Fluconazole
FULL PRESCRIBING INFORMATION: CONTENTS*
- FLUCONAZOLE DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- CLINICAL STUDIES
- FLUCONAZOLE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- DRUG INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- FLUCONAZOLE ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- REFERENCES
- INFORMATION FOR PATIENTS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
FLUCONAZOLE DESCRIPTION
CLINICAL PHARMACOLOGY
Pharmacokinetics and Metabolism**
DOSAGE AND ADMINISTRATION
Pharmacokinetics in Children
Pharmacokinetics in Elderly
Drug Interaction Studies
PRECAUTIONS
PRECAUTIONS
PRECAUTIONS
PRECAUTIONS
PRECAUTIONS
CONTRAINDICATIONSPRECAUTIONS
PRECAUTIONS
PRECAUTIONS
PRECAUTIONS
PRECAUTIONS
PRECAUTIONS
PRECAUTIONS
CONTRAINDICATIONSPRECAUTIONS
PRECAUTIONS
PRECAUTIONS
Microbiology
Mechanism of Action
Activity In Vitro and In Clinical Infections
DOSAGE AND ADMINISTRATION
Susceptibility Testing Methods
Cryptococcus neoformans and filamentous fungi:
Candida species:
Broth Dilution Techniques:
Diffusion Techniques:
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Quality Control
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Activity In Vivo
Drug Resistance
INDICATIONS & USAGE
CLINICAL STUDIES
CLINICAL STUDIES
Pediatric Studies
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FLUCONAZOLE CONTRAINDICATIONS
CLINICAL PHARMACOLOGY: Drug Interaction StudiesPRECAUTIONSWARNINGS
Hepatic injury:Fluconazole should be administered with caution to patients with liver dysfunction. 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.
Anaphylaxis:
Dermatologic:
Use in Pregnancy:
PRECAUTIONS, Pregnancy
PRECAUTIONS
GeneralSingle Dose
ADVERSE REACTIONSCLINICAL STUDIES
DRUG INTERACTIONS
CLINICAL PHARMACOLOGY: Drug Interaction StudiesCONTRAINDICATIONSCLINICAL 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 Studies
CLINICAL PHARMACOLOGY: Drug Interaction Studies
CLINICAL PHARMACOLOGY
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
CLINICAL PHARMACOLOGY
PREGNANCY
Teratogenic EffectsPregnancy Category C
Single 150 mg tablet use for Vaginal Candidiasis:
Pregnancy Category D
All other indications:
WARNINGS, Use in Pregnancy
NURSING MOTHERS
PEDIATRIC USE
CLINICAL STUDIESCLINICAL PHARMACOLOGYDOSAGE AND ADMINISTRATION
ADVERSE REACTIONS
CLINICAL PHARMACOLOGY
GERIATRIC USE
CLINICAL PHARMACOLOGYDOSAGE AND ADMINISTRATION
FLUCONAZOLE ADVERSE REACTIONS
In Patients Receiving a Single Dose for Vaginal Candidiasis:
In Patients Receiving Multiple Doses for Other Infections:
WARNINGS
Post-Marketing Experience
PRECAUTIONS
WARNINGS
Adverse Reactions in Children:
OVERDOSAGE
DOSAGE & ADMINISTRATION
Dosage and Administration in Adults:Single Dose
Multiple Dose
Dosage and Administration in Children:
**CLINICAL PHARMACOLOGY
Dosage In Patients With Impaired Renal Function:
Males:
Females:
Administration
HOW SUPPLIED
STORAGE AND HANDLING
REFERENCES
INFORMATION FOR PATIENTS
FLUCONAZOLE TABLETS USPRx Only
What Is Fluconazole?
What Is A Vaginal Yeast Infection?
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● itching
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● a burning feeling when you urinate
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● redness
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● soreness
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● a thick white vaginal discharge that looks like cottage cheese
What To Tell Your Doctor Before You Start Fluconazole?
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● diabetes medicines such as glyburide, tolbutamide, glipizide
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● blood pressure medicines like hydrochlorothiazide, losartan, amlodipine, nifedipine or felodipine
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● blood thinners such as warfarin
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● cyclosporine, tacrolimus or sirolimus (used to prevent rejection of organ transplants)
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● rifampin or rifabutin for tuberculosis
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● astemizole for allergies
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● phenytoin or carbamazepine to control seizures
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● theophylline to control asthma
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● cisapride for heartburn
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● quinidine (used to correct disturbances in heart rhythm)
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● amitriptyline or nortriptyline for depression
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● pimozide for psychiatric illness
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● amphotericin B or voriconazole for fungal infections
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● erythromycin for bacterial infections
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● cyclophosphamide or vinca alkaloids such as vincristine or vinblastine for treatment of cancer
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● fentanyl, afentanil or methadone for chronic pain
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● halofantrine for malaria
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● lipid lowering drugs such as atorvastatin, simvastatin, and fluvastatin
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● non-steroidal anti-inflammatory drugs including celecoxib, ibuprofen, and naproxen
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● prednisone, a steroid used to treat skin, gastrointestinal, hematological or respiratory disorders
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● antiviral medications used to treat HIV like saquinavir or zidovudine
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● vitamin A nutritional supplement
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● are taking any over-the-counter medicines you can buy without a prescription, including natural or herbal remedies
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● have any liver problems.
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● have any other medical conditions
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● are pregnant, plan to become pregnant, or think you might be pregnant. Your doctor will discuss whether fluconazole is right for you.
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● are breast-feeding. Fluconazole can pass through breast milk to the baby.
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● are allergic to any other medicines including those used to treat yeast and other fungal infections.
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● are allergic to any of the ingredients in fluconazole tablets. The main ingredient of fluconazole tablets is fluconazole. If you need to know the inactive ingredients, ask your doctor or pharmacist.
Who Should Not Take Fluconazole?
How Should I Take Fluconazole
Directions: Push tablet through foil and take by mouth
Just swallow 1 fluconazole tablet to treat your vaginal yeast infection.
What Should I Avoid While Taking Fluconazole?
What Are The Possible Side Effects of Fluconazole?
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● headache
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● diarrhea
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● nausea or upset stomach
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● dizziness
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● stomach pain
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● changes in the way food tastes
What To Do For An Overdose
How To Store Fluconazole
General Advice About Prescription Medicines
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FluconazoleFluconazole TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
