Diflucan

[Fluconazole]

Dosage and Administration in Children:

The following dose equivalency scheme should generally provide equivalent exposure in pediatric and adult patients:
Pediatric Patients Adults 3 mg/ kg 100 mg
6 mg/ kg 200 mg 12* mg/ kg 400 mg

* Some older children may have clearances similar to that of adults. Absolute doses exceeding 600 mg/ day are not recommended. Experience with DIFLUCAN in neonates is limited to pharmacokinetic studies in premature newborns. (See CLINICAL PHARMACOLOGY.) Based on the prolonged half-life seen in premature newborns (gestational age 26 to 29 weeks), these children, in the first two weeks of life, should receive the same dosage (mg/ kg) as in older children, but administered every 72 hours. After the first two weeks, these children should be dosed once daily. No information regarding DIFLUCAN pharmacokinetics in full-term newborns is available.

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Oropharyngeal candidiasis

The recommended dosage of DIFLUCAN for oropharyngeal candidiasis in children is 6 mg/ kg on the first day, followed by 3 mg/ kg once daily. Treatment should be administered for at least 2 weeks to decrease the likelihood of relapse.

Esophageal candidiasis

For the treatment of esophageal candidiasis, the recommended dosage of DIFLUCAN in children is 6 mg/ kg on the first day, followed by 3 mg/ kg once daily. Doses up to 12 mg/ kg/ day may be used based on medical judgment of the patient's response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least 2 weeks following the resolution of symptoms.

Systemic Candida infections:

For the treatment of candidemia and disseminated Candida infections, daily doses of 6-12 mg/ kg/ day have been used in an open, noncomparative study of a small number of children.

Cryptococcal meningitis

For the treatment of acute cryptococcal meningitis, the recommended dosage is 12 mg/ kg on the first day, followed by 6 mg/ kg once daily. A dosage of 12 mg/ kg once daily may be used, based on medical judgment of the patient's response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10-12 weeks after the cerebrospinal fluid becomes culture negative. For suppression of relapse of cryptococcal meningitis in children with AIDS, the recommended dose of DIFLUCAN is 6 mg/ kg once daily.

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 DIFLUCAN, 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) × (140-age) 72 × serum creatinine (mg/ 100 mL)

Females:

0.85 × 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 × 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 DIFLUCAN may be administered either orally or by intravenous infusion. DIFLUCAN injection has been used safely for up to fourteen days of intravenous therapy. The intravenous infusion of DIFLUCAN should be administered at a maximum rate of approximately 200 mg/ hour, given as a continuous infusion. DIFLUCAN injections in glass and Viaflex® Plus plastic containers are intended only for intravenous administration using sterile equipment.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Do not use if the solution is cloudy or precipitated or if the seal is not intact.

Directions for Mixing the Oral Suspension

Prepare a suspension at time of dispensing as follows: tap bottle until all the powder flows freely.

To reconstitute, add 24 mL of distilled water or Purified Water (USP) to fluconazole bottle and shake vigorously to suspend powder. Each bottle will deliver 35 mL of suspension. The concentrations of the reconstituted suspensions are as follows:

Fluconazole Content per Bottle Concentration of Reconstituted Suspension 350 mg 10 mg/ mL
1400 mg 40 mg/ mL
Note: Shake oral suspension well before using. Store reconstituted suspension between 86 F (30 C) and 41 F (5 C) and discard unused portion after 2 weeks. Protect from freezing.

Directions for IV Use of DIFLUCAN in Viaflex® Plus Plastic Containers Do not remove unit from overwrap until ready for use. The overwrap is a moisture barrier. The inner bag maintains the sterility of the product.

CAUTION:

Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

To Open Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. After removing overwrap, check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.

DO NOT ADD SUPPLEMENTARY MEDICATION.

Preparation for Administration:
1. Suspend container from eyelet support.
2. Remove plastic protector from outlet port at bottom of container.
3. Attach administration set. Refer to complete directions accompanying set.

HOW SUPPLIED

DIFLUCAN® Tablets: Pink trapezoidal tablets containing 50, 100 or 200 mg of fluconazole are packaged in bottles or unit dose blisters. The 150 mg fluconazole tablets are pink and oval shaped, packaged in a single dose unit blister.

DIFLUCAN® Tablets are supplied as follows:
DIFLUCAN® 50 mg Tablets: Engraved with "DIFLUCAN" and "50" on the front and "ROERIG" on the back.

NDC 0049-3410-30 Bottles of 30
DIFLUCAN® 100 mg Tablets: Engraved with "DIFLUCAN" and "100" on the front and "ROERIG" on the back.

NDC 0049-3420-30 Bottles of 30 NDC 0049-3420-41 Unit dose package of 100
DIFLUCAN® 150 mg Tablets: Engraved with "DIFLUCAN" and "150" on the front and "ROERIG" on the back.
NDC 0049-3500-79 Unit dose package of 1

DIFLUCAN® 200 mg Tablets: Engraved with "DIFLUCAN" and "200" on the front and "ROERIG" on the back.
NDC 0049-3430-30 Bottles of 30 NDC 0049-3430-41 Unit dose package of 100
Storage: Store tablets below 86 F (30 C).
DIFLUCAN® for Oral Suspension: DIFLUCAN® for oral suspension is supplied as an orange-flavored powder to provide 35 mL per bottle as follows:
NDC 0049-3440-19 Fluconazole 350 mg per bottle NDC 0049-3450-19 Fluconazole 1400 mg per bottle
Storage: Store dry powder below 86 F (30 C). Store reconstituted suspension between 86 F (30 C) and 41 F (5 C) and discard unused portion after 2 weeks. Protect from freezing.

DIFLUCAN® Injections:

DIFLUCAN® injections for intravenous infusion administration are formulated as sterile iso-osmotic solutions containing 2 mg/ mL of fluconazole. They are supplied in glass bottles or in Viaflex® Plus plastic containers containing volumes of 100 mL or 200 mL affording doses of 200 mg and 400 mg of fluconazole, respectively. DIFLUCAN® injections in Viaflex® Plus plastic containers are available in both sodium chloride and dextrose diluents.

DIFLUCAN® Injections in Glass Bottles:

NDC 0049-3371-26 Fluconazole in Sodium Chloride Diluent 200 mg/ 100 mL × 6 NDC 0049-3372-26 Fluconazole in Sodium Chloride Diluent 400 mg/ 200 mL × 6
Storage: Store between 86 F (30 C) and 41 F (5 C). Protect from freezing.
DIFLUCAN® Injections in Viaflex® Plus Plastic Containers:
NDC 0049-3435-26 Fluconazole in Sodium Chloride Diluent 200 mg/ 100 mL × 6 NDC 0049-3436-26 Fluconazole in Sodium Chloride Diluent 400 mg/ 200 mL × 6
NDC 0049-3437-26 Fluconazole in Dextrose Diluent 200 mg/ 100 mL × 6 NDC 0049-3438-26 Fluconazole in Dextrose Diluent 400 mg/ 200 mL × 6

Storage: Store between 77 F (25 C) and 41 F (5 C). Brief exposure up to 104 F (40 C) does not adversely affect the product. Protect from freezing.
2003 PFIZER INC

Printed in U. S. A. 70-4526-00-8 Revised June 2003
Roerig Division of Pfizer Inc, NY, NY 10017

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