Label: NYSTATIN suspension
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NDC Code(s):
66689-008-02,
66689-008-08,
66689-008-16,
66689-037-01, view more66689-037-50, 66689-037-99
- Packager: VistaPharm, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 30, 2022
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- Official Label (Printer Friendly)
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DESCRIPTION
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula:
Nystatin Oral Suspension, USP, for oral administration, contains 100,000 Nystatin Units per mL.
Inactive ingredients (cherry flavor): alcohol ( 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP.
Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP, Alcohol free Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF.
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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
- CONTRAINDICATIONS
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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. -
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 nonspecific myalgia have also been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact VistaPharm, Inc., at 1-888-655-1505 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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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).
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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.
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HOW SUPPLIED
Nystatin Oral Suspension, USP, 100,000 Nystatin Units per mL, cherry flavored, light creamy yellow, ready-to-use
suspension, is available as follows:NDC 66689-037-01: 5 mL unit dose cup.
NDC 66689-037-50: Case contains 50 unit dose cups of 5 mL (NDC 66689-037-01), packaged in 5 trays of 10 unit dose cups each.
NDC 66689-037-99: Case contains 100 unit dose cups of 5 mL (NDC 66689-037-01), packaged in 10 trays of 10 unit dose cups each.
Nystatin Oral Suspension, USP, 100,000 Nystatin units per mL, bubblegum flavored, yellow opaque, ready-to-use suspension is available as follows:
NDC 66689-008-02: 2 fl. oz. bottle (60 mL): supplied in individual carton with calibrated dropper.
NDC 66689-008-08: 8 fl. oz. bottle (237 mL).
NDC 66689-008-16: 16 fl. oz. bottle (480 mL).
- Storage
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Unit Dose Cup
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PRINCIPAL DISPLAY PANEL - 60 mL
NDC 66689-008-02
NYSTATIN ORAL
SUSPENSION, USP
100,000 units per mL
Contains: Alcohol 0.5% v/v
(Bubblegum Flavored)
SHAKE WELL BEFORE USING
At The Time Of Dispensing Replace
Cap with Safety Cap Dropper
2 fl. oz.
(60 mL)
Rx only
VistaPharm®
NDC 66689-008-02
NYSTATIN ORAL
SUSPENSION, USP
100,000 units per mL
Contains: Alcohol 0.5% v/v
(Bubblegum Flavored)
SHAKE WELL BEFORE USING
2 fl. oz.
(60 mL)
Rx only
VistaPharm®
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PRINCIPAL DISPLAY PANEL - 480 mL
NDC 66689-008-16
NYSTATIN ORAL
SUSPENSION, USP
100,000 units per mL
Contains: Alcohol 0.5% v/v
(Bubblegum Flavored)
SHAKE WELL BEFORE USING
16 fl. oz.
(480 mL)
Rx only
VistaPharm®
NDC 66689-008-16
NYSTATIN ORAL
SUSPENSION, USP
100,000 units per mL
(Bubblegum Flavored)
Contains: Alcohol 0.5% v/v
SHAKE WELL BEFORE USING
16 fl. oz.
(480 mL)
Rx only
VistaPharm®
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INGREDIENTS AND APPEARANCE
NYSTATIN
nystatin suspensionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66689-037 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E) NYSTATIN 100000 [USP'U] in 1 mL Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) GLYCERIN (UNII: PDC6A3C0OX) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCROSE (UNII: C151H8M554) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) ALCOHOL (UNII: 3K9958V90M) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color yellow (Light yellow) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66689-037-50 5 in 1 CASE 05/10/2010 1 10 in 1 TRAY 1 NDC:66689-037-01 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:66689-037-99 10 in 1 CASE 05/10/2010 2 10 in 1 TRAY 2 NDC:66689-037-01 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA064142 05/10/2010 NYSTATIN
nystatin suspensionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66689-008 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E) NYSTATIN 100000 [USP'U] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCROSE (UNII: C151H8M554) Product Characteristics Color yellow (Light yellow) Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66689-008-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2012 2 NDC:66689-008-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2012 3 NDC:66689-008-16 480 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA064142 05/01/2012 Labeler - VistaPharm, Inc. (116743084)
