Fluconazole Injection
Name: Fluconazole Injection
- Fluconazole Injection uses
- Fluconazole Injection other uses for
- Fluconazole Injection injection
- Fluconazole Injection used to treat
- Fluconazole Injection side effects
- Fluconazole Injection drug
- Fluconazole Injection names
- Fluconazole Injection 15 mg
- Fluconazole Injection effects of
- Fluconazole Injection 2 mg
- Fluconazole Injection 150 mg
- Fluconazole Injection mg
- Fluconazole Injection dosage
Other uses for this medicine
Fluconazole injection is also sometimes used to treat serious fungal infections that begin in the lungs and can spread through the body and fungal infections of the eye, prostate (a male reproductive organ), skin and nails. Fluconazole injection is also sometimes used to prevent fungal infections in people who are likely to become infected because they have human immunodeficiency virus (HIV) or cancer or have had a transplant operation (surgery to remove an organ and replace it with a donor or artificial organ). Talk to your doctor about the risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What side effects can this medication cause?
Fluconazole injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- headache
- dizziness
- diarrhea
- stomach pain
- heartburn
- change in ability to taste food
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency treatment:
- nausea
- vomiting
- extreme tiredness
- unusual bruising or bleeding
- lack of energy
- loss of appetite
- pain in the upper right part of the stomach
- yellowing of the skin or eyes
- flu-like symptoms
- dark urine
- pale stools
- seizures
- rash
- skin peeling
- hives
- itching
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- difficulty breathing or swallowing
Fluconazole injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
Brand names
- Diflucan®
Side effects
Precautions
Indications
Fluconazole 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.
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:
Fluconazole in Dextrose Diluent
| Unit of Sale | Concentration | Each |
| NDC 0409-4684-23 Carton containing 6 | 200 mg/100 mL (2 mg/mL) | NDC 0409-4684-27 100 mL flexible plastic container (Latex-free) |
| NDC 0409-4684-02 Carton containing 6 | 400 mg/200 mL (2 mg/mL) | NDC 0409-4684-06 200 mL flexible plastic container (Latex-free) |
| NDC 0409-4684-13 Case containing 24 | 200 mg/100 mL (2 mg/mL) | NDC 0409-4684-17 100 mL flexible plastic container |
| NDC 0409-4684-12 Case containing 24 | 400 mg/200 mL (2 mg/mL) | NDC 0409-4684-16 200 mL flexible plastic container |
Fluconazole in Sodium Chloride Diluent
| Unit of Sale | Concentration | Each |
| NDC 0409-4688-23 Carton containing 6 | 200 mg/100 mL (2 mg/mL) | NDC 0409-4688-29 100 mL flexible plastic container (Latex-free) |
| NDC 0409-4688-02 Carton containing 6 | 400 mg/200 mL (2 mg/mL) | NDC 0409-4688-06 200 mL flexible plastic container (Latex-free) |
| NDC 0409-4688-18 Case containing 24 | 200 mg/100 mL (2 mg/mL) | NDC 0409-4688-22 100 mL flexible plastic container |
| NDC 0409-4688-12 Case containing 24 | 400 mg/200 mL (2 mg/mL) | NDC 0409-4688-16 200 mL flexible plastic container |
Storage
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.
Hospira, Inc., Lake Forest, IL 60045 USA. Revised: Jul 2014
Warnings
- Hepatic Injury: Fluconazole should be administered with caution to patients with liver dysfunction. Fluconazole has been associated with rare cases of serious hepatic toxicity, including fatalities primarily in patients with serious underlying medical conditions. In cases of fluconazole-associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex, or age of the patient has been observed. Fluconazole hepatotoxicity has usually, but not always, been reversible on discontinuation of therapy. Patients who develop abnormal liver function tests during fluconazole therapy should be monitored for the development of more severe hepatic injury. Fluconazole should be discontinued if clinical signs and symptoms consistent with liver disease develop that may be attributable to fluconazole.
- Anaphylaxis: In rare cases, anaphylaxis has been reported.
- Dermatologic: Exfoliative skin disorders during treatment with fluconazole have been reported in patients with serious underlying diseases. Patients with deep seated fungal infections who develop rashes during treatment with fluconazole should be monitored closely and the drug discontinued if lesions progress. Fluconazole should be discontinued in patients treated for superficial fungal infection who develop rash that may be attributed to fluconazole.
- Use in Pregnancy: There are no adequate and well-controlled studies of fluconazole in pregnant women. Available human data do not suggest an increased risk of congenital anomalies following a single maternal dose of 150 mg. A few published case reports describe a rare pattern of distinct congenital anomalies in infants exposed in utero to high dose maternal fluconazole (400-800 mg/day) during most or all of the first trimester. These reported anomalies are similar to those seen in animal studies. If this drug is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus. (see PRECAUTIONS: Pregnancy).
Side effects
Fluconazole is generally well tolerated.
In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and hematological function test results and hepatic abnormalities have been observed during treatment with fluconazole and comparative agents, but the clinical significance and relationship to treatment is uncertain.
In Patients Receiving Multiple Doses For Other Infections
Sixteen percent of over 4,000 patients treated with fluconazole in clinical trials of 7 days or more experienced adverse events. Treatment was discontinued in 1.5% of patients due to adverse clinical events and in 1.3% of patients due to laboratory test abnormalities.
Clinical adverse events were reported more frequently in HIV infected patients (21%) than in non- HIV infected patients (13%); however, the patterns in HIV infected and non-HIV infected patients were similar. The proportions of patients discontinuing therapy due to clinical adverse events were similar in the two groups (1.5%).
