Nystatin

Dosage Form: Tablets

Rx only

Nystatin Description

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

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

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

Nystatin - 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

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).

Nystatin 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 is Nystatin Supplied

Nystatin TABLETS 500,000 units, 13/32 SC Brown film coated, debossed MP 83. Available as follows:

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

Store at controlled room temperature 15°-30°C (59°-86°F).

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

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

Rev.: May 2000Ch

Nystatin (Nystatin)

PRODUCT INFO Product Code 53489-400 Dosage Form TABLET Route Of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Nystatin (Nystatin) Active 500000 UNITS  In 1 TABLET Carnauba wax Inactive   microcrystalline cellulose Inactive   corn starch Inactive   anhydrous lactose Inactive   magnesium stearate Inactive   povidone Inactive   sodium starch glycolate Inactive   stearic acid Inactive   hydroxypropyl methylcellulose Inactive   hydroxypropyl cellulose Inactive   titanium dioxide Inactive   polyethylene glycol Inactive   FD&C Red No. 40 Aluminum Lake Inactive   FD&C Blue No. 2 Aluminum Lake Inactive

IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color BROWN (brown) Score 1 Shape ROUND (round) Symbol false Imprint Code MP;83 Coating true Size 10mm

PACKAGING # NDC Package Description Multilevel Packaging 1 53489-400-02 50 TABLET In 1 BOTTLE, PLASTIC None 2 53489-400-01 100 TABLET In 1 BOTTLE, PLASTIC None 3 53489-400-03 250 TABLET In 1 BOTTLE, PLASTIC None 4 53489-400-05 500 TABLET In 1 BOTTLE, PLASTIC None 5 53489-400-10 1000 TABLET In 1 BOTTLE, PLASTIC None

Revised: 01/2007