Nystatin Tablets, USP (Oral) Rx only

Label at a glance#

Contacts and useful links#

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.govwww.fda.gov/medwatch

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

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

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.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Pharmacokinetics

PHARMACOKINETICS SECTION

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

MICROBIOLOGY SECTION

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

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Nystatin Tablets are contraindicated in patients with a history of hypersensitivity to any of their components.

PRECAUTIONS

PRECAUTIONS SECTION

General

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

PREGNANCY SECTION

Teratogenic Effects

TERATOGENIC EFFECTS SECTION

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

NURSING MOTHERS SECTION

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

ADVERSE REACTIONS SECTION

Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See PRECAUTIONS: General .)

Gastrointestinal

SPL UNCLASSIFIED SECTION

Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.

Dermatologic

SPL UNCLASSIFIED SECTION

Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

Other

SPL UNCLASSIFIED SECTION

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

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

HOW SUPPLIED SECTION

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)

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

500,000 Units, 30 ct

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Billing Units#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

• nystatin
• STARCH, CORN
• SUCROSE
• HYDROXYPROPYL CELLULOSE (1600000 WAMW)
• ISOPROPYL ALCOHOL
• ANHYDROUS DIBASIC CALCIUM PHOSPHATE
• MICROCRYSTALLINE CELLULOSE
• TALC
• MAGNESIUM STEARATE
• HYPROMELLOSE 2910 (6 MPA.S)
• HYPROMELLOSE 2910 (3 MPA.S)
• POLYETHYLENE GLYCOL 400
• POLYETHYLENE GLYCOL 8000
• TITANIUM DIOXIDE
• FD&C YELLOW NO. 6
• FD&C RED NO. 40
• FD&C BLUE NO. 2
• POLYSORBATE 80

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.