NYSTATIN CREAM USP (100,000 units/g)

nystatin (Nystatincream 
[Actavis Mid Atlantic LLC]

DESCRIPTION

EACH GRAM OF NYSTATIN CREAM USP CONTAINS: 100,000 units in an aqueous cream base of aluminum hydroxide gel, cetearyl alcohol (and) ceteareth-20, citric acid, glyceryl stearate, methylparaben, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, sodium citrate, sorbic acid, sorbitol solution, titanium dioxide and white petrolatum.

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 a polyene antibiotic of undetermined structural formula that is obtained from Streptomyces noursei, and 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 USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) albicans and other Candida species.

CONTRAINDICATIONS

Nystatin Cream USP is contraindicated in patients with a history of hypersensitivity to any of its components.

PRECAUTIONS

Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.

This preparation is not for ophthalmic use.

ADVERSE REACTIONS

Nystatin is virtually nontoxic and nonsensitizing and is well tolerated by all age groups including debilitated infants, even on prolonged administration.

If irritation on topical application should occur, discontinue medication.

DOSAGE AND ADMINISTRATION

Nystatin Cream USP should be applied liberally to the affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions however are best treated with nystatin topical powder.

The cream does not stain the skin or mucous membranes and it provides a simple, convenient means of treatment.

HOW SUPPLIED

Nystatin Cream USP 100,000 units/g

15 g tube (0.53 oz)

30 g tube (1.1 oz)

Store at controlled room temperature 15°-30°C (59°-86°F). Avoid exposure to excessive heat, 40°C (104°F).

Manufactured by:
Actavis Mid Atlantic LLC
1877 Kawai Road
Lincolnton, NC 28092 USA

FORM NO. 0163


Rev. 1/06


VC2751


Nystatin (Nystatin)
PRODUCT INFO
Product Code0472-0163Dosage FormCREAM
Route Of AdministrationTOPICALDEA Schedule
INGREDIENTS
Name (Active Moiety)TypeStrength
nystatin (nystatin) Active100000 UNITS  In 1 GRAM
aluminum hydroxideInactive 
cetearyl alcoholInactive 
citric acidInactive 
gyceryl stearateInactive 
methylparabenInactive 
polyoxl 40 stearateInactive 
propylene glycolInactive 
propylparabenInactive 
waterInactive 
sodium citrateInactive 
sorbic acidInactive 
sorbitol solutionInactive 
titanium dioxideInactive 
white petrolatumInactive 
IMPRINT INFORMATION
CharacteristicAppearanceCharacteristicAppearance
ColorScore
ShapeSymbol
Imprint CodeCoating
Size
PACKAGING
#NDCPackage DescriptionMultilevel Packaging
10472-0163-151 TUBE In 1 CARTONcontains a TUBE
115 GRAM In 1 TUBEThis package is contained within the CARTON (0472-0163-15)
20472-0163-301 TUBE In 1 CARTONcontains a TUBE
230 GRAM In 1 TUBEThis package is contained within the CARTON (0472-0163-30)

Revised: 08/2007Actavis Mid Atlantic LLC