Anthelmintic / Antiparasitics

Nemozol 1’s 400 mg coated tablets

Brands: ipca (India)

$13.50

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Nemozol 1's 400 mg coated tablets quantity

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Brands:: ipca (India)

Description

The instruction for medical use

of Nemozol Torgovoye medicine a name

of Nemozol Mezhdunarodnoye medicine the unlicensed

name Albendazol Lekarstvennaya
the Tablet form, film coated, 400 mg

Structure
1 tablet soderzhitaktivny substance – an albendazola of 400 mg, excipients: corn starch, sodium lauryl sulfate, water purified, povidone (PVPR-30), methylparahydroxybenzoate, propilparagidroksibenzoat, the gelatin, talc purified of sodium of starch glikolit, silicon dioxide colloidal, the starch which corn is dried up of magnesium stearate.
tablet cover: 2 propyl alcohol, a gipromelloza, the titan dioxide (E171), talc purified, propylene glycol, methylene dichloride.

Description
of the Tablet of round shape, biconvex, film coated white or almost white color.

Pharmacotherapeutic group
Anthelminthic drugs. Drugs for treatment of a nematodosis. Benzimidazole derivatives. Albendazol
the ATX P02CA03 Code

the Pharmacological

Pharmacokinetics Later properties of oral administration albendazole is badly adsorbed from a gastro intestinal path (less than 5%), in not changed look the bioavailability – low is not defined in plasma.
Systemic pharmacological action increases if the dose is accepted with greasy food which increases absorption and the maximum concentration in plasma (Cmax) by 5 times. Linking with proteins of plasma of-70%, gets in significant amounts into bile, a liver, cerebrospinal fluid, urine, a wall and liquids of cysts of helminths. It is metabolized in a liver with formation of primary metabolite of albendazole of the sulphoxide having anthelminthic activity. Time of achievement of Cmax of albendazole of sulphoxide is 2-5 h. Albendazole sulphoxide is metabolized in albendazole sulphone (secondary metabolite) and other oxidized products.
After reception of a single dose of 400 mg pharmacological an active metabolite – sulphoxide of albendazole reaches plasma concentration from 1.6 to 6.0 µmol/l. Elimination half-life of albendazole makes 8.5 h. It is removed with bile through intestines in the form of albendazole of a sulfoksid and only an insignificant part of its quantity is removed with urine.
At damage of a liver the bioavailability increases, at this Cmax of albendazole of sulphoxide increases twice, and elimination half-life is extended. Induces P450 1A2 cytochrome in cells of a liver of the person.
A pharmacodynamics
Nemozol – antiprotozoan and anthelminthic drug of a broad spectrum of activity, derivative carbamate benzimidazole.
Nemozol breaks processes of transport of glucose, suppresses polymerization beta tubulina, causes disorder of function of the microtubular device in a helminth organism that leads to his death and removal from a human body.
Drug is active against the intestinal parasites causing a skin syndrome of Larva Migrans (syndrome of the wandering larvae)
– Nematodae (roundworms): Ascaris lumbricoides (ascarid), Enterobius vermicularis (pinworm), Ancylostoma duodenale (hookworm), Necator americanus, Strongyloides stercoralis,
– Cestoidea (tape-worms): Hymenolepsis nana (dwarfish tapeworm), Taenia solium (pork tapeworm), Taenia saginata (bull tapeworm),
– Trematodae (flukes): Opisthorchis viverrini, Clonorchis sinensis,
– Pretosae (elementary): Giardia lamblia (intestinal or duodenal).
Nemozol is active against tissue parasites, Echinococcus granulosus and Echinococcus multilocularis defiant cystous and alveolar echinococcosis. Nemozol is effective at treatment of the neurotsistitsirkoz caused by a larval invasion of Taenia solium, the gepatikolez caused by Capilaria philippinensis and a gnatostomoza, caused by Gnathostoma spinigerum invasion. The majority of the drugs used for treatment of an ascaridosis is effective only concerning an intestinal stage of this helminthosis. Nemozol is effective concerning all stages of development of an ascarid, a trichinella. The efficiency is 95–100%.

Indications
– intestinal nematodoses: an ascaridosis, an enterobiosis, a trichuriasis, ankilostomidoz, a strongyloidosis
– fabric nematodoses: a trichinosis, toksokaroz
– fabric tsestodoza: a teniosis, cysticercosis (including neurotsistitsirkoz), a hymenolepiasis, echinococcosis (cystous, an alveococcosis)
– an opisthorchosis, a clonorchosis
– a giardiasis

the Route of administration and doses
take the Drug inside, in time or after meal, do not chew a tablet, wash down with water. Use of laxative drugs and a special diet are not required. It is recommended to carry out simultaneous treatment of all family members. The dose is established individually, depending on a type of helminth and body weight of the patient.

