Brand of gentamicin sulfate
For dermatologic use only
Each gram of GARAMYCIN Cream and Ointment provides gentamicin suIfate, equivalent to 1.0 mg (0.1%) gentamicin base, in base formulated to provide optimum therapeutic benefit and patient acceptance.
Inactive ingredients of the cream:
Chlorocresol, monocetyl ether of polyethylene glycol, cetostearyl alcohol, white petrolatum, mineral Oil, sodium dihydrogen phosphate, and purified water.
Inactive ingredients of the ointment. Methylparaben, propylparaben, and white
Gentamicin, a wide-spectrum antibiotic, provides highly effective topical treatment in primary and secondary bacterial infections ofthe skin. Susceptible bacteria 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 AND USAGE:
GARAMYCIN Cream and Ointment are indicated for the topical treatment of both primary and secondary skin infections due to susceptible bacteria. Primary skin infections: impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, syocosis barbae and pyoderma gangrenosum. Secondary skin infections: infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis, infected excoriations and bacterial superinfections of fungal or viral infections.
GARAMYCIN Cream and Ointment are 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 jJave_b.aen_ob.tained in. the treatment ot-intected-stasis and other skin
ulcers, infected superficial burns, paronychia, infected insect bites and stings, and
infected cuts, scrapes, and wounds from minor surgery. Patients sensitive to neomycin can be treated with gentamicin, although regular observation of patients sensitive to topical antibiotics is advisable when’ such patients are treated with any topical antibiotic.GARAMYCIN Cream and Ointment have been used successfully in infants over one year of age as well as in adults and children.
GARAMYCIN Cream is recommended for wet, oozing primary infections, and
greasy, secondary infections, such as pustular acne or infected seborrheic dermatitis. GARAMYCIN Ointment helps retain moisture.and is especially useful in infections on dry eczematous or psoriatic skin.
DOSAGE AND ADMINISTRATION:
A thin film of GARAMYCIN Cream or Ointment should be applied to cover completely the affected area three or four times daily until favourable results are achieved. The area treated may be covered with a gauze dressing, if desired. In impetigo contagiosa, the crusts should be removedi>efore application to permit maximum contact-between thlrantibiotic and the infection. Care should be exercised to avoid further contamination of the infected skin. Infected stasis ulcers have responded well to GARAMYCIN Cream and Ointment under gelatin packing. Concomitant treatment of the skin around the ulcer with a topical corticosteroid helps to control inflammation.
Topical use of gentamicin was reported to produce lransient irritation (erythema ana pruritus) in a small percentage of cases that usually did not require discontinuance of treatment.
GARAMYCIN Cream and Ointment are contraindicated in those patients with a history of sensitivity reactions to any oftheir components.
Systemic absorption of topically applied gentamicin may be Increased if extensive body surface area are treated, especialy over prolonged time periods or in the presence of dermal disruption. In these cases, the undesirable effects which occur following systemic use of gentamicin may potentially occur. Cautious use is
recommended under these conditions. Particularly in infants and children. Use of topical antibiotics occasionally allows overgroWth of nonsusceptible organisms, including fungi. If this occurs, or if irritation, sensitization or superinfection develops, treatment with gentamicin should be discontinued and appropriate therapy instituted. The bacterial agent of GARAMYCIN Cream and Ointment is not effective against viruses or fungi in skin infections. Safety of the use of GARAMYCIN Cream and Ointment in pregnant women has not been absolutely established.
Therefore, they should not be used on pregnant patients in large amounts or for
prolonged periods of time. GARAMYCIN Cream and Ointment are not for ophthalmic use.
GARAMYCIN Cream : 15 g. tube
GARAMYCIN Ointment: 15 g. tube
below 30° C. trademark
Memphis ce. For Pharm. & Chem. Ind. Cairo· A.R.E.
Under authority of: Schering-Plough CorporatlonlU.S.A.