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Fluconazole is authorised in the world under the following brand names: Biocanol, Biozolene, Diflucan, Elazor, Flucazol, Flucostat, Flukezol, Flunizol, Flusol, Pritenzol, Triflucan.

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Fluconazole [US: Diflucan 50mg, 100mg, 150mg, 200mg]

Synonyms: Fluconazol; Fluconazolum; Flukonatsoli; Flukonazol; UK-49858 
USAN: Fluconazole
INN: Fluconazole [rINN (en)]
INN: Fluconazol [rINN (es)]
INN: Fluconazole [rINN (fr)]
INN: Fluconazolum [rINN (la)]
INN: Флуконазол [rINN (ru)]
Chemical name: 2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol
Molecular formula: C13H12F2N6O =306.3
CAS: 86386-73-4
ATC code: D01AC15; J02AC01
Read code: y02Ug

Pharmacopoeias

European Pharmacopoeia, 6th ed. (Fluconazole).

A white or almost white, hygroscopic, crystalline powder. It exhibits polymorphism. Slightly soluble in water freely soluble in methyl alcohol soluble in acetone. Store in airtight containers.

The United States Pharmacopeia 31, 2008, and Supplements 1 and 2 (Fluconazole).

A white or almost white, crystalline powder. Slightly soluble in water soluble in alcohol and in acetone sparingly soluble in chloroform and in isopropyl alcohol freely soluble in methyl alcohol very slightly soluble in toluene. Store in airtight containers at a temperature below 30°.

Diflucan (Fluconazole) 50/100/150/200mg

Generic Name: Fluconazole

Under what local brands and in what dosages is generic Fluconazole sold in pharmacies of Britain, United States, and Canada?

In pharmacies of the United States, Great Britain and Canada the pharmacists offer you to buy Fluconazole according to your prescription or without a prescription under such brand names and in such strengths and dosage forms:

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Adverse Effects

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Adverse effects reported with fluconazole most commonly affect the gastrointestinal tract and include abdominal pain, diarrhoea, flatulence, nausea and vomiting, and taste disturbance. Other adverse effects include headache, dizziness, leucopenia, thrombocyto-penia, hyperlipidaemias, and raised liver enzyme values. Serious hepatotoxicity has been reported in patients with severe underlying disease such as AIDS or malignancy. Anaphylaxis and angioedema have been reported rarely. Skin reactions are rare but exfoliative cutaneous reactions such as toxic epidermal necrolysis and Stevens-Johnson syndrome have occurred, more commonly in patients with AIDS.

Alopecia

Alopecia has occasionally been reported in patients receiving fluconazole, especially during prolonged use.

Effect on electrolyte balance

Hypokalaemia was associated with fluconazole in 3 patients with acute myeloid leukaemia.

Effects on the heart

Prolonged QT interval and torsade de pointes have been reported rarely in patients receiving fluconazole.

Effects on the liver

Although severe hepatic reactions to fluconazole are rare they have been reported, especially in patients with severe underlying diseases or hepatic dysfunction. Elevated liver enzymes are commonly found and there have been reports of jaundice. Hepatic necrosis has been seen rarely post mortem in patients with severe underlying disease who had received fluconazole. In one such patient, hepatotoxicity was concluded to be dose-dependent.

Diflucan (Fluconazole) 50/100/150/200mg

Hypersensitivity

Desensitisation has been successfully carried out in a patient with AIDS who exhibited hypersensitivity to both fluconazole and itraconazole. Gradually increasing oral doses of fluconazole (starting at 5 mg daily) were given over 7 days thereafter dosage was maintained at 400 mg daily. No adverse reactions were noted during the desensitisation period or in the 3 months up to the publication of the report.

Precautions

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Fluconazole should be used with caution in patients with impaired hepatic or renal function. Abnormalities in haematological, hepatic, and renal-function tests have been observed in patients with serious underlying diseases such as AIDS or malignancy. Cases of torsade de pointes and QT prolongation have been reported rarely and caution is advised when giving fluconazole to patients with proarrhythmic conditions. Teratogenicity has occurred in animals given high doses of fluconazole and its use is not recommended in pregnancy.

