NYSTATIN cream

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Bryant Ranch Prepack

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Nystatin Cream USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin Cream USP is not indicated for systemic, oral, intravaginal or ophthalmic use. Nystatin Cream USP is contraindicated in patients with a history of hypersensitivity to any of its components.

ملخص المنتج:

Nystatin Cream USP (100,000 USP Nystatin Units per gram) is a yellow cream available as follows: 15 g tube (NDC 63629-8694-1) Storage Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

NYSTATIN- NYSTATIN CREAM
BRYANT RANCH PREPACK
----------
NYSTATIN CREAM USP DRUG FACTS
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Nystatin is a polyene antifungal antibiotic obtained from
_Streptomyces noursei_. The
molecular formula is C
H
NO
, and the molecular weight is 926.13.
Structural formula:
Nystatin Cream USP is for dermatologic use.
Nystatin Cream USP for topical use, contains 100,000 USP nystatin
units per gram.
Inactive ingredients: emulsifying wax, glycerin, isopropyl myristate,
lactic acid, purified
water, sodium hydroxide, and sorbic acid.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Nystatin Cream USP 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 levels of
nystatin, _Candida_
_albicans_ does not develop resistance to nystatin. Generally,
resistance to nystatin does
47
75
17
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 Cream USP is indicated in the treatment of cutaneous or
mucocutaneous
mycotic infections caused by _Candida albicans_ and other susceptible
_Candida_ species.
NYSTATIN CREAM USP IS NOT INDICATED FOR SYSTEMIC, ORAL, INTRAVAGINAL
OR
OPHTHALMIC USE.
CONT