The Ascaridosis, a trichuriasis
Nemozol appoint treatment of intestinal nematodoses to adults and children 12 years in a dose of 400 mg a day once are more senior, if necessary repeat in 3 weeks. Special preparation and a diet is not required.
The enterobiosis
is Enough prescribing of drug in a dose 1 tablet (400 mg) to adults and children 12 years are more senior.
The strongyloidosis
Drug is appointed to adults and children 12 years 1 tablet (400 mg), once within 3 days are more senior.
Ankilostomidoz
Dozy of drug the same, as at treatment of a strongyloidosis.
Treatment of fabric nematodoses
the Trichinosis
of Standard schemes of treatment of a trichinosis does not exist. Treatment is carried out individually taking into account terms of an invasion, its clinical manifestations and also weight of a condition of the patient. Nemozol appoint to children 12 years (weighing more than 60 kg) an average dosage 1 tablet (400 mg) twice in day of reception after a meal within 5 – 10 days are more senior. At a heavy invasion and organ defeats (myocarditis, a pneumonitis, an encephalomeningitis) also glucocorticosteroids and symptomatic means are appointed. The efficiency of treatment is estimated on clinical, laboratory and tool indicators (normalization of temperature, the termination of muscular pains, disappearance of hypostases, normalization of the electrocardiogram, disappearance
of physical and radiological signs of damage of lungs, regression of neurologic symptomatology, decrease in an eosinophilia of blood, etc.).
Toksokaroz
Nemozol appoint to adults and children 12 years (weighing more than 60 kg) an average dosage of 800 mg (2 tablets) in day in 2 receptions after a meal within 5-10 days are more senior. Carrying out repeated courses of treatment at an interval of 2 weeks – month can demand. Side reactions are rare, are shown by slight dispeptic disorders. Increase in level of aminotransferases is extremely seldom observed.
Treatment of fabric tsestodoz
Cystous echinococcosis
Treatment of echinococcosis usually operational. The chemotherapy is carried out in cases of a rupture of cysts and planting of an organism, in the postoperative period when there is a danger of planting at disturbance of integrity of a cyst during operation and also in cases of multiple defeats by cysts of the small sizes (no more than 3-5 cm). Antirecurrent treatment is recommended after operation when it is impossible to exclude existence of other localizations of a parasite of the small sizes. Large cysts it is inexpedient to treat because of inefficiency and a possibility of receiving complications due to disturbance of integrity of a cyst under the influence of drug.
Before prescribing of drug the complete blood count test, biochemical blood test (hepatic, renal tests) is necessary. Treatment is carried out at normal laboratory indicators.
Nemozol appoint in a dose to adults and children 12 years (weighing more than 60 kg) on 400 mg 2 times a day, weighing less than 60 kg are more senior than 15 mg/kg/days of body weight in 2 receptions after a meal. Duration of a course of treatment – 4 weeks.
In the course of treatment each 5–7 days the test of blood and aminotransferases is conducted. At decrease in leukocytes lower than 3.0Õ109/l and 5–6 multiple increases in level of aminotransferases it is necessary to suspend treatment before normalization or considerable improvement of indicators. In cases of the progressing leukopenia and increase in liver enzymes the drug withdrawal is required. Purpose of gepatoprotektor during treatment and in cases of toxic manifestations is ineffective, drug withdrawal is necessary. Treatment of echinococcosis multicourse. Nemazol appoint courses at an interval of 2 weeks-1 month. Duration of treatment of clinically apparent forms of an invasion (presence of cysts) – 28 days.
The efficiency of treatment is estimated at tool control and observation of dynamics of a caption of specific antibodies. At correctly certain indications to prescribing of drug and observance of a dosage and mode of course treatment recovery is observed.
Alveolar echinococcosis
Treatment of alveolar echinococcosis operational. The chemotherapy is an additional tool. Nemozol’s doses and the mode of its appointment same, as well as in cystous echinococcosis. Duration of course treatment is defined by a condition of the patient and tolerance of drug. Full treatment at use only Nemozola does not come.
Cysticercosis
Nemozol is appointed to adults and children 12 years (weighing more than 60 kg) on 400 mg 2 times a day are more senior. Duration of a course is 7–30 days. In 2 days prior to administration of drug and in the first week (sometimes according to indications it is more long) administration of drug appoint glucocorticosteroids (40–50 mg of Prednisolonum). Before treatment, in the course of administration of drug and upon termination of carry out the same control, as at treatment of echinococcosis. Control of efficiency of treatment of cysticercosis of a brain is exercised in clinical parameters and results of a x-ray computer tomography of a brain and a nuclear magnetic resonance. At effective treatment the disappearance and/or calcification of the centers is observed. Quite often carrying out repeated courses of treatment is required. It is necessary to remember what even in cases of good effect of treatment of full regress of clinical symptomatology can not come because of the created permanent structural changes of brain fabric.
The giardiasis
to Adults and children is more senior than 12 years weighing more than 60 kg on 400 mg of 1 times a day within 5 days.
An opisthorchosis
the Maximum daily dose – 800 mg (2 tablets) 3 times a day.

