Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)
Teligent Pharma, 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 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
Gentamicin Sulfate Cream USP, 0.1% is supplied as follows: 15 gram tube (NDC 52565-085-15) 30 gram tube (NDC 52565-085-30)
Abbreviated New Drug Application
GENTAMICIN SULFATE- GENTAMICIN SULFATE CREAM TELIGENT PHARMA, INC. ---------- GENTAMICIN SULFATE CREAM USP, 0.1% 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 Note: Gentamicin sulfate is a bactericidal agent tha Прочетете целия документ