Label: NYSTATIN- nystatin suspension
- NDC Code(s): 64950-230-06, 64950-230-48
- Packager: Lehigh Valley Technologies, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated March 24, 2014
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- SPL UNCLASSIFIED SECTION
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula:
C47H75NO17 MW 926.13
Nystatin Oral Suspension, USP, for oral administration contains 100,000 Nystatin units per mL. In addition, the yellow opaque suspension contains the following inactive ingredients: Alcohol (0.5% v/v), USP, Alcohol free Bubble Gum 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.Close
- CLINICAL PHARMACOLOGY
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.
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, USP, is indicated for the treatment of candidiasis in the oral cavity.Close
The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.Close
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.
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.
- 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 FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Close
- DOSAGE AND ADMINISTRATION
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 Nystatin units per mL, is available as a bubble gum flavored, yellow opaque, ready-to-use suspension.
Nystatin Oral Suspension, USP, is available as follows:
NDC 64950-230-06: 2 fl. oz. bottle (60 mL): supplied in individual carton with calibrated dropper;
NDC 64950-230-48: 16 fl. oz. bottle (480 mL).Close
- SPL UNCLASSIFIED SECTION
Largo, FL 33771
Lehigh Valley Technologies, Inc.
Allentown, PA 18102
- PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton
100,000 units per mL
Contains alcohol 0.5% v/v
SHAKE WELL BEFORE USING
NET: 2 fl. oz. (60 mL)
with calibrated dropper
At the time of dispensing replace cap
with safety cap dropper
Manufactured by: VistaPharm, Inc. Largo, FL 33771
Distributed by: Lehigh Valley Technologies, Inc. Allentown, PA 18102
L V T
Lehigh Valley Technologies, Inc.
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64950-230 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Nystatin (UNII: BDF1O1C72E) (Nystatin - UNII:BDF1O1C72E) Nystatin 100000 [USP'U] in 15 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Carboxymethylcellulose Sodium (UNII: K679OBS311) Glycerin (UNII: PDC6A3C0OX) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Saccharin Sodium (UNII: SB8ZUX40TY) Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F) Sodium Phosphate, Monobasic (UNII: 3980JIH2SW) Sucrose (UNII: C151H8M554) Water (UNII: 059QF0KO0R) Product Characteristics Color YELLOW Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64950-230-06 1 in 1 CARTON 1 60 mL in 1 BOTTLE, PLASTIC 2 NDC:64950-230-48 1 in 1 CARTON 2 480 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065422 04/01/2014 Labeler - Lehigh Valley Technologies, Inc. (113290444)