Nemozole

Ipka Laboratories Limited, India

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$14 - $38
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Product Overview

Composition

Each film-coated tablet contains:

Active substance:
 
albendazole - 400.00 mg

Excipients:
 
corn starch - 83.00 mg,
 
dried corn starch - 10.00 mg,
 
sodium lauryl sulfate - 5.00 mg,
 
povidone (polyvinylpyrrolidone K 30) - 5.00 mg,
 
methylparahydroxybenzoate - 0.360 mg,
 
propylparahydroxybenzoate - 0.040 mg,
 
gelatin - 5.50 mg,
 
peeled talcum - 10.00 mg,
 
sodium carboxymethyl starch - 5.20 mg,
 
colloidal silicon dioxide - 3.00 mg,
 
magnesium stearate - 3.00 mg.

Shell:
 
hypromellosis - 5.32 mg,
 
titanium dioxide - 3.20 mg,
 
purified talc - 1.60 mg,
 
sodium lauryl sulfate - 0 mg,
 
macrogol 400 - 0 mg,
 
propylene glycol - 1.60 mg.

Pharmacological action

Pharmacotherapy group:

anthelmintic and antiprotozoal agent.

ATX code: P02CA03

Pharmacological properties

Pharmacodynamics

Albendazole is an anthelmintic drug, the pharmacological properties of which are due to the action of the active substance - albendazole. Albendazole belongs to the group of carbamatbenzimidazoles. The mechanism of action of albendazole is its ability to disrupt the activity of the microtubular system of helminth intestinal cells, causing damage to the tubulin protein. The consequence of this is biochemical disorders in the cell - inhibition of glucose and fumaratreductose transport, which is the basis for cell division suppression at the metaphase stage and which is associated with egg laying suppression and the development of helminth larvae. Albendazole blocks the movement of secretory granules and other organelles in the muscle cells of roundworms, causing their death.

Albendazole is effective for most intestinal nematodes, as well as larval (larval stages) cestodes, as well as lambliums. Albendazole as an antiparasitic drug has a fairly wide range of effects.

Pharmacokinetics

Suction. After ingestion, the drug is poorly absorbed in the gastrointestinal tract, and is not determined unchanged in blood plasma. Bioavailability when taken orally is low. Taking fatty food increases absorption and maximum concentration by 5 times.

Metabolism. Albendazole quickly turns into the primary metabolite -albendazole sulfoxide in the liver, which also has anthelmintic activity.

Distribution. The maximum plasma concentration of albendazole sulfoxide is reached 2-5 hours after administration. 70% of the metabolite is associated with plasma proteins and completely spreads throughout the body: it is found in urine, bile, liver, wall and fluid of helminth cysts, cerebrospinal fluid.

Withdignment. Albendazole sulfoxide in the liver turns into albendazole sulfon (secondary metabolite) and other oxidized products. The half-life of sulfoxide albendazole is 8-12 hours. It is excreted through the kidneys in the form of various metabolites. The excretion of albendazole and albendazole sulfoxide through the kidneys is insignificant. In patients with kidney dysfunction, clearance does not change.

In patients with liver damage, bioavailability increases, the maximum concentration of sulfoxide albendazole in blood plasma increases by 2 times, and the half-life is extended.

Albendazole induces cytochrome SUR1A2 in human liver cells, accelerates the metabolism of many drugs.

Indications

- Nematodes:
ascaris, pathogen - round helminth Ascaris lumbricoidesl;
trichocephalus (vlasoglav), causative agent - round helminth Trichocephalus trichiurus;
enterobiasis (pits), causative agent - round helminth Enterobius vermicularis;
ankylostomidose (curved head), pathogens - Ancylostoma duodenale and Necator americanus;
trichinellosis, pathogen - Trichinella spiralis;
toxocarasis, pathogen - Toxocara canis;
lambliosis, pathogen - Giardia intestinalis;
strohiloidosis (intestinal eel), pathogen - round helminth Strongiloides strcoralis, as well as mixed invasions.
 
- tissue cestodoses:
Neurocysticercus, causative agent - Cysticercus cellulosus (larval stage of the pig chain);
hydratidous echinococcus of the liver, lungs, peritoneum, pathogen - Echinococcus granulosus (larval stage of the dog's tapeworm);
as an aid in the surgical treatment of alveolar echinococcosis, the causative agent is Echinococcus multilocularis.

Contraindications

- Hypersensitivity to albendazole, other components of the drug and other benzimidazole derivatives;
- retinal pathology;
- children under 3 years of age (for this dosage form);
- pregnancy and breastfeeding
 
With caution
 
Albendazole is used with caution for liver disfunction (it is necessary to regularly monitor liver function before and during treatment), inhibition of bone hematopoiesis, liver cirrhosis.

Side effects

From the digestive system: liver disfunction with changes in functional liver tests (weak or moderate increase in the activity of "liver" transaminases), hepatitis, acute liver failure, epigastric pain, anorexia, constipation, diarrhea and dry mouth. nausea, vomiting.

From the hematopoiesis system: suppression of bone marrow hematopoiesis (leukopenia, granulocytopenia, agranulocytosis. thrombocytopenia, pancitopenia, aplastic anemia, suppression of bone marrow activity, neutropenia).
 
From the cardiovascular system: increased blood pressure.
 
From the central nervous system: headache and dizziness, meningeal symptoms, increased intracranial pressure.
 
From the urinary system: change in kidney function indicators (acute renal failure).
 
From the skin: itching, skin rash, multimorphic erythema, Stevens-Johnson syndrome.
 
