GENTAMICIN SULFATE cream

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. Please 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 Sul

제품 요약:

Gentamicin Sulfate Cream USP, 0.1% is available as follows: 15 g tube (NDC 45802-056 -35) 30 g tube (NDC 45802-056 -11)

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

GENTAMICIN SULFATE- GENTAMICIN SULFATE CREAM
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
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 of Gentamicin Sulfate Cream USP, 0.1%
contains Gentamicin
Sulfate USP equivalent to 1 mg of gentamicin base in a cream base of
isopropyl
myristate, propylene glycol, propylene glycol monostearate,
polysorbate 40, purified
water, sorbitol solution, and stearic acid, 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 USP, 0.1% may clear infections that have not responded to other
topical
antibiotic agents. In primary skin infections such as impetigo
contagiosa, treatment
three or four times daily with Gentamicin Sulfate Cream USP, 0.1%
usually clears the
lesions promptly. In secondary skin infections, Gentamicin Sulfate
Cream USP, 0.1% aids
in 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 aerogenes, 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 v