NYSTATIN ORAL SUSPENSION solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Preferred Pharmaceuticals Inc.

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

Nystatin Oral Suspension, USP, 100,000 USP Nystatin Units per mL, is available as a cherry-mint flavored, light creamy yellow, ready-to-use suspension in 60 mL bottles with calibrated dropper and 473 mL bottles. It is supplied as follows: Storage Store at 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]; avoid freezing. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 L7046 Rev. 09/19 Relabeled By: Preferred Pharmaceuticals Inc.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

NYSTATIN ORAL SUSPENSION- NYSTATIN ORAL SUSPENSION SOLUTION
PREFERRED PHARMACEUTICALS INC.
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NYSTATIN ORAL SUSPENSION, USP
100,000 UNITS PER ML
RX ONLY
DESCRIPTION
Nystatin is an antimycotic polyene antibiotic obtained from_
Streptomyces noursei_.
Structural formula:
Nystatin Oral Suspension is a cherry-mint flavored suspension for oral
administration. It
contains 100,000 USP Nystatin Units per mL. Inactive ingredients:
alcohol (≤ 1% v/v),
carboxymethylcellulose sodium, flavor, glycerin, methylparaben,
propylparaben, purified
water, saccharin sodium, sodium citrate, and sucrose (50% w/v). May
also contain citric
acid for pH adjustment.
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 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,