Fluconazole (injection)

Fluconazole (injection)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Overview

Fluconazole (injection) is an antifungal agent that is FDA approved for the {{{indicationType}}} of . Common adverse reactions include nausea, vomiting, headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Fluconazole Injection is indicated for the treatment of:

• Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.

Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.

• Prophylaxis:

• Fluconazole is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
• Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.

Dosage

• Dosage and Administration in Adults:

• Multiple Dose

• SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL 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 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 1000 cells per cu mm.

• Dosage In Patients With Impaired RenalFunction:

• Fluconazole is cleared primarily by renal excretion as unchanged drug. In patients with impaired renal function who will receive multiple doses of Fluconazole Injection, 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:

table02

• 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:

table03

• 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:

table04

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Fluconazole (injection) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluconazole (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Dosage

• The following dose equivalency scheme should generally provide equivalent exposure in pediatric and adult patients:

table01

• Experience with fluconazole 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 fluconazole pharmacokinetics in full-term newborns is available.

• Oropharyngeal candidiasis:

• The recommended dosage of fluconazole 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 fluconazole 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 to 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 to 12 weeks after the cerebrospinal fluid becomes culture negative. For suppression of relapse of cryptococcal meningitis in children with AIDS, the recommended dose of Fluconazole Injection is 6 mg/kg once daily.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Fluconazole (injection) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluconazole (injection) in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Fluconazole (injection) in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Fluconazole (injection) in the drug label.

Drug Interactions

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fluconazole (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Fluconazole (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Fluconazole (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Fluconazole (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Fluconazole (injection) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Fluconazole (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Fluconazole (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Fluconazole (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Fluconazole (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Fluconazole (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Fluconazole (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Administration:

• Fluconazole may be administered either orally or 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 glass and 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 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:

• Suspend container from eyelet support.
• Remove plastic protector from outlet port at bottom of container.
• Attach administration set. Refer to complete directions accompanying set.

Monitoring

There is limited information regarding Monitoring of Fluconazole (injection) in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Fluconazole (injection) in the drug label.

Overdosage

• There have been reports of overdose with fluconazole accompanied by hallucination and paranoid behavior.

• In the event of overdose, symptomatic treatment (with supportive measures and gastric lavage if clinically indicated) should be instituted.

• Fluconazole is largely excreted in urine. A three-hour hemodialysis session decreases plasma levels by approximately 50%.

• In mice and rats receiving very high doses of fluconazole, clinical effects in both species included decreased motility and respiration, ptosis, lacrimation, salivation, urinary incontinence, loss of righting reflex and cyanosis; death was sometimes preceded by clonic convulsions.

Pharmacology

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Fluconazole (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Fluconazole (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Fluconazole (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Fluconazole (injection) in the drug label.

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 glass bottles or in plastic containers containing volumes of 100 mL or 200 mL affording doses of 200 mg and 400 mg of fluconazole, respectively. Fluconazole injections in plastic containers are available in both sodium chloride and dextrose diluents.
• Fluconazole Injections in Glass Bottles:

• NDC 36000-004-06 Fluconazole in Sodium Chloride Diluent 200 mg/100 mL X 6
• NDC 36000-005-06 Fluconazole in Sodium Chloride Diluent 400 mg/200 mL X 6

• Storage: Store between 20° to 30°C (68° to 86°F). Avoid excessive heat. Protect from freezing.

• Fluconazole Injections in Plastic flexible I.V. containers

• NDC 36000-002-06 Fluconazole in Sodium Chloride Diluent 200 mg/100 mL X 6
• NDC 36000-003-06 Fluconazole in Sodium Chloride Diluent 400 mg/200 mL X 6
• NDC 36000-006-06 Fluconazole in Dextrose Diluent 200 mg/100 mL X 6
• NDC 36000-007-06 Fluconazole in Dextrose Diluent 400 mg/200 mL X 6
• NDC 36000-287-06 Fluconazole in Sodium Chloride Diluent 200 mg/100 mL X 6
• NDC 36000-288-06 Fluconazole in Sodium Chloride Diluent 400 mg/200 mL X 6

• Storage: Store units in moisture barrier overwrap between 20° to 30°C (68° to 86°F) until ready to use. Avoid excessive heat. Protect from freezing.

Storage

There is limited information regarding Fluconazole (injection) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Fluconazole (injection) in the drug label.

Precautions with Alcohol

• Alcohol-Fluconazole (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

There is limited information regarding Fluconazole (injection) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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