NYSTATIN suspension

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

ATLANTIC BIOLOGICALS CORP.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

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 17856-1008-01  NYSTATIN 100,000 UNITS/ML - 5 ML CUP 72 ct UD Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature] AVOID FREEZING

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

NYSTATIN- NYSTATIN SUSPENSION
ATLANTIC BIOLOGICALS CORP.
----------
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 sensi