ble, 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 can be taken with or without food. 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