Nystatin by PAI Holdings, LLC dba PAI Pharma / PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma NYSTATIN suspension

Nystatin by

Drug Labeling and Warnings

Nystatin by is a Prescription medication manufactured, distributed, or labeled by PAI Holdings, LLC dba PAI Pharma, PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx only

DESCRIPTION

Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei.

Structural formula:

C 47H 75NO 17     MW 926.13

Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), cherry flavor, citric acid, D&C Yellow No. 10, FD&C Red No. 40, glycerin, magnesium aluminum silicate, methylparaben, potassium phosphate dibasic, propylene glycol, propylparaben, purified water and sucrose.

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 components.

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

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 pregnant 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 rarely. Stevens-Johnson syndrome has been reported very rarely.

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

To report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal 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 to 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 in a cherry flavored, light creamy yellow, ready-to-use suspension, supplied in the following oral dosage forms:

NDC: 0121-1045-02:  2 fl oz (60 mL) bottle with calibrated dropper

NDC: 0121-1045-16:  16 fl oz (473 mL) bottle

NDC: 0121-4045-05:  5 mL unit dose cup.  Case contains 40 unit dose cups of 5 mL (NDC: 0121-4045-40) packaged in 4 trays of 10 unit dose cups each, 50 unit dose cups of 5 mL (NDC: 0121-4045-50) packaged in 5 trays of 10 unit dose cups each and 100 unit dose cups of 5 mL (NDC: 0121-4045-00) packaged in 10 trays of 10 unit dose cups each.

Storage

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

SPL UNCLASSIFIED SECTION

MANUFACTURED BY
PAI Pharma
Greenville, SC 29605
www.paipharma.com

R06/24

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC: 0121-1045-16

Nystatin Oral Suspension, USP

100,000 units per mL

SHAKE WELL BEFORE USING

Cherry Flavored

Rx only

16 fl oz (473 mL)

PAI Pharma
Greenville, SC 29605

INGREDIENTS AND APPEARANCE

NYSTATIN 
nystatin suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0121-1045
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E)	NYSTATIN	100000 [USP'U]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCROSE (UNII: C151H8M554)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0121-1045-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/21/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA203621	06/21/2024

Labeler - PAI Holdings, LLC dba PAI Pharma (044940096)

Establishment
Name	Address	ID/FEI	Business Operations
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma		097630693	analysis(0121-1045) , label(0121-1045) , manufacture(0121-1045) , pack(0121-1045)