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Nemozol

Препарат Немозол. Ipca Laboratories (Ипка Лаборатории) Индия


Producer: Ipca Laboratories (Ipk Laboratoriya) India

Code of automatic telephone exchange: P02CA03

Release form: Firm dosage forms. Tablets.

Indications to use: Nematodoses. Ascaridosis. Ankilostomidoz. Necatoriasis. Trichuriasis. Strongyloidosis. Neurocysticercosis. Echinococcosis. Lambliasis. Toksokaroz.


General characteristics. Structure:

Active agent: албендазол 200 mg

Excipients: starch corn, sodium the lauryl sulfate, povidone-30, methylparaben, propylparaben, gelatin, talc purified starch sodium glycollate, silicon dioxide colloid, magnesium stearate.

Structure of a cover: a gidroksipropilmetiltsellyuloza, titanium the dioxide, talc purified sodium lauryl sulfate, polyethyleneglycol-400; methanol, methylene dichloride (evaporate during drying).
 
Active agent: албендазол 400 mg

Excipients: starch corn, sodium the lauryl sulfate, povidone-30, methylparaben, propylparaben, gelatin, talc purified starch sodium glycollate, silicon dioxide colloid, magnesium stearate.

Structure of a cover: gidroksipropilmetiltsellyuloza, titanium dioxide, propylene glycol; isopropanol, methylene dichloride (evaporate during drying).




Pharmacological properties:

Protivogelmintny drug. The main mechanism of action is connected with the inhibiting effect on polymerization beta тубулина which leads to destruction of cytoplasmatic microtubules of cells of an intestinal path of helminths; changes the course of biochemical processes (suppresses glucose utilization), blocks movement of secretory granules and other organellas in muscle cells of roundworms, causing their death. It is most active concerning larval forms of cestodes - Echinococcus granulosus and Taenia solium, a nematode - Strongyloides stercolatis.

Pharmacokinetics. Absorption and distribution. After intake it is badly absorbed from a GIT, in not changed look is not defined in a blood plasma. Bioavailability at intake low, about 30%. Reception along with greasy food increases absorption and the size Cmax in a blood plasma by 5 times.

Metabolism and removal. Albendazol biotransformirutsya quickly in a liver in primary metabolite — an albendazol the sulphoxide which also have anthelmintic activity. Cmax of an albendazol of sulphoxide in a blood plasma is reached in the range from 2 to 5 h, linkng with proteins of plasma – 70%. Albendazola sulphoxide is almost completely distributed on an organism; it is found in urine, bile, a liver, in a wall of a cyst and cystous liquid, cerebrospinal fluid.
Albendazola sulphoxide in a liver turns into an albendazol sulphone (a secondary metabolite) and other oxidized products. T1/2 of an albendazol of sulphoxide is 8-12 h. It is removed in the form of various metabolites with urine.

Pharmacokinetics in special clinical cases. Removal of an albendazol and its main metabolite does not change at a renal failure.
At patients with abnormal liver functions bioavailability increases, Cmax of an albendazol of sulphoxide in a blood plasma increases twice, T1/2 is extended. Albendazol is the inductor of microsomal enzymes of system of P450 cytochrome; accelerates metabolism of many medicines.


Indications to use:

nematodoses (ascaridosis, enterobiosis, анкилостомидоз, necatoriasis, trichuriasis);
— the mixed helminthic invasions;
strongyloidosis;
— the neurocysticercosis caused by the larval Taenia solium form;
the echinococcosis of a liver, lungs, a peritoneum caused by the larval Echinococcus granulosus form;
lambliasis;
токсокароз;
— as supportive application at surgical treatment of ekhinokokkozny cysts.


Route of administration and doses:

The average therapeutic dose at treatment of nematodoses for adults and children is more senior than 2 years makes 400 mg or 20 ml of suspension inside once.
Drug is accepted during meal. It is recommended to carry out simultaneous treatment of all family members.

At neurocysticercosis and echinococcosis to patients with the body weight of 60 kg and more drug appoint 400 mg of 2 times/days; with body weight less than 60 kg establish a dose at the rate of 15 mg/kg/days in 2 receptions. The maximum daily dose - 800 mg (on 400 mg of 2 times/days). A course of treatment at neurocysticercosis - 8-30 days; at an echinococcosis - 3 cycles for 28 days with a 14-day interval between cycles.

At a lambliasis to children drug is appointed at the rate of 10-15 mg/kg of 1 time/days within 5-7 days.

At a toksokaroza to adults and children 14 years with body weight are more senior appoint more than 60 kg on 400 mg of 2 times/days; with body weight less than 60 kg - on 200 mg of 2 times/days; to children 14 years a dose are younger establish at the rate of 10 mg/kg of 2 times/days. Duration of therapy is 7-14 days.


Features of use:

At neurocysticercosis it is necessary to carry out the corresponding therapy of GKS and anticonvulsant drugs. GKS to intake or in/in introductions apply to prevention of a hypertensive attack on the first week of antitsistovy therapy.

Control of laboratory indicators

Against the background of use of drug recommend to control cellular composition of blood. At emergence of a leukopenia stop therapy.

Blood tests it is necessary to spend at the beginning of each 28-day cycle each 2 weeks during therapy albendazoly. It is possible to continue treatment albendazoly if decrease in the general maintenance of leukocytes and neutrophilic leukocytes moderate and does not progress.


Side effects:

From the alimentary system: an abnormal liver function with change of functional hepatic tests (weak or moderate increase in activity of transaminases), pains in a stomach, nausea, vomiting.
From system of a hemopoiesis: leukopenia, granulocytopenia, agranulocytosis, thrombocytopenia, pancytopenia.
From TsNS: headache, dizziness, meningeal symptoms.
Dermatological reactions: reversible alopecia, skin rash, itch.
Others: temperature increase, increase in the ABP, acute renal failure, allergic reactions.


Interaction with other medicines:

At combined use with albendazoly dexamethasone and Cimetidinum increase concentration of an albendazol of sulphoxide in blood.


Contraindications:

— damage of a retina;
— pregnancy;
— hypersensitivity to components of drug and other derivatives of benzimidazole.
With care apply at hemopoiesis disturbance, abnormal liver functions (to and during treatment it is regularly necessary to control function of a liver), during breastfeeding.

Use of drug NEMOZOL at pregnancy and feeding by a breast
Drug is contraindicated to use at pregnancy. In need of purpose of drug in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination.
Before purpose of drug it is necessary to carry out the test for lack of pregnancy at women of childbearing age. During therapy it is necessary to use reliable methods of contraception.

Use at abnormal liver functions
With care apply at abnormal liver functions (to and during treatment it is regularly necessary to control function of a liver).

Use for children
Use according to indications and in the doses considering age of patients is possible.


Overdose:

Treatment: gastric lavage, absorbent carbon. If necessary carry out symptomatic therapy.


Storage conditions:

List B. Drug should be stored in the unavailable to children, dry, protected from light place at a temperature not above 25 °C.


Issue conditions:

According to the recipe


Packaging:

Tablets, покр. film cover, 200 mg: 2 pieces. 

Tablets, покр. film cover, 400 mg: 1 pieces.



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