NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL

NYSTATIN - nystatin suspension 
Qualitest Pharmaceuticals

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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:

This is an image of the structural formula for Nystatin.

Nystatin Oral Suspension is a cherry-mint flavored suspension for oral administration. It contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), carboxymethylcellulose sodium, flavor, glycerin, methylparaben, propylparaben, purified water, saccharin sodium, sodium citrate, and sucrose (50% w/v). May also contain citric acid 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 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 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 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: 4–6 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 cherry-mint flavored, light creamy yellow, ready-to-use suspension in 60 mL bottles with calibrated dropper and 473 mL bottles.

Storage

Store at 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]; avoid freezing.

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

8180391
R6/09-R2

PRINCIPAL DISPLAY PANEL

This is the 473mL label for the Nystatin Oral Suspension, USP.

PRINCIPAL DISPLAY PANEL

This is the 60mL label for the Nystatin Oral Suspension, USP.

PRINCIPAL DISPLAY PANEL

This is the 60mL carton for the Nystatin Oral Suspension, USP.

NYSTATIN 
nystatin   suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0603-1481
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NYSTATIN (NYSTATIN) NYSTATIN100000   in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
CARBOXYMETHYLCELLULOSE SODIUM 
GLYCERIN 
METHYLPARABEN 
PROPYLPARABEN 
WATER 
SACCHARIN SODIUM 
SUCROSE 
ANHYDROUS CITRIC ACID 
SODIUM CITRATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10603-1481-4960 mL In 1 BOTTLE, DROPPERNone
20603-1481-58473 mL In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06514806/28/2005

Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIOperations
Vintage Pharmaceuticals-Huntsville958430845MANUFACTURE
Revised: 06/2009Qualitest Pharmaceuticals