Nystatin Suspension [Atlantic Biologicals Corp.] -

NYSTATIN SUSPENSION [ATLANTIC BIOLOGICALS CORP.]
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NDC	17856-0538-1, 17856-0538-5, 17856-0538-6, 17856-0538-7, 17856-0538-8, 17856-0538-9
Set ID	8d3531b9-13b4-471b-8315-9d05c80208f6
Category	HUMAN PRESCRIPTION DRUG LABEL
Packager	ATLANTIC BIOLOGICALS CORP.
Generic Name
Product Class
Product Number
Application Number	ANDA062512

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SPL UNCLASSIFIED SECTION

(100,000 units per mL)

Rx only
DESCRIPTION

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

Nystatin Oral Suspension, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), artificial wild cherry flavor, banana flavor, D&C yellow #10, FD&C red #40, glycerin, USP, magnesium aluminum silicate, methylparaben, NF, potassium phosphate dibasic, USP, propylene glycol, USP, propylparaben, NF, purified water, USP and sucrose 33.5%. May also contain citric acid, USP for pH adjustment.
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 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

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: 4–6 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 as a fruit flavored, light creamy yellow, ready-to-use suspension.

60 mL bottles with a calibrated dropper and 1 Pint (473 mL) bottles.

Storage

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

Rx Only

Product No.: 8537

Manufactured For:
Wockhardt USA, LLC
Parsippany, NJ 07054

Manufactured By:
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053

28537B
REV. 09-09

Distributed by Atlantic Biologicals

Miami, Fl 33179
PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

MGP

NDC

17856-0538-06    1 ML ENFIT SYR

17856-0538-07    2 ML ENFIT SYR

17856-0537-08    3 ML ENFIT SYR

17856-0537-09    .5 ML ENFIT SYR

NYSTATIN ORAL
SUSPENSION, USP
(100,000 units
per mL)

Fruit Flavored

Rx Only
PRINCIPAL DISPLAY PANEL

MGP

NDC 17856-0538-1

NYSTATIN ORAL

SUSPENSION, USP 5mL CUP 72

Fruit Flavored

RX ONLY

INGREDIENTS AND APPEARANCE

NYSTATIN
nystatin suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:17856-0538(NDC:60432-537)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Nystatin (UNII: BDF1O1C72E) (Nystatin - UNII:BDF1O1C72E)	Nystatin	100000 [USP'U] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
propylene glycol (UNII: 6DC9Q167V3)
glycerin (UNII: PDC6A3C0OX)
sucrose (UNII: C151H8M554)
potassium phosphate, dibasic (UNII: CI71S98N1Z)
alcohol (UNII: 3K9958V90M)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
D&C yellow no. 10 (UNII: 35SW5USQ3G)
FD&C red no. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	YELLOW (Light creamy yellow)	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17856-0538-6	1 mL in 1 SYRINGE; Type 0: Not a Combination Product	10/13/2017
2	NDC:17856-0538-7	2 mL in 1 SYRINGE; Type 0: Not a Combination Product	10/13/2017
3	NDC:17856-0538-8	3 mL in 1 SYRINGE; Type 0: Not a Combination Product	10/13/2017
4	NDC:17856-0538-9	.5 mL in 1 SYRINGE; Type 0: Not a Combination Product	10/13/2017
5	NDC:17856-0538-5	5 mL in 1 SYRINGE; Type 0: Not a Combination Product	11/10/2017
6	NDC:17856-0538-1	72 in 1 BOX, UNIT-DOSE	09/25/2018
6		5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA062512	04/15/1995

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Name	Address	ID/FEI	Business Operations
Establishment
ATLANTIC BIOLOGICALS CORP.		047437707	repack(17856-0538) , relabel(17856-0538)

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Medic

NYSTATIN SUSPENSION [ATLANTIC BIOLOGICALS CORP.]

Pharmacokinetics

Microbiology

General

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Teratogenic Effects Category C

Nursing Mothers

Pediatric Use

Storage

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