ELAZOR ® Fluconazole

ELAZOR ® is a Fluconazole based drug

THERAPEUTIC GROUP: Antimycotics for systemic use - triazole derivatives

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications ELAZOR ® Fluconazole

ELAZOR ® is indicated in the treatment of infections caused by yeasts, dermatophytes and fungi sensitive to Fluconazole.

This drug can be used successfully in the treatment of systemic and cutaneous mycoses of responses to topical antifungal therapy.

Oral Fluconazole has also been shown to be effective in the prophylaxis of fungal infections in immunocompromised patients.

Mechanism of action ELAZOR ® Fluconazole

Fluconazole, the active ingredient of ELAZOR ®, is a drug with marked antifungal activity particularly used in the course of oropharyngeal esophageal and vaginal candidiasis, in the candidemia and in the cryptococcosis of immunocompromised patients as well as in the prophylaxis of systemic fungal infections.

Taken orally it is rapidly absorbed by the gastro-enteric mucosa with a bioavailability equal to 90% of the total dose, homogeneously distributed among the various biological fluids to be, following a hepatic metabolism supported by cytochromial enzymes, eliminated predominantly via the kidney.

The biological and therapeutical activity of the active principle is due to its ability to permeate the membrane of yeasts and fungi, exerting a highly selective inhibiting action against fungal enzymes and thus compromising membrane integrity through reduced synthesis of ergosterol.

To the fragility of the membrane is also added the interfering action of the various accumulated catabolites, on the energy activities of the cell, thus determining the death of the pathogenic element and the consequent regression of the symptomatology.

Studies carried out and clinical efficacy

MUTATIONS AND RESISTANCE TO FLUCONAZOLE

Rev Iberoam Micol. 2013 Feb 8. pii: S1130-1406 (13) 00013-2.

High-tech molecular study that characterizes the role of a gene mutation in Candida Albicans responsible for the onset of Fluconazole resistance mechanisms.

THE FLUCONAZOLE IN THE INTRAMIOTIC INFECTIONS FROM CANDIDA

Obstet Gynecol. 2013 Feb; 121 (2 Pt 2 Suppl 1): 452-4.

Work that evaluates the possibility of intramniotic use of Fluconazole in intramniotic Candida infections often responsible for severe neonatal infections, preterm births, spontaneous abortions and fetal death.

THE FLUCONAZOLO IN PEDIATRIC AGE

Eur J Clin Pharmacol. 2013 Jan 17.

Review that assesses the safety of the use of Fluconazole in children, reaffirming its safety and denouncing the most frequent side effects of hepatotoxicity and gastro-intestinal toxicity.

Method of use and dosage

ELAZOR ®

Hard capsules of 50 mg - 100 mg - 150 mg and 200 mg of Fluconazole.

The dosage and duration of treatment must necessarily be defined by a specialist doctor, based on the patient's physiopathological characteristics and the severity of his clinical picture.

Warnings ELAZOR ® Fluconazole

Before starting therapy with ELAZOR ® a thorough medical check-up is necessary to assess the prescriptive appropriateness and to characterize all the possible contraindications to the use of the drug rather than situations capable of increasing the risk of side effects.

In this regard the use of Fluconazole should be done with particular caution in patients suffering from hepatic, renal and cardiac pathologies, for which a continuous monitoring would be indicated.

ELAZOR ® contains lactose among its excipients, making it therefore contraindicated in patients with lactase enzyme deficiency, glucose-galactose malabsorption syndrome and galactose intolerance.

It is recommended to store the drug in a cool, dry place out of reach of children

PREGNANCY AND BREASTFEEDING

Studies in the literature regarding the safety profile of Fluconazole for fetal health are still insufficient to clarify the tolerability of this drug for the fetus and infant.

Therefore the use of ELAZOR ® in pregnancy and during the subsequent breastfeeding period is generally contraindicated.

Interactions

The inhibitory activity of Fluconazole on cytochromial enzymes CYP3A4 and CYP2C9 exposes the patient to the risk of numerous pharmacologically relevant interactions.

It would therefore be advisable for the patient undergoing therapy with ELAZOR ® to consult their physician should the need arise to extend drug therapy to other drugs such as oral anticoagulants, azithromycin, benzodiazepines, cyclosporine, cyclophosphamide, statins, antihypertensives, oral contraceptives, phenytoin, prednisone, immunosuppressants and others.

Contraindications ELAZOR ® Fluconazole

The use of ELAZOR ® is contraindicated in patients hypersensitive to the active ingredient or to one of its excipients, rather than in patients contextually subjected to pharmacological therapies with active principles metabolised by the cytochromial system.

Undesirable effects - Side effects

Although the therapy is free of clinically relevant side effects at high frequency, it should be remembered that the use of Fluconazole could cause headache, abdominal pain, diarrhea, nausea, vomiting, hypertransaminasemia, rash and hypersensitivity reactions to the product.