Fluconazole injection is used to treat serious fungal or yeast infections, such as vaginal candidiasis, oropharyngeal candidiasis (thrush, oral thrush), esophageal candidiasis (candida esophagitis), other candida infections (including urinary tract infections, peritonitis [inflammation of the lining of the abdomen or stomach], and infections that may occur in different parts of the body), or fungal (cryptococcal) meningitis. Fluconazole works by killing the fungus or yeast, or preventing its growth.
Fluconazole injection is also used to prevent candidiasis in patients having bone marrow transplants, who receive cancer or radiation treatment.
Fluconazole is to be given only by or under the direct supervision of a doctor.
Fluconazole indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Fluconazole tablets, USP are indicated for the treatment of:
Vaginal candidiasis (vaginal yeast infections due to Candida).
Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, Fluconazole tablets, USP were 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 tablets, USP 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 tablets, USP are 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 should I use Fluconazole?
Use Fluconazole solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Fluconazole solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Fluconazole solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Fluconazole solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use Fluconazole solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
To clear up your infection completely, use Fluconazole solution for the full course of treatment. Keep using it even if you feel better in a few days. Do not miss any doses.
Fluconazole solution works best if it is taken at the same time each day.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
If you miss a dose of Fluconazole solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Fluconazole solution.
Uses of Fluconazole in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Treatment of candidiasis (esophageal, oropharyngeal, peritoneal, urinary tract, vaginal); systemic candida infections (eg, candidemia, disseminated candidiasis, pneumonia); and cryptococcal meningitis; and antifungal prophylaxis in allogeneic hematopoietic cell transplant recipients
Off Label Uses
Blastomycosis
Data from a randomized, multicenter, open-label study comparing Fluconazole 400 mg versus 800 mg suggest that the use of Fluconazole at each of these doses is effective for the treatment of non-life-threatening blastomycosis.
Fluconazole description
A semisynthetic antibiotic produced from Streptomyces mediterranei. It has a broad antibacterial spectrum, including activity against several forms of Mycobacterium. In susceptible organisms it inhibits DNA-dependent RNA polymerase activity by forming a stable complex with the enzyme. It thus suppresses the initiation of RNA synthesis. Fluconazole is bactericidal, and acts on both intracellular and extracellular organisms. (From Gilman et al., Goodman and Gilman&
Fluconazole dosage
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Dosage and Administration in Adults
Single Dose: Vaginal Candidiasis: The recommended dosage of Fluconazole for vaginal candidiasis is 150 mg as a single oral dose.
Multiple Dose: 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 in 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 and Administration in Children
The following dose equivalency scheme should generally provide equivalent exposure in pediatric and adult patients:
Experience with Fluconazole in neonates is limited to pharmacokinetic studies in premature newborns. 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 is 6 mg/kg once daily.
Dosage in Patients with Impaired Renal Function
Fluconazole is cleared primarily by renal excretion as unchanged drug. There is no need to adjust single dose therapy for vaginal candidiasis because of impaired renal function. 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:
Patients on regular dialysis should receive 100% of the recommended dose after each dialysis; on non-dialysis days, patients should receive a reduced dose according to their creatinine clearance.
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:
Females: 0.85 x 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:
(Where K=0.55 for children older than 1 year and 0.45 for infants.)
Administration
Fluconazole for
Oral Suspension USP is administered orally. Fluconazole can be taken with or without food.
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:
Note: Shake oral suspension well before using. Before Reconstitution: Store at 20° to 25°C (68° to 77°F). After Reconstitution: Store suspension at 5° to 25°C (41° to 77°F). Discard unused portion after 2 weeks. Protect from freezing.
Anticoagulants: Bleeding events (bruising, epistaxis, gastrointestinal bleeding, hematuria, and melena), have been reported, in association with increases in prothrombin time in patients receiving Fluconazole concurrently with warfarin. Prothrombin time in patients receiving coumarin-type anticoagulant should be carefully monitored.
Azithromycin: There was no significant pharmacokinetic interaction between Fluconazole and Azithromycin.
Benzodiazepines (Short Acting): Following oral administration of midazolam, Fluconazole resulted in substantial increases in midazolam concentrations and psychomotor effects. This effect on midazolam appears to be more pronounced following oral administration of Fluconazole than with Fluconazole administered intravenously. If concomitant benzodiazepine therapy is necessary in patients being treated with Fluconazole, consideration should be given to decreasing the benzodiazepine dosage, and the patients should be appropriately monitored.
Cisapride: Cisapride increased risk of ventricular arrhythmia troubles notably torsades de pointes. The interaction between Fluconazole and cisapride yielded significant increase in cisapride plasma levels and prolongation of QTc interval. Coadministration of cisapride is contraindicated in patients receiving Fluconazole.
Cyclosporin: Fluconazole slowly increase cyclosporin concentrations in renal transplant patients. Fluconazole did not affect cyclosporine levels in patients with bone marrow transplants. Cyclosporin plasma concentration monitoring in patients receiving Fluconazole is recommended.
Hydrochlorothiazide: Interaction between multiple-dose hydrochlorothiazide and Fluconazole has increased plasma concentrations of Fluconazole by 40%. An effect of this magnitude should not necessitate a change in the Fluconazole dose regimen in subjects receiving concomitant diuretics, although the prescriber should bear it in mind.
Oral Contraceptives:
Multiple dose use of Fluconazole at these doses is unlikely to have an effect on the efficacy of the combined oral contraceptive.
