NYSTATIN- nystatin suspension 
Lehigh Valley Technologies, Inc.

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NYSTATIN ORAL SUSPENSION, USP

Rx Only

DESCRIPTION

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

Chemical Structure

C47H75NO17                              MW 926.13      

Nystatin Oral Suspension, USP, for oral administration contains 100,000 Nystatin units per mL. In addition, the yellow opaque suspension contains the following inactive ingredients: Alcohol (0.5% v/v), USP, Alcohol free Bubble Gum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF.

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, USP, 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 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 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 nonspecific myalgia have also been rarely reported.

To report SUSPECTED ADVERSE REACTIONS, contact 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 or 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 Nystatin units per mL, is available as a bubble gum flavored, yellow opaque, ready-to-use suspension.

Nystatin Oral Suspension, USP, is available as follows:

NDC 64950-230-06: 2 fl. oz. bottle (60 mL): supplied in individual carton with calibrated dropper;

NDC 64950-230-48: 16 fl. oz. bottle (480 mL).

Storage

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

AVOID FREEZING

Rx Only

Manufactured By:
VistaPharm, Inc.
Largo, FL 33771

Distributed By:
Lehigh Valley Technologies, Inc.
Allentown, PA 18102

VP2129
10/13

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

NDC 64950-230-06

NYSTATIN ORAL
SUSPENSION, USP

100,000 units per mL
Contains alcohol 0.5% v/v

Bubblegum Flavored

SHAKE WELL BEFORE USING

NET: 2 fl. oz. (60 mL)

with calibrated dropper

At the time of dispensing replace cap
with safety cap dropper

Rx
only
VP2128

Manufactured by: VistaPharm, Inc. Largo, FL 33771
Distributed by: Lehigh Valley Technologies, Inc. Allentown, PA 18102

L V T
Lehigh Valley Technologies, Inc.

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton
NYSTATIN 
nystatin suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:64950-230
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Nystatin (Nystatin) Nystatin100000 [USP'U]  in 15 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Carboxymethylcellulose Sodium 
Glycerin 
Methylparaben 
Propylparaben 
Saccharin Sodium 
Sodium Phosphate, Dibasic, Anhydrous 
Sodium Phosphate, Monobasic 
Sucrose 
Water 
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64950-230-061 in 1 CARTON
160 mL in 1 BOTTLE, PLASTIC
2NDC:64950-230-481 in 1 CARTON
2480 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06542204/01/2014
Labeler - Lehigh Valley Technologies, Inc. (113290444)

Revised: 3/2014
Document Id: a84ad934-f9bb-4f36-a103-be706788accd
Set id: d868575c-7eea-483e-ac35-151398bfa01e
Version: 1
Effective Time: 20140324
 
Lehigh Valley Technologies, Inc.