GENTAMICIN SULFATE ointment

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Teligent Pharma, Inc.

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

Gentamicin Sulfate Ointment USP, 0.1% is available as follows: 15 g tube (NDC 52565-090-15) 30 g tube (NDC 52565-090-30)

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

GENTAMICIN SULFATE- GENTAMICIN SULFATE OINTMENT
TELIGENT PHARMA, INC.
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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,
alpha-hemolytic), _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 infect