Funginok - instructions for use, dose, side effects, contraindications

Antifungal drug, a synthetic derivative of imidazolidioxolane, which has fungicidal and fungistatic action against dermatophytes, yeast-like (Candida, Pityrosporum, Torulopsis, Cryptococcus), dimorphic fungi and higher fungi (eumycetes). Less sensitive to the action of ketoconazole Aspergillus spp., Sporothrix schenckii, others Dermatiacceae, Mucor spp. and other fikomitsety, except for Entomophthorales.

Pharmacokinetics:

The average maximum plasma concentration of 3.5 μg / ml is achieved 1-2 hours after a single oral intake of 200 mg of the drug during meals.

The binding with plasma proteins is 90%.A small part of the drug penetrates into the cerebrospinal fluid.

The metabolites formed are not active. The main ways of metabolism are oxidation and cleavage of imidazole and piperazine rings, oxidative O-dealkylation and aromatic hydroxylation.

Excretion from the plasma is biphasic: during the first 10 hours, the elimination half-life is 2 hours, and in the subsequent - 8 hours.

About 13% of the dose is excreted in the urine, of which 2 to 4% is an unchanged drug substance. The drug is excreted, mainly with bile.

Indications:

- Infections of smooth skin, scalp, nails caused by dermatophytes and / or yeast-like fungi (dermatophytosis, onychomycosis, paronychia caused by fungi of the genus Candida, multicolored lichen, dandruff, folliculitis caused by fungi of the genus Pityrosporum, chronic candidiasis of the skin and mucous membranes) in those cases when local treatment of large areas of affected areas, significant depth of skin damage, and also without the effect of previous local treatment can not be used;

- infections of the gastrointestinal tract caused by yeast-like fungi;

- chronic recurrent vaginal candidiasis in the absence of the effect of local therapy;

- systemic fungal infections, for example, systemic candidiasis, paracoccidiomycosis, histoplasmosis, coccidiomycosis, blastomycosis;

- preventive use in patients with a decrease in body defenses (congenital or caused by disease or drug action).

Contraindications:

Acute and chronic diseases of the liver, kidneys, hypersensitivity to components of the drug.

Carefully:

Pregnancy, lactation, age over 50, insufficiency of the adrenal cortex and pituitary gland.

Pregnancy and lactation:

Studies on the use of ketoconazole in pregnant women are not available, so it is not recommended to use the drug during pregnancy, except when the potential benefits of treatment can justify the possible risk to the fetus.

Ketoconazole penetrates into breast milk, breast-feeding while taking the drug is not recommended.

Dosing and Administration:

Fungin should be taken orally during meals.

Treatment

Dosing regimen

Adults and children weighing more than 30 kg:

- fungal lesions of the skin, gastrointestinal tract and systemic fungal infections: it is recommended to take 1 tablet (200 mg) of Funginoka per day with meals. If there is no adequate response to this dose, you can increase the dose to 2 tablets (400 mg) once a day;

- vaginal candidiasis: 2 tablets (400 mg) once a day, with meals, for 5 days.

Children with body weight from 15 to 30 kg: 1/2 tablets (100 mg) per day.

Treatment under this scheme should be carried out at least a week after all symptoms disappear, until negative results of microbiological studies are obtained.

Preventative use in patients with immunodeficiency

Adults: 2 tablets (400 mg) per day;

Children: 4-8 mg / kg body weight per day, but not more than 400 mg.

The average duration of treatment is:

- vaginal candidiasis - 5 days;

- skin mycoses caused by dermatophytes - about 4 weeks;

- multi-colored lichen - 10 days;

- Candidiasis of the skin and oral cavity - 2-3 weeks;

- fungal lesions of the scalp - 1-2 months;

- fungal nail infections - 6-12 months;

- Systemic candidiasis - 1-2 months;

- paracoccidiomycosis, histoplasmosis, coccidiomycosis - the optimal duration of treatment is 3-6 months.

Side effects:

The most common effects associated with the administration of ketoconazole are abnormalities in the gastrointestinal tract, such as dyspepsia, nausea, abdominal pain, diarrhea.

Less common headache, insomnia, arthralgia, fever, reversible increase in the activity of "liver" enzymes, hepatotoxicity, menstrual disorders, dizziness, photophobia, paresthesia, hypercreatininaemia. allergic reactions (urticaria, skin rash), exanthema.

