Generic Sporanox

1. Denomination

Sporanox

2. Active Substance

Itraconazole

3. Indications for Use.

Mycoses of the skin, oral and eye’s mucosa; onychomycoses provoked by dermatophytes, yeast fungi and molds; candidiasis with skin diseases and that of mucosa, including vulvovaginal candidiasis; scaly skin disease; systemic mycoses, including aspergillus infection (under resistance or bad tolerability of amphotericine В), cryptococcosis (including cryptococcosis meningitis), histoplasmosis, sporotricosis, paracoccidioidal granuloma, blastomycosis.

4. Action

Synthetic anti-fungous remedy for local application, having a wide spectrum of activities. Mechanism of action is not determined.

5. Posology and Administration

The drug is to be administered orally just after meal, the capsules are to be swallowed in whole. In vagina candidiasis the drug is to be administered in a dose of 200 mg twice/daily during one day or in a dose of 200 mg once/daily during 3 days. In fungous skin diseases 100 mg once/daily during 15 days. In candidiasis of the mouth cavity - 100 mg once/daily during 15 days. In fungous nails diseases the drug is to be administered in a dose of 200 mg/daily during 3 months or repeating courses 200 mg twice/daily during one week with follow-up breaks (pulse-therapy) should be carried our. In mycoses diseases of internals - 200 mg once/daily during 2-7 months, if necessary the drug dose is to be increased up to 200 mg twice/daily.

6. Counterindications

Hypersensitivity to Itraconazole.
Age less than 6 years.
Pregnancy.
Breastfeeding.

7. Should Be Taken with Precautions, if…

In administration of Intraconazole to the patients who suffer from chronic heart failure individual evaluation of risk and benefit ratio with consideration of such factors as criticality of indications, dosage rate, individual risk factors (heart diseases, valvular defect), chronic obstructive pulmonary diseases, kidney failure is needed. In occurrence of evidences or symptoms of backward heart failure, likewise of symptoms of neuropathy Intraconazole therapy should be stopped.
In the process of Intraconazole therapy it is necessary to control the liver function (especially if the therapy is long-termed). In liver cirrhosis patients and/or in kidney failure patients it is necessary to control and correct a dosage rate.
Women of childbearing age should use adequate contraception methods during the entire treatment course, up to the first menstruation after the therapy end.

8. Interface with Other Medications

If it is necessary to use Itraconazole along with other drugs doctor’s advice is needed.

9. Overdosing

In overdosage cases symptoms of side effects are to be enhanced significantly; if the patient faces such events medical aid is needed.

10. Side Effects

Gastrointestinal tract: dyspepsia, nausea, pain in stomach, anorexia, vomiting, constipation, increment in activity of liver transaminases, hepatitis, in very rare cases – severe toxic liver disruption, including a case of acute liver failure with a lethal outcome.

 Nervous system and sense organs: headache, dizziness, peripheric neuropathy, fatigability, drowsiness.

Cardio-vascular system and blood (blood formation, blood stasis): arterial hypotension. There are notices about the cases of chronic heart failure associated with Itraconazole therapy.

Genitourinary system: dysmenorrhea, edema syndrome, albuminuria, dark color of urine.

Allergic reactions: skin itching, hives, angioedema, Stevens-Johnson syndrome.

Others: alopecia, hypocaliemia, fluid lungs, decrease of libido, impotency.

11. Pregnancy and Lactation

It can be used in pregnancy only in system mycoses and in cases when a supposed effect exceeds a potential risk for the fetus. Nursing mothers should cease breastfeeding (the drug excretes into human milk).

12. Driving

The drug has a series of side effects which are not compatible with vehicle driving and other activities which require alertness. First of all learn the reaction of your body upon Itraconazole.

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