected superficial burns, paronychia, infected insect bites and stings, infected lacerations and abrasions, and wounds from minor surgery. -Patients sensitive to neomycin can be treated with gentamicin sulfate, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic. -Garamycin Cream is recommended for wet, oozing primary infections, and greasy, secondary infections, such as pustular acne or infected seborrheic dermatitis. If a water-washable preparation is desired, the cream is preferable. -Garamycin Cream has been used successfully in infants over one year of age, as well as in adults and children. DOSAGE AND ADMINISTRATION: - A small amount of Garamycin Cream should be applied gently to the lesions three or four times daily. The area treated may be covered with a gauze dressing if desired. - In impetigo contagiosa, the crusts should be removed before application of gentamicin sulfate to permit maximum contact between the antibiotic and the infection. Care should be exercised to avoid further contamination of the infected skin. - Infected stasis ulcers have responded well to treatment with gentamicin sulfate under gelatin packing. CONTRAINDICATIONS: This drug product is contraindicated in individuals with a history of sensitivity to any of its components. UNDESIRABLE EFFECTS: * In patients with dermatoses treated with Garamycin cream, irritation (erythema and pruritis) that did not usually require discontinuance of treatment has been reported in a small percentage of cases. There was no evidence of irritation or sensitization, however, in any of these patients patch-tested subsequently with Garamycin cream on normal skin. * Possible photosensitization has been reported in several patients but could not be elicited in these patients by reapplication of Garamycin cream followed by exposure to ultraviolet radiation. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via sending e-mail to pv@memphis.com.eg or via website www.epvc.gov.eg WARNINGS AND PRECAUTIONS: The use of topical antibiotics occasionally allows overgrowth of nonsusceptible organisms, including fungi. If this condition occurs, or if irritation, sensitization or superinfection develops, treatment with Garamycin cream should be discontinued and appropriate therapy instituted. STORAGE :Store at a temperature not exceeding 30˚C. PACKAGE : Carton box containing aluminum metallic tube containing 15gm cream with white opaque (HDPE) screw cap with aluminium membrane piercer + inner leaflet.
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