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








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 StudiesPRECAUTIONS

WARNINGS









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



Single 150 mg tablet use for Vaginal Candidiasis





All other indications


WARNINGS, Use in Pregnancy

Human Data



Animal Data



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



Postmarketing Experience







PRECAUTIONS















WARNINGS

Adverse Reactions in Children





Fluconazole (N=577)Comparative Agents (N=451)


OVERDOSAGE








DOSAGE & ADMINISTRATION

Dosage and Administration in Adults

Single 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 USP



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, alfentanil 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 breastfeeding. 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?





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:49349-864(NDC:65862-061)
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
cellulose, microcrystalline
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
POVIDONE K30
CROSCARMELLOSE SODIUM
FD&C RED NO. 40
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
pink 14 mm C;07 BULLET

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-864-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077731 2011-12-28


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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