NYSTATIN- nystatin tablet, film coated
Cardinal Health
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NYSTATIN TABLETS USP
0983
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.
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.
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.
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 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
| NYSTATIN
nystatin tablet, film coated |
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| Labeler - Cardinal Health (188557102) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Cardinal Health | 188557102 | REPACK(55154-8252) | |