The following Structured Product Label (SPL) was submitted to the FDA by Avkare for the product Nystatin (NDC 42291-651). 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 Streptomyces noursei. Its structural formula:
Structural Formula For Nystatin (28415493 E4d9 4d63 A557 9ee7d9433fdd 01)
C 47H 75NO 17 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.
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 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 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 CLINICAL PHARMACOLOGY, 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.
Nystatin Tablets USP, 500,000 Units are round, convex, brown, film-coated tablet debossed with 93 on one side and 983 on the reverse and are packaged in bottles of 100.
NDC 42291-651-90
Store at 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Manufactured For:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. M 08/12
AV 01/14 (P)
AvKARE
NDC
42291-651-90
Nystatin Tablets USP
500,000 units (oral)
90 Tablets Rx Only
Each film-coated tablet contains 500,000 units nystatin.
Usual Dosage: See package insert for full prescribing information.
Store at 20° to 25°C (68° to 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).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. K 08/12 AV 12/13 (P)
N3 42291-651-90 6
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