The following treatment-related clinical adverse events occurred at an incidence of 1% or greater in 4,048 patients receiving fluconazole for 7 or more days in clinical trials: nausea 3.7%, headache 1.9%, skin rash 1.8%, vomiting 1.7%, abdominal pain 1.7%, and diarrhea 1.5%.
HepatobiliaryIn combined clinical trials and marketing experience, there have been rare cases of serious hepatic reactions during treatment with fluconazole. (See WARNINGS.) The spectrum of these hepatic reactions has ranged from mild transient elevations in transaminases to clinical hepatitis, cholestasis and fulminant hepatic failure, including fatalities. Instances of fatal hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly AIDS or malignancy) and often while taking multiple concomitant medications. Transient hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors. In each of these cases, liver function returned to baseline on discontinuation of fluconazole.
In two comparative trials evaluating the efficacy of fluconazole for the suppression of relapse of cryptococcal meningitis, a statistically significant increase was observed in median AST (SGOT) levels from a baseline value of 30 IU/L to 41 IU/L in one trial and 34 IU/L to 66 IU/L in the other. The overall rate of serum transaminase elevations of more than 8 times the upper limit of normal was approximately 1% in fluconazole-treated patients in clinical trials. These elevations occurred in patients with severe underlying disease, predominantly AIDS or malignancies, most of whom were receiving multiple concomitant medications, including many known to be hepatotoxic. The incidence of abnormally elevated serum transaminases was greater in patients taking fluconazole concomitantly with one or more of the following medications: rifampin, phenytoin, isoniazid, valproic acid, or oral sulfonylurea hypoglycemic agents.
Post-Marketing Experience
In addition, the following adverse events have occurred during post-marketing experience:
Immunologic: In rare cases, anaphylaxis (including angioedema, face edema and pruritus) has been reported.
Body as a Whole: Asthenia, fatigue, fever, malaise.
Cardiovascular: QT prolongation, torsade de pointes. (See PRECAUTIONS.)
Central Nervous System: Seizures, dizziness.
Hematopoietic and Lymphatic: Leukopenia, including neutropenia and agranulocytosis, thrombocytopenia.
Metabolic: Hypercholesterolemia, hypertriglyceridemia, hypokalemia.
Gastrointestinal: Cholestasis, dry mouth, hepatocellular damage, dyspepsia, vomiting.
Other Senses: Taste perversion.
Musculoskeletal System: Myalgia.
Nervous System: Insomnia, paresthesia, somnolence, tremor, vertigo.
Skin and Appendages: Acute generalized exanthematous-pustulosis, drug eruption, increased sweating, exfoliative skin disorders including Stevens-Johnson syndrome and toxic epidermal necrolysis (see WARNINGS), alopecia.
Adverse Reactions In Children
The pattern and incidence of adverse events and laboratory abnormalities recorded during pediatric clinical trials are comparable to those seen in adults.
In Phase II/III clinical trials conducted in the United States and in Europe, 577 pediatric patients, ages 1 day to 17 years were treated with fluconazole at doses up to 15 mg/kg/day for up to 1,616 days. Thirteen percent of children experienced treatment-related adverse events. The most commonly reported events were vomiting (5%), abdominal pain (3%), nausea (2%), and diarrhea (2%). Treatment was discontinued in 2.3% of patients due to adverse clinical events and in 1.4% of patients due to laboratory test abnormalities. The majority of treatment-related laboratory abnormalities were elevations of transaminases or alkaline phosphatase.
Percentage of Patients with Treatment-related Side Effects
| Fluconazole (N = 577) | Comparative Agents (N = 451) | |
| With any side effect | 13.0 | 9.3 |
| Vomiting | 5.4 | 5.1 |
| Abdominal pain | 2.8 | 1.6 |
| Nausea | 2.3 | 1.6 |
| Diarrhea | 2.1 | 2.2 |
Read the entire FDA prescribing information for Fluconazole Injection (Fluconazole Injection)
Read More »PRINCIPAL DISPLAY PANEL - 100 mL Bag Overwrap Label
TO OPEN – TEAR AT NOTCH
100 mL
Rx only
NDC 0409-4688-22
FLUCONAZOLE IN
SODIUM CHLORIDE INJECTION, USP
200 mg/100 mL (2 mg/mL)
ISO-OSMOTIC SODIUM CHLORIDE DILUENT
FOR INTRAVENOUS USE. Each 100 mL contains 200 mg of Fluconazole and
900 mg of Sodium Chloride, USP, in Water for Injection, USP.
Osmolarity 315 mOsmol/L (Calc.). Sterile, nonpyrogenic.
Single-dose container
CAUTIONS: Do not add supplementary medication. The overwrap is a moisture
barrier. Do not remove unit from overwrap until ready for use. Use unit promptly
when overwrap is opened.
RECOMMENDED STORAGE: Store at 20 to 25°C (68 to 77°F). [See USP
Controlled Room Temperature.] Avoid excessive heat. Protect from freezing.
USUAL DOSAGE: See insert. After removing the overwrap, check for minute
leaks by squeezing container firmly. If leaks are found, discard solution as
sterility may be impaired. Do not use unless solution is clear.
MUST NOT BE USED IN SERIES CONNECTIONS.
F WR - 0475
Hospira, Inc., Lake Forest, IL 60045 USA
Hospira
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| Labeler - Hospira, Inc. (141588017) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Hospira, Inc. | 093132819 | ANALYSIS(0409-4688) | |