Nystatin by Chartwell RX, LLC NYSTATIN suspension

Nystatin by

Drug Labeling and Warnings

Nystatin by is a Prescription medication manufactured, distributed, or labeled by Chartwell RX, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Nystatin, USP 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-transpolyene system, and a mycosamine (3-amino-3-deoxyrhamose) moiety. 

Its structural formula is:

C 47H 75NO 17                M.W .926 .13

Nystatin Oral Suspension, USP, is a cherry-flavored, ready-to-use suspension containing 100,000 units of Nystatin, USP per mL. Nystatin, USP contains the following inactive ingredients: artificial (wild) cherry flavor, D&C Yellow 10, edetate calcium disodium, hydrochloric acid, methylparaben, polysorbate 80, propylparaben, purified bentonite, purified water, sodium hydroxide and sucrose.

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.

INDICATIONS AND USAGE

Nystatin oral suspension is indicated for the treatment of infections of the oral cavity caused by Candida albicans.

CONTRAINDICATIONS

Nystatin is contraindicated in patients with a history of hypersensitivity to nystatin or any of the suspension components.

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 - Pregnancy Category C

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

See DOSAGE AND ADMINISTRATIONsection for pediatric dosing recommendations.

ADVERSE REACTIONS

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.

OVERDOSAGE

Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset. 

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.

HOW SUPPLIED

Nystatin Oral Suspension, USP is a bright yellow color suspension with cherry flavor containing 100,000 units of nystatin per mL, supplied as follows:

NDC: 62135-813-46 – bottle of 60 mL

NDC: 62135-813-47 – bottle of 473 mL

NDC: 62135-813-05 – 5 mL Unit Dose Cups

NDC: 62135-813-24 – 20 Unit Dose Cups of 5 mL each

Store at controlled room temperature between 20°C to 25°C (68°F -77°F).

DO NOT FREEZE

Manufactured for:
Chartwell RX, LLC.
Congers, NY 10920

L71884

Rev. 10/2024

PRINCIPAL DISPLAY PANEL

Nystatin Oral Suspension, USP 100,000 units/mL - NDC: 62135-813-46 - 60 ml Bottle Label

Nystatin Oral Suspension, USP 100,000 units/mL - NDC: 62135-813-47 - 1 Pint (473 mL) Bottle Label

Nystatin Oral Suspension, USP 500,000 units/5mL - NDC: 62135-813-05 – 5 mL Unit Dose Label

INGREDIENTS AND APPEARANCE

NYSTATIN 
nystatin suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62135-813
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E)	NYSTATIN	100000 U  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
HYDROCHLORIC ACID (UNII: QTT17582CB)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BENTONITE (UNII: A3N5ZCN45C)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SUCROSE (UNII: C151H8M554)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	yellow (bright yellow color)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62135-813-47	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/10/2024
2	NDC: 62135-813-46	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/27/2024
3	NDC: 62135-813-24	2 in 1 BOX	10/22/2024
3		10 in 1 TRAY
3	NDC: 62135-813-05	5 mL in 1 CUP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA050299	04/14/1971

Labeler - Chartwell RX, LLC (079394054)