NYSTATIN
NYSTATIN ORAL SUSPENSION, USP
954205d8-47ba-4c89-95cd-f0066a514cf9
HUMAN PRESCRIPTION DRUG LABEL
Mar 19, 2024
Leading Pharma, LLC
DUNS: 079575060
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NYSTATIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (14)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
INDICATIONS AND USAGE
Nystatin oral suspension is indicated for the treatment of infections of the oral cavity caused by Candida albicans.
CONTRAINDICATIONS SECTION
CONTRAINDICATIONS
Nystatin is contraindicated in patients with a history of hypersensitivity to nystatin or any of the suspension components.
ADVERSE REACTIONS SECTION
ADVERSE REACTIONS
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500 or www.fda.gov/medwatch.
Gastrointestinal symptoms including diarrhea, gastrointestinal distress, nausea, vomiting and burning of the mouth have been reported. Hypersensitivity reactions including rash, pruritus, and anaphylactoid reaction have also been reported.
CLINICAL PHARMACOLOGY SECTION
CLINICAL PHARMACOLOGY
Nystatin acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is absorbed very sparingly following oral administration, with no detectable blood levels when given in the recommended doses.
DESCRIPTION SECTION
DESCRIPTION
Nystatin is obtained from Streptomyces noursei. It is known to be a mixture,
but the composition has not been completely elucidated. Nystatin A is closely
related to amphotericin B. Each is a macro-cyclic lactone containing a ketal
ring, an all-trans polyene system, and a mycosamine (3-amino-3-deoxyrhamose)
moiety.
Structural formula:
Nystatin Oral Suspension, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), sucrose 50% w/v, peppermint oil, NF, cinnamaldehyde, disodium hydrogen phosphate, USP, carboxymethylcellulose sodium, USP, glycerin, USP, saccharin sodium, USP, cherry flavor, methylparaben, NF, propylparaben, NF and purified water, USP. May also contain sodium hydroxide, NF and/ or hydrochloric acid, NF for pH adjustment.
PRECAUTIONS SECTION
PRECAUTIONS
General
Discontinue treatment with nystatin if sensitization or irritation is reported
during use.
Nystatin is not effective in the treatment of systemic mycoses since it is not
significantly absorbed from the gastrointestinal
tract.
Information for the Patient
Patient should be advised to retain nystatin in the mouth as long as possible
and to continue its use for at least 2 days after symptoms have subsided.
There should be no interruption or discontinuation of the medication until the
prescribed course of treatment is completed, even though symptomatic relief
may occur within a few days.
If symptoms of local irritation develop, the physician should be notified
immediately.
Laboratory Tests
If there is a lack of therapeutic response, appropriate microbiological
studies (e .g., KOH smears and/or cultures) should be repeated to confirm the
diagnosis of candidiasis and rule out other pathogens before instituting
another course of therapy.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate the carcinogenic
potential of nystatin. In mice exposed to nystatin 50 mg/kg by injection, an
increased incidence of chromosomal aberrations, consisting primarily of
chromatid breaks, was observed in bone marrow cells. However, there have been
no studies to determine the mutagenicity of orally-administered nystatin or
its effects on fertility in males or females.
Pregnancy:
Teratogenic Effects
Teratogenicity 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.
Nonteratogenic Effects
In one rat reproductive study, nystatin was administered orally to pregnant
rats in single doses of 100, 500, or 3000 mg/kg on the ninth day of gestation,
or as multiple doses of 500 mg/kg/day on gestation days 1-20, 1-4, 7-10,
11-14, or 15-18. It was found that nystatin had a slight abortive effect when
used during the whole period of pregnancy. No abnormalities were seen in
surviving fetuses. Although no adverse effects or complications have been
attributed to the use of intra-vaginal nystatin in neonates born to women
treated during pregnancy, no similar studies evaluating complications of oral
nystatin have been conducted.
Nursing Mothers
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.
Pediatric Use
SeeDOSAGE AND ADMINISTRATION section for pediatric dosing
recommendations.
OVERDOSAGE SECTION
OVERDOSAGE
Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset.
DOSAGE & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION
Infants: 2 mL (200,000 units) four times daily (1 mL in each side of mouth).
Pediatric patients and adults: 4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth).
NOTE: Limited clinical studies in neonates, including premature and low-birth weight neonates, indicate that 1 mL (100,000 units) four times daily is effective.
Local treatment should be continued at least 48 hours after perioral symptoms have disappeared and/or cultures returned to normal. It is recommended that the drug be retained in the mouth as long as possible before swallowing.
SPL UNCLASSIFIED SECTION
Manufactured by:
Medley Pharmaceuticals Ltd.
Plot No. 18 and 19, Survey No. 378 / 7 & 8, 379 / 2 & 3,
Zari Causeway Road, Kachigam, Daman - 396210, INDIA.
Distributed by:
Leading Pharma, LLC
3 Oak Rd, Fairfield,.
New Jersey (NJ) 07004, United States (USA)
REV. 03/22 P000324
HOW SUPPLIED SECTION
HOW SUPPLIED
Nystatin Oral Suspension, USP, 100,000 USP Nystatin Units per mL, is available
as a cherry-mint flavored, light creamy yellow, ready-to-use suspension, in
the following sizes: 60 mL bottles with a child-resistant cap and calibrated
dropper.
1 Pint (473 mL) bottles with a child-resistant cap.
Storage
This package is child-resistant. Keep out of reach of children. Store at 20°
to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing
NDC for 60 ml: 69315-504-60
NDC for 473 ml: 69315-504-47
Rx Only