NYSTATIN - nystatin suspension 
Precision Dose Inc.

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NYSTATIN ORAL SUSPENSION, USP
(100,000 units per mL)

Rx Only

DESCRIPTION

Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula:

Nystatin Oral Suspension, for oral administration, contains 100,000 USP Nystatin Units per mL.

Inactive ingredients: alcohol (≤ 1% v/v), artificial wild cherry flavor, banana flavor, D&C yellow # 10, FD&C red # 40, glycerin, USP, magnesium aluminum silicate, methylparaben, NF, potas-sium phosphate dibasic, USP, propylene glycol, USP, propylparaben, NF, purified water, USP and sucrose 33.5%. May also contain citric acid, USP for pH adjustment.

CLINICAL PHARMACOLOGY

Pharmacokinetics

Gastrointestinal absorption of Nystatin is insignificant. Most orally administered Nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of Nystatin may occasionally occur.

Microbiology

Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Candida albicans demonstrates no significant resistance to Nystatin in vitro on repeated subculture in increasing levels of nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo. Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

INDICATIONS AND USAGE

Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.

CONTRAINDICATIONS

The preparation is contraindicated in patients with a history of hypersensitivity to any of its com-ponents.

PRECAUTIONS

General

This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.

Pregnancy

Teratogenic Effects Category C

Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a preg-nant woman or can affect reproduction capacity. Nystatin oral suspension should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.

Pediatric Use

See DOSAGE AND ADMINISTRATION.

ADVERSE REACTIONS

Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See PRECAUTIONS: General).

Gastrointestinal: Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.

Dermatologic: Rash, including urticaria has been reported very rarely. Stevens-Johnson syndrome has been reported very rarely.

Other: Tachycardia, bronchospasm, facial swelling, and non-specific myalgia have also been rarely reported.

OVERDOSAGE

Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointesti-nal upset. There have been no reports of serious toxic effects of superinfections (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

DOSAGE AND ADMINISTRATION

INFANTS

2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes).

NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective.

CHILDREN AND ADULTS

4-6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing.

Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans.

HOW SUPPLIED

Nystatin Oral Suspension, USP, 100,000 USP Nystatin Units per mL, is available as a fruit fla-vored, light creamy yellow, ready-to-use suspension.

NDC 68094-599-58
5 mL per unit dose syringe
Fifty (50) syringes per shipper

NDC 68094-599-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-599-62
5 mL per unit dose cup
Thirty (30) cups per shipper

SHAKE CUPS WELL BEFORE USING

STORAGE

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing.

Rx Only

Manufactured By:
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053

Manufactured For:
Wockhardt USA, LLC.
Parsippany, NJ 07054

Packaged By:
Precision Dose, Inc.
S. Beloit, IL 61080

LI825

Rev. 07/10

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

NDC 68094-599-59

PrecisionDose™

NYSTATIN
Oral Suspension, USP
500,000 units per 5 mL

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

NDC 68094-599-59

PrecisionDose™

NYSTATIN
Oral Suspension, USP
500,000 units per 5 mL

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label

Rx Only

NDC# 68094-599-58

NYSTATIN Oral Suspension, USP

500,000 units per 5 mL  Delivers 5 mL
Alcohol ≤ 1% v/v
Store at 20° to 25°C (68° to 77°F)
Pkg: Precision Dose, Inc. S. Beloit, IL 61080
LSY824 Rev. 09/10

For Oral Use Only

NYSTATIN  nystatin   suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68094-599 (60432-537) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Nystatin (Nystatin) Nystatin 500000 [USP'U]  in 5 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color YELLOW Score      Shape Size Flavor CHERRY, MINT Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68094-599-62 3 TRAY In 1 CASE contains a TRAY 1 10 CUP In 1 TRAY This package is contained within the CASE (68094-599-62) and contains a CUP, UNIT-DOSE (68094-599-59) 1 68094-599-59 5 mL In 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (68094-599-62) 2 68094-599-61 10 TRAY In 1 CASE contains a TRAY 2 10 CUP In 1 TRAY This package is contained within the CASE (68094-599-61) and contains a CUP, UNIT-DOSE (68094-599-59) 2 68094-599-59 5 mL In 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (68094-599-61) 3 68094-599-58 5 BAG In 1 CASE contains a BAG 3 10 SYRINGE In 1 BAG This package is contained within the CASE (68094-599-58) and contains a SYRINGE, PLASTIC 3 5 mL In 1 SYRINGE, PLASTIC This package is contained within a BAG and a CASE (68094-599-58)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA062512	12/15/2005

Labeler - Precision Dose Inc. (035886746)

Revised: 11/2010Precision Dose Inc.