Nemozole, 100mg/5ml suspension, 20ml

Composition

>

of 5 ml of suspension contains:

Active ingredient:

albendazole 100 mg;

Auxiliary substances:

microcrystalline cellulose,

sodium carboxymethylcellulose,

glycerin (glycerol),

benzoic acid,

potassium hydrochloride,

sorbic acid,

polysorbate-80,

sorbitol solution,

mixed fruit flavor

essence, ice cream essence,

purified water.

Pharmacological action

Nemozole is an anthelmintic drug. The main mechanism of action is associated with the inhibitory effect on polymerization of beta-tubulin, which leads to the destruction of cytoplasmic microtubules of helminth intestinal tract cells; changes the course of biochemical processes (suppresses glucose utilization), blocks the movement of secretory granules and other organelles in roundworm muscle cells, causing their death. It is most active against larval forms of cestodes-Echinococcus granulosus and Taenia solium, nematodes-Strongyloides stercolatis.

Suction and distribution

After oral use, it is poorly absorbed from the gastrointestinal tract, and is not detected unchanged in blood plasma. Oral bioavailability is low, about 30%. Intake simultaneously with fatty foods increases absorption and Cmax in blood plasma by 5 times.

Metabolism and elimination

Albendazole is rapidly biotransformed in the liver into its primary metabolite, albendazole sulfoxide, which also has anthelmintic activity. Cmax of albendazole sulfoxide in blood plasma is reached in the range from 2 to 5 hours, binding to plasma proteins is 70%. Albendazole sulfoxide is almost completely distributed throughout the body; it is found in the urine, bile, liver, in the cyst wall and cystic fluid, cerebrospinal fluid.

Albendazole sulfoxide is converted in the liver to albendazole sulfone (a secondary metabolite) and other oxidized products. T1 / 2 of albendazole sulfoxide – 8-12 hours. It is excreted as various metabolites in the urine.

Pharmacokinetics in special clinical cases

The excretion of albendazole and its main metabolite does not change with impaired renal function.

In patients with impaired liver function, bioavailability increases, Cmax of Bendazole sulfoxide in blood plasma increases 2-fold, and T1 / 2 is prolonged. Albendazole is an inducer of microsomal enzymes of the cytochrome P450 system; it accelerates the metabolism of many drugs.

Indications

• nematodoses (ascariasis, enterobiosis, hookworm disease, necatorosis, trichocephalosis);
• mixed helminth infestations;
• strongyloidosis;
• neurocysticercosis caused by the larval form of Taenia solium;
• echinococcosis of the liver, lungs, peritoneum caused by the larval form of Echinococcus granulosus;
• giardiasis;
• toxocariasis;
• as an auxiliary agent in surgical treatment echinococcal cysts.

Contraindications

Hypersensitivity, pregnancy, lactation, children’s age (up to 6 years-safety is not determined).

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

Side effects

From the digestive system:  abdominal pain, nausea, vomiting, increased activity of “hepatic” transaminases.

Nervous system disorders:  headache, dizziness, meningeal symptoms.

From the side of hematopoietic organs:  leukopenia, granulocytopenia, agranulocytosis, thrombocytopenia, pancytopenia. Allergic reactions: skin rash, pruritus.

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

How to take, course of use and dosage

Nemozole is prescribed orally, during a meal or after a meal, tablets are not chewed, washed down with water. The use of laxatives and a special diet are not required. Simultaneous treatment of all family members is recommended.

The dose of Nemozole is set individually, depending on the type of helminth and the patient’s body weight. Use of Nemozole in children under 2 years

of age Cysticercosis of the brain (neurocysticercosis):  15 mg / kg / day for 8 days; repeat if necessary.

Hookworm disease, enterobiosis, ascariasis:  200 mg once, if necessary, repeated after 3 weeks.

Strongyloidosis and cestodosis:  200 mg once a day for 3 days, if necessary, repeat after 3 weeks. Use of Nemozole in children over 2 years of age and adults

Neurocysticercosis and echinococcosis:  patients with a body weight of 60 kg and more Nemozole are prescribed 400 mg 2 times/day, with a body weight of less than 60 kg, the dose is set at the rate of 15 mg / kg/day, divided into 2 doses; the maximum daily dose is 800 mg; the course of treatment for neurocysticercosis is 8-30 days; for echinococcosis-3 cycles of 28 days with a 14-day interval between cycles.

Ascariasis, trichocephalosis, enterobiosis and hookworm disease:  400 mg once, if necessary, repeated after 3 weeks.

Strongyloidosis and cestodosis:  400 mg once a day for 3 days, if necessary, repeat after 3 weeks.

Giardiasis:  400 mg once a day for 3 days or at the rate of 10-15 mg / kg once a day for 5-7 days.

Toxocariasis:  adults and children over 14 years of age with a body weight of more than 60 kg Nemozole is used in a single dose of 400 mg; with a body weight of less than 60 kg-200 mg, children under 14 years of age the dose is set at the rate of 10 mg / kg; the frequency of use is 2 times/day, the duration of therapy is 7-14 days.

Special instructions

It is necessary to stop therapy with the development of leukopenia.

In case of neurocysticercosis with eye damage, before starting treatment, it is necessary to study the retina of the eye (the risk of aggravation of its pathology). Women of reproductive age are tested for the absence of pregnancy before starting treatment. Reliable contraception is required during therapy.

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

Form of production

suspension for oral use

Storage conditions

Store in a dry place, protected from light, at temperatures below 25 °C

Shelf life

3 years

Active ingredient

Albendazole

Conditions of release from pharmacies

By prescription

Dosage form

suspension for oral use

Description

For adults as prescribed by a doctor, Children over 1 year old, Children as prescribed by a doctor

Indications

Worms