Nystatin

Cardinal Health

NYSTATIN TABLETS USP0983

FULL PRESCRIBING INFORMATION: CONTENTS*

• NYSTATIN DESCRIPTION
• CLINICAL PHARMACOLOGY
  • Pharmacokinetics
  • Microbiology
• NYSTATIN INDICATIONS AND USAGE
• NYSTATIN CONTRAINDICATIONS
• PRECAUTIONS
  • General
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Pregnancy
  • Nursing Mothers
• NYSTATIN ADVERSE REACTIONS
  • Gastrointestinal
  • Dermatologic
  • Other
• OVERDOSAGE
• NYSTATIN DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• Principal Display Panel - Carton
• Principal Display Panel - Pouch
• Principal Display Panel - Bag

FULL PRESCRIBING INFORMATION

NYSTATIN DESCRIPTION

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

C₄₇H₇₅NO₁₇ M.W. 926.13

Nystatin Tablets contain the inactive ingredients Corn Starch, Povidone, Compressible Sugar, Microcrystalline Cellulose, Sodium Starch Glycolate, Talc, Magnesium Stearate, Purified Water, and Coloring.

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.

NYSTATIN INDICATIONS AND USAGE

Nystatin Tablets are intended for the treatment of non‑esophageal mucus membrane gastrointestinal candidiasis.

NYSTATIN 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.

NYSTATIN 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 SUPPLIED

Nystatin Tablets USP, 500,000 Units are brown, film‑coated tablets debossed "93"‑"983" and are packaged in bottles of 100.

Store at controlled room temperature , between 20° and 25°C (689° and 77°F) (see USP).

Rev. L 2/2003

Manufactured By:

Novopharm Limited

Toronto, Canada M1B 2K9

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Nystatin Tablets USP, 500,000 Units are available from Cardinal Health in unit dose packages of 100.

500,000 Units, NDC 55154-8252-4, Unit Dose Package of 100.

Cardinal Health

Zanesville OH 43701

IU85500406

Principal Display Panel - Carton

NDC 55154-8252-4

Nystatin Tablets USP

500,000 units (oral)

100 Tablets

Each tablet contains: nystatin 500,000 units

See product insert for full prescribing information, precautions and warnings.

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

KEEP TIGHTLY CLOSED.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

RX ONLY

WARNING: This package is intended for institutional use only. This package is not child resistant. Keep this and all drugs out of the reach of children.

See window for lot number and expiration date.

Manufactured in Canada By: NOVOPHARM LIMITED

Toronto, Canada M1B 2K9

Manufactured For: TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Repackaged by: Cardinal Health

Zanesville, OH 43701

LUC37359171208

Principal Display Panel - Pouch

Nystatin Tablet USP

500,000 units (oral)

Principal Display Panel - Bag

Nystatin Tablets USP

500,000 units (oral)

10 Tablets