Very rarely - thrombocytopenia, alopecia, reversible increase in intracranial pressure (eg, edema of the optic nerve discs, bulging of the fontanelle in children), temporary drop in testosterone in the blood plasma, reversible gynaecomastia and oligospermia, impotence, decreased libido.

Overdose:

When overdosing, supportive measures are recommended.

During the first hour after taking - washing the stomach, Activated carbon.

Careful monitoring of the patient's condition and symptomatic treatment are necessary.

There is no specific antidote.

Interaction:

Drugs that affect the metabolism of Funginoka:

- rifampicin, rifabutin, carbamazepine, isoniazid and phenytoin significantly reduce the bioavailability of ketoconazole;

- drugs that affect the acidity of gastric juice, reduce the absorption of ketoconazole;

- ritonavir increases the bioavailability of ketoconazole, as a result of this, when combined, it is necessary to reduce the dose of Funginoka.

Ketoconazole may enhance or prolong the action of medicinal products. drugs metabolized with the participation of cytochrome P 450, especially from the group CYP3A. Examples of such drugs are:

- drugs that can not be prescribed for the course of treatment with ketoconazole: terfenadine, astemizole, cisapride, triazolam, oral forms of midazolam, quinidine, pimozide, enzyme cleaved CYP3A4, HMG-CoA reductase inhibitors, such as simvastatin and lovastatin;

- drugs, in the appointment of which it is necessary to monitor their plasma levels, action, side effects. Their dosage when taken together with Funginok should be reduced if necessary;

- oral anticoagulants;

- HIV protease inhibitors, such as indinavir, saquinavir;

- Some antineoplastic agents, such as alkaloids Carbon Pink, docetaxel;

- enzyme cleavable CYP3A4 calcium channel blockers and, possibly, verapamil;

- some immunosuppressive agents: ciclosporin;

- other drugs: digoxin, carbamazepine, buspirone, sildenafil, alprazolam, midazolam, rifabutin, methylprednisolone.

In exceptional cases, a disulfiram-like reaction to alcohol, characterized by redness, rash, peripheral edema, nausea and headache. All symptoms disappear completely within a few hours.

Reduced acidity. At this condition, the absorption of the drug worsens. Patients receiving antacids, for example aluminum hydroxide, should be taken no earlier than 2 hours after taking Funginoka. Patients with chlorhydria or patients taking drugs that suppress the secretion of hydrochloric acid in the stomach (for example, H2-histamine receptors or inhibitors of the "proton pump"), it is desirable to take Funginok with acidic drinks.

Ketoconazole weakens the effect amphotericin B.

Reduces the stimulating effect corticotropin on the function of the adrenal glands.

Increases the risk of bleeding "breakthrough" against the background of admission oral contraceptives with a low content of hormones.

Increases toxicity phenytoin.

Special instructions:

In some cases, an insignificant, transient asymptomatic increase in the activity of "hepatic" transaminases or alkaline phosphatase is observed. This reaction is not dangerous and does not require mandatory cessation of treatment, however such patients should be under special supervision.

If the duration of Funginokom treatment exceeds 2 weeks, liver function should be monitored: before treatment, two weeks and then monthly. In case of detection of violations of the liver, treatment should be discontinued.

It is very important to acquaint patients who need long-term treatment with Funginokom, with symptoms of liver disease (fatigue, general weakness, fever, darkening of urine, fecal decolorization, jaundice).

In patients with adrenal insufficiency, as well as in patients undergoing significant stress (surgical intervention), when taking the drug at a dose of 400 mg or more, adrenal function should be monitored.

Effect on the ability to drive transp. cf. and fur:

When treating the drug may be dizzy, it is recommended to refrain from engaging in potentially hazardous activities.

Form release / dosage:

Tablets of 200 mg.

Packaging:

10 tablets in a strip of aluminum foil.

1, 3 or 10 strips of 10 tablets and instructions for use in a cardboard box.

Sample not for sale: 2 or 10 tablets in a strip of aluminum foil. 1 strip with instructions for use in a cardboard box.

Storage conditions:

Store below 30 ° C.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LS-000938

Date of registration:27.07.2010

The owner of the registration certificate:Torrent Pharmaceuticals Co., Ltd.Torrent Pharmaceuticals Co., Ltd. India

Manufacturer: & nbsp

TORRENT PHARMACEUTICALS, Ltd. India

Representation: & nbspTORRENT PHARMACEUTICALS LTD. TORRENT PHARMACEUTICALS LTD. India

Information update date: & nbsp27.07.2010

Illustrated instructions

Instructions

Funginka (Funginoc)