GENTAMICIN SULFATE CREAM 0.1% cream

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Sola Pharmaceuticals

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 wi

Proizvod sažetak:

Gentamicin Sulfate Cream USP, 0.1% is supplied as follows: 30 gram tube (NDC 70512-036-30) Store at controlled room temperature 15°-30°C (59°-86°F). Manufactured for: SOLA Pharmaceuticals Baton Rouge, LA 70810 C101322 PI-036-00 Rev 12/2019 Rev. 2

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

GENTAMICIN SULFATE CREAM 0.1%- GENTAMICIN SULFATE CREAM 0.1% CREAM
SOLA PHARMACEUTICALS
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GENTAMICIN SULFATE CREAM USP, 0.1%
FOR DERMATOLIGIC USE ONLY
NOT FOR OPTHALMIC 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 Klebsiella
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 Note: Gentamicin Sulfate is a bactericidal agent