INSTRUCTIONS FOR MEDICAL USE

VERMIN

Trade name of the drug: Vermin®.

Active substance (INN): Albendazole.

Dosage form: suspension

Contents:

Active ingredient: Albendazole – 400 mg

Excipients: sodium saccharin, sodium benzoate, citric acid, guar gum, xanthan gum, anhydrous silica (aerosil), peppermint oil, sucrose, menthol, tween 80 (polysorbitol 80), sorbitol, methyl paraben, propyl paraben, sodium hydroxide, purified water.

Description: white or almost white suspension with characteristic odor.

Pharmacotherapeutic group: De-worming medicines

ATX code: Р02СА03

Pharmacological properties

Anthelminthic drug, 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 particularly effective against larval forms of cestodes – Echinococcus granulosus and Taenia solium, nematodes – Strongyloides stercolatis.

Indications for use

It is used to treat giardiasis, oxyurosis, ascariasis, ankylostomiasis, trichuriosis, angilosis, tenuosis and trichinellosis.

Dosage and administration method

The drug is administered orally. Before use, the contents of the bottle should be shaken until a homogeneous suspension is formed.

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

-Oxyurosis: for children from 1 to 2 years old a daily dose is 200 mg, i.e. 5 ml (1/2 ml of the vial of suspension). Duration of treatment: one single dose repeated after 7 days;

For adults and children over 2 years old the daily dose is 400 mg, i.e. 10 ml (1 vial of suspension). Duration of treatment: one single dose repeated after 7 days. Strict hygiene measures must be observed and anyone in close contact with the patient must also be treated.

-Ascaridosis, ankylostomosis, trichuriosis: for children from 1 to 2 years old the daily dose is 200 mg, i.e. 5 ml (1/2 bottle of suspension). Duration of treatment: one single dose;

-For adults and children over 2 years old a daily dose is 400 mg, i.e. 10 ml (vial of suspension). Duration of treatment: one single dose.

-In case of trichuriosis in particular, if the parasitological stool analysis is positive 3 weeks after treatment, a second course of treatment should be carried out.

-Angylosis, teniosis (associated with other parasitic infestations): for adults and children over 2 years old the daily dose is 400 mg, i.e. 10 ml (vial of suspension). Duration of treatment: one daily dose is repeated, for at least 3 consecutive days.

-In case of angylosis and teniosis, in particular if the parasitological stool analysis is positive 3 weeks after treatment, a second course of treatment should be carried out.

-Liambliosis: for children the daily dose is 400 mg, i.e. 10 ml (vial of suspension). Duration of treatment: one daily dose is repeated, for at least 5 consecutive days.

-Trichinellosis: daily dose for children-15 mg/kg/day, divided into two single doses per day.

-For adults: 800 mg, i.e. 20 ml (2×10 ml vial of suspension), divided into two single doses per day. Duration of treatment: one single dose in the morning and in the evening, for 10-15 days, depending on the severity of signs and how soon to start treatment.

Side effects

Possible: gastrointestinal disorders (diarrhea, vomiting, abdominal pain), dizziness, headaches, hyperthermia, temporary hair loss, skin rashes with prolonged use.

Rarely, temporary deviations in blood tests (decrease in the number of leukocytes, erythrocytes, thrombocytes) or liver parameters have been observed.

Contraindications

• Hypersensitivity to the drug components and other benzimidazole derivatives
• Period of pregnancy and lactation;
• Retinal lesions.

Drug interactions

Dexamethasone, praziquantel and cimetidine increase the blood concentration of albendazole.

Increased concentrations of albendazole in bile and in the contents of echinococcal cysts have been found when used concomitantly with cimetidine, which may increase the effectiveness of treatment of echinococcosis.

Special indications

When using the drug for treatment of trichinellosis, regular blood tests are recommended, due to the risk of abnormalities in blood tests and liver function. To increase the effectiveness of the drug in the treatment of trichinellosis infestations, the treatment should be started as soon as possible after the beginning of the infestation.

It is not recommended to use the drug during pregnancy. If pregnancy is detected during treatment, it is necessary to consult the attending physician as soon as possible, as he will be able to decide whether it is really necessary to continue this treatment.

Overdose

Symptoms: Worsening of side effects is possible.

Treatment: gastric lavage, prescription of activated charcoal. If necessary, symptomatic therapy is carried out.

Form of production

400 mg/10 ml suspension, in 10 ml vials.

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.

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.