Spyrocon

Each capsule contains: Itraconazole 100 mg.

Itraconazole is a synthetic triazole-derivative antifungal agent. It is effective for superficial and systemic fungal infections.
In vitro studies have demonstrated that Itraconazole inhibits the cytochrome P-450 dependent synthesis of ergosterol, which is a vital component of fungal cell membranes.

Short-term therapy: For the treatment of dermatomycosis, fungal keratitis, pityriasis versicolor, oral candidiasis and vulvovaginal candidiasis.
Long-term therapy: For the treatment of onychomycosis and systemic mycosis: aspergillosis, blastomycosis, histoplasmosis, candidiasis, cryptococcosis (including cryptococcal meningitis), paracoccidioidomycosis, sporotrichosis.

Short-term treatment: Dermatomycosis : 100 mg once daily for 15 days.
Pityriasis versicolor: 200 mg once daily for 7 days.
Vulvovaginal candidiasis: 200 mg twice daily for only 1 day; or 200 mg once daily for 3 days.
Highly keratinized regions as in plantar tinea pedis and palmar tinea manus require additional treatment of 100 mg daily for 15 days.
Oral candidiasis: 100 mg once daily for 15 days. In some immunocompromised patients, e.g. neutropenic, AIDS or organ transplant patients, the oral bioavailabillity of Itraconazole may be decreased. Therefore, the dose may need doubling.
Fungal keratitis: 200 mg once daily for 21 days.
Elimination of Itraconazole from skin tissue is slower than from plasma. Optimal clinical and mycological effects are thus reached 2-4 weeks after the cessation of these treatment courses.
Long-term treatment: Aspergillosis: 200 mg once daily for 2-5 months.
Candidiasis: 100-200 mg once daily for 3-7 weeks.
Increase dose to 200 mg twice daily in case of invasive or disseminated disease.
Non-meningeal cryptococcosis: 200 mg once daily for 2 months-1 year.
Cryptococcal meningitis: 200 mg twice daily for 2 months-1 year.
Maintenance therapy (meningeal cases) 200 mg once daily.
Blastomycosis: 100 mg once daily or 200 mg twice daily for 6 months.
Histoplasmosis: 200 mg once daily to 200 mg twice daily for 8 months. Paracoccidioidomycosis: 100 mg once daily for 6 months.
Sporotrichosis: 100 mg once daily for 3 months.

Patients who have shown hypersensitivity to the drug or its excipients.

Since clinical data of the use of Itraconazole in paediatric patients is limited, it is advised that Itraconazole should not be used in these patients unless the potential benefits outweigh the potential risks.
If during treatment patients develop symptoms, e.g. fatigue, nausea, vomiting, anorexia, abdominal pain or dark urine, liver enzymes should be monitored promptly and if abnormal, treatment should be stopped.
In patients with raised liver enzymes, treatment should not be started unless the expected benefit exceeds the risk of hepatic injury. In this instance, liver enzymes monitoring is required. Itraconazole is predominantly metabolized in 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.
If neuropathy occurs that may be attributable to Itraconazole, the treatment should be discontinued.
Renal impaired patients: 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 Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.

Administration of Itraconazole in childbearing women must be together with contraceptive pill and the contraceptive therapy must be continued for one menstruation period once Itraconazole therapy has stopped.
Itraconazole should not be given to pregnant women.
Adequate contraceptive precautions should be taken by women of childbearing potential during the menstrual cycle of Itraconazole therapy.

Short-term: headache, dizziness, nausea, stomach disorder, dyspepsia, rash, pruritus, urticaria, angioedema, reversible increasement of hepatic enzymes. An isolated case of Stevens-Johnson syndrome has been reported.
Long-term: edema, gastrointestinal disturbance, reversible increase in hepatic enzymes, hair loss, hepatitis and peripheral neuropathy have been observed as well.

Concomitant use of Itraconazole with Rifampicin and Phenytoin can cause a decrease of Itraconazole level in plasma.
Use with antacid, absorbent or histamine H₂-antagonist can decrease Itraconazole absorption.
The metabolism of Itraconazole can be accelerated by Rifampicin.
Itraconazole could have an interaction with Cyclosporin A, Warfarin, and Digoxin.

Store below 30°C.
Protect from light.

Antifungals

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

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