Fluconazole description, usages, side effects, indications, overdosage, supplying and lots more!

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Fluconazole

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

FLUCONAZOLE DESCRIPTION


Fluconazole





CLINICAL PHARMACOLOGY

Pharmacokinetics and Metabolism







Tissue or FluidRation of Fluconazole (Fluid)/Plasma Concentration*DOSAGE AND ADMINISTRATION


Pharmacokinetics in Children


AgeDoseClearanceHalf-lifeCmaxVdssStudied(mg/kg)(mL/min/kg)(Hours)(ug/mL)(L/kg)


Pharmacokinetics in Elderly


Drug Interaction Studies






PRECAUTIONS
PRECAUTIONS
PRECAUTIONS
PRECAUTIONS

PRECAUTIONS
CONTRAINDICATIONSPRECAUTIONS
PRECAUTIONS
PRECAUTIONS
PRECAUTIONS
PRECAUTIONS.
PRECAUTIONS
PRECAUTIONS
CONTRAINDICATIONSPRECAUTIONSPRECAUTIONS


Microbiology









Table 1Dosage and Administration









Susceptibility Testing Methods







+
+







Quality Control




Activity In Vivo





Drug Resistance






INDICATIONS & USAGE




CLINICAL STUDIES


CLINICAL STUDIES




Fluconazole POVaginal Product qhs150mg tabletx 7 days


ParameterFluconazole POVaginal Products



FluconazoleNystatinEnrolled9690Clinical Cure76/88 (86%)36/78 (46%)Mycological55/72 (76%)6/54 (11%)eradication**Subjects without follow-up cultures for any reason were considered nonevaluable for mycological response.The proportion of patients with clinical relapse 2 weeks after the end of treatment was 14% for subjects receiving fluconazole and 16% for subjects receiving nystatin. At 4 weeks after the end of treatment the percentages of patients with clinical relapse were 22% for fluconazole and 23% for nystatin.

FLUCONAZOLE CONTRAINDICATIONS

CLINICAL PHARMACOLOGY: Drug Interaction StudiesPRECAUTIONS

WARNINGS

1. Hepatic injury: Fluconazole has been associated with rare cases of serious hepatic toxicity, including fatalities primarily in patients with serious underlying medical conditions. In cases of fluconazole-associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex or age of the patient has been observed. Fluconazole hepatotoxicity has usually, but not always, been reversible on discontinuation of therapy. Patients who develop abnormal liver function tests during fluconazole therapy should be monitored for the development of more severe hepatic injury. Fluconazole should be discontinued if clinical signs and symptoms consistent with liver disease develop that may be attributable to fluconazole.



PRECAUTIONS

General



ADVERSE REACTIONSCLINICAL STUDIES

Interactions

Drug Interactions
CLINICAL PHARMACOLOGY: Drug Interaction StudiesCONTRAINDICATIONS











CLINICAL PHARMACOLOGY: Drug Interaction Studies
CLINICAL PHARMACOLOGY: Drug Interaction Studies
CLINICAL PHARMACOLOGY: Drug Interaction Studies
CLINICAL PHARMACOLOGY: Drug Interaction Studies
CLINICAL PHARMACOLOGY: Drug Interaction Studies
CLINICAL PHARMACOLOGY: Drug Interaction Studies
CONTRAINDICATIONSCLINICAL PHARMACOLOGY: Drug Interaction Studies
CONTRAINDICATIONSCLINICAL PHARMACOLOGY: Drug Interaction Studies

CLINICAL PHARMACOLOGY: Drug Interaction Studies
CLINICAL PHARMACOLOGY: Drug Interaction Studies
CLINICAL PHARMACOLOGY: Drug Interaction StudiesCLINICAL PHARMACOLOGY: Drug Interaction Studies
CLINICAL PHARMACOLOGY

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



CLINICAL PHARMACOLOGY

PREGNANCY

Teratogenic Effects

Pregnancy Category C:

There are no adequate and well controlled studies in pregnant women. There have been reports of multiple congenital abnormalities in infants whose mothers were being treated for 3 or more months with high dose (400-800 mg/day) fluconazole therapy for coccidioidomycosis (an unindicated use). The relationship between fluconazole use and these events is unclear. Fluconazole should be used in pregnancy only if the potential benefit justifies the possible risk to the fetus.

NURSING MOTHERS



PEDIATRIC USE

CLINICAL STUDIES
CLINICAL PHARMACOLOGYDOSAGE AND ADMINISTRATION
ADVERSE REACTIONS
CLINICAL PHARMACOLOGY

GERIATRIC USE



CLINICAL PHARMACOLOGYDOSAGE AND ADMINISTRATION

FLUCONAZOLE ADVERSE REACTIONS





WARNINGS




PRECAUTIONS

WARNINGS








FluconazoleComparative Agents(N = 577)(N = 451)


OVERDOSAGE




DOSAGE & ADMINISTRATION
















Pediatric PatientsAdultsCLINICAL PHARMACOLOGY







Creatinine Clearance (mL/min)Percent of Recommended Dose


Weight (kg) x (140-age)










STORAGE AND HANDLING



REFERENCES




SPL PATIENT PACKAGE INSERT

PATIENT INFORMATION



































































PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Fluconazole

Fluconazole


















Fluconazole
Fluconazole



Fluconazole

Fluconazole TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-199(NDC:0172-5412)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FLUCONAZOLE FLUCONAZOLE 150 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
FD&C RED NO. 40
ALUMINUM OXIDE
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
talc

Product Characteristics

Color Size Imprint Code Shape
pink 12 mm 5412 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-199-01 1 in 1 BLISTER PACK
2 NDC:49349-199-11 7 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074681 2011-04-21


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