Nystatin Oral Suspension USP [100,000 units per mL]

Nystatin Oral Suspension USP [100,000 units per mL]

Drug Labeling and Warnings

Drug Details

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NYSTATIN- nystatin suspension 
Pharmaceutical Associates, Inc.

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Nystatin Oral Suspension USP







[100,000 units per mL]

Rx Only

DESCRIPTION

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

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.

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 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.

R10/16

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

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 DOSAGE: 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 the mouth and avoid feeding 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

R04/17

X01810020417

60 mL bottle label

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

5 mL unit dose cup label

NYSTATIN 
nystatin suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0121-0810
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E) NYSTATIN100000 [USP'U]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SUCROSE (UNII: C151H8M554)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
Product Characteristics
Coloryellow (Light - Creamy) Score    
ShapeSize
FlavorCHERRY (w/Peppermint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0121-0810-0260 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/01/2016
2NDC: 0121-0810-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20362102/01/2016
NYSTATIN 
nystatin suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0121-4810
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E) NYSTATIN100000 [USP'U]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SUCROSE (UNII: C151H8M554)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
Product Characteristics
Coloryellow (Light - Creamy) Score    
ShapeSize
FlavorCHERRY (w/Peppermint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0121-4810-404 in 1 CASE02/01/2016
110 in 1 TRAY
1NDC: 0121-4810-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20362102/01/2016
Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaceutical Associates, Inc.097630693manufacture(0121-0810, 0121-4810)

Revised: 3/2020
 
Pharmaceutical Associates, Inc.


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