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, is available as a bubble gum flavored, yellow opaque, ready-to-use suspension. Nystatin Oral Suspension, USP, 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). Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature] AVOID FREEZING

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NYSTATIN- NYSTATIN SUSPENSION
VISTAPHARM, INC.
----------
NYSTATIN ORAL
SUSPENSION, USP
RX ONLY
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. In
addition, the yellow opaque suspension contains the following inactive
ingredients : Alcohol (0.5%
v/v), USP, Alcohol free Bubble Gum 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 Suspension, USP, is indicated for the treatment of
candidiasis in the oral cavity.
CONTRAINDICATIONS
The preparation is contraindicated in patients with a history of
hypersensitivity to any of its components.
PRECAUTIONS
GENERAL
This medication is not to be used for the treatment of systemic
mycoses. Discontinue treatment if
sensitization or