GENTAMICIN SULFATE ointment

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Cosette Pharmaceuticals, Inc.

Spôsob podávania:

TOPICAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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

Prehľad produktov:

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

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

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