NYSTATIN ointment

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Viona Pharmaceuticals Inc

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Nystatin Ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin Ointment 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.

ملخص المنتج:

Nystatin ointment (100,000 USP Nystatin Units per gram) is a yellow colored ointment is supplied in 15g and 30g tubes. NDC 72578-089-01 in tube of 15 gm NDC 72578-089-04 in tube of 30 gm

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

NYSTATIN - NYSTATIN OINTMENT
VIONA PHARMACEUTICALS INC
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NYSTATIN OINTMENT, USP
DESCRIPTION
Nystatin is a polyene antifungal antibiotic drug obtained from
_Streptomyces nursei._
Structural formula:
Nystatin Ointment is for dermatologic use. Nystatin Ointment USP, for
topical use only,
contains 100,000 USP Nystatin Units per gram, in a white petrolatum
and light mineral oil
base.
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 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 is indicated in the treatment of cutaneous or
mucocutaneous mycotic
infections caused by _Candida albicans _and other susceptible Candida
species.
NYSTATIN OINTMENT IS NOT INDICATED FOR SYSTEMIC, ORAL, INTRAVAGINAL OR
OPHTHALMIC USE.
CONTRAINDICATIONS
Nystatin Ointment is contraindicated in patients with a history of
hypersensitivity to any
of their components.
PRECAUTIONS
GENERAL
NYSTATIN OINTMENT SHOULD NOT BE USED FOR THE TREATMENT OF SYSTEMIC,
ORAL,