Diflucan

Diflucan

fluconazole

Manufacturer:

Pfizer
Full Prescribing Info
Contents
Fluconazole.
Description
Each capsule also contains the following inactive ingredients: Lactose, cornstarch, silicon dioxide, magnesium stearate and sodium lauryl sulfate. The hard gelatin capsule may also contain Blue 5 and other inert ingredients.
Each mL of vial also contains sodium chloride 9 mg. The pH ranges from 4-8.6.
Fluconazole, bis-triazole, is a 2-(2,4-difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)-2-propanol.
Fluconazole has a molecular weight of 306.3. It is a white to off-white crystalline powder which is sparingly soluble in water and saline.
Action
Pharmacology: Fluconazole, a member of triazole antifungal agents, is a potent and specific inhibitor of fungal sterol synthesis.
Both orally and IV administered fluconazole was active in a variety of animal fungal infection models. Activity has been demonstrated against opportunistic mycoses eg, infections with Candida spp, including systemic candidiasis in immunocompromised animals; with Cryptococcus neoformans, including intracranial infections; with Microsporum spp; and with Trichophyton spp. Fluconazole has also been shown to be active in animal models of endemic mycoses, including infections with Blastomyces dermatitides; with Coccidioides immitis, including intracranial infection; and with Histoplasma capsulatum in normal and immunosuppressed animals.
There have been reports of cases of superinfection with Candida spp other than C. albicans, which are often inherently not susceptible to fluconazole (eg, Candida krusei). Such cases may require alternative antifungal therapy.
Fluconazole is highly specific for fungal cytochrome P-450-dependent enzymes.
Fluconazole 50 mg daily given up to 28 days has been shown not to affect testosterone plasma concentrations in males or steroid concentrations in females of childbearing age. Fluconazole 200-400 mg daily has no clinically significant effect on endogenous steroid levels or on ACTH-stimulated response in healthy male volunteers. Interaction studies with antipyrine indicate that single or multiple doses of fluconazole 50 mg do not affect its metabolism.
Pharmacokinetics: The pharmacokinetic properties of fluconazole are similar following administration by the IV or oral route. After oral administration, fluconazole is well absorbed, and plasma levels (and systemic bioavailability) are >90% of the levels achieved after IV administration.
Oral absorption is not affected by concomitant food intake. Peak plasma concentrations in the fasting state occur between 0.5 and 1.5 hrs post-dose with a plasma elimination half-life of approximately 30 hrs. Plasma concentrations are proportional to dose. Ninety percent steady-state levels are reached by days 4-5 with multiple once-daily dosing.
Administration of loading dose (on day 1) of twice the usual daily dose enables plasma levels to approximate to 90% steady-state levels by day 2. The apparent volume of distribution approximates to total body water. Plasma protein-binding is low (11-12%).
Fluconazole achieves good penetration into all body fluids studied. The levels of fluconazole in saliva and sputum are similar to plasma levels. In patients with fungal meningitis, fluconazole levels in the CSF are approximately 80% the corresponding plasma levels.
High skin concentrations of fluconazole, above serum concentrations, are achieved in the stratum corneum, epidermis-dermis and eccrine sweat. Fluconazole accumulations in the stratum corneum. At a dose of 50 mg once daily, the concentration of fluconazole after 12 days was 73 mcg/g and 7 days after cessation of treatment, the concentration was still 5.8 mcg/g. At the 150-mg once-a-week dose, the concentrations of fluconazole in stratum corneum on day 7 was 23.4 mcg/g and 7 days after the 2nd dose was still 7.1 mcg/g.
The major route of excretion is renal, with approximately 80% of the administered dose appearing in the urine as unchanged drug. Fluconazole clearance is proportional to creatinine clearance. There is no evidence of circulating metabolites.
The long plasma elimination half-life provides the basis for single-dose therapy for vaginal candidiasis, daily dosing, once weekly for all other indications.
A study compared the saliva and plasma concentrations of a single fluconazole 100 mg dose administered in a capsule or in an oral suspension by rinsing and retaining in mouth for 2 min and swallowing. The maximum concentration of fluconazole in saliva after the suspension was observed 5 min after ingestion, and was 182 times higher than the maximum saliva concentration after the capsule which occurred 4 hrs after ingestion. After about 4 hrs, the saliva concentrations of fluconazole were similar. The mean AUC (0-96) in saliva was significantly greater after the suspension compared to the capsule. There was no significant difference in the elimination rate from saliva or the plasma pharmacokinetic parameters for the 2 formulations.
