SPORANOX ® Itraconazole

SPORANOX ® 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 SPORANOX ® Itraconazole

SPORANOX ® is used in the medical clinic in the treatment of superficial and systemic mycoses sustained by dermatophytes, molds, yeasts and fungi sensitive to? Itraconazole.

Mechanism of action SPORANOX ® Itraconazole

SPORANOX ® is a drug based on Itraconazole, an active ingredient belonging to the antifungal family, which has replaced Ketoconazole in the treatment of mycoses, especially the systemic ones, due to the wide range of action and the ability to do not inhibit the adrenal production of corticosteroids, thus preserving the patient's hematological characteristics.

Orally, in fact, ? ™ Itraconazole is absorbed in the gastrointestinal tract, binding to plasma proteins and reaching stationary therapeutic concentrations after about 4 days of treatment.

The good destruction between the various tissues, with the exception of the lower urinary tract and the central nervous system, allows the active principle to carry out a wide antimycotic activity permeating the plasma membranes of the various pathogenic elements and at the same time inhibiting the synthesis of ergosterol, a key component in structuring of the plasma membrane.

The greater membrane permeability on the one hand and the accumulation of metabolic interferents from the other reduce the energy and biosynthetic properties of the cell, compromising its vitality and preventing proliferative capacities at the same time.

Studies carried out and clinical efficacy

ITRACONAZOLE AND FUNGIN ENDOFTALMITE

Int Ophthalmol. 2012 Dec 21.

Study demonstrating that oral use of Itraconazole cannot guarantee the achievement of therapeutically effective drug concentrations at the ocular level, thus being of little use during endophthalmitis.

THE ANTITUMORAL EFFECT OF THE ITRACONAZOLE

Oncologist. 2013 Jan 22.

Work demonstrating that treatment with high dose Itraconazole may have a modest antitumor effect in patients suffering from metastatic prostate cancer, leading to the onset of side effects.

NEW RELEASE SYSTEMS OF THE ITRACONAZOLE AND IMPROVEMENT OF BIOLOGICAL EFFECTIVENESS

ISRN Pharm. 2012; 2012: 653465.

Very interesting pharmacokinetic work that demonstrates how the improvement of the absorption properties of the drug, guaranteed by the creation of new delivery systems, can also determine a prompt remission of the symptomatology during Candidiasis.

Method of use and dosage

SPORANOX ®

Hard capsules for oral use with Itraconazole 100 mg.

The dosage, dosage schedule and duration of therapy should be defined by the physician based on the patient's pathophysiological characteristics and the severity of his / her clinical picture.

Generally longer therapies are necessary in case of systemic fungal infections, for which the duration of treatment can be extended even for several months.

In order to optimize the systemic absorption of the drug, it is recommended to take SPORANOX ® on a full stomach, therefore immediately after meals.

Warnings SPORANOX ® Itraconazole

The use of SPORANOX ® must necessarily be preceded by a careful medical examination in order to evaluate the patient's clinical conditions, the possible presence of contraindications to the use of the drug and clearly the prescription appropriateness.

In light of the various studies published in the literature, maximum caution is recommended for the use of SPORANOX ® in patients suffering from cardiac, hepatic and renal diseases, given the capacity of the? Itraconazole taken orally to aggravate the patient's clinical picture, resulting in the appearance of clinically relevant adverse reactions.

Rarely, the use of SPORANOX ® has been associated with the appearance of ENT diseases.

The use of SPORANOX ® is also not indicated in patients with sucrase-isomaltase enzyme deficiency, fructose intolerance and glucose-galactose malabsorption syndrome.

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

PREGNANCY AND BREASTFEEDING

The presence in the literature of studies that have documented the potential toxic effects of the? Even accidental exposure of? ™ Itraconazole on the fetus extends the aforementioned contraindications also to pregnancy and the subsequent breastfeeding period.

Therefore the use of SPORANOX ® during pregnancy would be justified only in cases with a high risk of life, when the benefits would be more important than the potential risks.

Interactions

The intense hepatic metabolism that characterizes Itraconazole exposes the patient on SPORANOX ® therapy to numerous drug interactions, some of which are clinically relevant.

More precisely :

Drugs capable of reducing gastric acidity could also limit the? Systemic absorption of? ™ Itraconazole;
Active ingredients metabolised by the CYP3A4 cytochrome system could cause pharmacokinetic changes that alter both the biological efficacy and the safety profile of the drug.

In light of the aforementioned evidence it would be advisable to read carefully the list of active ingredients contraindicated during therapy with Itraconazole, always consulting your doctor.

Contraindications SPORANOX ® Itraconazole

The use of SPORANOX ® is contraindicated in patients who are hypersensitive to the active substance 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

Treatment with SPORANOX ® may expose the patient to risk of abdominal pain, nausea, rash and hypersensitivity reactions, asthenia, myalgia and rarely hepatic, renal and cardiac failure.