Nystatin: Package Insert and Label Information

NYSTATIN- nystatin suspension
ATLANTIC BIOLOGICALS CORP.

Rx Only

DESCRIPTION

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

nystatin chemical structure
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C 47 H 75 NO 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.

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 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.

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 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 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 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 17856-0811-01 NYSTATIN 100,000 UNITS/ML 0.5ML ENFIT SYRINGE 120 ct UD

NDC 17856-0811-02 NYSTATIN 100,000 UNITS/ML 1ML ENFIT SYRINGE 120 ct UD

NDC 17856-0811-03 NYSTATIN 100,000 UNITS/ML 2ML ENFIT SYRINGE 120 ct UD

NDC 17856-0811-04 NYSTATIN 100,000 UNITS/ML 5ML ENFIT SYRINGE 48 ct UD

NDC 17856-0811-05 NYSTATIN 100,000 UNITS/ML 5ML CUP 72 ct UD

Storage

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

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP

20101 N.E 16TH PLACE

MIAMI, FL 33179

PRINCIPAL DISPLAY PANEL

NDC 17856-0811

NYSTATIN
ORAL
SUSPENSION, USP

[100,000 units per mL]

Alcohol ≤ 1% v/v SHAKE WELL

Rx ONLY

FOR INSTITUTIONAL USE ONLY

SEE INSERT

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NYSTATIN
nystatin suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17856-0811(NDC:0121-0810)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NYSTATIN (NYSTATIN) NYSTATIN 100000 [USP’U] in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
CITRIC ACID MONOHYDRATE
D&C YELLOW NO. 10
FD&C RED NO. 40
GLYCERIN
METHYLPARABEN
POTASSIUM PHOSPHATE, DIBASIC
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SUCROSE
MAGNESIUM ALUMINUM SILICATE
Product Characteristics
Color yellow (Light — Creamy) Score
Shape Size
Flavor CHERRY (w/Peppermint) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17856-0811-1 120 SYRINGE in 1 BOX, UNIT-DOSE contains a SYRINGE
1 0.5 mL in 1 SYRINGE This package is contained within the BOX, UNIT-DOSE (17856-0811-1)
2 NDC:17856-0811-2 120 SYRINGE in 1 BOX, UNIT-DOSE contains a SYRINGE
2 1 mL in 1 SYRINGE This package is contained within the BOX, UNIT-DOSE (17856-0811-2)
3 NDC:17856-0811-3 120 SYRINGE in 1 BOX, UNIT-DOSE contains a SYRINGE
3 2 mL in 1 SYRINGE This package is contained within the BOX, UNIT-DOSE (17856-0811-3)
4 NDC:17856-0811-4 48 SYRINGE in 1 BOX, UNIT-DOSE contains a SYRINGE
4 5 mL in 1 SYRINGE This package is contained within the BOX, UNIT-DOSE (17856-0811-4)
5 NDC:17856-0811-5 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE contains a CUP, UNIT-DOSE
5 5 mL in 1 CUP, UNIT-DOSE This package is contained within the BOX, UNIT-DOSE (17856-0811-5)
6 NDC:17856-0811-6 120 SYRINGE in 1 BOX, UNIT-DOSE contains a SYRINGE
6 1 mL in 1 SYRINGE This package is contained within the BOX, UNIT-DOSE (17856-0811-6)
7 NDC:17856-0811-7 120 SYRINGE in 1 BOX, UNIT-DOSE contains a SYRINGE
7 2 mL in 1 SYRINGE This package is contained within the BOX, UNIT-DOSE (17856-0811-7)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203621 05/07/2019
Labeler — ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
Name Address ID/FEI Operations
ATLANTIC BIOLOGICALS CORP. 047437707 relabel (17856-0811), repack (17856-0811)

Revised: 01/2021 ATLANTIC BIOLOGICALS CORP.

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