Carcinogenicity: Fluconazole showed no evidence of carcinogenic potential in mice and rats treated orally for 24 months at doses of 2.5, 5 or 10 mg/kg/day (approximately 2-7 times the recommended human dose). Male rats treated with 5 and 10 mg/kg/day had an increased incidence of hepatocellular adenomas.
Mutagenicity: Fluconazole, with or without metabolic activation, was negative in tests for mutagenicity in 4 strains of S. typhimurium, and in the mouse lymphoma L5178Y system. Cytogenetic studies in vivo (murine bone marrow cells, following oral administration of fluconazole) and in vitro (human lymphocytes exposed to fluconazole at 1000 mcg/mL) showed no evidence of chromosomal mutations.
Impairment of Fertility: Fluconazole did not affect the fertility of male or female rats treated orally with daily doses of 5, 10 or 20 mg/kg or with parenteral doses of 5, 25 or 75 mg/kg, although the onset of parturition was slightly delayed at 20 mg/kg orally. In an IV perinatal study in rats at 5, 20 and 40 mg/kg, dystocia and prolongation of parturition were observed on a few dams at 20 mg/kg (approximately 5-15 times the recommended human dose) and 40 mg/kg, but not at 5 mg/kg. The disturbance in parturition was reflected by a slight increase in the number of stillborn pups and decrease of neonatal survival at these dose levels.
The effects of parturition in rats are consistent with the species-specific estrogen-lowering property produced by high doses of fluconazole. Such a hormone change has not been observed in women treated with fluconazole (see Pharmacology under Actions).
Indications/Uses
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.
Cryptococcosis, including cryptococcal meningitis and infections of other sites (eg, pulmonary, cutaneous). Normal hosts and patients with AIDS, organ transplants or other causes of immunosuppression may be treated. Fluconazole can be used as maintenance therapy to prevent relapse of cryptococcal disease in patients with AIDS.
Systemic candidiasis, including candidemia, disseminated candidiasis and other forms of invasive candidal infection. These include infections of the peritoneum, endocardium and pulmonary and urinary tracts. Patients with malignancy, in intensive care units, receiving cytotoxic or immunosuppressive therapy, or with other factors predisposing to candidal infections may be treated.
Mucosal candidiasis. These include oropharyngeal, esophageal, non-invasive bronchopulmonary infections, candiduria, mucocutaneous and chronic oral atropic candidiasis (denture sore mouth). Normal hosts and patients with compromised immune function may be treated. Prevention of relapse of oropharyngeal candidiasis in patients with AIDS.
Genital candidiasis. Vaginal candidiasis, acute or recurrent (oral preparation). Candidal balanitis.
Prevention of fungal infections in patients with malignancy who are predisposed to such infections as a result of cytotoxic chemotherapy or radiotherapy.
Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections.
Dosage/Direction for Use
The daily dose of fluconazole should be based on the nature and severity of the fungal infection. Most cases of vaginal candidiasis respond to single-dose therapy.
Therapy for those types of infections requiring multiple-dose 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.
Adults: Cryptococcal Meningitis and Cryptococcal Infections at Other Sites: Usual Dose: 400 mg on the 1st day followed by 200-400 mg once daily. Duration of treatment for cryptococcal infections will depend on the clinical and mycological response, but is usually at least 6-8 weeks for cryptococcal meningitis.
For the prevention of relapse of cryptococcal meningitis in patients with AIDS, after the patient receives a full course of primary therapy, fluconazole may be administered indefinitely at a daily dose of 200 mg.
Candidemia, Disseminated Candidiasis and Other Invasive Candidal Infections: Usual Dose: 400 mg on the 1st day followed by 200 mg daily. Depending on the clinical response, the dose may be increased to 400 mg daily. Duration of treatment is based upon the clinical response.
Oropharyngeal Candidiasis: Usual Dose: 50-100 mg once daily for 7-14 days. If necessary, treatment can be continued for longer periods in patients with severely compromised immune function.
For atropic oral candidiasis associated with dentures, the usual dose is 50 mg once daily for 14 days administered concurrently with local antiseptic measures to the denture.
For other candidal infections of mucosa (except genital candidiasis) eg, esophagitis, non-invasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc, the usual effective dose is 50-100 mg daily given for 14-30 days. For the prevention of relapse of oropharyngeal candidiasis in patients with AIDS, after patient receives a full course of primary therapy, fluconazole may be administered at a 150-mg once-weekly dose.
Treatment of Vaginal Candidiasis and Candida balanitis: 150 mg should be administered as a single oral dose.
