Posology : מינונים

4.2. Posology and method of administration
For optimal absorption, administer Itranol capsules immediately after a full meal.
The capsules must be swallowed whole.

Gynecological indication

Indication                           Dose                       Treatment Duration Vulvovaginal candidosis             200 mg b.i.d.                   1 day or                              or
200 mg once daily               3 days




Dermatological / mucosal / ophthalmological indications
Indication                                   Dose                          Treatment Duration Dermatomycosis                          200 mg once daily                     7 days or                                    or
100 mg once daily                     15 days
Highly keratinized regions as in        200 mg b.i.d.                         7 days plantar tinea pedis and palmar tinea or                                       or manus                                   100 mg once daily                     30 days Pityriasis versicolor                   200 mg once daily                     7 days Oral candidosis                         100 mg once daily                     15 days In some immunocompromised patients (e.g. neutropenic, AIDS or organ transplant patients), the oral bioavailability of itraconazole from itraconazole capsules may be decreased. Therefore the doses may need doubling.


Onychomycosis, caused by dermatophytes and/or yeasts
Onychomycosis                                Dose and Treatment duration Pulse treatment
A pulse treatment consists of two capsules twice daily
(200 mg b.i.d.) for one week. Two pulse treatments are recommended for fingernail infections, and three pulse treatments for toenail infections. Pulse treatments are always separated by a 3-week drug-free interval. Clinical response will become evident as the nail re-grows, following discontinuation of the treatment.
Site of       Week 1        Week 2     Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 onychomycosis
Toenails with Pulse 1       Itraconazole-free weeks         Pulse 2   Itraconazole-free weeks         Pulse 3 or without fingernail involvement
Fingernails   Pulse 1       Itraconazole-free weeks         Pulse 2 only


Onychomycosis
Dose                                     Treatment duration
Continuous treatment
Toenails with or without fingernail
200 mg once daily                        3 months involvement


Elimination of itraconazole from skin and nail tissue is slower than from plasma. Optimal clinical and mycological response is thus reached 2 to 4 weeks after the cessation of treatment for skin infections and 6 to 9 months after the cessation of treatment for nail infections.

Systemic mycoses
Indication                 Dose     Median Treatment                    Remarks 1
Duration
Aspergillosis                         200 mg   2-5 months         Increase dose to 200 mg b.i.d. in case of once                        invasive or disseminated disease.
daily
Candidosis                           100 - 200   3 weeks -            Increase dose to 200 mg b.i.d. in case of mg once     7 months             invasive or disseminated disease.
daily
Non-meningeal cryptococcosis         200 mg      2 months - 1 year once daily
Cryptococcal meningitis              200 mg      2 months -1 year     Maintenance therapy: b.i.d.                           See section 4.4. Special warnings and precautions for use.
Histoplasmosis                       200 mg 8 months once daily -
200 mg b.i.d.
Blastomycosis                        100 mg 6 months once daily -200 mg b.i.d.
Lymphocutaneous and Cutaneous        100 mg 3 months
Sporotrichosis                       once daily
Paracoccidioido-mycosis              100 mg 6 months                  Data on the efficacy of itraconazole capsules once                             at this dosage for treatment of daily                            paracoccidioido-mycosis in patients with AIDS is not available.
Chromomycosis                        100 – 200 6 months mg once daily
1
The duration of treatment should be adjusted depending on the clinical response.

Special populations
Pediatrics
Clinical data on the use of itraconazole capsules in pediatric patients are limited. The use of Itranol capsules in pediatric patients is not recommended unless it is determined that the potential benefit outweighs the potential risks. See section 4.4 Special warnings and precautions for use.

Elderly
Clinical data on the use of itraconazole capsules in elderly patients are limited. It is advised to use Itranol capsules in these patients only if it is determined that the potential benefit outweighs the potential risks. In general, it is recommended that the dose selection for an elderly patient should be taken into consideration, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. See section 4.4 Special warnings and precautions for use.

Renal impairment
Limited data are available on the use of oral itraconazole in patients with renal impairment. The exposure of itraconazole may be lower in some patients with renal insufficiency. Caution should be exercised when this drug is administered in this patient population and adjusting the dose may be considered.

Hepatic impairment
Limited data are available on the use of oral itraconazole in patients with hepatic impairment.
Caution should be exercised when this drug is administered in this patient population. (See section 5.2 Pharmacokinetic properties- Special populations, Hepatic impairment).