The instruction for medical use of ALBEZOL® medicine Trade name АЛЬБЕЗОЛ® the International unlicensed name Albendazol Lekarstvennaya a form of the Tablet of 400 mg Structure One tablet contains active agent – albendazol 400 mg, excipients: lactoses monohydrate, starch corn, K 30 polyvinylpirrolidone (PVP K30), sodium lauryl sulfate, sodium saccharin, gland (III) oxide red (E172), sodium of starch glikolit type A (Explotab), cellulose microcrystalline PH 102, dense vanilla fragrance, orange fragrance, magnesium stearate the Description of the Tablet of an oval form, with a biconvex surface, mramorno – pink color, from risky on one party 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 albendazol 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 an albendazol of the sulphoxide having anthelminthic activity. Time of achievement of Cmax of an albendazol of sulphoxide is 2-5 h Albendazol sulphoxide sulphone (secondary metabolite) and other oxidized products is metabolized in an albendazol. After reception of a single dose of 400 mg pharmacological an active metabolite – sulphoxide of an albendazol reaches plasma concentration from 1.6 to 6.0 µmol/l. Elimination half-life of an albendazol makes 8.5 h. It is removed with bile through intestines in the form of an albendazol 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 an albendazol of sulphoxide increases twice, and elimination half-life is extended. Induces P450 1A2 cytochrome in cells of a liver of the person. Pharmacodynamics АЛЬБЕЗОЛ® – antiprotozoan and anthelminthic drug of a broad spectrum of activity, derivative carbamate benzimidazole. АЛЬБЕЗОЛ® 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), Trichocephalus trichiuris (threadworm), Enterobius vermicularis (pinworm), Ancylostoma duodenale (hookworm), Necator americanus, Strongyloides stercoralis, – Cestoidea (tape-worms): Hymenolepsis nana (dwarfish tapeworm), Taenia saginata (bull tapeworm), – Pretosae (elementary): Giardia lamblia (intestinal or duodenal). АЛЬБЕЗОЛ® it is active against tissue parasites, Echinococcus granulosus and Echinococcus multilocularis defiant cystous and alveolar echinococcosis. АЛЬБЕЗОЛ® it is effective at treatment, the gepatikolez caused by Capilaria philippinensis. The majority of the drugs used for treatment of an ascaridosis are effective only concerning an intestinal stage of this helminthosis. АЛЬБЕЗОЛ® it is effective at all stages of development of an ascarid, a trichinella. The efficiency is 95–100%. Indications – an enterobiosis, – ankilostomidoz and a necatoriasis, – a hymenolepiasis, – a teniosis, – a strongyloidosis, – an ascaridosis, – a trichuriasis, – a skin syndrome of Larva Migrans, – a giardiasis, – cystous echinococcosis (hepatic, alveolar, peritoneal), – a trichinosis 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 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. For patients who are not able to swallow a tablet entirely it is recommended to crush it and to wash down with a small amount of liquid Intestinal infections and a skin syndrome of Larva Migrans the Infection Age reception Duration the Enterobiosis, ankilostomidoz, a necatoriasis, an ascaridosis, pinworms, a trichuriasis Adult 400 mg of 1 times/days (1 tablet) once the Strongyloidosis, a teniosis, a hymenolepiasis Adult 400 mg of 1 times/days (1 tablet) within 3 days. In a hymenolepiasis the repeated course of treatment lasting from 10 days up to 21 days is recommended. A skin syndrome of Larva Migrans Adult 400 mg (1 tablet) of 1 times a day. Duration of reception is from 1 day up to 3 days. A giardiasis Adult 400 mg (1 tablet) of 1 times a day within 5-7 days. Elderly patients Experience of use for patients are more senior than 65 years is limited. Correction of a dose is not required, however patients should be careful when assigning with abnormal liver functions. A renal failure As removal of an albendazol and its primary metabolite, albendazol sulphoxide, slightly, influence of renal pathology on renal clearance is improbable. However at patients with a renal failure it is necessary to carry out monitoring of function of kidneys when prescribing the drug Albezol®. The liver failure Because albendazol it is quickly metabolized by means of hepatic metabolism to primary metabolite albendazol sulphoxide, an abnormal liver function has considerable impact on pharmacokinetics albendazol sulphoxide. Patients with disturbance of indicators of hepatic tests (transamins) have to be carefully examined until prescribing of the drug Albezol®. System gelmintny infections (long treatment is carried out by higher doses). The mode of dosing is set individually