NYSTATIN suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E)

Available from:

VistaPharm, Inc.

INN (International Name):

NYSTATIN

Composition:

NYSTATIN 100000 [USP'U] in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nystatin Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity. The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.

Product summary:

Nystatin Oral Suspension, USP, 100,000 Nystatin Units per mL, cherry flavored, light creamy yellow, ready-to-use suspension, is available as follows: NDC 66689-037-01: 5 mL unit dose cup. NDC 66689-037-50: Case contains 50 unit dose cups of 5 mL (NDC 66689-037-01), packaged in 5 trays of 10 unit dose cups each. NDC 66689-037-99: Case contains 100 unit dose cups of 5 mL (NDC 66689-037-01), packaged in 10 trays of 10 unit dose cups each. Nystatin Oral Suspension, USP, 100,000 Nystatin units per mL, bubblegum flavored, yellow opaque, ready-to-use suspension is available as follows: NDC 66689-008-02: 2 fl. oz. bottle (60 mL): supplied in individual carton with calibrated dropper. NDC 66689-008-08: 8 fl. oz. bottle (237 mL). NDC 66689-008-16: 16 fl. oz. bottle (480 mL).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NYSTATIN- NYSTATIN SUSPENSION
VISTAPHARM, INC.
REFERENCE LABEL SET ID: 3651AD5B-436C-4AE9-9AB1-80B6AC8AE0A8
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NYSTATIN ORAL SUSPENSION, USP 100,000 UNITS/ML
DESCRIPTION
Nystatin is an antimycotic polyene antibiotic obtained from
_Streptomyces noursei_.
Structural formula:
Nystatin Oral Suspension, USP, for oral administration, contains
100,000 Nystatin Units
per mL.
Inactive ingredients (cherry flavor): alcohol ( 1% v/v),
methylparaben, NF; dibasic sodium
phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium,
USP; sucrose
(50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP;
propylparaben, NF;
artificial wild cherry flavor # 14783 and purified water, USP.
Inactive ingredients (bubblegum flavor): Alcohol (0.5% v/v), USP,
Alcohol free
Bubblegum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic
Sodium Phosphate,
USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative),
Monobasic Sodium
Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water,
USP, Saccharin
Sodium, USP, and Sucrose, NF.
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 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