INSTRUCTIONS FOR MEDICAL USE
VERMIN
Trade name of the drug: Vermin®.
Active substance (INN): Albendazole.
Dosage form: Coated tablets.
Contents:
1 coated tablet contains:
The active substance: Albendazole 200 mg or 400 mg.
Excipients: Lactose monohydrate, corn starch, magnesium stearate, sodium glycolate, crosspovidone, polyvinylpyrrolidone K25, sodium lauryl sulfate.
Excipients in the shell: hydroxypropyl methylcellulose, polyethylene glycol 4000, titanium dioxide, talc, Sunset Yellow dye for the dosage of 200 mg.
Description:
Coated tablets, 200 mg: Round, biconvex, light orange coated tablets, with a characteristic odor.
Coated tablets 400 mg: Biconvex, oblong-shaped, film-coated tablets with a slit on one side, white or almost white coating with distinctive odor.
ATX code: P02CA03
Pharmacotherapeutic group: De-worming medicines
Pharmacological properties
Anthelminthic agent, effective in mono- and polyinvasions. It selectively inhibits polymerization of beta-tubulin, disrupts activity of microtubular system of cells in intestinal canal of helminthes; inhibits utilization of glucose, blocks movement of secretory granules and other organelles in muscle cells of roundworms, causing their death. It is especially effective against larval forms of cestodes – Echinococcus granulosus and Taenia solium, against nematodes – Strongyloides stercolatis.
Pharmacokinetics
During oral administration albendazole is poorly absorbed from gastro-intestinal tract, it is not determined in unchanged form in plasma, because it is rapidly converted in the liver to the primary metabolite – albendazole sulfoxide, which also has anthelmintic activity.
Bioavailability is low. Fatty food increases absorption and maximum concentration (Cmax) of albendazole by 5 times. Time to reach Cmax of albendazole sulfoxide is 2-5 hours. It is bound to plasma proteins by 70%.
It is almost completely distributed throughout the body; it is found in urine, bile, liver, cyst wall and cystic fluid, cerebrospinal fluid. It penetrates the wall and fluids of helminth cysts. Albendazole sulfoxide is metabolized to albendazole sulfone (secondary metabolite) and other oxidized products. The elimination half-life (T1/2) of albendazole sulfoxide is 8-12 hours.
It is excreted with the bile through the intestine as an active metabolite of albendazole sulfoxide, only a small amount is excreted with the urine. Clearance does not change in patients with impaired renal function. In liver damage, bioavailability is increased, while Cmax of albendazole sulfoxide increases 2-fold and T1/2 is prolonged. Albendazole is an inducer of microsomal enzymes of cytochrome P 450 (IA) system; it accelerates metabolism of many drugs.
Indications for use
The drug is used in helminth infestations, including nematode infestations:
- neurocysticercosis caused by a larval form of swine chain (Taenia solium);
- Echinococcosis of the liver, lungs, peritoneum, caused by the larval form of the dog tapeworm (Echinococcus granulosus); as an aid in the surgical treatment of echinococcal cysts;
- ascariasis;
- trichocephaliasis;
- ankylostomidosis
- enterobiasis;
- necatoriasis;
- strongyloidiasis (strohyloidiasis);
- opisthorchiasis;
- microsporidiosis;
- toxocariasis;
- giardiasis;
- mixed helminthiasis.
Dosage and administration
Inside, after a meal, the tablets are not chewed, drink water. The daily dose – 0.4 g (one meal), for children – 6 mg / kg. The use of laxatives and special diets are not required.
Ankylostomidosis and ascariasis 0.4 g, enterobiasis 0.2 g once, repeat after 3 weeks, if necessary. Strongyloidiasis 0.4 g and cestodiasis 0.2 g once daily for 3 days, repeat after 3 weeks if necessary. Children over 2 years of age and adults with cerebral cysticercosis: 0.4 g 2 times a day for 8-30 days. Ascaridiasis, trichocephaliasis, enterobiasis and ankylostomidiasis – 0.4 g once, repeated in 3 weeks if necessary. Lambliosis: 0.4 g once daily for 3 days.
Strongyloidiasis and cestodiasis: 0.4 g once a day for 3 days, repeated in 3 weeks if necessary.
Side effects
Digestive system: abdominal pain, nausea, vomiting, dyspepsia, increased liver transaminase activity. Nervous system disorders: headache, dizziness, meningeal symptoms.
Blood organs: inhibition of medullary hematopoiesis, leukopenia, granulocytopenia, agranulocytosis, thrombocytopenia, pancytopenia. Urinary system: impaired renal function, acute renal failure.
Allergic reactions: skin rash, itching.
Other: hyperthermia (increased temperature), increased blood pressure, reversible alopecia.
Contraindications .
Hypersensitivity, pregnancy, lactation, children under 6 years of age – safety is not defined. With caution: inhibition of medullary hematopoiesis, liver failure, cirrhosis, retinal pathology.
Drug interactions
Dexamethasone, praziquantel and cimetidine increase the blood concentration of albendazole. Increase of albendazole concentration in bile and in contents of echinococcal cyst was found in combination with cimetidine, which can increase effectiveness of treatment of echinococcosis.
Special indications
Albendazole is prescribed with caution in patients with inhibition of bone marrow hematopoiesis, hepatic insufficiency, cirrhosis, retinal pathology.
Blood tests should be performed at the beginning of each 28-day cycle and every 2 weeks during the drug therapy. Therapy should be discontinued if leukopenia develops. It is possible to continue treatment with albendazole, if the decrease in total leukocytes and neurotrophilic leukocytes is moderate and does not progress. Patients receiving high doses of the drug should be closely monitored, with constant monitoring of liver function. Women of reproductive age are tested for the absence of pregnancy before starting treatment. During therapy, reliable contraception is mandatory.
In cases of neurocysticercosis with eye lesions, retinal examination is necessary before starting treatment with albendazole (risk of aggravation of its pathology).
Patients with neurocysticercosis should receive appropriate therapy with steroids (GCS) and anticonvulsants. Oral or intravenous corticosteroids are used to prevent a hypertensive attack during the first week of anticystic therapy.
Overdose
Treatment: gastric lavage, prescription of activated charcoal. If necessary, symptomatic therapy is carried out.
Form of production
Coated tablets 200 mg #2 and 400 mg #1 in a single-circuit pack.
Storage conditions
Store in a dry, dark place at a temperature not exceeding 25°C. Keep out of the reach of children!
Shelf life
3 years. Do not use after the expiration date.
Conditions of dispensing from pharmacies
Released by a doctor’s prescription.