GENTAMICIN SULFATE ointment

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Padagis Israel Pharmaceuticals Ltd

INN (국제 이름):

GENTAMICIN SULFATE

구성:

GENTAMICIN 1 mg in 1 g

관리 경로:

TOPICAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic. Gentamicin sulfate cream is recommended for wet, oozing primary infections, and greasy, secondary infections, such as postular acne or infected seborrheic dermatitis. Gentamicin Sulfate Ointment USP, 0.1% helps retain moisture and has been useful in infection on dry eczematous or psoriatic skin. Gentamicin Sulfate Ointment USP, 0.1% has been used successfully in infants over one year of age as well as in adults and children. Gentamicin Sulfate Ointment USP, 0.1% is contraindicated in individuals with a history of sensitivity reactions to any of its components.

제품 요약:

Gentamicin Sulfate Ointment USP, 0.1% is available as follows: 15 g tube (NDC 45802-046 -35) 30 g tube (NDC 45802-046 -11)

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

GENTAMICIN SULFATE- GENTAMICIN SULFATE OINTMENT
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
GENTAMICIN SULFATE OINTMENT USP, 0.1%
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
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,
Aerobacter aerogens, 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 superinfections of fungal or viral
infections. NOTE: Gentamicin Sulfate is a
bactericidal agent that is not effective against viruses or fungi in
ski