NYSTATIN suspension

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Bryant Ranch Prepack

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Nystatin Oral Suspension 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.

Rezumat produs:

Nystatin Oral Suspension, USP, 100,000 USP Nystatin Units per mL, is available as a cherry-mint flavored, yellow, ready-to-use suspension. 1 Pint (473 mL) bottles (NDC: 63629-2492-1) SHAKE WELL BEFORE USE Storage Store at 20° - 25°C (68° - 77°F); excursions permitted between 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]. AVOID FREEZING. PHARMACIST: Dispense in a tight light-resistant container as defined in USP. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

NYSTATIN- NYSTATIN SUSPENSION
BRYANT RANCH PREPACK
----------
NYSTATIN ORAL
SUSPENSION, USP
(100,000 UNITS PER ML)
RX ONLY
DESCRIPTION
Nystatin is an antimycotic polyene antibiotic obtained from
_Streptomyces noursei._
Structural formula: C
H
NO MW = 926.13
Nystatin Oral Suspension, for oral administration, is cherry/mint
flavored, containing
100,000 USP Nystatin Units per mL. Inactive ingredients: disodium
edetate, sodium
benzoate, sodium hexametaphosphate, dibasic sodium phosphate
heptahydrate,
monobasic sodium phosphate monohydrate, glycerin, methyl paraben,
propyl paraben,
sucrose, cherry flavor and peppermint oil.
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
47 75
17
exhibits no appreciable activity against bacteria, protozoa, or
viruses.
INDICATIONS AND USAGE
Nystatin Oral Suspension 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 irritation is reported during use.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTI