Each capsule of  SPORAL®100 contains:

•   Itraconazole    100 mg .

 SPORAL® is used for several indications including:

Gynecological indications:

• Treatment of vulvovaginal candidosis .

Dermatological/mucosal/ophthalmological indications:

• Treatment of dermatomycosis – including highly keratinized regions as in plantar tinea pedis and palmar tinea manus.
• Treatment of pityriasis versicolor and palmer tinea manus.
• Treatment of oral candidosis .
• Treatment of fungal keratitis.
• Onychomycosis caused by dermatophytes and/or yeasts.

Systemic mycoses, only in the following fungal infections:

• Treatment of systemic aspergillosis and candidosis.
• Treatment of Cryptococcosis (including cryptococcal meningitis) SPORAL® is indicated only when first line treatment is considered inappropriate or has proven ineffective.

Histoplasmosis, maintenance therapy only in AIDS patients.

Treatment of chromomycosis,

Treatment of blastomycosis.

Treatment of sporotrichosis (including lymphocutaneous/ cutaneous and extracutaneous).

Treatment of paracoccidioidomycosis.

¤ SPORAL® is only recommended when first-line treatment is not appropriate or has proven ineffective.

• SPORAL® capsules are contraindicated in patients with unknown hypersensitivity to itraconazole.   
• SPORAL® capsules are contraindicated in pregnant women except for the treatment of systemic mycoses, where the potential advantages must be weighed against the potential harm to the foetus. Highly effective contraceptive precautions should be used by women of childbearing potential throughout SPORAL® therapy, and continued until the next menstrual period following the end of SPORAL® therapy.
• SPORAL® capsules should not be administerted to paients with evidence of ventrivular dysfunction such as congestive heart failure (CHF) or any a history of CHF except for treatment of life-threatening or other serious infections.
• SPORAL® capsules should not be used in children unless the potential benefit out-weighs the potential risks.
• Co-administration of a number of CYP3A4 substrates is contraindicated with SPORAL®.capsules. Increased plasma concentrations of these drugs, caused by co-administration with itraconazole, may increase or prolong the QT-interval, both therapeutic and adverse effects to such an extent that a potentially serious situation may occur.
• Co-administration of SPORAL® and quinidine may cause transient or permanent hearing loss.

Drugs affecting the absorption of itraconazole:

• Drugs that reduce the gastric acidity impair the absorption of itraconazole.

Drugs affecting the metabolism of itraconazole:

• Itraconazole is mainly metabolized through cytochrome CYP3A4, interactions studies have  been performed with rifampicin, rifabutin and phenytoin, which are potent enzyme inducers of CYP3A4. Since the bioavability of itraconazole and hydroxy-itraconazole was decreased in these studies to such an extend that efficacy may be largely reduced.

Effect of itraconazole on the metabolism of other drugs :

• Itraconazole can inhibit the metabolism of drugs metabolized by the cytochrome 3A family. Thiscan result in an increase and/or a prolongation of their effects inculding side effects. For example: ( Astemizole, bepridil, cisapride, dofetilide, levacetylmethadol (levomethadyl), mizolastine,pimozide, quinidine, sertindole and terfenadine).
• CYP3A4 metabolized HMG-CoA reductase inhibitors such as lovastatin and simvastatin.
• Triazolam and midazolam.
• Ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine).
• CYP3A4 metabolized calcium channal blockers such as dihydropyridines  and verapamil.
• Nisoldipine (Caution should be exercised when co-administering itraconazle with calcium channel blockers due to an increase risk of CHF).
• Oral anticoagulants.
• HIV Protease inhibitors such as indinavir,ritonavir and saquinavir.
• Certain antineoplastic agents such as busulphan,docetaxel, trimetrexate and vinca alkaloids.
• Certain immunosuppressive agents:cyclosporine,rapamycin (also known as sirolimus) and tacrolimus.
• Certain CYP3A4 metabolized HMG-CoA reducase inhibitors such as atorvastatin.
• Certain glucocorticosteroids such as budesonide, dexamethasone, fluticasone and methylprednisolone.
• Digoxin (via inhibition of P-glycoprotein).

Others:

• alfentanil, alprazolam, brotizolam, buspirone, carbamazepine, cilostazole, disopyramide, ebastine, eletriptan, fentanyl, halofantrine, midazolam IV, reboxetine, repaglinide, rifabutin.

• SPORAL® must not be used during pregnancy except for life-threatening cases.
• A very small amount of itraconazle is excreted in human milk may accumulate; avoid to use.

Common or very common:

• dyspnoea, headache, hepatitis, hypokalaemia, nausea, rash, taste disturbances, vomiting

   Rare:

• Alopecia. deafness, erectile dysfunction, heart failure, hypertriglyceridaemia, leucopenia, pancreatitis, photosensitivity, Stevens-Johnson syndrome, tinnitus, toxic epidermal necrolysis, urinary frequency, visual disturbances.

Overdosage:

• Gastric lavage may be performed, activated charcoal may be given if considered appropriate, no specific antidote exists.

¤ For optimal absorption, it is essential to administer SPORAL® capsules immediately after a full meal.
-Adults:
Tinea of body & groin:

• 1 capsule (100 mg) once daily for 2 weeks or 2 capsules (200 mg) once daily for 1 week.

Tinea of hands & feet:

• 2 capsules (200 mg) twice daily for 1 week or 1 capsule (100 mg) once daily for 4 weeks.

Other skin infections:

• 1 capsule (100 mg) twice daily or 2 capsules (200 mg) daily for 5 to 7 days.

Eye infections:

• 2 capsules (200 mg) once daily for 3 weeks.

Vaginal infections:

• 2 capsules (200 mg) morning & evening for 1 day, or 2 capsules (200 mg) once daily for 3 days.

Mouth infections:

• 1 capsule (100 mg) daily for 2 weeks. 

Systemic infections:

• 1 to 2 capsules (100 mg to 200 mg) once or twice daily for 3 weeks to 12 months, depending on the condition.

Nail infections:

• 2 capsules (200 mg) once daily for 3 months.

♦ Cyclic (pulse) nail therapy:

• 2 capsules twice daily for 1 week. After that, stop taking SPORAL®.for 3 weeks. Then the cycle is repeated, once for fingernails and twice for toenail infections(with or without fingernail infections). (Seebelow).

♦ Fingernails only

• Week 1: Take 2 capsules twice daily.
• Week 2, 3, 4: No SPORAL®.
• Week 5: Take 2 capsules twice daily.
• Week 6: Stop.

♦ Toenails with or without fingernails:

• Week 1: Take 2 capsules twice daily.
• Week 2, 3, 4: No SPORAL®.
• Week 5: Take 2 capsules twice daily.
• Week 6, 7, 8: No SPORAL®.
• Week 9: Take 2 capsules twice daily.
• Week 10: Stop.

-Children and Elderly: 

• SPORAL® capsules are not recommended for use in children and in the elderly.

¤ Caution should be taken in prescribing SPORAL® capsules to patients with

• hypersensitivity to other azoles.
• Renal impairment

¤ Do not take SPORAL® capsules with any of the following:

• Colchicine (used to treat gout).
• Fesoterodine or solifenacin (used to control irritated urinary bladder);
• Telithromycin (an antibiotic).

• SPORAL® (Blister of 4 capsules, pack of one Blister).

• Store at a temperature not exceeding 25 °C, protect from light.