Label: NYSTATIN tablet, film coated
- NDC Code(s): 62135-741-90
- Packager: Chartwell RX, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 23, 2024
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- Official Label (Printer Friendly)
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DESCRIPTION
Nystatin, USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:
C 47H 75NO 17 M.W. 926.13
Nystatin tablets, USP are for oral administration and contain 500,000 units of nystatin, USP per tablet.
Nystatin tablets, USP contain the inactive ingredients: corn starch, confectioner sugar, dibasic calcium phosphate, FD&C yellow #6, FD&C red #40, FD&C blue #2, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, polysorbate 80, talc and titanium dioxide. -
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 vitroagainst a wide variety of yeasts and yeast-like fungi. Candida albicansdemonstrates no significant resistance to nystatin in vitroon repeated subculture in increasing levels of nystatin; other Candidaspecies become quite resistant. Generally, resistance does not develop in vivo. Nystatin acts by binding to sterols in the cell membrane of susceptible Candidaspecies 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. It is also not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin should be given to a pregnant woman only if clearly needed.
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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 Chartwell RX, LLC. at 1-845-232-1683 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).
- DOSAGE AND ADMINISTRATION
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HOW SUPPLIED
Nystatin Tablets, USP 500,000 Units are round brown, film-coated tablets debossed "HP51" on one side and plain on the other side are packaged in:
Bottles of 90: NDC 62135-741-90Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
Manufactured by:
Vivimed Life Sciences Private Limited
Alathur, Kanchipuram – 603 110, Tamilnadu, India.
M.L. No.: TN00002327Manufactured for:
Chartwell RX, LLC.
Congers, NY 10920Revised: 08/2023
L71669
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NYSTATIN
nystatin tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-741 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E) NYSTATIN 500000 [USP'U] Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) TALC (UNII: 7SEV7J4R1U) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code HP51 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62135-741-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/08/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA062474 10/31/2011 Labeler - Chartwell RX, LLC (079394054)
