NYSTATIN cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Nystatin (UNII: BDF1O1C72E) (Nystatin - UNII:BDF1O1C72E)

Available from:

Rebel Distributors Corp

INN (International Name):

Nystatin

Composition:

Nystatin 100000 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nystatin Cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) albicans and other Candida species. Nystatin Cream is contraindicated in patients with a history of hypersensitivity to any of its components.

Product summary:

Nystatin Cream is a smooth yellow cream with a characteristic perfume odor. Nystatin Cream is supplied in 15g (NDC 21695-761-15) and 30g (NDC 21695-761-30) tubes providing 100,000 USP Nystatin Units per gram. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NYSTATIN- NYSTATIN CREAM
REBEL DISTRIBUTORS CORP
----------
NYSTATIN
CREAM USP, 100,000 UNITS PER GRAM
RX ONLY
DESCRIPTION
Nystatin Cream is for dermatologic use.
Nystatin is a polyene antimycotic obtained from _Streptomyces
noursei_. It is a yellow to light tan powder
with a cereal-like odor, very soluble in water, and slightly to
sparingly soluble in alcohol. Structural
formula:
Nystatin Cream contains the antifungal antibiotic nystatin at a
concentration of 100,000 USP Nystatin
Units per gram in an aqueous, perfumed cream base containing purified
water, propylene glycol,
methylparaben, propylparaben, white petrolatum, glyceryl monostearate,
polyethylene glycol 400
monostearate, ceteareth-15, medical antifoam AF emulsion, aluminum
hydroxide gel, titanium dioxide,
sorbitol solution, and, if necessary, sodium hydroxide for pH
adjustment.
CLINICAL PHARMACOLOGY
Nystatin is an antifungal antibiotic which is both fungistatic and
fungicidal _in vitro_ against a wide variety
of yeasts and yeast-like fungi. It probably acts by binding to sterols
in the cell membrane of the fungus
with a resultant change in membrane permeability allowing leakage of
intracellular components. Nystatin
is the first well tolerated antifungal antibiotic of dependable
efficacy for the treatment of cutaneous,
oral and intestinal infections caused by _Candida_ (Monilia)
_albicans_ and other Candida species. It exhibits
no appreciable activity against bacteria.
Nystatin provides specific therapy for all localized forms of
candidiasis. Symptomatic relief is rapid,
often occurring within 24 to 72 hours after the initiation of
treatment. Cure is effected both clinically
and mycologically in most cases of localized candidiasis.
INDICATIONS AND USAGE
Nystatin Cream is indicated in the treatment of cutaneous or
mucocutaneous mycotic infections caused
by _Candida_ (Monilia) _albicans_ and other Candida species.
CONTRAINDICATIONS
Nystatin Cream is contraindicated in patients with a history of
hypersensitivity to any of its components.
PRECAUTIONS
Should