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Diflucan - Indications & Dosage

[Fluconazole]



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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