Breast feeding

Fluconazole is distributed into breast milk, achieving concentrations similar to those found in maternal plasma, and its use in women who are breast feeding is not recommended by licensed product information. In one report, no untoward effects, other than a slight increase in lactase dehydrogenase level, were seen in an infant who was exposed to fluconazole in breast milk for 6 weeks. The American Academy of Pediatrics considers that the use of fluconazole tablets is usually compatible with breast feeding.

Pregnancy

High (toxic) doses of fluconazole, itraconazole, and ketoconazole have been reported to be teratogenic in rodents.

Although there is little information about the use of these drugs in human pregnancy, there is a report of a woman who took fluconazole 400 mg daily throughout pregnancy and who gave birth to an infant with severe craniofacial and limb abnormalities. The abnormalities resembled those associated with the Antley-Bixler syndrome, a genetic disorder, but a teratogenic effect could not be excluded.

Although prescription-event-monitoring studies of fluconazole did not reveal adverse effects on the fetus, congenital abnormalities have occurred in infants whose mothers were given high doses of fluconazole for 3 months or more. Data collected by the manufacturer, relating to 198 women exposed to itraconazole during the first trimester of pregnancy, indicated that the malformation rate for both exposed women and matched controls was within the expected baseline risk for the general population.

Nevertheless, the manufacturers recommend that fluconazole, itraconazole, and ketoconazole should be avoided during pregnancy. Licensed product information states that doses of voriconazole equivalent to those used therapeutic ally have been shown to be teratogenic and embryotoxic in rodents. It therefore recommends that voriconazole should be avoided during pregnancy and that women of child bearing potential should use effective contraception during treatment.

Similar recommendations have been made for posaconazole. Other azole antifungals including butoconazole, clotrimazole, econazole, miconazole, sulconazole, terconazole, and tiocona-zole are reported to be embryotoxic but not teratogenic in rodents given high doses. Many of these drugs are used topically or in-travaginally and the systemic absorption from these routes of administration varies. While these drugs may not necessarily be contra-indicated in pregnancy, consideration should be given to these potential risks when choosing antifungal therapy for such patients.

Renal impairment

For dose adjustments in renal impairment, see Administration in Renal Impairment, under Uses and Administration, below. Fluconazole cost…

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Pharmacokinetics

Fluconazole is well absorbed after oral doses, bioavail-ability from the oral route being 90% or more of that from the intravenous route. Mean peak plasma concentrations of 6.72 micrograms/mL have been reported in healthy subjects after a 400-mg oral dose. Peak concentrations are reached within 1 to 2 hours of oral doses. Plasma concentrations are proportional to the dose over a range of 50 to 400 mg. Multiple dosing leads to increases in peak plasma concentrations steady-state concentrations are reached in 5 to 10 days but may be attained on day 2 if a loading dose is given.

Fluconazole is widely distributed and the apparent volume of distribution is close to that of total body water. Concentrations in breast milk, joint fluid, saliva, sputum, vaginal fluids, and peritoneal fluid are similar to those achieved in plasma. Concentrations in the CSF range from 50 to 90% of plasma concentrations, even in the absence of meningeal inflammation.

Protein binding is only about 12%. About 80% of a dose is excreted unchanged in the urine and about 11% as metabolites. The elimination half-life of fluconazole is about 30 hours and is increased in patients with renal impairment. Fluconazole Tablets is removed by dialysis.

Burns

The mean half-life of fluconazole was decreased to 24.4 hours in 9 patients with burns.

Fluconazole clearance was 27.5 mL/minute, which was 30% higher than that reported in healthy subjects.

Distribution

Salivary concentrations of fluconazole after oral doses should be adequate for the treatment of oropharyngeal and oesophageal candidiasis' even in patients with AIDS who may have decreased salivation. Treatment failures are more likely to be due to inadequate dosage or resistant organisms than to decreased salivary secretion. Pharmacologically active concentrations of fluconazole have been detected in scalp hair and nails after oral treatment with conventional daily doses and with once-weekly dosage.

HIV-infected patients

Plasma clearance of fluconazole may be lower in patients with HIV infection than in immunocompetent patients, and the half-life may be prolonged.

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Preparations

International Brand Drug Names

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Proprietary Preparations

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Multi-ingredient

Argentina: Gynerium UD; Australia: Canesoral Duo; India: Forcan TZ; Orflaz Kit; Safkit; Mexico: Afumix.

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Therapeutic classes of Fluconazole:

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