GENTAMICIN SULFATE- gentamicin sulfate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)

Available from:

E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.

INN (International Name):

GENTAMICIN SULFATE

Composition:

GENTAMICIN 1 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic 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 w

Product summary:

Gentamicin Sulfate Cream USP, 0.1% is supplied in 15 gram tubes NDC 0168-0071-15. Store at controlled room temperature 15°-30°C (59°-86°F). E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I27115E R12/11 #161

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GENTAMICIN SULFATE- GENTAMICIN SULFATE CREAM
E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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GENTAMICIN SULFATE CREAM USP, 0.1% - GENTAMICIN SULFATE CREAM
For Dermatologic Use Only
Not For Ophthalmic Use
Rx Only
DESCRIPTION
Gentamicin Sulfate Cream is a wide spectrum antibiotic preparation for
topical administration. Each
gram contains Gentamicin Sulfate USP equivalent to 1 mg gentamicin
base in a cream base containing
stearic acid, propylene glycol monostearate, isopropyl myristate,
polysorbate 40, propylene glycol,
sorbitol solution and purified water with methylparaben and
butylparaben as preservatives.
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 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 Gentamicin
Sulfate Cream usually clears the
lesions promptly. In secondary skin infections, Gentamicin Sulfate
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 Kiebsiella pneumoniae.
INDICATIONS AND USAGE
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
No