Instructions for the medical use of the medicinal product

VORMITOL

Tradename:

Vormitol, Вормитол

International non-proprietary name or generic name:

Albendazole, Альбендазол

Dosage form: Chewable tablets.

Composition

Each chewable tablet contains:

active substance: albendazole 400 mg;

excipients: lactose, powdered sugar, aspartame, povidone K30, magnesium stearate.

Pharmacotherapeutic group: Anthelmintic and antiprotozoal agent.

ATX code: P02CA03

Pharmacological properties

Pharmacodynamics

Broad-spectrum anthelmintic; benzimidazole carbamate derivative. Selectively inhibits the polymerization of beta-tubulin, which leads to the destruction of cytoplasmic microtubules of helminth intestinal tract cells; causes an irreversible disruption of glucose utilization in the helminth’s body and inhibits ATP synthesis; blocks the movement of secretory granules and other organelles in the muscle cells of roundworms, causing their death. Most effective against larval forms of cestodes - Echinococcus granulosus and Taenia solium; nematodes - Strongyloides stercolatis.

Pharmacokinetics

When taken orally, albendazole is poorly absorbed from the gastrointestinal tract, is not detected unchanged in plasma, and bioavailability is low. Eating fatty foods increases absorption and Cmax by 5 times. The time to reach Cmax of albendazole sulfoxide is 2-5 hours. Plasma protein binding is 70%, penetrates in significant quantities into bile, liver, cerebrospinal fluid, urine, wall and fluid of helminth cysts. Metabolized in the liver to form a primary metabolite (albendazole sulfoxide), which has anthelmintic activity. Albendazole sulfoxide is metabolized to albendazole sulfone (a secondary metabolite) and other oxidized products.

T1/2 of albendazole sulfoxide - 8-12 hours. Excreted in bile through the intestines in the form of an active metabolite of albendazole sulfoxide, only a small amount is excreted in the urine. With liver damage, bioavailability increases, while the Cmax of albendazole sulfoxide increases by 2 times, and T1/2 is prolonged. It is an inducer of the CYP1A2 isoenzyme in human liver cells.

Indications for use

•      neurocysticercosis caused by the larval form of the pork tapeworm (Taenia solium);

•      echinococcosis of the liver, lungs, peritoneum, caused by the larval form of the canine tapeworm (Echinococcus granulosus);

•      nematodes: ascariasis, trichuriasis, hookworm disease, enterobiasis, strongyloidiasis, opisthorchiasis, giardiasis, microsporidiosis;

•      mixed helminthiases.

Contraindications

•      hypersensitivity to albendazole or to any of the components of the drug;

•      pregnancy;

•      breastfeeding period;

•      children under 3 years of age.

With caution: suppression of bone marrow hematopoiesis, liver failure, liver cirrhosis, retinal pathology.

Method of administration and dosage

Take orally, during meals or aſter meals, do not chew the tablets, wash them down with water.

The use of laxatives and a special diet are not required.

It is recommended to treat all family members simultaneously. The dose of the drug is set individually, depending on the type of invasion and the patient’s body weight.

The maximum daily dose is 800 mg.

In children, long-term use of high doses of albendazole should be avoided if possible.

For nematodes (including ascariasis, trichuriasis, necatoriasis), patients weighing 60 kg or more are prescribed 400 mg per day once; patients weighing less than 60 kg - 15 mg/kg body weight once or in 2 doses.

For enterobiasis, adults and children over 3 years of age take the drug in a dose of 400 mg once. Aſter 14 days, the course of treatment should be repeated at the same dose and in the same regimen.

For strongyloidiasis and hookworm, adults and children over 3 years of age take the drug in a dose of 400 mg once for 3 days. Aſter a week, it is recommended to repeat the treatment cycle in the same doses.

For trichinosis, the drug is taken at a dose of 400 mg 2 times a day for 10-14 days. In case of severe invasion and organ damage (myocarditis, pneumonitis, meningoencephalitis), glucocorticosteroid and symptomatic drugs are also prescribed.

For toxocariasis, adults and children over 14 years of age and with a body weight of more than 60 kg take the drug 400 mg 2 times a day for 10 days, with a body weight of less than 60 kg -

200 mg. Repeated courses of treatment are required at intervals of 2 weeks/month. During treatment, it is necessary to monitor peripheral blood (once every 5-7 days) and aminotransferases at the same time.

For neurocysticercosis and hydatid echinococcosis, patients weighing 60 kg or more take 400 mg 2 times a day, with a body weight less than 60 kg - at the rate of 15 mg/kg body weight per day in two doses; the maximum daily dose is 800 mg. The course of treatment for neurocysticercosis is 28-30 days (2 days before taking the drug and in the first week of taking glucocorticosteroid drugs), for echinococcosis - 3 cycles of 28 days with a 14-day break between cycles.

For giardiasis: 400 mg 1 time per day for 3 days. Children weighing less than 10 kg - 200 mg 1 time per day once for 5 days.

For mixed invasions, the drug is taken 400 mg 2 times a day for 3 days. If necessary, the course of treatment can be repeated aſter 1 month.

Before using the drug, a clinical blood test and biochemical blood test are required. Treatment is carried out with normal laboratory values. During treatment, blood and aminotransferase tests are performed every 5-7 days. If leukocytes decrease below 3.0x109 and aminotransferase activity increases 2-fold, it is necessary to suspend treatment until the parameters normalize.

Therapy with the drug can be resumed aſter laboratory values return to the level that was before the start of therapy, however, laboratory tests should be performed regularly during therapy. Prescription of hepatoprotectors during treatment and in cases of toxic manifestations is ineffective; discontinuation of the drug is necessary.

Treatment of alveolar echinococcosis with albendazole is an additional treatment. The doses and regimen of the drug are the same as for hydatid echinococcosis. The duration and course of treatment are determined by the patient's condition and tolerability of the drug.

Side effect

From the digestive system: abdominal pain, nausea, vomiting, increased activity of liver transaminases.

From the nervous system: headache, dizziness, meningeal symptoms.

From the hematopoietic organs: leukopenia, granulocytopenia, agranulocytosis, thrombocytopenia, pancytopenia.

Allergic reactions: skin rash, itching.

Other: hyperthermia, increased blood pressure, impaired renal function, alopecia, acute renal failure.

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Special instructions and precautions

Before using the drug, consult your doctor.

Monitoring of blood cellular composition is recommended; If leukopenia occurs, discontinue drug therapy.

In women of childbearing age, a pregnancy test is performed before starting treatment. During therapy and for 1 month aſter its completion, reliable contraception is necessary.

In case of neurocysticercosis with eye damage, before starting treatment, it is necessary to examine the retina (risk of worsening its pathology).

Patients receiving high doses should be closely monitored, with constant monitoring of blood status and liver function.

It is recommended to treat all family members simultaneously. It should be remembered that before prescribing the drug, like any other anthelmintic drug, you should thoroughly clean the room, wash children's toys, take a shower before and aſter bedtime, and change your underwear. It is advisable to iron bed linen with a hot iron during the days of treatment and for several days aſter taking the drug.

Influence on the ability to drive vehicles and machinery

It is necessary to avoid driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, as the drug can cause dizziness and other side effects that can affect these abilities.

Interaction with other medicinal products

Concomitant use of albendazole with praziquantel, dexamethasone and cimetidine may increase the concentration of albendazole sulfoxide in the blood.

Concomitant use with carbamazepine, phenytoin, phenobarbital and panax ginseng may lead to a decrease in the concentration of albendazole in the intestine.

Patients should avoid consuming products containing grapefruit and its derivatives while taking albendazole, as this may lead to increased concentrations of albendazole, which increases the risk of adverse reactions.

Concomitant use of albendazole and theophylline may lead to an increased risk of theophylline toxicity (nausea, vomiting, rapid heartbeat, seizures). In this regard, it is recommended to monitor plasma concentrations of theophylline during treatment with albendazole.

Overdose

Symptoms: increased dose-dependent side effects.

Treatment: gastric lavage, administration of activated carbon, symptomatic therapy.

Release form

2    tablets in an aluminum foil blister. 1 blister along with instructions for use in a cardboard box.

Storage conditions

Store in a dry place, at a temperature not exceeding 30°C. Keep out of the reach of children!

Shelf life

3   years. Do not use aſter the expiration date stated on the packaging.

Vacation conditions

By prescription.