Prevention of Candidiasis: Recommended Dosage: 50-400 mg once daily, based on the patient's risk for developing fungal infection. For patients at high risk of systemic infection eg, patients who are anticipated to have profound or prolonged neutropenia, the recommended daily dose is 400 mg once daily. Fluconazole administration should start several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises >1000 cells/mm3.
A higher dose of 100 mg once daily may be used in patients at risk of severe recurrent infections.
Dermal Infections Including Tinea Pedis, Corporis, Cruris and Candida Infections: Recommended Dosage: 150 mg once weekly or 50 mg once daily. Duration of treatment is normally 2-4 weeks but tinea pedis may require treatment for up to 6 weeks. For tinea versicolor, the recommended dose is 50 mg once daily for 2-4 weeks. Duration of treatment should not exceed 6 weeks.
Children: Use in children <16 years is not recommended. However, when the treating physician considers fluconazole therapy imperative, the following daily doses for children ≥1 year with normal renal function are recommended: 1-2 mg/kg for superficial candidal infections and 3-6 mg/kg for systemic candidal/cryptococcal infections.
These recommendations approximate the doses used in adults on a mg/kg basis. However, preliminary data in children 5-13 years indicate fluconazole elimination may be faster than in adults. Therefore, for serious or life-threatening infections, higher daily doses may be required. Daily doses up to 12 mg/kg have been used in a small number of children. The maximum approved adult daily dose of 400 mg should not be exceeded.
For children with impaired renal function, the daily dose should be reduced in accordance with the guidelines given for adults, depending on the degree of renal impairment.
Elderly: When there is no evidence of renal impairment, normal dosage recommendations should be adopted. For patients with renal impairment (creatinine clearance <50 mL/min), the dosage schedule should be adjusted as follows:
Patients with Renal Impairment: Fluconazole is predominantly excreted in the urine as unchanged drug. No adjustments in single-dose therapy are necessary. In patients with impaired renal function who will receive multiple doses of fluconazole, an initial loading dose of 50-400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table. (See table.)


Click on icon to see table/diagram/image


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.
When serum creatinine is the only measure of renal function available, the following formula (based on sex, weight and age of the patients) should be based on the following equation:


Click on icon to see table/diagram/image


Administration:
Fluconazole may be administered either orally or by IV infusion at a rate not exceeding 200 mg/hr given as a continuous infusion, the route being dependent on the clinical state of the patient. On transferring from the IV to the oral route or vice versa, there is no need to change the daily dosage. Capsules should be swallowed whole. Diflucan injection in glass containers is intended only for IV administration using sterile equipment. Fluconazole is formulated in 0.9 % sodium chloride solution, each 200 mg (100 mL bottle) containing 15 mmol each of Na+ and Cl-. Because fluconazole is available as a dilute saline solution, in patients requiring sodium or fluid restriction, consideration should be given to the rate of fluid administration.
Overdosage
There has been a reported case of overdosage with fluconazole accompanied by hallucination and paranoid behavior.
In the event of overdosage, symptomatic treatment (with supportive measures and gastric lavage if necessary) may be adequate.
Fluconazole is largely excreted in the urine; forced volume diuresis would probably increase the elimination rate. A 3-hr hemodialysis session decreases plasma levels by approximately 50%.
Contraindications
Patients with known sensitivity to fluconazole, any of the inert ingredients or to related azole compounds.
Co-administration of terfenadine is contraindicated in patients receiving fluconazole at multiple doses of 400 mg daily or higher based upon result of a multiple dose interaction study. Co-administration of other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 eg, cisapride, astemizole, erythromycin, pimozide and quinidine are contraindicated in patients receiving fluconazole.
Co-administration of cisapride is contraindicated in patients receiving fluconazole.
Special Precautions
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 patient has been observed. Fluconazole hepatotoxicity has usually been reversible on discontinuation of therapy.
Patients who develop abnormal liver function tests during fluconazole therapy should be monitored for the development of more serious hepatic injury. Fluconazole should be discontinued if clinical signs or symptoms consistent with liver disease develop that may be attributable to fluconazole.
Patients have rarely developed exfoliative cutaneous reactions eg, Stevens-Johnson syndrome and toxic epidermal necrolysis, during treatment with fluconazole. AIDS patients are more prone to the development of severe cutaneous reactions to many drugs. If a rash develops in a patient treated for a superficial fungal infection which is considered attributable to fluconazole, further therapy with this agent should be discontinued.
If patients with invasive/systemic fungal infections develop rashes, they should be monitored closely and fluconazole discontinued if bullous lesions or erythema multiforme develop.
The co-administration of fluconazole at doses lower than 400 mg daily with terfenadine should be carefully monitored.
In rare cases, as with other azoles, anaphylaxis has been reported.
Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation and Torsade de pointes in patients taking fluconazole. These reports included seriously ill patients with multiple confounding risk factors eg, structural heart disease, electrolyte abnormalities and concomitant medications that may have been contributory.
Fluconazole should be administered with caution to patients with these potentially proarryhthmic conditions.
Fluconazole should be administered with caution to patients with renal dysfunction.
Fluconazole is a potent CYP2C9 inhibitor and a moderate CYP3A4 inhibitor. Fluconazole treated patients who are concomitantly treated with drugs with a narrow therapeutic window metabolized through CYP2C9 and CYP3A4 should be monitored.
Diflucan capsules contain lactose and should not be given to patients with rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
Effects on the Ability to Drive or Operate Machinery: Experience with fluconazole indicates that therapy is unlikely to impair a patient's ability to drive or use machinery.
Use in pregnancy: Adverse fetal effects have been seen in animals only at high-dose levels associated with maternal toxicity. However, use in pregnancy should be avoided except in patients with severe or potentially life-threatening fungal infections in whom fluconazole may be used if the anticipated benefit outweighs the possible risk to the fetus.
Use in lactation: Fluconazole is found in human breast milk at concentrations similar to plasma; hence, its use in nursing mothers is not recommended.
Use In Pregnancy & Lactation
Use in pregnancy: Adverse fetal effects have been seen in animals only at high-dose levels associated with maternal toxicity. However, use in pregnancy should be avoided except in patients with severe or potentially life-threatening fungal infections in whom fluconazole may be used if the anticipated benefit outweighs the possible risk to the fetus.
Use in lactation: Fluconazole is found in human breast milk at concentrations similar to plasma; hence, its use in nursing mothers is not recommended.
Side Effects
Fluconazole is generally well tolerated. The most common side effects during clinical trials and associated with fluconazole are as follows: Nervous System Disorders: Headache.
Gastrointestinal Disorders: Abdominal pain, diarrhea, flatulence, nausea.
Hepatobiliary Disorders: Hepatic toxicity including rare cases of fatalities, elevated alkaline phosphatase, elevated bilirubin, elevated SGOT, elevated SGPT.
Skin and Subcutaneous Tissue Disorders: Rash.
In some patients, particularly those with serious underlying diseases eg, AIDS and cancer, changes in renal, and hematological function test results and hepatic abnormalities (see Precautions) have been observed during treatment with fluconazole and comparative agents, but the clinical significance and relationship to treatment is uncertain.
Psychiatric Disorders ( Uncommon): Insomnia, somnolence.
Ear and Labyrinth Disorders (Uncommon): Vertigo.
Musculoskeletal, Connective Tissue and Bone Disorders (Uncommon): Myalgia.
General Disorders and Administration Site Conditions (Uncommon): Fatigue, malaise, asthenia, fever.
Skin and Subcutaneous Tissue Disorders (Uncommon): Increased sweating, drug eruption, acute generalized exanthematous-pustulosis (rare).
Hepatobiliary Disorders (Rare): Hepatocellular damage.
In addition, the following undesirable effects have occurred during post-marketing: Blood and Lymphatic System Disorders: Leukopenia including neutropenia and agranulocytosis, thrombocytopenia.
Immune System Disorders: Anaphylaxis (including angioedema, face edema, pruritus, urticaria).
Metabolism and Nutrition Disorders: Hypercholesterolemia, hypertriglyceridemia, hypokalemia.
Nervous System Disorders: Dizziness, seizures, paraesthesia, taste perversion, tremor.
Cardiac Disorders: QT prolongation, Torsade de pointes (see Precautions).
Gastrointestinal Disorders: Dyspepsia, vomiting, dry mouth.
Hepatobiliary Disorders: Hepatic failure, hepatitis, hepatocellular necrosis, jaundice.
Skin and Subcutaneous Tissue Disorders: Alopecia, exfoliate skin disorders including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Drug Interactions
Anticoagulants: In an interaction study, fluconazole increased the prothrombin time after warfarin administration in healthy males. Though the magnitude of change was small (12%), careful monitoring of prothrombin time in patients receiving coumarin-type anticoagulants is recommended.
Azithromycin: An open-label, randomized, 3-way crossover study in 18 healthy subjects assessed the effect of a single oral dose of azithromycin 1200 mg on the pharmacokinetics of a single oral dose of fluconazole 800 mg as well as the effects of fluconazole on the pharmacokinetics of azithromycin. There was no significant pharmacokinetics 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 benzodiazepines 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: There have been reports of cardiac events including Torsade de pointes in patients to whom fluconazole and cisapride were co-administered. A controlled study found that concomitant fluconazole 200 mg once daily and cisapride 20 mg 4 times daily yielded a significant increases in cisapride plasma levels and prolongation of QTc interval. Co-administration of cisapride is contraindicated in patients receiving fluconazole.
