Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)
Cosette Pharmaceuticals, Inc.
TOPICAL
PRESCRIPTION DRUG
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 superinfections of fungal or viral infections. NOTE: Gentamicin Sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections. It 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, al
Gentamicin Sulfate Ointment, USP 0.1% is available as follows: 15 g tube (NDC 0713- 0682 -15) 30 g tube (NDC 0713- 0682 -31) STORAGE 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 8-0682CPLNC2 VC7635
Abbreviated New Drug Application
GENTAMICIN SULFATE- GENTAMICIN SULFATE OINTMENT COSETTE PHARMACEUTICALS, INC. ---------- GENTAMICIN SULFATE OINTMENT, USP 0.1% RX ONLY FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE DESCRIPTION Gentamicin Sulfate Ointment, USP 0.1% is a wide spectrum antibiotic preparation for topical administration. Each gram of Gentamicin Sulfate Ointment, USP 0.1% contains Gentamicin Sulfate USP equivalent to 1 mg of gentamicin base in a base of light mineral oil and white petrolatum, with 0.5 mg methylparaben and 0.1 mg propylparaben 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. This product may clear infections that have not responded to other topical antibiotic agents. In impetigo contagiosa and other primary skin infections, treatment with a small amount of Gentamicin Sulfate Ointment three to four times daily usually clears the lesions promptly. In secondary skin infections, the product facilitates the treatment of the underlying dermatosis by controlling the infection. Bacteria susceptible to the action of Gentamicin Sulfate include sensitive strains of _Streptococci_(group A beta-hemolytic, alphahemolytic), _Staphylococcus aureus_(coagulase positive, coagulase negative, and some penicillinase- producing strains), and the gram-negative bacteria, _Pseudomonas aeruginosa,_ _Aerobacteraerogens, Escherichia coli, Proteus vulgaris_and _Klebsiellapneumoniae._ 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 superinfections of fungal or viral infections. NOTE: Gentamicin Sulfate is a bactericidal agent that is not effective against viruses or fungi in skin Прочитајте комплетан документ