ITRANOX 15CAP; itraconazole, antifungals .
ACTIVE-INGREDIENT OF ITRANOX 15CAP
each hard gelatin capsule contains : itraconazole 100 mg.
INDICATION OF ITRANOX 15CAP
Vulvovaginal candidiasis. Oral candidiasis. Dermatophytes caused by organisms susceptible to itraconazole (Trichophyton spp. , Microsporum spp., Epidermatophytes floccosum) e.g. tinea pedis, tinea cruris, tinea corporis, tinea manuum. Pityriasis versicolor. Onychomycosis caused by dermatophytes & or yeasts. Systemic candidiasis. Cryptococcal infections (including cryptococcal meningitis). In immunosuppressed patients suffering from cryptococcosis and in patints with cryptococcosis of the CNF itraconazole is indicated only if the usually recommended initial therapy seems to be inappropriate or ineffective. histoplasmosis. Aspergillosis. Itraconazole can be used to treat patients suffering from invasive aspergillosis who were found to be refractory or intolerant to Amphotercin B. Maintenance therapy in AIDS patients to prevent relapse of underlying fungal infection who were found to be refractory or intolerant to first-line systemic anti-fungal therapy is inappropriate or has proved ineffective. Due to PK properties, orally administered itraconazole (capsules) should not be used as the initial treatment in patients with severe life-threatening forms of systemic mycoses. Oral forms should be used as a continuation therapy. After initial treatment with i.v. itraconazole. Consideration should be given to official guidance regarding the appropriate use of antifungal agents.
DOSAGE OF ITRANOX 15CAP
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
Route of administration: Oral use for maximum drug absorption itraconazole should be taken immediately following a meal. Capsules must be swallowed whole. In case of Gynecological infections (Vulvovaginal candidosis): Dose is 200 mg b.i.d. for 1 day Or 200 mg o.d. for 3 days. In case of Dermatological/ophthalmic indications (Pityriasis versicolor) : Dose is 200 o.d. for 7 days. In case of Dermatological/ophthalmic indications ( tinea corporis, tinea cruris ) : Dose is 100 mg o.d. for 15 days. Or 200 o.d. for 7 days. In case of Dermatological/ophthalmic indications (tinea pedis, tinea manuum): Dose is 100 mgo.d. for 30 days. In case of Dermatological/ophthalmic indications ( Oral candidiasis) : Dose is 100 mg o.d. for 15 days. In some patients with compromised immune systems, such as neurtropenic. AIDS or transplant patients, the bioavailability of oral itraconazol may be diminished. In these cases the dose may have to be doubled. Onychomycoses: Onychomycoses can be treated using a pulse or a continous regime. Pulse treatment: Pulse itraconazole treatment consists of taking two capsules twice a day (200 mg b.i.d) for one week. For fingernail infections two pulse treatments are recommended, and for toenail infections, three. Each pulse should be separated by a period of three weeks with no treatment. Clinical response can be seen by in the form of nail growth when the treatment is ended. For Toenails with or without fingernail involvement: week 1 : first pulse cycle, week 2, 3, 4 : No itraconazole therapy, week 5: Second pulse cycle, week 6, 7, 8 : No itraconazole therapy, week 9 : Third pulse cycle. For Finger nails only: week 1 : first pulse cycle, week 2, 3, 4 : No itraconazole therapy, week 5: Second pulse cycle. Continous treatment: Two capsules a day (200 mg o.d.) for three months. The rate of elimination of itraconazole in skin and nail tissue is slower than in blood plasma . Optimum clinical and mycological response is reached two to four weeks after treatment for skin infections. and six to nine months after treatment for nail infections. Systemic mycoses ( doses vary depending on the infecting organism) The length of treatment for systemic fungal infections should be dictated by the mycological and clinical response to therapy: In case of Aspergillosis: Dose is 200 mg o.d. for 2-5 months ( increase dose to 200 mg b.i.d. in the case of widespread infection). In case of Candidiasis: Dose is 100-200 mg o.d. for 3 weeks – 7 months ( increase dose to 200 mg b.i.d. in the case of widespread infection). In case of non-meningeal cryptococcosis: Dose is 200 mg o.d. for 10 weeks ( Maintenance therapy (meningeal cases): 200 mg o.d.). In case of Cryptococcal meningitis: Dose is 200 mg b.i.d. for 2 months – 6 months ( Maintenance therapy (meningeal cases): 200 mg o.d.). In case of Histoplasmosis: Dose is 200 mg o.d. for 8 months. Or 200 mg b.i.d. Decreased gastric acidity: Absorption of itraconazole is impaired when gastric acidity is decrease. For information on patients with achlorhydria and patients on acid secretion suppressors or taking acid neutralising medicinal products. Impaired absorption in AIDS and neuropenic patients may lead to low itraconazole blood levels and lack of efficacy, in such cases, blood level monitoring and if necessary dose adjustment might be indicated. Itraconazole should not be administered to children as there is limited clinical data describing the pediatric use of this drug. Use in elderly patients. Not recommended. Use in patients with hepatic impairment: Limited data are available in the use of oral itraconazole in patients with hepatic impairment. Caution should be exercised when this drug is administered in this patient population. Use in patients with renal impairment: Limited data are available in the use of oral itraconazole in patients with renal impairment. Caution should be exercised when this drug is administered in this patient population.
OVER-DOSAGE OF ITRANOX 15CAP
No data available. In the event of an overdose, supportive measures should be employed. Within the first hour after ingestion, gastric lavage may be performed. Activated charcoal may be given if considered appropriate. Itraconazole cannot be removed by hemodialysis. No specific is available.
CONTRA-INDICATION OF ITRANOX 15CAP
Itranox capsules are contraindicated in patients with known hypersensitivity to itraconazole or to any of the excipients. Co-administartion of the following drugs is contraindicated with Itranox capsules. CYP3A4 metabolized substrates that can prolong the QT-interval e.g., astmizole, beoridil, cisapride, defetilide, levacetylmethadol (levomethadyl), mizolastine, pimozide, quinidine, sertindoe and terfenadine are contraindicated with Itranox capsules. Co- administration may result in increased plasma concentrations of these substrates, which can lead to QT prolongation and rare occurrences of torsade de pointes. CYP3A4 metabolized HMG-CoA reductase inhibitors such as atorvastatin, lovastatin and simvastatin. Triazolam and oral midazoiam. Ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergotamine (methylergonovine). Eietriptan. Nisoldiptine. Itranox capsules should not be administered to patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF except for the treatment of life-threatining or other serious infections. Itranox capsules must not be used during pregnancy (except for life-threatining cases). Women of chilbearing potential taking itraconazole should use contraceptive precautions. Effective contraception should be continued until the menstrual period following the end of Itranox therapy.
STORAGE OF ITRANOX 15CAP
Store at temperature not exceeding 30 C, & in dry place. Protect from light and moisture.
PACK OF ITRANOX 15CAP
Carton box containing 3 (AL/PVC) strips each of 5 capsules + inner leaflet .
ITRANOX 15CAP MANUFACTURED BY
ADWIA Co. S.A.E. Tenth of Ramadan City Egypt.