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 co-administered to diabetic patients, but the possibility of a hypoglycemic episode should be borne in mind. Frequent monitoring of blood glucose and appropriate reduction of sulfonylurea dosage is recommended during co-administration.
Hydrochlorothiazide: In a kinetic interaction study, co-administration of multiple-dose hydrochlorothiazide to healthy volunteers receiving fluconazole 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 physician should bear it in mind.
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.
Oral Contraceptives: Two kinetic studies with a combined oral contraceptive have been performed using multiple doses of fluconazole. There were no relevant effects on either hormone level in the 50-mg fluconazole study, while at 200 mg daily, the AUCs of ethinyl estradiol and levonorgestrel were increased, 40% and 24%, respectively. Thus, multiple-dose use of fluconazole at these doses is unlikely to have an effect on the efficacy of the combined oral contraceptive.
Rifabutin: There have been reports that an interaction exists when fluconazole is administered concomitantly with rifabutin, leading to increased serum levels of rifabutin. There have been reports of uveitis in patients to whom fluconazole and rifabutin were co-administered. 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 20% shorter half-life of fluconazole. In patients receiving concomitant rifampicin, an increase of the fluconazole dose should be considered.
Cyclosporin: A kinetic study in renal transplant patients found fluconazole 200 mg daily to slowly increase cyclosporin concentrations. However, in another multiple-dose study with 100 mg daily, fluconazole did not affect cyclosporin levels in patients with bone marrow transplants. Cyclosporin plasma concentration monitoring in patients receiving fluconazole is recommended.
Tacrolimus: There have been reports that 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 to whom fluconazole and tacrolimus were co-administered. Patients receiving tacrolimus and fluconazole concomitantly should be carefully monitored.
Theophylline: In a placebo-controlled interaction study, the administration of fluconazole 200 mg for 14 days resulted in an 18% decrease in the mean plasma clearance rate of theophylline. Patients who are receiving high doses of theophylline or who are otherwise at increased risk for theophylline toxicity should be observed for signs of theophylline toxicity while receiving fluconazole, the co-administration of fluconazole and therapy modified appropriately if signs of toxicity develop.
Terfenadine: Because of the occurrence of serious cardiac dysrhythmias secondary to prolongation of the QTc interval in patients receiving other azole antifungals in conjunction with terfenadine, interaction studies have been performed. One study at a dose of fluconazole 200 mg daily failed to demonstrate a prolongation in QTc interval. Another study at a dose of fluconazole 400 mg and 800 mg daily demonstrated that fluconazole taken in doses of ≥400 mg/day significantly increases plasma levels of terfenadine when taken concomitantly. The combined use of fluconazole at doses of ≥400 mg with terfenadine is contraindicated (see Contraindications). The co-administration of fluconazole at doses <400 mg/day with terfenadine should be carefully monitored.
Astemizole: Concomitant administration of fluconazole with astemizole may decrease the clearance of astemizole. Resulting increased plasma concentrations of astemizole can lead to QT prolongation and rare occurrences of Torsade de pointes. Co-administration of fluconazole and astemizole is contraindicated.
Pimozide: Although not studied in vitro or in vivo, concomitant administration of fluconazole with pimozide may result in inhibition of pimozide metabolism. Increased pimozide plasma concentrations can lead to QT prolongation and rare occurrences of Torsade de pointes. Co-administration of fluconazole and pimozide is contraindicated.
Quinidine: Although not studied in vitro or in vivo, concomitant administration of fluconazole with quinidine may result in inhibition of quinidine metabolism. Use of quinidine has been associated with QT prolongation and rare occurrences of Torsade de pointes. Co-administration of fluconazole and quinidine is contraindicated.
Interaction studies have shown that when oral fluconazole is co-administered with food, cimetidine, antacids or following total body irradiation for bone marrow transplantation, no clinically significant impairment of fluconazole absorption occurs.
Physicians should be aware that drug-drug interaction studies with other medications have not been conducted, but such interactions may occur.
Storage
Store in a dry place below 30°C.
Shelf-Life: Cap: 4 years.
Inj: 5 years.
MIMS Class
ATC Classification
J02AC01 - fluconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Cap 50 mg x 10's. 150 mg x 5 x 1's. Inj 2 mg/mL (vial, iso-osmotic, sterile, nonpyrogenic soln) x 100 mL x 1's.
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