NYSTATIN ORAL SUSPENSION, USP

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

Nystatin (UNII: BDF1O1C72E) (Nystatin - UNII:BDF1O1C72E)

Saatavilla:

Genus Lifescience Inc.

INN (Kansainvälinen yleisnimi):

Nystatin

Koostumus:

Nystatin 100000 [USP'U] in 15 mL

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

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 64950-230-06: 2 fl. oz. bottle (60 mL): supplied in individual carton with calibrated dropper; NDC 64950-230-48: 16 fl. oz. bottle (480 mL). Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature] AVOID FREEZING

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

NYSTATIN- NYSTATIN SUSPENSION
GENUS LIFESCIENCE INC.
----------
NYSTATIN ORAL SUSPENSION, USP
RX ONLY
DESCRIPTION
Nystatin is an antimycotic polyene antibiotic obtained from
_Streptomyces noursei._ Structural formula:
C
H NO MW 926.13
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.
4 7
75
17
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. Discontinu