Label: NYSTATIN- nystatin suspension
- NDC Code(s): 68094-599-58, 68094-599-59, 68094-599-61, 68094-599-62
- Packager: Precision Dose, Inc.
- This is a repackaged label.
- Source NDC Code(s): 60432-537
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated February 17, 2012
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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, 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, potas-sium phosphate dibasic, USP, propylene glycol, USP, propylparaben, NF, purified water, USP and sucrose 33.5%. May also contain citric acid, USP for pH adjustment.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 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 com-ponents.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 preg-nant 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 very rarely. Stevens-Johnson syndrome has been reported very rarely.
Other: Tachycardia, bronchospasm, facial swelling, and non-specific myalgia have also been rarely reported.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
4-6 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 fla-vored, light creamy yellow, ready-to-use suspension.
5 mL per unit dose syringe
Fifty (50) syringes per shipper
5 mL per unit dose cup
One hundred (100) cups per shipper
5 mL per unit dose cup
Thirty (30) cups per shipper
SHAKE CUPS WELL BEFORE USINGClose
- SPL UNCLASSIFIED SECTION
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053
Wockhardt USA, LLC.
Parsippany, NJ 07054
Precision Dose, Inc.
S. Beloit, IL 61080
- PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
Oral Suspension, USP
500,000 units per 5 mL
Pkg: Precision Dose, Inc., S. Beloit, IL 61080
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68094-599(NDC:60432-537) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Nystatin (UNII: BDF1O1C72E) (Nystatin - UNII:BDF1O1C72E) Nystatin 500000 [USP'U] in 5 mL Inactive Ingredients Ingredient Name Strength alcohol (UNII: 3K9958V90M) D&C yellow no. 10 (UNII: 35SW5USQ3G) FD&C red no. 40 (UNII: WZB9127XOA) glycerin (UNII: PDC6A3C0OX) magnesium aluminum silicate (UNII: 6M3P64V0NC) methylparaben (UNII: A2I8C7HI9T) potassium phosphate, dibasic (UNII: CI71S98N1Z) propylene glycol (UNII: 6DC9Q167V3) propylparaben (UNII: Z8IX2SC1OH) water (UNII: 059QF0KO0R) sucrose (UNII: C151H8M554) Product Characteristics Color YELLOW Score Shape Size Flavor FRUIT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68094-599-62 3 in 1 CASE 1 10 in 1 TRAY 1 NDC:68094-599-59 5 mL in 1 CUP, UNIT-DOSE 2 NDC:68094-599-61 10 in 1 CASE 2 10 in 1 TRAY 2 NDC:68094-599-59 5 mL in 1 CUP, UNIT-DOSE 3 NDC:68094-599-58 5 in 1 CASE 3 10 in 1 BAG 3 5 mL in 1 SYRINGE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA062512 12/15/2005 Labeler - Precision Dose, Inc. (035886746)