NYSTATIN powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Leading Pharma, LLC

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: 15g (NDC 69315-306-15) 30g (NDC 69315-306-30) 60g (NDC 69315-306-60) STORAGE Store at 20°C to 25°C (68°F to 77°F)[see USP Controlled Room Temperature]; avoid excessive heat (40°C/104°F). Keep tightly closed. Manufactured for: Leading Pharma LLC, Fairfield, NJ 07004 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 R0-06/17

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NYSTATIN- NYSTATIN POWDER
LEADING PHARMA, LLC
----------
NYSTATIN TOPICAL POWDER
RX ONLY
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 C47H75NO17. The molecular weight of
Nystatin is
926.1.
Structural formula:
Nystatin topical powder is for dermatologic use.
Nystatin topical powder contains 100,000 nystatin units per gram
dispersed in talc.
CLINCAL 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 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 history
of hypersensitivity to
ANY of its components.
PR