Label: NYSTATIN suspension
0121-0868-16, view more0121-0868-40, 0121-0868-50
- Packager: Pharmaceutical Associates, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated July 21, 2020
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- SPL UNCLASSIFIED SECTION
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei.
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.
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
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.
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.
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.
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 0121-0868-02: 2 fl oz (60mL) bottle with calibrated dropper
NDC 0121-0868-16: 16 fl oz (473mL) bottle
NDC 0121-0868-05: 5 mL unit dose cup
NDC 0121-0868-40: Case contains 40 unit dose cups of 5 mL (0121-0868-05) packaged in
4 trays of 10 unit dose cups each.
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
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.
Pharmaceutical Associates, 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
- PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-0868 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) 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 Color yellow (Light - Creamy) Score Shape Size Flavor CHERRY (w/Peppermint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0121-0868-02 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 07/17/2020 2 NDC:0121-0868-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/17/2020 3 NDC:0121-0868-40 4 in 1 CASE 07/17/2020 3 10 in 1 TRAY 3 NDC:0121-0868-05 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 4 NDC:0121-0868-50 5 in 1 CASE 07/17/2020 4 10 in 1 TRAY 4 NDC:0121-0868-05 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 5 NDC:0121-0868-00 10 in 1 CASE 07/17/2020 5 10 in 1 TRAY 5 NDC:0121-0868-05 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 ANDA203621 07/17/2020 Labeler - Pharmaceutical Associates, Inc. (044940096) Registrant - Pharmaceutical Associates, Inc. (097630693) Establishment Name Address ID/FEI Business Operations Pharmaceutical Associates, Inc. 097630693 manufacture(0121-0868) , label(0121-0868)