Your browser does not support JavaScript! NYSTATIN TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]
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NYSTATIN tablet, film coated
[Mutual Pharmaceutical Company, Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Rx only

DESCRIPTION

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

Chemical Structure

Nystatin tablets are provided for oral administration as coated tablets containing 500,000 units nystatin.

Inactive ingredients: anhydrous lactose, carnauba wax, corn starch, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, and titanium dioxide.

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 tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

CONTRAINDICATIONS

Nystatin tablets are contraindicated in patients with a history of hypersensitivity to any of their 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. It is also not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin 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.

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.

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

The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units nystatin) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

HOW SUPPLIED

Nystatin tablets, USP 500,000 units, are round, brown, film coated, debossed MP 83. Available as follows:

Bottles of 50NDC 53489-400-02
Bottles of 100NDC 53489-400-01
Bottles of 250NDC 53489-400-03
Bottles of 500NDC 53489-400-05
Bottles of 1000NDC 53489-400-10

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Manufactured by:
MUTUAL PHARMACEUTICAL COMPANY, INC.
Philadelphia, PA 19124 USA

Rev 01, July 2009

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle

MP

NDC 53489-400-01

NYSTATIN TABLETS USP
(ORAL)

500,000 units

100 TABLETS
Rx only

MUTUAL PHARMACEUTICAL CO., INC.
PHILADELPHIA, PA 19124 USA

Principal Display Panel - 100 Tablet Bottle
NYSTATIN 
nystatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:53489-400
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
nystatin (nystatin) nystatin500000 [USP'U]
Inactive Ingredients
Ingredient NameStrength
anhydrous lactose 
carnauba wax 
starch, corn 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
hydroxypropyl cellulose 
hypromellose 
magnesium stearate 
cellulose, microcrystalline 
polyethylene glycol 
povidone 
starch, potato 
stearic acid 
titanium dioxide 
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint Code MP;83
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53489-400-0250 in 1 BOTTLE
2NDC:53489-400-01100 in 1 BOTTLE
3NDC:53489-400-03250 in 1 BOTTLE
4NDC:53489-400-05500 in 1 BOTTLE
5NDC:53489-400-101000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06283812/22/1988
Labeler - Mutual Pharmaceutical Company, Inc. (121735955)

Revised: 11/2009
 
Mutual Pharmaceutical Company, Inc.

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