TRAZER ® Itraconazole

TRAZER ® is a drug based on Itraconazole

THERAPEUTIC GROUP: Antimycotics for systemic use - triazole derivatives

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

Indications TRAZER ® Itraconazole

TRAZER ® is indicated in the treatment of fungal infections both superficial and systemic sustained by fungi, yeasts, dermatophytes and microorganisms sensitive to Itraconazole.

Mechanism of action TRAZER ® Itraconazole

Itraconazole, active ingredient of TRAZER ®, is an antifungal drug effective against many dermatophytes, yeasts, fungi and various microorganisms, therefore characterized by a wide spectrum of action that guarantees an important extension of clinical applications.

The cytostatic and sometimes cytotoxic activity is determined by the ability of the Itraconazole to inhibit the enzymatic pathway leading to the synthesis of ergosterol, a key element of the plasma membrane of the microorganism, whose presence gives the structure rigidity and resistance, guaranteeing its correct functionality and vitality .

The inhibition of this pathway leads at the same time to an increase in the concentrations of numerous catabolites, whose presence interferes with the normal functioning of membrane transporters, thus inducing the death of the micro-organism due to the absence of pro-energetic pathways.

The clinical efficacy of this drug is also supported by the excellent pharmacokinetic properties, which allow orally Itraconazole to reach the plasma peak within the first 5 hours after intake.

Well distributed to all tissues and partly metabolized by cytochromial enzymes, Itraconazole is eliminated both unchanged by urine and faeces and by the normal skin desquamation process.

Studies carried out and clinical efficacy

ITRACONAZOLE IN SEBORROCIC DERMATITIS

Postepy Hig Med Dosw (Online). 2012 Nov 14; 66: 848-54.

Very interesting study that tests the efficacy and the molecular mechanism of action of Itraconazole in seborrheic dermatitis. The results in addition to demonstrating an improvement in the clinical condition also observed a significant reduction in blood concentrations of inflammatory cytokines.

THE ANTITUMORAL EFFECT OF ITRACONAZOLE

Oncologist. 2013 Jan 22.

Experimental study that tests the ability of Itraconazole to inhibit angiogenesis during rheumatoid arthritis. However, the results, which will clearly need to be investigated by adequate clinical trials, show a significant reduction in blood concentrations of VEGF, a growth factor involved in the development of new vessels.

ITRACONAZOLE IN THE TREATMENT OF ASPERGILLOSIS

J Infect Chemother. 2012 Jun; 18 (3): 378-85.

Complex clinical trial that evaluates the efficacy of short and long term treatment with Itraconazole during pathologies such as chronic necrotizing pulmonary aspergillosis. Oral or injective use seems to guarantee improvement in clinical conditions over the long term.

Method of use and dosage

TRAZER ®

Hard capsules for oral use with Itraconazole 100 mg.

The treatment of both cutaneous and systemic fungal infections with TRAZER ® must be defined by a physician based on the patient's physiopathological features and the severity of his / her clinical picture.

For these reasons, therefore, the duration of therapy can vary significantly from case to case.

In any case, however, we recommend taking the capsule on a full stomach to facilitate absorption of the active ingredient.

Warnings TRAZER ® Itraconazole

The potential side effects induced by Itraconazole, the complexity of the definition of the therapeutic scheme and the importance in itself of the therapy require the need for a careful medical examination before the beginning of the therapy, in order to identify any incompatible or potentially dangerous conditions with taking the drug.

Therefore patients with liver, kidney and heart disease should define with their doctor the cost-benefit ratio of Itraconazole therapy, and possibly undergo therapy under strict medical supervision.

The presence of sugars among the excipients of TRAZER ® would expose the patient suffering from lactase enzyme deficiency, glucose-galactose malabsorption syndrome, fructose intolerance and sucrase-isomaltase insufficiency to unpleasant side effects.

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

PREGNANCY AND BREASTFEEDING

The use of TRAZER ® in pregnancy and during breastfeeding is generally contraindicated due to the potential side effects of Itraconazole on the fetus and to the infant, as shown by the numerous studies present in the literature conducted mostly on laboratory animals.

Interactions

The complex hepatic metabolism of Itraconazole, which involves cytochromial enzymes such as CYP3A4 normally responsible for the metabolism of other drugs, exposes the patient on TRAZER ® therapy to the risk of potentially dangerous drug interactions.

Therefore, if the need arises to undertake a drug therapy together with that with Itraconazole, it would be advisable to consult your doctor immediately.

Numerous are the active ingredients metabolized by cytochromial enzymes, whose pharmacokinetic characteristics could be compromised by the simultaneous use of Itraconazole.

At the same time, the intake of drugs capable of reducing gastric acidity could compromise the normal absorption of ostraconazole.

Contraindications TRAZER ® Itraconazole

The use of TRAZER ® is contraindicated in patients who are hypersensitive to the active ingredient or to one of its excipients, in patients who undergo pharmacological therapy with active ingredients metabolised by the cytochromial system and in patients with severe hepatic, renal and cardiac insufficiency.

Undesirable effects - Side effects

Oral intake of Itraconazole could lead to the appearance of gastrointestinal disorders such as nausea, diarrhea, vomiting, dyspepsia and flatulence and dermal disorders such as rash or eczema.

The side effects described for other organs and systems are decidedly more rare.