FLUCONAZOLE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Fluconazole (UNII: 8VZV102JFY) (Fluconazole - UNII:8VZV102JFY)

Commercializzato da:

Dr. Reddy's Laboratories Limited

INN (Nome Internazionale):

Fluconazole

Composizione:

Fluconazole 50 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Fluconazole tablets are indicated for the treatment of:  1. Vaginal candidiasis (vaginal yeast infections due to Candida ) 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.  3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted.  Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.  Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtai

Dettagli prodotto:

Fluconazole tablets USP, 50 mg are peach colored, oval, flat, bevelled edged, uncoated tablets debossed ‘R’ on one side and “143’ on other side and are supplied in bottles of 30, 100, 500 and unit dose package of 100 (10 x 10).  Bottles of 30 NDC 55111-143-30 Bottles of 100 NDC 55111-143-01 Bottles of 500 NDC 55111-143-05 Unit Dose Package of 100 (10 x 10) NDC 55111-143-78  Fluconazole tablets USP, 100 mg are peach colored, oval, flat, bevelled edged, uncoated tablets debossed ‘R’ on one side and “144’ on other side and are supplied in bottles of 30, 100, 500 and unit dose package of 100 (10 x 10).  Bottles of 30 NDC 55111-144-30 Bottles of 100 NDC 55111-144-01 Bottles of 500 NDC 55111-144-05 Unit Dose Package of 100 (10 x 10) NDC 55111-144-78  Fluconazole tablets USP, 150 mg are peach colored, oval, flat, bevelled edged, uncoated tablets debossed ‘R’ on one side and “145’ on other side and are supplied in unit dose package of 12 (12 x 1).  Unit Dose Package of 12 (12 x 1) NDC 55111-145-12  Fluconazole tablets USP, 200 mg are peach colored, oval, flat, bevelled edged, uncoated tablets debossed ‘R’ on one side and “146’ on other side and are supplied in bottles of 30, 100, 500 and unit dose package of 100 (10 x 10).  Bottles of 30 NDC 55111-146-30 Bottles of 100 NDC 55111-146-01 Bottles of 500 NDC 55111-146-05 Unit Dose Package of 100 (10 x 10) NDC 55111-146-78  Storage: Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Maalox® is a registered trademark of Novartis Consumer Health, Inc. XELJANZ® is a registered trademark of Pfizer Inc. Rx Only Manufactured by: Dr. Reddy’s Laboratories Limited Bachupally – 500 090 INDIA Revised: 07/2023

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

FLUCONAZOLE- FLUCONAZOLE TABLET
DR. REDDY'S LABORATORIES LIMITED
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FLUCONAZOLE TABLETS USP
DESCRIPTION
Fluconazole, the first of a new subclass of synthetic triazole
antifungal agents, is
available as tablets for oral administration.
Fluconazole is designated chemically as 2,4-difluoro-α,α
-bis(1H-1,2,4-triazol-1-ylmethyl)
benzyl alcohol with a molecular formula of C
H
F N O and molecular weight of 306.3.
The structural formula is:
Fluconazole USP is a white or almost white crystalline powder, which
is freely soluble in
methanol, soluble in alcohol and in acetone, sparingly soluble in
isopropyl alcohol and in
chloroform. Slightly soluble in water, very slightly soluble in
toluene.
Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of
fluconazole USP
and the following inactive ingredients: dibasic calcium phosphate
anhydrous, ferric oxide
(iron oxide, red), magnesium stearate, microcrystalline cellulose,
povidone, sodium
starch glycolate, and starch.
Fluconazole tablets meets USP _Dissolution_ Test 2.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS AND METABOLISM
The pharmacokinetic properties of fluconazole are similar following
administration by the
intravenous or oral routes. In normal volunteers, the bioavailability
of orally administered
fluconazole is over 90% compared with intravenous administration.
Bioequivalence was
established between the 100 mg tablet and both suspension strengths
when
administered as a single 200 mg dose.
Peak plasma concentrations (C
) in fasted normal volunteers occur between 1 and 2
hours with a terminal plasma elimination half-life of approximately 30
hours (range: 20 to
50 hours) after oral administration.
In fasted normal volunteers, administration of a single oral 400 mg
dose of fluconazole
leads to a mean C
of 6.72 mcg/mL (range: 4.12 to 8.08 mcg/mL) and after single oral
1
13
12 2
6
max
max
doses of 50 to 400 mg, fluconazole plasma concentrations and area
under the plasma
concentration-time curve (AUC) are dose proportional.
The C
and AUC data from a food-eff