Fluconazole – Diflucan ®

Fluconazole - Diflucan ®

Usual Diluents

Standard Dilutions   [Amount of drug] [Infusion volume] [Infusion rate]

Stability / Miscellaneous

Label: Protect from freezing. Avoid excessive heat.
[Store at 20° to 25°C (68° to 77°F) -  Room Temperature.]

Maximum IV rate: 200 mg/hr.

Oral: Oropharyngeal candidiasis: 200mg orally x 1, followed by 100mg orally once daily. Esophageal candidiasis: 100-200 mg orally once daily (up to 400mg/day). Cryptococcal meningitis: 400mg orally x 1, followed by 200mg orally once daily x 10-12 weeks (Suppression: 50-200mg orally once daily). Onychomycosis: 200-300mg once weekly or 100-200mg orally every other day (further studies needed).

IV: since oral absorption is rapid and essentially complete--IV dose=oral dose.

Renal dosing: >50/ no change || <50 / 50% of usual dose. || Alternatively: 20 to 50/ give normal dose q48h. || <20 / 50% of usual dose q48h. || Hemodialysis: give 100-200mg after each dialysis. || CAPD: give 50% of usual dose at usual interval.

DOSAGE AND ADMINISTRATION
Dosage and Administration in Adults:

SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL (TABLETS AND SUSPENSION) AND INTRAVENOUS ADMINISTRATION. In general, a loading dose of twice the daily dose is recommended on the first day of therapy to result in plasma concentrations close to steady-state by the second day of therapy.

The daily dose of fluconazole for the treatment of infections other than vaginal candidiasis should be based on the infecting organism and the patient’s response to therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse.

Oropharyngeal candidiasis: The recommended dosage of fluconazole for oropharyngeal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of oropharyngeal candidiasis generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.

Esophageal candidiasis: The recommended dosage of fluconazole for esophageal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/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 two weeks following resolution of symptoms.

Systemic Candida infections: For systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia, optimal therapeutic dosage and duration of therapy have not been established. In open, noncomparative studies of small numbers of patients, doses of up to 400 mg daily have been used.

Urinary tract infections and peritonitis: For the treatment of Candida urinary tract infections and peritonitis, daily doses of 50 to 200 mg have been used in open, noncomparative studies of small numbers of patients.

Cryptococcal meningitis: The recommended dosage for treatment of acute cryptococcal meningitis is 400 mg on the first day, followed by 200 mg once daily. A dosage of 400 mg 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 to 12 weeks after the cerebrospinal fluid becomes culture negative. The recommended dosage of fluconazole for suppression of relapse of cryptococcal meningitis in patients with AIDS is 200 mg once daily.

Prophylaxis in patients undergoing bone marrow transplantation: The recommended fluconazole daily dosage for the prevention of candidiasis of patients undergoing bone marrow transplantation is 400 mg, once daily. Patients who are anticipated to have severe granulocytopenia (less than 500 neutrophils per cu mm) should start fluconazole prophylaxis several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1,000 cells per cu mm.

Dosage In Patients With Impaired Renal Function:
Fluconazole is cleared primarily by renal excretion as unchanged drug. 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:

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

Administration
Fluconazole injection may be administered by intravenous infusion. Fluconazole injection has been used safely for up to fourteen days of intravenous therapy. The intravenous infusion of fluconazole should be administered at a maximum rate of approximately 200 mg/hour, given as a continuous infusion.

Fluconazole injections in flexible 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 IV Use of Fluconazole in Flexible 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 flexible 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 outer wrap at notch 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:

(Use Aseptic Technique)

1.Close flow control clamp of administration set.
2.Remove cover from outlet port at bottom of container.
3.Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: When using a vented administration set, replace bacterial retentive air filter with piercing pin cover. Insert piercing pin with twisting motion until shoulder of air filter housing rests against the outlet port flange. NOTE: See full directions on administration set carton.
4.Suspend container from hanger.
5.Squeeze and release drip chamber to establish proper fluid level in chamber.
6.Open flow control clamp and clear air from set. Close flow control clamp.
7.Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
8.Regulate rate of administration with flow control clamp.

WARNING: Do not use flexible container in series connections.

HOW SUPPLIED
Fluconazole Injections: Fluconazole injections for intravenous infusion administration are formulated as sterile iso-osmotic solutions containing 2 mg/mL of fluconazole. They are supplied in flexible plastic containers containing volumes of 100 mL or 200 mL affording doses of 200 mg and 400 mg of fluconazole, respectively. Fluconazole injections in flexible plastic containers are available in both sodium chloride and dextrose diluents.

Fluconazole Injections in Flexible Plastic Containers are supplied in the following:

NDC ---- Size
0409-4684-23 - Fluconazole in Dextrose Diluent 200 mg/100 mL

0409-4684-02 - Fluconazole in Dextrose Diluent 400 mg/200 mL

0409-4688-23 - Fluconazole in Sodium Chloride Diluent 200 mg/100 mL

0409-4688-02 - Fluconazole in Sodium Chloride Diluent 400 mg/200 mL

Storage: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA
©Hospira 2005
EN-0897

Source: [package insert]