NYSTATIN ointment

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 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.

Product summary:

Nystatin Ointment, USP (100,000 nystatin units per gram) is a yellow ointment available as follows: NDC 69315-307-15                   15 gram tube NDC 69315-307-30                   30 gram tube STORAGE Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for:  Leading Pharma LLC, Fairfield, NJ 07004 Manufactured by:  Lyne Laboratories, Inc. Brockton, MA 02301 R0-12/17

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NYSTATIN- NYSTATIN OINTMENT
LEADING PHARMA, LLC
----------
NYSTATIN OINTMENT, USP
RX ONLY
FOR TOPICAL USE ONLY • NOT FOR OPHTHALMIC USE
DESCRIPTION
Nystatin is a polyene antifungal antibiotic drug obtained from
Streptomyces nursei.
Structural formula:
Molecular Weight 926.13
Molecular Formula C
H NO
Nystatin Ointment is for dermatologic use. Nystatin Ointment for
topical use contains
100,000 USP nystatin units per gram in a polyethylene and mineral oil
base.
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.
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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 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
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