Gelmodol-VM

General characteristics. Structure:

Active agent: албендазол (micronized)-200,0 mg.

Excipients: lactoses monohydrate of-164,5 mg, starch corn - 70,0 mg, magnesium stearate - 5,5 mg, carboxymethylstarch of sodium of-10,0 mg, кросповидон - 80,0 mg, povidone of-17,0 mg, l sodium auryl mg sulfate-1,0.

Cover: a gipromelloza - 7,5 mg, a macrogoal - 3,75 mg, titanium dioxide - 3,0 mg, the talc purified - 30,0 mg.

Pharmacological properties:

Gelmodol-VM is protivogelmintny drug which pharmacological properties are caused by effect of active agent - an albendazola. Albendazol treats group a carbamate benzimidazoles. The mechanism of action of an albendazol - its ability to break activity of microtubular system of cells of the intestinal channel of helminths, causing at the same time damage of tubulinovy protein. Biochemical disturbances in a cell - oppression of transport of glucose and a fumaratreduktoza which is the cornerstone of suppression of cellular division into stages of metaphase and with which oppression of a yaytsekladka and development of larvae of helminths is connected are a consequence of it.
Albendazol blocks movement of secretory granules and other organellas in muscle cells of roundworms, causing their death.
Albendazol is effective concerning the majority of intestinal nematodes, and also larvaceous (larval forms) cestodes. Albendazol as antiparasitic drug possesses enough broad spectrum of activity.

Pharmacokinetics. Absorption. After intake drug is badly absorbed in digestive tract, in an invariable look is not defined in a blood plasma. Bioavailability at intake low. Reception of greasy food increases absorption and the maximum concentration by 5 times.
Metabolism. Albendazol quickly turns in a liver into primary metabolite - an albendazol sulphoxide which also has anthelmintic activity.
Distribution. The maximum concentration in a blood plasma of an albendazol of sulphoxide is reached in 2-5 hours after reception. For 70% the metabolite is connected with proteins of plasma and completely extends on an organism: it is found in urine, bile, a liver, in a wall and liquid of cysts of helminths, cerebrospinal fluid.
Removal. Albendazola sulphoxide in a liver turns into an albendazol sulphone (a secondary metabolite) and other oxidized products. Elimination half-life of an albendazol of sulphoxide of-8-12 hours. It is removed with urine in the form of various metabolites.
Removal through kidneys of an albendazol and albendazol of sulphoxide insignificant. At patients with a renal failure the clearance does not change.
At patients with damage of a liver - bioavailability increases, the maximum concentration of an albendazol of sulphoxide in a blood plasma increases twice, and the elimination half-life is extended. Albendazol induces CYP1A2 cytochrome in cells of a liver of the person; accelerates metabolism of many medicines.

Indications to use:

Gelmodol-VM - the highly effective anthelmintic and antiprotozoan medicine of polyvalent action intended for therapy of the majority of the existing helminthoses:

- nematodoses:
ascaridosis, the activator - round Ascaris lumbricoidesl helminth;
trichuriasis (threadworm), the activator - round Trichocephalus trichiurus helminth;
enterobiosis (pinworms), the activator - round Enterobiusvermicularis helminth;
ankilostomidoza (krivogolovka), activators - Ancylostoma duodenale and Necatoramericanus;
trichinosis, meat activators trichinellas;
токсокароз, the activator - Tokhosaga of canis, a parasite of dogs;
строгилоидоз (an intestinal ugritsa), the activator - round Strongiloidesstrcoralis helminth, and also the mixed invasions;
- fabric tsestodoza:
cysticercosis (Cysticercus cellulosus activator, larval stage of a tape parasite of a pork tapeworm);
the gidatidozny echinococcosis of a liver, lungs, a peritoneum caused by a larval form of a dog tape-worm (Echinococcus granulosus)
also drug is used as supportive application at surgical treatment of an alveolar echinococcosis.

Route of administration and doses:

Drug is accepted inside, in time or after meal. Special preparation and a diet is not required.
The dosage form is chosen individually, depending on convenience of reception of medicine and portability of the substances entering it.
The dose of drug is established individually, depending on a type of an invasion, body weight of the patient.
The maximum daily dose - 800 mg.
- At an ascaridosis, a trichuriasis Gelmodol-VM appoint by the patient with body weight 60 kg and more - 400 mg a day once or in 2 receptions; the patient with body weight less than 60 kg-15 mg/kg a day in 2 receptions.
- At an enterobiosis drug appoint in a dose 5 mg/kg of body weight once. In 14 days it is necessary to repeat a course of treatment in the same dose and in the same mode.
- At a strongyloidosis, an ankilostomidoza Gelmodol-VM appoint in a dose 10 mg/kg of body weight once within 3 days. In a week it is recommended to carry out a treatment recycle in a tekhzha doses. At a trichinosis drug appoint in a dose 10 mg/kg of body weight a day in 2 receptions within 7-10 days. At a heavy invasion and organ defeats (myocarditis, a pneumonitis, an encephalomeningitis) also glucocorticosteroid and symptomatic means are appointed.
- Treatment of a toksokaroz. Gelmodol-VM appoint in a dose 10 mg/kg of body weight a day in 2 receptions after food within 10 days. Carrying out repeated courses of treatment at an interval of 2 weeks/month is required. In the course of treatment control of peripheral blood (once in 5-7 days) and aminotransferases in the same terms is necessary.
- Treatment of a gidatidozny echinococcosis. Before purpose of drug clinical blood test, a biochemical blood analysis (a hepatonephric complex) is necessary. Treatment is carried out at normal laboratory indicators. Gelmodol-VM appoint in a dose 10 mg/kg of body weight in 2-3 receptions. Duration of a course of treatment - 3 cycles for 28 days with the 14th day break between cycles. In the course of treatment each 5-7 days the blood analysis and aminotransferases is carried out. At decrease in leukocytes lower than 3,0x109/l and 5-6 multiple increases in level of aminotransferases it is necessary to suspend treatment before normalization or considerable improvement of indicators. Purpose of gepatopotektor during treatment and in cases of toxic manifestations is ineffective, drug withdrawal is necessary.
Treatment by chemotherapy of an alveolar echinococcosis is an additional tool. Doses and the mode of purpose of drug same, as well as at a gidatidozny echinococcosis. Duration and a course of treatment is defined by a condition of the patient and portability of drug.
- At cysticercosis Gelmodol-VM appoint in a dose 15 mg/kg of body weight in 3 receptions. Duration of a course is 28-30 days. In 2 days prior to administration of drug and in the first week of reception appoint glucocorticosteroid means. Before treatment, in the course of administration of drug and upon termination of carry out the same control, as at treatment of echinococcosis.

Features of use:

Monitoring of cellular composition of blood is recommended; at emergence of a leukopenia stop therapy by drug.
At women of childbearing age before an initiation of treatment carry out the test for lack of pregnancy. During therapy reliable contraception is necessary.
It is necessary to remember that before appointment Gelmodol-VM, as well as any other protivogelmintny drug, it is necessary to clean thoroughly the room, to wash up children's toys, before going to bed and after a dream to take a shower and to replace underwear. Bed linen is reasonable in days of treatment and several days after administration of drug to iron the hot iron.

Influence on ability to manage vehicles, mechanisms
Gelmodol-VM does not influence ability of driving of the car and the performance of work demanding the high speed of psychomotor reactions.

Side effects:

- From the alimentary system: abnormal liver functions with change of functional hepatic tests (weak or moderate increase in activity of "hepatic" transaminases), pains in a stomach, nausea, vomiting.
- From system of a hemopoiesis: oppression of a marrowy hemopoiesis (leukopenia, granulocytopenia, agranulocytosis, thrombocytopenia, pancytopenia).
- From cardiovascular system: increase in arterial pressure.
- From the central nervous system: headache and dizziness, meningeal symptoms.
- From an urinary system: change of indicators of function of kidneys (acute renal failure).
- Dermatological reactions: itch, skin rash.
- Allergic reactions: Quincke's disease, reactions of immediate hypersensitivity.
- Prochiye:gipertermiya, alopecia.

Interaction with other medicines:

Dexamethasone and Cimetidinum increase concentration of an albendazol of sulphoxide in blood.

Contraindications:

- hypersensitivity to components of drug and other derivatives of benzimidazole;
- deficit of lactase, lactose intolerance, glyukozo-galaktozny malabsorption;
- eye retina pathology;
- children's age up to 3 years (for this dosage form).

With care
Drug Gelmodol-VM with care is used at abnormal liver functions (it is necessary to and during treatment regularly to control functions of a liver), oppression of a marrowy hemopoiesis, cirrhosis.

Use at pregnancy and a lactation
Drug Gelmodol-VM is contraindicated to use during pregnancy and a lactation (breastfeeding).

Use in pediatrics
Drug is intended for use for children aged from 3 years. Clinical data on use of an albendazol aged up to 3 years are limited. At children it is necessary to avoid whenever possible use of high doses of an albendazol for a long time.

Overdose:

Symptoms: strengthening of dozozavisimy side effects.
Treatment: gastric lavage, purpose of absorbent carbon, symptomatic therapy.

Storage conditions:

To store at a temperature from 15 to 25 °C.
To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated 200 mg.
2 tablets in the blister from PVC-aluminum foil.
One blister together with the application instruction is placed in a cardboard pack.