Nystatin Oral Suspension

Pronunciation

Dosage Form: oral suspension

NYSTATIN ORAL
SUSPENSION, USP
100,000 Units/mL

Rx Only

Nystatin Oral Suspension Description

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

C47H75NO17        MW 926.13

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Nystatin Oral Suspension, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodiumphosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxymethylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP

Nystatin Oral Suspension - 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 for Nystatin Oral Suspension

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

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 non-specific myalgia have also been rarely reported.

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).

Nystatin Oral Suspension 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 is Nystatin Oral Suspension Supplied

Nystatin Oral Suspension, USP, 100,000 USP Nystatin Units per mL, is available as a cherry flavored, light creamy yellow, ready-to-use suspension. It is supplied as follows:

NDC 66689-037-01. 5 mL unit dose cup.

NDC 66689-037-50. Case contains 50 unit dose cups of 5 mL (NDC 66689-037-01), packaged in 5 trays of 10 unit dose cups each.

NDC 66689-037-99. Case contains 100 unit dose cups of 5 mL (NDC 66689-037-01), packaged in 10 trays of 10 unit dose cups each.

Storage

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

Rx Only

Manufactured by:
VistaPharm®

Largo, FL 33771

VP2053
04/10

PRINCIPAL DISPLAY PANEL - 100,000 units/mL cup label

Xact DOSE™

NYSTATIN
ORAL SUSPENSION, USP
500,000 units/ 5 mL

NDC 66689-037-01

Alcohol not more than 1% v/v
SHAKE WELL BEFORE USING
Protect from freezing
Store at 20°–25°C (68°–77°F)

[See USP CONTROLLED RM TEMP]

Rx Only    This cup delivers 5 mL    VP2052R1

Manufactured by VistaPharm, Inc.
Largo, FL 33771

NYSTATIN 
nystatin suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66689-037
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Nystatin (Nystatin) Nystatin 100000 [USP'U]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Methylparaben  
Sodium Phosphate, Dibasic, Anhydrous  
Sodium Phosphate, Monobasic, Monohydrate  
Glycerin  
Saccharin Sodium Dihydrate  
Sucrose  
Carboxymethylcellulose Sodium  
Alcohol  
Propylparaben  
Product Characteristics
Color YELLOW (Light yellow) Score     
Shape Size
Flavor CHERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:66689-037-50 5 TRAY in 1 CASE
1 10 CUP, UNIT-DOSE in 1 TRAY
1 NDC:66689-037-01 5 mL in 1 CUP, UNIT-DOSE
2 NDC:66689-037-99 10 TRAY in 1 CASE
2 10 CUP, UNIT-DOSE in 1 TRAY
2 NDC:66689-037-01 5 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064142 05/10/2010
Labeler - VistaPharm, Inc (116743084)
Establishment
Name Address ID/FEI Operations
VistaPharm, Inc 116743084 MANUFACTURE(66689-037)
Establishment
Name Address ID/FEI Operations
VistaPharm, Inc. 125330188 ANALYSIS(66689-037)
Revised: 08/2012
 
VistaPharm, Inc
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