Label: NYSTATIN- nystatin suspension
- NDC Code(s): 66689-037-01, 66689-037-50, 66689-037-99
- Packager: VistaPharm, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated March 4, 2019
If you are a consumer or patient please visit this version.
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), 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, USPClose
- 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 intra-cellular 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.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.
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).Close
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, broncho-spasm, facial swelling, and non-specific myalgia have also been rarely reported.
- 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).Close
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 cherry flavored, light creamy yellow, ready-to-use suspension. It is supplied as follows:Close
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.
Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Avoid freezing.Close
- SPL UNCLASSIFIED SECTION
Largo, FL 33771
- PRINCIPAL DISPLAY PANEL
Oral Suspension, USP
500,000 units/5 mL
Alcohol not more than 1% v/v
SHAKE WELL. AVOID FREEZING.
Delivers 5 mL
Store at 20°–25°C (68°–77°F); see USP CRT conditions.
Largo, FL 33771, USA
- INGREDIENTS AND APPEARANCE
Product 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 Labeler - VistaPharm, Inc. (116743084)