Allergic reactions: angioedema, immediate hypersensitivity reactions.
 
Others: hyperthermia, alopecia.
 
If any of the side effects specified in the instructions are aggravated, or you notice any other side effects not specified in the instructions, please inform your doctor.

Interaction

Simultaneous use of albendazole with irazikvantel, dexamethasone and cimetidine can increase the concentration of albendazole sulfoxide in the blood.
 
Simultaneous use with carbamazepine, phenytoin, phenobarbital and common ginseng can lead to a decrease in the concentration of albendazole in the intestines.

How to take, course of administration and dosage

Inside, during or after meals. No special training or diet is required. The drug form is chosen individually, depending on the convenience of taking the drug and the tolerance of the substances included in it.
 
The dose of the drug is determined individually, depending on the type of invasion and body weight of the patient.
The maximum daily dose is 800 mg.
 
Children should, if possible, avoid using high doses of albendazole for a long time.
In nematodes (including ascariasis, trichocephalus, necathorosis)
 
Standard dose in the treatment of invasion with roundworms for adults and children with a body weight of 60 kg or more - 400 mg per day once;
for adults and children with a body weight of less than 60 kg -15 mg/kg body weight once or in 2 doses.
 
In enterobiosis, adults and children over 3 years of age take the drug at a dose of 400 mg once. If necessary, after 14 days, repeat the course of treatment at the same dose and in the same mode.
 
In case of strongiloidosis, ankylostomidosis, adults and children over 3 years of age take the drug at a dose of 400 mg once for 3 days. If necessary, after 7 days, repeat the course of treatment in the same doses.
 
In trichinellosis, the drug is taken 400 mg 2 times a day for 10-14 days. Glucocorticosteroid and symptomatic agents are also taken in severe invasion and organ lesions (myocarditis, pneumonianite, meningoencephalitis).
 
In case of toxocorosis, adults and children over 14 years of age and with a body weight of more than 60 kg, the drug is taken 400 mg 2 times a day for 10 days, with a body weight of less than 60 kg 200 mg. Repeated courses of treatment at intervals of 2 weeks/month are required. During treatment, peripheral blood control (once every 5-7 days) and aminotransferase are necessary at the same time.
 
For giardiasis: 400 mg once a day for 3 days. Children with a body weight of less than 10 kg -200 mg once a day once for 5 days.
In case of mixed invasion, the drug is taken 400 mg 2 times a day, for 3 days. If necessary, the course of treatment can be repeated after 1 month.
 
In neurocysticercosis and hydratidous echinoccusosis, patients with a body weight of 60 kg or more should take 400 mg 2 times a day, with a body weight of less than 60 kg - at the rate of 15 mg / kg of body weight per day in 2 doses; the maximum daily dose is 800 mg. The course of treatment for neurocysticercosis is 28-30 days (2 days before taking the drug and in the first week of administration, glucocorticosteroid drugs are taken), for echinococcus - 3 cycles of 28 days with a 14-day break between cycles.

A clinical blood test and a biochemical blood test are required before using the drug. Treatment is carried out with normal laboratory indicators. During treatment, blood and aminotransferase are examined every 5-7 days.
 
If leukocytes decrease below 3.0x109 and 2 times increase in aminotransferase activity, treatment should be suspended until the indicators normalize.
 
Therapy with the drug can be resumed after laboratory indicators return to the level that was before therapy began, however, laboratory tests should be carried out regularly during therapy.
 
Prescribing hepatoprotectors during treatment and in cases of toxic manifestations is ineffective, it is necessary to cancel the drug.
Albenzole treatment of alveolar echinococcus is an additional tool.
 
The doses and prescription regimen of the drug are the same as in hydratidous echinococcosis. The duration and course of treatment are determined by the patient's condition and tolerance of the drug.

Overdose

Symptoms: increased dose-dependent side effects.
 
Treatment: stomach rinsing, activated carbon use, symptomatic therapy.

Special instructions

It is recommended to treat all family members simultaneously.
 
Monitoring of blood cell composition is recommended; in case of leukopenia, therapy with the drug is suspended.
 
In case of neurocysticercosis with eye damage, it is necessary to study the retina before treatment due to the risk of aggravation of its pathology.
 
In women of childbearing age, a pregnancy test is carried out before starting treatment. Reliable contraception is required during therapy and within 1 month after its end.
 
It should be remembered that before using Nemozol, like any other anthelmintic drug, you should carefully clean the room, wash children's toys, daily (morning and evening) carry out hygiene procedures, change underwear. During treatment and a few days after taking the drug, it is advisable to change bed linen more often or iron it with a hot iron.
 
Simultaneous use of albendazole and theophylline can lead to an increase in the risk of toxic action of theophylline (nausea, vomiting, heart rate, seizures). Although single doses of albendazole do not inhibit the metabolism of theophylline, albendazole still induces cytochrome P4501A in hepatocytes. In this regard, it is recommended to control plasma concentrations of theophylline during treatment with albendazole.
 
Patients should avoid eating grapefruit products while taking albendazole, as plasma concentrations of albendazole may increase, which increases the risk of adverse adverse adverse reactions.
 
Impact on the ability to drive vehicles, mechanisms
 
Driving and other potentially dangerous activities that require increased concentration and speed of psychomotor reactions should be avoided, as the drug can cause dizziness and other side effects that may affect these abilities.

Release form

Film-coated tablets

Storage conditions

Store in a dry, dark place at temperatures below 25° C.
 
Keep out of reach of children.

Shelf life

3 years.

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