Itranstad

Itraconazole.

Each capsule contains itraconazole 100 mg (as itraconazole pellets 22%).

Short-term treatment: Vulvovaginal candidiasis, Pityriasis versicolor, dermatophytosis, fungal keratitis and oral candidiasis.
Long-term treatment: Systemic aspergillosis and Candidiasis, Cryptococcosis (including Cryptococcal meningitis), Histoplasmosis, Sporotrichosis, Paracoccidioidomycosis, Blastomycosis and other rarely occurring systemic or tropical mycosis.

Itranstad is administered orally.
For optimal absorption, it is essential to administer immediately after a full meal.
The capsules must be swallowed whole.
Short-term therapy: Vulvovaginal candidiasis: 2 capsules once a day for three days or 2 capsules twice a day for 1 day.
Pityriasis versicolor: 2 capsules once a day for 7 days.
Dermatophytosis: 2 capsules once a day for 7 days.
Dermatophytosis in highly keratinized regions such as plantar and palmar ones: 2 capsules twice a day for 7 days.
Oral candidiasis: 1 capsule once a day for 15 days.
Fungal keratitis: 2 capsules once a day for 21 days.
Onychomycosis due to dermatophytosis, yeast or mold: Two to three pulse treatments (each pulse treatment duration is about 7 days) are recommended: 4 capsules daily: 2 capsules in the morning and 2 capsules in the evening. Pulse treatments are separated by a 3-week drug-free interval (see table as follows).

Click on icon to see table/diagram/image

or Continuous treatment: 2 capsules daily for 3 months.
Elimination of Itranstad from skin and nail tissue is slower than from plasma. Optimal clinical and mycological response is reached 2 - 4 weeks after cessation of treatment for skin infections and 6 - 9 months after the cessation of treatment for nail infections.
Long-term therapy: Systemic mycosis (dosage recommendations vary according to the type of infection): Aspergillosis: 2 capsules once a day for 2 - 5 months. Increase dose to 2 capsules 2 times a day in case of invasive or disseminated disease.
Candidiasis: 1 - 2 capsules daily for 3 weeks to 7 months. Increase dose to 2 capsules 2 times a day in case of invasive or disseminated disease.
Non-meningeal cryptococcosis: 2 capsules once a day for 2 - 12 months.
Cryptococcal meningitis: 2 capsules twice daily for 2 - 12 months. Maintenance therapy: 2 capsules once a day.
Histoplasmosis: 2 capsules 1 - 2 times daily for 8 months.
Sporotrichosis: 1 capsule once a day for 3 months.
Paracoccidioidomycosis: 1 capsule once a day for 6 months.
Chromoblastomycosis: 1- 2 capsules once daily for 6 months.
Blastomycosis: 1 capsule once daily to 2 capsules twice daily for 6 months.

No data are available. Itraconazole is not removed by dialysis. In case of accidental overdosage, supportive measures including gastric lavage with sodium bicarbonate should be employed.

Hypersensitivity to itraconazole or any of its excipients.

Itraconazole is predominantly metabolized by the liver. The oral bioavailability in cirrhotic patients is somewhat decreased. It is advised to monitor the Itraconazole plasma concentrations and to adapt the dose when necessary.
Although Itraconazole has no relation with hepatic function disorders in patients receiving short-term therapy, it should not be administered in patients with history of hepatic diseases or hepatotoxicity caused by other drugs. It is advisable to monitor liver function in patients receiving continuous treatment of more than 1 month.
Renal impairment: The oral bioavailability of Itraconazole may be lower in patients with renal insufficiency. Monitoring of the Itraconazole plasma concentrations and a dose adaptation are advisable.
Use in children: Since clinical data on the use of Itraconazole in children is limited, it is advised that Itraconazole should not be used in these patients unless the potential benefit outweighs the potential risks.

Lactation: Not recommended during Itranstad treatment.

During short-term therapy (less than 1 month) 7.0% of patients have side effects: nausea (1.3%), abdominal pain (1.2%), headache (1%), dyspepsia (0.7%).
More frequently occurring side effects (16.2%) have been observed in patients receiving prolonged (approximately 1 month) treatment, most of which had major underlying pathology and multiple concomitant medications.
Side effects relating to the gastro-intestinal tract are 6.1%, in which nausea (2%) and epigastric pain (0.9%).
Some cases of hypokalemia during long-term treatment have been observed.

Contraindicated concomitant administration: Terfenadine, Astemizole, Cisapride, Dofetilide, Pimozide and Quinidine.
Concomitant administration to be monitored: Enzyme-inducing drugs e.g., Rifampicin and Phenytoin, significantly reduce the oral bioavailability of Itraconazole. Consequently, monitoring of the Itraconazole plasma concentrations is advised when enzyme-inducing agents are co-administered.
In vitro studies have shown that there are no interactions on the plasma protein-binding between Itraconazole and Imipramine, Propranolol, Diazepam, Cimetidine, Indomethacin, Tolbutamide and Sulfamethazine and Warfarin.
Drug interactions have been reported when concomitant administration with Cyclosporine A and Itraconazole at dosage of 40 mg daily. So that, Cyclosporine A concentrations should be monitored at the initiation of Itraconazole therapy, if necessary, the dose of Cyclosporine A should be reduced.
With Digoxin and similar, the drug interactions have been established. But vomiting and nausea have been reported in patients concomitantly receiving Itraconazole.
No interaction of Itraconazole with AZT (Zidovudine) has been observed.
No inducing effects of Itraconazole on the metabolism of Ethyloestradiol and Norethisterone were observed.

Protect from light. Do not store above 30°C.

Antifungals

J02AC02 - itraconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.

P₁S₁S₃