NYSTATIN- nystatin ointment ointment
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
29-11-2023
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Active ingredient:
NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E)
Available from:
Cosette Pharmaceuticals, Inc.
INN (International Name):
Nystatin
Composition:
Nystatin 100000 [USP'U] in 1 g
Administration route:
TOPICAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Nystatin Ointment, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candidaspecies. Nystatin Ointment, USP is not indicated for systemic, oral, intravaginal or ophthalmic use. Nystatin Ointment is contraindicated in patients with a history of hypersensitivity to any of their components.
Product summary:
Nystatin Ointment, USP (100,000 USP Nystatin Units per gram) is a light yellow to yellow ointment available as follows: NDC 0713-0686-15 15 gram tube NDC 0713-0686-31 30 gram tube Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0686CPLNC3 Rev.03/2022 VC7623
Authorization status:
Abbreviated New Drug Application
Summary of Product characteristics
NYSTATIN- NYSTATIN OINTMENT OINTMENT
COSETTE PHARMACEUTICALS, INC.
----------
NYSTATIN OINTMENT, USP
100,000 USP NYSTATIN UNITS P ER GRAM
FOR TOPICAL USE ONLY.NOT FOR OPHTHALMIC USE.
RX ONLY
DESCRIPTION
Nystatin Ointment, USP is for dermatologic use. Nystatin Ointment, USP
for topical use
only, contains 100,000 USP nystatin units per gram, in a white
petrolatum base.
Nystatin is a polyene antifungal antibiotic drug obtained from
_Streptomyces nursei_.
The structural formula is as follows:
Molecular Weight 926.13
Molecular Formula C
H
NO
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Nystatin is not absorbed from intact skin or mucous membrane.
MICROBIOLOGY
Nystatin is an antibiotic which is both fungistatic and fungicidal _in
vitro_against a wide
variety of yeasts and yeast-like fungi, including _Candida albicans,
C. parapsilosis, C._
_tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei,
Torulopsis glabrata, Tricophyton_
47
75
17
_rubrum, T. mentagrophytes._
Nystatin acts by binding to sterols in the cell membrane of
susceptible species resulting
in a change in membrane permeability and the subsequent leakage of
intracellular
components. On repeated subculturing with increasing concentrations of
nystatin,
_Candida albicans_does not develop resistance to nystatin. Generally,
resistance to
nystatin does not develop during therapy. However, other species of
_Candida_( _C._
_tropicalis, C. guilliermondi, C. krusei, and C. stellatoides_) become
quite resistant on
treatment with nystatin and simultaneously become cross resistant to
amphotericin as
well. This resistance is lost when the antibiotic is removed.
Nystatin exhibits no appreciable activity against bacteria, protozoa,
or viruses.
INDICATIONS AND USAGE
Nystatin Ointment, USP is indicated in the treatment of cutaneous or
mucocutaneous
mycotic infections caused by _Candidaalbicans_and other susceptible
Candidaspecies.
NYSTATIN OINTMENT, USP IS NOT INDICATED FOR SYSTEMIC, ORAL,
INTRAVAGINAL OR
OPHTHALMIC USE.
CONTRAINDICATIONS
Nystatin Ointment is contraindicated
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