Sporaxol 100mg, 10 capsules — Made in Spain — Free Delivery

Product description

Sporaxol is an antifungal preparation. Capsules "Sporaxol" are used for the following indications:

• vulvovaginal candidiasis;
• pityriasis versicolor;
• dermatomycosis caused by pathogens sensitive to itraconazole (Trichophyton spp., Microsporum spp., Epidermophyton floccosum), for example, dermatophytosis of the feet, inguinal dermatomycosis, dermatophytosis of the trunk, dermatophytosis of the hands;
• oropharyngeal candidiasis;
• onychomycosis caused by dermatophytes and / or yeast;
• histoplasmosis;
• systemic mycoses (in cases where first-line antifungal therapy cannot be applied, or in case of ineffectiveness of treatment with other antifungal preparations, which may be due to the existing pathology, pathogen insensitivity or preparation toxicity): aspergillosis and candidiasis; cryptococcosis (including cryptococcal meningitis): treatment of immunocompromised patients with cryptococcosis and all patients with cryptococcosis of the central nervous system; maintenance therapy in patients with AIDS in order to prevent recurrence of an existing fungal infection;
• Itraconazole is also indicated for the prevention of fungal infection in patients with prolonged neutropenia in cases where standard therapy is insufficient.

Composition

The active ingredient is itraconazole (one capsule contains 100 mg itraconazole).

Excipients: spherical sugar (sucrose, corn starch, purified water), poloxamer 188, hypromellose 6 CP, poloxamer 188 micronized, capsule (indigo (E 132), quinoline yellow (E 104), titanium dioxide (E 171), purified water , gelatin).

Contraindications

Hypersensitivity to the active substance or to any of the excipients of the preparation.

The simultaneous use of itraconazole and CYP3A4 substrates is contraindicated. Simultaneous use can cause an increase in the concentration of these preparations in the blood plasma, which can lead to an increase or prolongation of therapeutic and adverse reactions and conditions that can potentially be life-threatening. For example, increased concentrations of these preparations can lead to an increase in the QT interval and ventricular tachyarrhythmias, including cases of atrial fibrillation, and potentially fatal arrhythmias.

Use in patients with ventricular dysfunction such as congestive heart failure or a history of congestive heart failure, except for treatment of life-threatening infections.

You should not use the preparation during pregnancy, except for the treatment of conditions that threaten the life of a pregnant woman.

Women of reproductive age who take itraconazole capsules should use reliable contraception throughout the course of treatment until the onset of the first menstrual period after its completion.

Mode of application

Used internally. For optimal absorption of the preparation, it is necessary to use the "Sporaxol" capsules immediately after meals. The capsules should be swallowed whole.

Treatment regimens for adults for each indication:

vulvovaginal candidiasis - 200 mg 2 times a day (duration - 1 day);

pityriasis versicolor - 200 mg once a day (duration - 7 days);

inguinal ringworm, dermatophytosis of the trunk - 100 mg once a day (duration - 15 days), 200 mg once a day (duration - 7 days);

dermatophytosis of the feet, dermatophytosis of the hands - 100 mg once a day (duration - 30 days);

oropharyngeal candidiasis - 100 mg once a day (duration - 15 days);

the dose should be increased to 200 mg once a day for 15 days in patients with neutropenia or AIDS due to impaired absorption in these patients;

onychomycosis (damage to the nail plates on the toes, both with and without damage to the nails on the hands) - 200 mg once a day (duration - 3 months).

Optimal clinical and mycological effects are achieved 1-4 weeks after the end of treatment for skin infections, vulvovaginal and oropharyngeal candidiasis and 6-9 months after the end of treatment for infections of the nail plate. This is due to the fact that the withdrawal of itraconazole from the tissues of the skin, nails and mucous membranes occurs more slowly than from blood plasma.

The duration of treatment for systemic fungal infections is adjusted depending on the mycological and clinical response to therapy.

Systemic mycoses:

• aspergillosis - 200 mg once a day;
• candidiasis - 100-200 mg once a day;
• cryptococcosis (without signs of meningitis) - 200 mg once a day;
• cryptococcal meningitis - 200 mg 2 times a day;
• histoplasmosis - from 200 mg 1 time per day to 200 mg 2 times a day;
• supportive treatment of patients with AIDS - 200 mg once a day;
• prophylaxis in patients with neutropenia - 200 mg once a day.

Application features

Pregnant

"Sporaxol" should not be prescribed to pregnant women, except in cases of systemic leukemia, which are life-threatening, when the potential benefit to the pregnant woman outweighs the risk of negative effects on the fetus. In animal studies, itraconazole has shown reproductive toxicity. There are limited data on the use of the preparation "Sporaxol" during pregnancy. During the post-marketing period, cases of developmental anomalies were reported, which included malformations of the skeleton, genitourinary tract, cardiovascular system and visual organs, as well as chromosomal abnormalities and multiple malformations. A causal relationship with the use of itraconazole has not been established. Epidemiological data on the effect of itraconazole in the first trimester of pregnancy (mainly in patients receiving it for short-term treatment of vulvovaginal candidiasis) did not reveal an increased risk of malformations compared with that in women who did not use preparations with a teratogenic effect.

Very small amounts of itraconazole are excreted in breast milk. Therefore, during the period of breastfeeding, it is necessary to compare the possible risk to the child with the expected benefit from treatment with Sporaxol for the mother. If treatment is necessary, a woman should stop breastfeeding.

Children

Since the clinical data on the use of itraconazole capsules in children are limited, "Sporaxol" should not be prescribed to children, unless the expected benefit significantly outweighs the potential risks.

Drivers

The study of the effect on the reaction rate when driving or working with other mechanisms has not been carried out. It should be remembered about the possibility of adverse reactions such as dizziness, visual disturbances and hearing loss, which can lead to negative consequences while driving and working with other mechanisms.

Overdose

Symptoms

Overdose manifestations were similar to adverse reactions that were observed when using the preparation in the recommended doses.

Treatment

In case of accidental overdose, supportive measures should be taken. If justified, activated carbon can be prescribed. Itraconazole is not excreted from the body by hemodialysis. There is no specific antidote.

Side effects

The most common adverse reactions during treatment with itraconazole capsules in clinical trials and / or reported spontaneously were headache, abdominal pain and nausea. The most serious adverse reactions were severe allergic reactions, heart failure / congestive heart failure / pulmonary edema, pancreatitis, severe hepatotoxicity (including some cases of fatal acute liver failure), and skin reactions.

Storage conditions

Store in its original packaging at a temperature not exceeding 25 ° C, out of the reach of children.

Shelf life is 2 years.