Fluconazole (Page 8 of 9)

Dosage In Patients With Impaired Renal Function:

Fluconazole is cleared primarily by renal excretion as unchanged drug. There is no need to adjust single dose therapy for vaginal candidiasis because of impaired renal function. In patients with impaired renal function who will receive multiple doses of fluconazole, an initial loading dose of 50 to 400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table:

Creatinine Clearance (mL/min) Percent of Recommended Dose
> 50 100%
≤ 50 (no dialysis) 50%
Regular dialysis 100% after each dialysis

These are suggested dose adjustments based on pharmacokinetics following administration of multiple doses. Further adjustment may be needed depending upon clinical condition.

When serum creatinine is the only measure of renal function available, the following formula (based on sex, weight, and age of the patient) should be used to estimate the creatinine clearance in adults:

Males:

Weight (kg) x (140-age)
72 x serum creatinine (mg/100 mL)

Females:

0.85 x above value

Although the pharmacokinetics of fluconazole has not been studied in children with renal insufficiency, dosage reduction in children with renal insufficiency should parallel that recommended for adults. The following formula may be used to estimate creatinine clearance in children:

K x linear length or height (cm)
serum creatinine (mg/100 mL)

(Where K = 0.55 for children older than 1 year and 0.45 for infants.)

Administration

Fluconazole may be administered orally.

HOW SUPPLIED

Fluconazole Tablets USP: Pink trapezoidal tablets containing 100 or 200 mg of fluconazole USP are packaged in bottles. The 150 mg fluconazole tablets are pink, oval shaped, packaged in a blister card of 1 tablet.

Fluconazole Tablets USP are supplied as follows:

Fluconazole Tablets USP 100 mg: Engraved with “100” on one side and plain on the other side.

NDC 21695-131-30 Bottles of 30

Fluconazole Tablets USP 150 mg: Engraved with “150” on one side and plain on the other side.

NDC 21695-193-01 Carton of 1 blister card of 1 tablet

NDC 21695-193-02 Carton of 2 blister cards of 1 tablet

NDC 21695-193-12 Carton of 12 blister cards of 1 tablet

Fluconazole Tablets USP 200 mg: Engraved with “200” on one side and plain on the other side.

NDC 21695-560-07 Bottles of 7
NDC 21695-560-30 Bottles of 30

Storage: Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature].

REFERENCES

  1. Clinical and Laboratory Standards Institute. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard-Second Edition. CLSI Document M27-A2, 2002 Volume 22, No 15, CLSI, Wayne, PA, August 2002.
  2. Clinical and Laboratory Standards Institute. Methods for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline. CLSI Document M44-A, 2004 Volume 24, No. 15 CLSI, Wayne, PA, May 2004.
  3. Pfaller, M.A., Messer, S.A., Boyken, L., Rice, C., Tendolkar, S., Hollis, R.J., and Diekemal, D.J. Use of Fluconazole as a Surrogate Marker To Predict Susceptibility and Resistance to Voriconazole among 13,338 Clinical Isolates of Candida spp. Tested by Clinical and Laboratory Standard Institute-Recommended Broth Microdilution Methods. 2007. Journal of Clinical Microbiology. 45: 70-75

Manufactured by:

Glenmark Generics Ltd.
Colvale-Bardez, Goa 403513, India.

Manufactured for:

Glenmark Logo

Glenmark Generics Inc., USA
Mahwah, NJ 07430.

Questions? 1 (888)721-7115
www.glenmarkgenerics.com

May 2010

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

PATIENT INFORMATION

FLUCONAZOLE TABLETS USP

Rx Only

This leaflet contains important information about fluconazole. It is not meant to take the place of your doctor’s instructions. Read this information carefully before you take fluconazole. Ask your doctor or pharmacist if you do not understand any of this information or if you want to know more about fluconazole.

What Is Fluconazole?

Fluconazole is a tablet you swallow to treat vaginal yeast infections caused by a yeast called Candida. Fluconazole helps stop too much yeast from growing in the vagina so the yeast infection goes away.

Fluconazole is different from other treatments for vaginal yeast infections because it is a tablet taken by mouth. Fluconazole is also used for other conditions. However, this leaflet is only about using fluconazole for vaginal yeast infections. For information about using fluconazole for other reasons, ask your doctor or pharmacist. See the section of this leaflet for information about vaginal yeast infections.

What Is A Vaginal Yeast Infection?

It is normal for a certain amount of yeast to be found in the vagina. Sometimes too much yeast starts to grow in the vagina and this can cause a yeast infection. Vaginal yeast infections are common. About three out of every four adult women will have at least one vaginal yeast infection during their life.

Some medicines and medical conditions can increase your chance of getting a yeast infection. If you are pregnant, have diabetes, use birth control pills, or take antibiotics you may get yeast infections more often than other women. Personal hygiene and certain types of clothing may increase your chances of getting a yeast infection. Ask your doctor for tips on what you can do to help prevent vaginal yeast infections.

If you get a vaginal yeast infection, you may have any of the following symptoms:

  • 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?

Do not take fluconazole if you take certain medicines. They can cause serious problems. Therefore, tell your doctor about all the medicines you take including:

  • 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®† ; used for stomach acid problems)
  • terfenadine (Seldane®‡ ; used for allergies)
    Since there are many brand names for these medicines, check with your doctor or pharmacist if you have any questions.
  • 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. The main ingredient of Fluconazole tablet is fluconazole. If you need to know the inactive ingredients, ask your doctor or pharmacist.

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