NYSTATIN ointment

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E)

Dostupné s:

Preferred Pharmaceuticals, Inc.

INN (Mezinárodní Name):

NYSTATIN

Složení:

NYSTATIN 100000 [USP'U] in 1 g

Podání:

TOPICAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Nystatin Ointment USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia]albicans and other Candida species. Nystatin Ointment USP is contraindicated in patients with a history of hypersensitivity to any of its components.

Přehled produktů:

Nystatin Ointment USP (100,000 USP Nystatin Units per gram) is a yellow ointment available as follows: 15 g tube (NDC 68788-9516-1) 30 g tube (NDC 68788-9516-3) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Manufactured By Perrigo Bronx, NY 10457 Distributed By Perrigo® Allegan, MI 49010 • www.perrigo.com Rev 08-15 : 2K800 RC JX1 Relabeled By: Preferred Pharmaceuticals Inc.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

NYSTATIN- NYSTATIN OINTMENT
PREFERRED PHARMACEUTICALS, INC.
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NYSTATIN OINTMENT USP
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Nystatin Ointment USP for topical use only, contains 100,000 USP
Nystatin units per
gram, in an ointment base of light mineral oil and white petrolatum.
The structural
formula is as follows:
Molecular Weight 926.13
Molecular Formula C
H
NO
CLINICAL PHARMACOLOGY
Nystatin is an antifungal antibiotic which is both fungistatic and
fungicidal _in vitro_ against
a wide variety of yeasts and yeast-like fungi. It probably acts by
binding to sterols in the
cell membrane of the fungus with a resultant change in membrane
permeability allowing
leakage of intracellular components. Nystatin is a polyene antibiotic
that is obtained from
_Streptomyces noursei_, and is the first well tolerated antifungal
antibiotic of dependable
efficacy for the treatment of cutaneous, oral and intestinal
infections caused by _Candida_
[Monilia]_albicans_ and other _Candida_ species. It exhibits no
appreciable activity against
bacteria.
Nystatin Ointment USP provides specific therapy for all localized
forms of candidiasis.
Symptomatic relief is rapid, often occurring within 24 to 72 hours
after the initiation of
treatment. Cure is effected both clinically and mycologically in most
cases of localized
candidiasis.
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INDICATIONS AND USAGE
Nystatin Ointment USP is indicated in the treatment of cutaneous or
mucocutaneous
mycotic infections caused by _Candida_ [Monilia]_albicans_ and other
_Candida_ species.
CONTRAINDICATIONS
Nystatin Ointment USP is contraindicated in patients with a history of
hypersensitivity to
any of its components.
PRECAUTIONS
Should a reaction of hypersensitivity occur, the drug should be
immediately withdrawn
and appropriate measures taken.
This preparation is not for ophthalmic use.
ADVERSE REACTIONS
Nystatin Ointment USP is virtually non-toxic and nonsensitizing and is
well tolerated by all
age groups including debilitated infants, even on prolonged
administra