FDA Label for Nystatin

Description

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

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C₄₇H₇₅NO₁₇                                         M.W. 926.13

Nystatin Tablets are for oral administration and contain 500,000 units of nystatin per tablet.

Nystatin Tablets contain the inactive ingredients: corn starch, confectioner sugar, hydroxypropyl cellulose, dibasic calcium phosphate, microcrystalline cellulose, talc, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, FD&C yellow #6, FD&C red #40, FD&C blue # 2 and polysorbate 80.

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 s pecies 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.

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.

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.

To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 "HP51" on one side and plain on the other side are packaged in:

bottles of 30: NDC 71205-575-30

bottles of 60: NDC 71205-575-60

bottles of 90: NDC 71205-575-90

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

Manufactured by:

Strides Pharma Science Limited

Puducherry- 605 014, India.

PON/DRUGS/16 13 4193

Distributed by:

Avet Pharmaceuticals Inc.

East Brunswick, NJ 08816

1.866.901.DRUG (3784)

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1041073

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

Rev: 06/2020

Package Label.Principal Display Panel

Nystatin Tablets USP, 500,000 Units, 30 count bottles

71205-575-30 - f0db891f 18a9 451a 90b1 2b202258c5df 03

500,000 Units, 30 ct