The following Structured Product Label (SPL) was submitted to the FDA by Carilion Materials Management for the product Nystatin (NDC 68151-1487). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, pharmacokinetics, microbiology, indications and usage, contraindications, general, carcinogenesis, mutagenesis, impairment of fertility, pregnancy category c, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Nystatin is an antimycotic polyene antibiotic obtained from . Its structural formula: Streptomyces noursei
Structural Formula For Nystatin (28415493 E4d9 4d63 A557 9ee7d9433fdd 01)
C H NO M.W. 926.13 477517
Nystatin tablets contain the inactive ingredients: Corn Starch, Povidone, Compressible Sugar, Microcrystalline Cellulose, Sodium Starch Glycolate, Talc, Magnesium Stearate, Purified Water, and Coloring.
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.
Nystatin is both fungistatic and fungicidal against a wide variety of yeasts and yeast like fungi. demonstrates no significant resistance to nystatin on repeated subculture in increasing levels of nystatin; other species become quite resistant. Generally, resistance does not develop . Nystatin acts by binding to sterols in the cell membrane of susceptible species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses. in vitroCandida albicansin vitroCandidain vivoCandida
Nystatin Tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.
Nystatin Tablets are contraindicated in patients with a history of hypersensitivity to any of their components.
This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.
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.
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.
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 is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (see ). PRECAUTIONS, General
Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.
Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.
Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported.
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 ). CLINICALPHARMACOLOGY, Pharmacokinetics
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.
NDC:68151-1487-0 in a PACKAGE of 1 TABLET, FILM COATEDS
0093- -01 NDC0983
NYSTATIN
Tablets USP
500,000 units (oral)
Rx only
100 TABLETS
TEVA
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