NEMOZOL

Active material: Albendazol
When ATH: P02CA03
CCF: Worming medication
ICD-10 codes (testimony): A07.1, B67, B69, B76, B77, B78, B79, B80
When CSF: 10.01
Manufacturer: IPCA LABORATORIES Ltd. (India)

Pharmaceutical form, composition and packaging

Pills, Film-coated white or nearly white, round, lenticular.

Excipients: corn starch, sodium lauryl, povidone-30, methylparaben, propyl, gelatin, Talcum cleared, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate.

The composition of the shell: hydroxypropyl, Titanium dioxide, Talcum cleared, sodium lauryl, polyethylene glycol 400; methanol, DCM (evaporate during drying).

2 PC. – blisters (1) – packs cardboard.

Pills, Film-coated white or nearly white, round, lenticular.

Excipients: corn starch, sodium lauryl, povidone-30, methylparaben, propyl, gelatin, Talcum cleared, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate.

The composition of the shell: hydroxypropyl, Titanium dioxide, propylene glycol; isopropanol, DCM (evaporate during drying).

1 PC. – blisters (1) – packs cardboard.

Chewable Tablets from white to almost white, Oval, kapsulovidnye, lenticular, with Valium on one side.

Excipients: corn starch, sodium lauryl, povidone-30, methylparaben, propyl, lemon acid, gelatin, Talcum cleared, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, Aspartame, pineapple flavor, aroma of mint.

1 PC. – blisters (1) – packs cardboard.

Oral suspension white.

Excipients: microcrystalline cellulose, sodium carboxymethylcellulose, glycerol (glycerol), benzoic acid, potassium hydrochloride, sorbic acid, polysorbate-80, sorbitol solution, the essence of mixed fruit flavor, essence cream, Purified water.

20 ml – plastic bottles (1) – packs cardboard.

* international non-proprietary name, recommended by the WHO – Albendazole.

Pharmacological action

Worming medication. The main mechanism of action is associated with an inhibitory effect on beta-tubulin polymerization, which leads to degradation of cytoplasmic microtubules cells intestinal helminths; change the course of biochemical processes (suppresses glucose utilization), blocks the movement of secretory granules and other organelles in muscle cells roundworms, causing their death. Most active against larval forms of cestodes – Echinococcus granulosus and Taenia solium, round worm – Strongyloides stercolatis.

Pharmacokinetics

Absorption and distribution

After ingestion poorly absorbed from the gastrointestinal tract, in unmodified form is not determined in plasma. Oral bioavailability is low, about 30%. Admission at the same time increases the absorption of fatty foods and the amount of C_max blood plasma 5 time.

Metabolism and excretion

Albendazole rapidly biotransformed in the liver to the primary metabolite - albendazole sulfoxide, also has anthelmintic activity. C_max albendazole sulfoxide in plasma is in the range of 2 to 5 no, Plasma protein binding - 70%. Albendazole sulfoxide is almost completely distributed throughout the body; found in urine, bile, liver, in the wall of the cyst and cystic fluid, cerebrospinal fluid.

Albendazole sulfoxide is converted in the liver to albendazole sulfone (secondary metabolite) and other oxygenated products. T_1/2 alʙendazola sulьfoksida – 8-12 no. Excreted as various metabolites in the urine.

Pharmacokinetics in special clinical situations

Excretion of albendazole and its primary metabolite is not altered by impaired renal function.

In patients with impaired liver function increases the bioavailability, C_max albendazole sulfoxide plasma increases 2 times, T_1/2 lengthens. Albendazole is an inducer of microsomal enzymes of the cytochrome P450; It accelerates the metabolism of many drugs.

Testimony

- Nematodozы (askaridoz, эnterobyoz, ankylostomydoz, necatoriasis, tryhotsefalez);

- Mixed worm infestation;

- Strongiloidoz;

- Nejrocisticerkoz, caused by the larval form of Taenia solium;

- Hydatid disease of the liver, light, peritoneum, caused by the larval form of Echinococcus granulosus;

- Giardiasis;

- Toksokaroz;

- As an adjunct to surgical treatment of cysts ehinokokkoznyh.

Dosage regimen

The average therapeutic dose treatment nematosis to adults and children over 2 years is 400 mg dose.

At echinococcosis and neurocysticercosis patients with a body weight 60 kg or more the drug is prescribed for 400 mg 2 times / day, weighing less than 60 kg dose set based 15 mg / kg / day 2 admission. The maximum daily dose – 800 mg (by 400 mg 2 times / day). The course of treatment for nejrocisticerkoze – 8-30 days; at echinococcosis – 3 cycle 28 days with 14-day interval between cycles.

At giardiasis children the drug is prescribed on the basis of 10-15 mg / kg 1 times / day for 5-7 days.

At toksokaroze adults and children over 14 years old with a body weight more 60 kg appoint 400 mg 2 times / day; weighing less than 60 kg – by 200 mg 2 times / day, children under 14 years dose set based 10 mg / kg. Duration of therapy 7-14 days.

The drug is taken during meals. It is recommended that simultaneous treatment of all family members.

Side effect

From the digestive system: abnormal liver function with changes in liver function tests (slight to moderate increase in transaminases), abdominal pains, nausea, vomiting.

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

CNS: headache, dizziness, meningeal symptoms.

Dermatological reactions: obratimaya alopecia, skin rash, itch.

Other: temperature rise, increased blood pressure, acute renal failure, allergic reactions.

Contraindications

- Retinal damage;

- Pregnancy;

- Hypersensitivity to the drug and other benzimidazole derivatives.

FROM caution used in violation of hematopoiesis, hepatic dysfunction (Before and during treatment should regularly monitor liver function), during breastfeeding.

Pregnancy and lactation

The drug is contraindicated during pregnancy. If necessary, the appointment during lactation should decide the issue of termination of breastfeeding.

Before the appointment of the drug should be tested for the absence of pregnancy Women of childbearing age. During treatment should use reliable methods of contraception.

Cautions

When neurocysticercosis should be appropriate therapy and GCS anticonvulsants. GCS for oral or / in the introduction are used to prevent hypertensive attack in the first week of therapy antitsistovoy.

Monitoring of laboratory parameters

Against the background of the drug is recommended to monitor blood cell composition. In the event of leukopenia suspend therapy.

Blood tests should be carried out at the beginning of each 28-day cycle every 2 week treatment period Albendazole. Continue treatment Albendazole possible, if the reduction in total leukocytes and neutrophils moderate and progresses.

Overdose

Treatment: gastric lavage, Activated carbon. If necessary spend symptomatic therapy.

Drug Interactions

In sovmestnom primenenii albendazolom with dexamethasone and cimetidine uvelichivayut kontsentratsiyu albendazole sulyfoksida in Resurrection.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored out of reach of children, dry, dark place at a temperature no higher than 25 ° C. Shelf life - 3 year.