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 MetabolismDOSAGE AND ADMINISTRATION
Tissue or FluidRatio of Fluconazole Tissue (Fluid)/Plasma Concentration*
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
DOSAGE AND ADMINISTRATION
Susceptibility Testing Methods
Broth Dilution Techniques:
Diffusion Techniques:
INDICATIONS & USAGE
CLINICAL STUDIES
CLINICAL STUDIES
Fluconazole PO 150 mg tabletVaginal Product qhs x 7 days
ParameterFluconazole POVaginal Products
Pediatric Studies
FluconazoleNystatin
FLUCONAZOLE CONTRAINDICATIONS
CLINICAL PHARMACOLOGY: Drug Interaction StudiesPRECAUTIONSWARNINGS
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 EffectsSingle 150 mg tablet use for Vaginal Candidiasis
All other indications
WARNINGS, Use in Pregnancy
Human Data
Animal Data
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
Postmarketing Experience
PRECAUTIONS
WARNINGS
Adverse Reactions in Children
Fluconazole (N=577)Comparative Agents (N=451)
OVERDOSAGE
DOSAGE & ADMINISTRATION
Dosage and Administration in AdultsSingle Dose
Multiple Dose
Dosage and Administration in Children
Pediatric PatientsAdults
CLINICAL PHARMACOLOGY
Dosage In Patients With Impaired Renal Function
Creatinine Clearance (mL/min)Percent of Recommended Dose
Administration
HOW SUPPLIED
STORAGE AND HANDLING
REFERENCES
INFORMATION FOR PATIENTS
Fluconazole Tablets USPWhat 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
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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, alfentanil 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 breastfeeding. 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?
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!