Phenytoin: Concomitant administration of Fluconazole and phenytoin may increase the levels of phenytoin to a clinically significant degree. If it is necessary to administer both drugs concomitantly, phenytoin levels should be monitored and the phenytoin dose adjusted to maintain therapeutic levels.
Pimozide: Combination of Fluconazole will increase the risk of ventricular arrhythmia troubles notably torsades de pointes.
Rifabutin: An interaction exists when Fluconazole is administered concurrently with rifabutin, leading to increased serum levels of rifabutin. There have been reports of uveitis in patients to whom Fluconazole and rifabutin were coadministered. Patients receiving rifabutin and Fluconazole concomitantly should be carefully monitored.
Rifampicin: Concomitant administration of Fluconazole and rifampicin resulted in a 25% decrease in the AUC and a 20% shorter half-life of Fluconazole. In patients receiving concomitant rifampicin, an increase of the Fluconazole dose should be considered.
Sulfonylureas: Fluconazole has been shown to prolong the serum half-life of concomitantly administered oral sulfonylureas (chlorpropamide, glibenclamide, glipizide and tolbutamide) in healthy volunteers. Fluconazole and oral sulfonylureas may be coadministered to diabetic patients, but the possibility of a hypoglycemic episode should be borne in mind.
Tacrolimus: An interaction exists when Fluconazole is administered concomitantly with tacrolimus, leading to increased serum levels of tacrolimus. There have been reports of nephrotoxicity in patients also. Patients receiving tacrolimus and Fluconazole concomitantly should be carefully monitored.
Terfenadine: Concomitant Fluconazole and terfenadine causes palpitations, tachycardia, dizziness, and chest pain where the relationship of the adverse events to drug therapy or underlying medical condition was not clear. Because of the potential seriousness of such an interaction, it is recommended that terfenadine not be taken in combination with Fluconazole.
Theophylline: Patients who are receiving high dose theophylline or who are otherwise at increased risk for theophylline toxicity should be observed for signs of theophylline toxicity while receiving Fluconazole, and therapy modified appropriately it signs of toxicity develop.
Zidovudine: Increased levels of zidovudine most likely caused by the decreased conversion of zidovudine to its major metabolite. Patients receiving this combination of Fluconazole and zidovudine should be monitored for the development of zidovudine-related adverse reaction.
Use of Fluconazole in combination with astemizole or other drugs metabolized by the cytochrome P-450 system may be associated with elevations in serum levels of these drugs.
Oral Fluconazole is coadministered with food, cimetidine, antacids or following total body irradiation for bone marrow transplantation. No clinically significant impairment of Fluconazole absorption.
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 a Single Dose for Vaginal Candidiasis
During comparative clinical studies conducted in the United States, 448 patients with vaginal candidiasis were treated with Fluconazole, 150 mg single dose. The overall incidence of side effects possibly related to Fluconazole was 26%. In 422 patients receiving active comparative agents, the incidence was 16%. The most common treatment-related adverse events reported in the patients who received 150 mg single dose Fluconazole for vaginitis were headache (13%), nausea (7%), and abdominal pain (6%). Other side effects reported with an incidence equal to or greater than 1% included diarrhea (3%), dyspepsia (1%), dizziness (1%), and taste perversion (1%). Most of the reported side effects were mild to moderate in severity. Rarely, angioedema and anaphylactic reaction have been reported in marketing experience
In Patients Receiving Multiple Doses for Other Infections
Sixteen percent of over 4000 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 4048 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%.
Hepatobiliary: In combined clinical trials and marketing experience, there have been rare cases of serious hepatic reactions during treatment with Fluconazole.. 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, torsades de pointes.
Central Nervous System: Seizures, dizziness.
Hematopoietic and Lymphatic: Leukopenia, including neutropenia and agranulocytosis, thrombocytopenia.
Skin and Appendages: Acute generalized exanthematous-pustulosis, drug eruption, increased sweating, exfoliative skin disorders including Stevens-Johnson syndrome and toxic epidermal necrolysis, 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.
Fluconazole is contraindicated in patients who have shown hypersensitivity to Fluconazole or to any of its excipients. There is no information regarding cross-hypersensitivity between Fluconazole and other azole antifungal agents. Caution should be used in prescribing Fluconazole to patients with hypersensitivity to other azoles. Coadministration of terfenadine is contraindicated in patients receiving Fluconazole at multiple doses of 400 mg or higher based upon results of a multiple dose interaction study. Coadministration of other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as cisapride, astemizole, erythromycin, pimozide and quinidine are contraindicated in patients receiving Fluconazole.
DailyMed. "FLUCONAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Fluconazole are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Fluconazole. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
User reports
Consumer reported useful
No survey data has been collected yet
2 consumers reported price estimates
Was the price you paid to purchase the drug reasonable? Did you feel it was expensive? The below mentioned numbers have been reported by ndrugs.com website users about whether the Fluconazole drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
Users
%
Not expensive
2
100.0%
3 consumers reported time for results
To what extent do I have to use Fluconazole before I begin to see changes in my health conditions? As part of the reports released by ndrugs.com website users, it takes > 3 month and a few days before you notice an improvement in your health conditions. Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Fluconazole. To get the time effectiveness of using Fluconazole drug by other patients, please click here.
Users
%
> 3 month
1
33.3%
3 month
1
33.3%
1 month
1
33.3%
5 consumers reported age
Users
%
16-29
2
40.0%
30-45
2
40.0%
> 60
1
20.0%
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