Side effects
According to manifestation frequency side reactions are defined as very frequent (& gt, 1/10), frequent (& gt, 1/100, & lt, 1/10), sometimes (& gt, 1/1000, & lt, 1/100), rare (≥1/10, 000 and & lt, 1/1000), very rare (& lt, 1/10, 000).
Short-term therapy by low doses
Sometimes
– a headache and dizziness
– pain in the field of epigastrium or a stomach, nausea, vomiting and diarrhea
Seldom
– reactions of hypersensitivity, including rash, an itching and urticaria
– increase in level of liver enzymes
is Very rare
– a multiformny erythema, Stephenson-Johnson’s syndrome
Long-term therapy by high doses
Very often
– a headache
– slight or average increase of level of hepatic enzymes
Is frequent
– dizziness
– an abdominal pain, nausea, vomiting and diarrhea (at treatment of echinococcosis)
– a reversible alopecia (poredeniye and moderate loss of hair)
– fever
Sometimes
– reactions of hypersensitivity, including rash, an itching and urticaria
– a leukopenia
– hepatitis
Very seldom
– the pancytopenia, aplastic anemia, an agranulocytosis
Patients with liver pathology, including hepatic echinococcosis, are more predisposed to suppression of a funtskiya of marrow.
– the multiformny erythema, Stephenson-Johnson’s syndrome

of the Contraindication
– hypersensitivity to an albendazol and other components of medicine
– eye retina pathology
– pregnancy and the period of a lactation
– children’s age up to 12 years

Medicinal interactions
Tsimetedin, a praziquantel and dexamethasone increase plasma levels of a metabolite of an albendazol responsible for system efficiency of a product.
Ritonavir, Phenytoinum, carbamazepine and phenobarbital can potentially reduce plasma concentration of an active metabolite of an albendazol – an albendazol of sulphoxide. The clinical value of this fact is unknown, however can affect Nemozol’s efficiency, especially at treatment of system helminthoses. Patients have to be under observation of the doctor regarding efficiency of treatment that can demand purpose of the alternative mode of dosing or revision of the carried-out therapy.

Special instructions
Perhaps weak or moderate increase in level of hepatic enzymes which are normalized after the termination of reception of Nemozol. Definition of indicators of function of a liver has to is carried out before each cycle of treatment and each two weeks during treatment. If indicators of transaminases increase twice and more, Nemozol it is necessary to cancel. Treatment is repeated when indicators of function of a liver are normalized.
Nemozol can cause reversible moderate lowering of total number of leukocytes. Blood tests have to be made at the beginning and each two weeks during each 28-day cycle. At development of a leukopenia, drug should be cancelled. In the course of short courses of treatment the control of peripheral blood (once in 5–7 days) and aminotransferases in the same terms is necessary.
If necessary patients with neurocysticercosis, have to receive the complex therapy including steroids and antikonvulsant. In diseases of eyes before an initiation of treatment the eye retina research is necessary. In eye cysticercosis the antiparasitic treatment is contraindicated because of a possibility of heavy complications (amotio of a retina) and development of a blindness.
To avoid Nemozol’s reception in early pregnancy, women of childbearing age have to carry out treatment in the first week after periods or after the negative test for pregnancy. It is necessary to take contraception measures during treatment and within one month after completion of administration of drug in system helminthosis.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
does not influence.

Overdose
Symptoms are not described.

The form of release and packing
On 1 tablet place in blister strip packaging from aluminum foil.
On 1 blister strip packaging together with the instruction for use in the state and Russian languages place in a cardboard pack.
On 10 packs place in a group cardboard box.

To Store storage conditions in the dry, protected from light place at a temperature not over 250C. To store out of children’s reach!

3 years
not to apply a period of storage after expiry date.

Prescription status
According to the prescription

Ipca laboratories Limited Producer, India
48, Kandivili Ind. Estate, Mumbai 400067, India

the Owner of the registration certificate
of “Ipca laboratories Limited”, India
the Address of the organization accepting claims for territories of the Republic of Kazakhstan from consumers on quality produktsiig. Almaty, Kurmangaza St., 48 and, office 10 of ph.: 261-51-41факс:
To Develop 261-44-66regulatory@kazeuropharm.com

Additional information