NYSTATIN- nystatin powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Vensun Pharmaceuticals, Inc.

INN (International Name):

NYSTATIN

Composition:

NYSTATIN 100000 [USP'U] in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

 Nystatin Topical Powder is supplied as 100,000 units nystatin per gram in plastic squeeze bottles. NDC 42543-052-61 for 15 g. NDC 42543-052-62 for 30 g. NDC 42543-052-63 for 60 g.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NYSTATIN- NYSTATIN POWDER
VENSUN PHARMACEUTICALS, INC.
----------
RX ONLY.
NYSTATIN TOPICAL POWDER, USP
FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC USE.
DESCRIPTION
Nystatin is a polyene antifungal antibiotic obtained from
_Streptomyces noursei. _The molecular formula
for nystatin is C
H NO .
The molecular weight of nystatin is 926.1.
STRUCTURAL FORMULA
Nystatin Topical Powder is for dermatologic use.
Nystatin Topical Powder contains 100,000 USP nystatin units per gram
dispersed in talc.
CLINICAL PHARMACOLOGY
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75
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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 levels 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 Topical Powder is indicated in the treatment of cutaneous or
mucocutaneous mycotic infections
caused by _Candida albicans _and other susceptible _Candida_ species.
NYSTATIN TOPICAL POWDER IS NOT INDICATED FOR SYSTEMIC, ORAL,
INTRAVAGINAL OR OPHTHALMIC USE.
CONTRAINDICATIONS
Nystatin Topical Powder is contraindicated in patients with a h