Document
DailyMed Label: GENTAMICIN SULFATE
Title
DailyMed Label: Gentamicin Sulfate
Date
2010
Document type
DailyMed Prescription
Name
Gentamicin Sulfate
Generic name
gentamicin sulfate
Manufacturer
Physicians Total Care, Inc.
Product information
NDC: 54868-6126
Product information
NDC: 54868-6126
Description
Gentamicin Sulfate Ointment is a wide spectrum antibiotic preparation for
topical administration. Each gram contains 1.0 mg of Gentamicin in a base of
White Petrolatum with Methylparaben and Propylparaben as preservatives.
Indications
Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma,
furunculosis, sycosis barbae, and pyoderma gangrenosum. 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. Gentamicin Sulfate Ointment helps retain moisture
and has been useful in infection on dry eczematous or psoriatic skin. Gentamicin
Sulfate Ointment may be used in children over one year of age as well as in
adults.
Dosage
A small amount of Gentamicin Sulfate Ointment 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.
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 gentamicin sulfate
should be discontinued and appropriate therapy instituted.
Adverse reactions
In patients with dermatoses treated with gentamicin sulfate, 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 gentamicin sulfate on normal skin. Possible photosensitization
has been reported in several patients but could not be elicited in these
patients by reapplication of gentamicin sulfate followed by exposure to
ultraviolet radiation.
How supplied
Gentamicin Sulfate Ointment USP, 0.1% is supplied in 15 gram
tubes NDC 54868-6126-0.
Store at controlled room temperature 15°-30°C (59°-86°F).
E FOUGERA & CO A division of Nycomed US Inc. Melville, New York
11747 USA
I27815C R2/08 #292
Relabeling of "Additional Barcode" by: Physicians Total Care, Inc. Tulsa, OK 74146
Clinical pharmacology
Gentamicin sulfate is a wide spectrum antibiotic that provides highly effective
topical treatment in primary and secondary bacterial infections of the skin.
Gentamicin Sulfate Ointment 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 Gentamicin Sulfate
Ointment usually clears the lesions promptly. In secondary infections,
Gentamicin Sulfate Ointment 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 Kiebsiella
pneumoniae .
Package label
GENTAMICIN SULFATE OINTMENT UPS, 0.1%
Rx only
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
Each gram contains 1.0 mg of Gentamicin in a base of White Petrolatum
with Methylparaben and Propylparaben as preservatives.
NET WT 15 grams
image of package label
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