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









**
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:


***

Quality Control



******
Activity In Vivo





Drug Resistance







INDICATIONS & USAGE




CLINICAL STUDIES



CLINICAL STUDIES









Pediatric Studies



**

FLUCONAZOLE CONTRAINDICATIONS

CLINICAL PHARMACOLOGY: Drug Interaction StudiesPRECAUTIONS

WARNINGS

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

General







Single Dose
ADVERSE REACTIONSCLINICAL STUDIES

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 Studies
CLINICAL PHARMACOLOGY: Drug Interaction Studies
























CLINICAL PHARMACOLOGY

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



CLINICAL PHARMACOLOGY

PREGNANCY

Teratogenic Effects

Pregnancy 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 STUDIES
CLINICAL 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 USP
Rx Only



What Is Fluconazole?



What Is A Vaginal Yeast Infection?



  • ●     itching
  • ●     a burning feeling when you urinate
  • ●     redness
  • ●     soreness
  • ●     a thick white vaginal discharge that looks like cottage cheese

What To Tell Your Doctor Before You Start Fluconazole?

  • ●     diabetes medicines such as glyburide, tolbutamide, glipizide
  • ●     blood pressure medicines like hydrochlorothiazide, losartan, amlodipine, nifedipine or felodipine
  • ●     blood thinners such as warfarin
  • ●     cyclosporine, tacrolimus or sirolimus (used to prevent rejection of organ transplants)
  • ●     rifampin or rifabutin for tuberculosis
  • ●     astemizole for allergies
  • ●     phenytoin or carbamazepine to control seizures
  • ●     theophylline to control asthma
  • ●     cisapride for heartburn
  • ●     quinidine (used to correct disturbances in heart rhythm)
  • ●     amitriptyline or nortriptyline for depression
  • ●     pimozide for psychiatric illness
  • ●     amphotericin B or voriconazole for fungal infections
  • ●     erythromycin for bacterial infections
  • ●     cyclophosphamide or vinca alkaloids such as vincristine or vinblastine for treatment of cancer
  • ●     fentanyl, afentanil or methadone for chronic pain
  • ●     halofantrine for malaria
  • ●     lipid lowering drugs such as atorvastatin, simvastatin, and fluvastatin
  • ●     non-steroidal anti-inflammatory drugs including celecoxib, ibuprofen, and naproxen
  • ●     prednisone, a steroid used to treat skin, gastrointestinal, hematological or respiratory disorders
  • ●     antiviral medications used to treat HIV like saquinavir or zidovudine
  • ●     vitamin A nutritional supplement

  • ●     are taking any over-the-counter medicines you can buy without a prescription, including natural or herbal remedies
  • ●     have any liver problems.
  • ●     have any other medical conditions
  • ●     are pregnant, plan to become pregnant, or think you might be pregnant. Your doctor will discuss whether fluconazole is right for you.
  • ●     are breast-feeding. Fluconazole can pass through breast milk to the baby.
  • ●     are allergic to any other medicines including those used to treat yeast and other fungal infections.
  • ●     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


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?


  • ●     headache
  • ●     diarrhea
  • ●     nausea or upset stomach
  • ●     dizziness
  • ●     stomach pain
  • ●     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














Fluconazole

Fluconazole

Fluconazole

Fluconazole TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-892(NDC:68462-104)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FLUCONAZOLE FLUCONAZOLE 200 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
FD&C RED NO. 40
MAGNESIUM STEARATE
cellulose, microcrystalline
povidone

Product Characteristics

Color Size Imprint Code Shape
pink 12 mm 200 TRAPEZOID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-892-07 12 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077253 2012-03-05


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Be sure to consult your doctor before taking any medication!
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