Nystatin

NYSTATIN- nystatin tablet, coated
Bryant Ranch Prepack

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DESCRIPTION

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

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C47 H75 NO17 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, dibasic calcium phosphate, FD&C yellow #6, FD&C red #40, FD&C blue # 2, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, polysorbate 80, talc and titanium dioxide.

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.

Pregnancy

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

NDC: 63629-8350-3: 30 Tablets in a BOTTLE

NDC: 63629-8350-1: 28 Tablets in a BOTTLE

NDC: 63629-8350-2: 56 Tablets in a BOTTLE

Nystatin(oral) 500,000 Units Tablet

Label
(click image for full-size original)
NYSTATIN
nystatin tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-8350(NDC:23155-051)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NYSTATIN (NYSTATIN) NYSTATIN 500000 [USP’U]
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
SUCROSE
HYDROXYPROPYL CELLULOSE (90000 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
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 10mm
Flavor Imprint Code HP;51
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-8350-3 30 TABLET, COATED in 1 BOTTLE None
2 NDC:63629-8350-1 28 TABLET, COATED in 1 BOTTLE None
3 NDC:63629-8350-2 56 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062474 10/31/2011
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (63629-8350), RELABEL (63629-8350)

Revised: 04/2022 Bryant Ranch Prepack

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