Nystatin

NYSTATIN- nystatin tablet, film coated
Mutual Pharmaceutical Company, Inc.

Rx only

DESCRIPTION

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

Chemical Structure
(click image for full-size original)

Nystatin tablets are provided for oral administration as coated tablets containing 500,000 units nystatin.

Inactive ingredients: anhydrous lactose, carnauba wax, corn starch, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, 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.

Nystatin 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 to Nystatin

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.

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 round, brown, film coated, debossed MP 83. Available as follows:

Bottles of 50 NDC 53489-400-02
Bottles of 100 NDC 53489-400-01
Bottles of 250 NDC 53489-400-03
Bottles of 500 NDC 53489-400-05
Bottles of 1000 NDC 53489-400-10

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512

Rev 02, November 2014

PRINCIPAL DISPLAY PANEL — 100 Tablet Bottle Label

NDC 53489-400-01

Nystatin
Tablets USP
(oral)

500,000 units

Rx Only 100 Tablets

SUN
PHARMA

Principal Display Panel -- 100 Tablet Bottle Label
(click image for full-size original)
NYSTATIN
nystatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53489-400
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
anhydrous lactose
carnauba wax
starch, corn
FD&C BLUE NO. 2
FD&C RED NO. 40
hydroxypropyl cellulose (type H)
hypromelloses
magnesium stearate
cellulose, microcrystalline
polyethylene glycols
povidones
starch, potato
stearic acid
titanium dioxide
D&C yellow no. 10
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 10mm
Flavor Imprint Code MP;83
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53489-400-02 50 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:53489-400-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:53489-400-03 250 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:53489-400-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:53489-400-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062838 12/22/1988
Labeler — Mutual Pharmaceutical Company, Inc. (121735955)

Revised: 01/2015 Mutual Pharmaceutical Company, Inc.

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