GENTAMICIN SULFATE cream

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Cosette Pharmaceuticals, Inc.

INN (الاسم الدولي):

Gentamicin Sulfate

تركيب:

Gentamicin 1 mg in 1 g

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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

ملخص المنتج:

Gentamicin Sulfate Cream, USP 0.1% is supplied in 15 gram tubes (0713-0683-15) and 30 gram tubes (0713-0683-31). Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Rev. 05/2022 8-0683CPLNC2 VC7632

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

GENTAMICIN SULFATE- GENTAMICIN SULFATE CREAM
COSETTE PHARMACEUTICALS, INC.
----------
GENTAMICIN SULFATE CREAM, USP 0.1%
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Gentamicin Sulfate Cream, USP 0.1% 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 of isopropyl myristate, propylene
glycol, propylene
glycol monostearate, polysorbate 40, purified water, sorbitol solution
and stearic acid.
Preserved with butylparaben and methylparaben.
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 Note:
Gentamicin sulfate is
a bactericidal agent that is not eff