FDA Label for Nystatin

Other

Rx Only

R10/16

Pharmaceutical
Associates, Inc.
Greenville, SC 29605
www.paipharma.com

Description

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

nystatin chemical structure - nystatin chemical structure

C ₄₇H ₇₅NO ₁₇     MW 926.13

Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), artificial peppermint flavor, cherry flavor, citric acid, D&C Yellow No. 10, FD&C Red No. 40, glycerin, magnesium aluminum silicate, methylparaben, potassium phosphate dibasic, propylene glycol, propylparaben, purified water and sucrose.

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 oral suspension is indicated for the treatment of candidiasis in the oral cavity.

Contraindications

The preparation is contraindicated in patients with a history of hypersensitivity to any of its 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 oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin oral suspension 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.

Pediatric Use

See DOSAGE AND ADMINISTRATION.

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 non-specific 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

INFANTS: 2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes).

NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective.

CHILDREN AND ADULTS: 4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing.

Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans.

How Supplied

Nystatin Oral Suspension USP, 100,000 USP Nystatin Units per mL, is available in a cherry, peppermint flavored, light creamy yellow, ready-to-use suspension, supplied in the following oral dosage forms:

NDC 0121-0810-02:  2 fl oz (60mL) bottle with calibrated dropper

NDC 0121-0810-16:  16 fl oz (473mL) bottle

NDC 0121-4810-05:  5mL unit dose cup

NDC 0121-4810-40:  Case contains 40 unit dose cups of 5mL (0121-4810-05) packaged in 
                                  4 trays of 10 unit dose cups each.

Storage

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

Principal Display Panel - 473 Ml Bottle Label

NDC 0121-0810-16

Nystatin Oral
Suspension, USP

100,000 units per mL

SHAKE WELL BEFORE USING

Cherry/Peppermint Flavor

Rx ONLY

16 fl oz (473 mL)

PharmaceuticalAssociates, Inc.Greenville, SC 29605

Each mL contains: 100,000 units Nystatin
USP with the following inactive ingredients: 
alcohol (≤ 1% v/v), artificial peppermint flavor,
cherry flavor, citric acid, D&C Yellow No. 10,
FD&C Red No. 40, glycerin, magnesium
aluminum silicate, methylparaben, potassium
phosphate dibasic, propylene glycol,
propylparaben, purified water and sucrose.

USUAL DOAGE: For Infants: 2 mL
(200,000 units) four times daily (in infants and
young children, use dropper to place one-half
of dose in each side of mouth and avoid
feeding for 5 to 10 minutes). 

USUAL DOSAGE: For Children and Adults:
See Package Insert. 

WARNINGS: KEEP THIS AND ALL
DRUGS OUT OF REACH OF
CHILDREN.  In case of accidental
overdose, seek professional assistance
or contact a Poison Control Center
immediately.

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

AVOID FREEZING

Dispense in a tight, light-resistant

container as defined in the USP/NF.

R02/15

L08101600

Principal Display Panel - 60 Ml Bottle Label

60 mL

NDC 0121-0810-02

Nystatin Oral
Suspension, USP

100,000 units per mL

SHAKE WELL BEFORE USING

Packaged with Calibrated Dropper

DO NOT USE IF TAMPER EVIDENT
SEAL IS BROKEN OR MISSING. 

Rx ONLY

PharmaceuticalAssociates, Inc.Greenville, SC 29605

Each mL of cherry, peppermint flavored
oral suspension contains 100,000 units
Nystatin, USP and alcohol (≤ 1% v/v).

USUAL DOAGE: For Infants: 2 mL(200,000 units) four times daily (in infants andyoung children, use dropper to place
one-half  of dose in each side of mouth and
avoid  feeding for 5 to 10 minutes). See insert. 

WARNINGS:  Keep this and all drugs out ofreach of children. In case of accidentaloverdose, seek professional assistance orcontact a Poison Control Center immediately.

Keep tightly closed. Protect from light.

Store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room
Temperature].  AVOID FREEZING

R02/15

L08100200

Principal Display Panel - 5 Ml Unit Dose Cup Label

Delivers 5 mL

NDC 0121-4810-05

N YSTATIN
O RAL S USPENSION, USP

500,000 units / 5 mL

Alcohol ≤ 1% v/v   SHAKE WELL

Rx ONLY

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.,
GREENVILLE, SC 29605

SEE INSERT

A48100500