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









**



Pharmacokinetics in Children





Pharmacokinetics in Elderly


Drug Interaction Studies

Oral contraceptives




Cimetidine


Antacid


Hydrochlorothiazide


Rifampin


Warfarin


Phenytoin


Cyclosporine


Zidovudine


Theophylline


Terfenadine


Oral Hypoglycemics








Rifabutin


Tacrolimus


Cisapride


Midazolam



Azithromycin


Microbiology

Mechanism of Action


Activity In Vitro and In Clinical Infections
















Susceptibility Testing Methods






Table 1: Susceptibility Interpretive Criteria for Fluconazole





Quality Control


Table 2: Acceptable Quality Control Ranges for Fluconazole to be Used in Validation of Susceptibility Test Results



Activity In Vivo





Drug Resistance







INDICATIONS & USAGE






Prophylaxis



CLINICAL STUDIES

Cryptococcal Meningitis


Vaginal Candidiasis







Pediatric Studies

Oropharyngeal Candidiasis



**

FLUCONAZOLE CONTRAINDICATIONS



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.

2. Anaphylaxis

3. Dermatologic


PRECAUTIONS

General



Single Dose


DRUG INTERACTIONS















Oral Hypoglycemics


Coumarin-Type Anticoagulants


Phenytoin


Cyclosporine


Rifampin


Theophylline


Terfenadine


Cisapride


Astemizole


Rifabutin


Tacrolimus


Short-acting Benzodiazepines




CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY





PREGNANCY

Teratogenic Effects
Pregnancy Category C




NURSING MOTHERS



PEDIATRIC USE








GERIATRIC USE





FLUCONAZOLE ADVERSE REACTIONS

In Patients Receiving a Single Dose for Vaginal Candidiasis


In Patients Receiving Multiple Doses for Other Infections




Hepatobiliary



Postmarketing Experience


Immunologic


Cardiovascular


Central Nervous System


Dermatologic


Hematopoietic and Lymphatic


Metabolic


Other Senses


Adverse Reactions in Children




OVERDOSAGE

OVERDOSAGE






DOSAGE & ADMINISTRATION

Dosage and Administration in Adults

Single Dose



Multiple Dose















Dosage and Administration in Children


**

Oropharyngeal candidiasis


Esophageal candidiasis


Systemic candida infections


Cryptococcal meningitis


Dosage in Patients With Impaired Renal Function














HOW SUPPLIED






STORAGE AND HANDLING







REFERENCES





INFORMATION FOR PATIENTS

Fluconazole Tablets

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 you take by mouth such as glyburide, tolbutamide, glipizide
  • ●     blood thinners such as warfarin
  • ●     cyclosporine (used to prevent rejection of organ transplants)
  • ●     rifampin or rifabutin (used for tuberculosis)
  • ●     astemizole (used for allergies)
  • ●     tacrolimus (used to prevent rejection of organ transplants)
  • ●     phenytoin (used for seizures)
  • ●     theophylline (used for asthma)
  • ●     cisapride (Propulsid
  • ●     terfenadine (Seldane

  • ●     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. 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:49349-860(NDC:0172-5411)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FLUCONAZOLE FLUCONAZOLE 100 mg

Inactive Ingredients

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

Product Characteristics

Color Size Imprint Code Shape
pink 10 mm 5411;100 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-860-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076077 2011-12-19


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Be sure to consult your doctor before taking any medication!
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