depending on age, body weight and also from severity of an infection. The dose for patients at body weight more than 60 kg makes 400 mg (1 tablet) 2 times a day. Weighing less than 60 kg drug is appointed at the rate of 15 mg/kg / in day. This dose has to be divided into 2 receptions. The maximum daily dose makes 800 mg. The infection reception Duration Cystous echinococcosis the Course of treatment makes 28 days. At an inoperable form of peritoneal cysts, cysts in lungs and in a liver, three 28-day cycles of treatment divided by a 14-day break in administration of drug are recommended. In the presence of cysts in a brain and bones longer course of therapy can be required. Before operation two 28-day cycles divided by a 14-day break in administration of drug are recommended. If surgical treatment is necessary before the termination of a two-cyclic course, then АЛЬБЕЗОЛ® has to be accepted before operation. If the presurgical course is less than 14 days or viable cysts are found, then after operation carry out two cycles for 28 days divided by a 14-day break in administration of drug. Alveolar echinococcosis of 28 days. The second 28-dnevny year is repeated after a two-week break in administration of drug. Treatment can be continued within several months or years. The trichinosis of 400 mg 2 times a day a course of 5-10 days, if necessary treatment can be continued. 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, Stephens-Johnson’s syndrome Long-term therapy by high doses Very often – a headache, – slight or moderate increase of level of hepatic enzymes Is frequent – dizziness, – the 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 – a pancytopenia, aplastic anemia, an agranulocytosis (patients with liver pathology, including hepatic echinococcosis, are more predisposed to suppression of function of marrow), – a multiformny erythema, Stephens-Johnson’s syndrome of the Contraindication – hypersensitivity to an albendazol and other components of medicine, – eye retina pathology, – intolerance of a galactose, insufficiency of Lappa lactase, malabsorption of a glucose/galactose, – pregnancy and the period of a lactation, – children’s and teenage age up to 18 years Medicinal interactions Cimetidinum, a praziquantel and dexamethasone increase plasma levels of a metabolite of an albendazol responsible for system efficiency of a product. Increase in concentration of an albendazol in bile and in an echinococcal cyst is revealed at simultaneous use with Cimetidinum. 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 efficiency of the drug ALBEZOL®, 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 to avoid reception АЛЬБЕЗОЛ® in the early stages of 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. Perhaps weak or moderate increase in level of hepatic enzymes which are normalized after the termination of administration of drug АЛЬБЕЗОЛ®. Definition of indicators of function of a liver has to be carried out before each cycle of treatment and each two weeks during treatment. If indicators of transaminases increase twice and more, АЛЬБЕЗОЛ® it is necessary to cancel. Treatment is repeated when indicators of function of a liver are normalized. АЛЬБЕЗОЛ® can cause suppression of function of marrow in this connection, blood tests need to be controlled at the beginning and every two weeks each 28-day cycle. Patients with liver diseases, including hepatic echinococcosis, have more expressed tendency to suppression of marrow conducting to a pancytopenia, aplastic anemia, an agranulocytosis and a leukopenia that demands careful monitoring of a picture of blood. At clinically significant decrease in level of uniform elements of blood, АЛЬБЕЗОЛ® it is necessary to cancel. 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. Administration of drug АЛЬБЕЗОЛ® for treatment of system gelmintny infections can cause the attacks of spasms, increase in intracranial pressure and focal symptomatology connected with death of parasites. In this case it is necessary to begin immediately treatment with steroids and antikonvulsant. At damage of eyes before an initiation of treatment the eye retina research is necessary. It is necessary to appoint drug with care sick diabetes. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Considering a possibility of development of such side effects as dizziness, it is necessary to be careful when driving, and performance of work demanding exact coordination of movements. Overdose Symptoms: so far cases of overdose of drug are not described. Treatment: gastric lavage, intake of activated carbon. The form of release and packing On 1 or 6 tablets place in blister strip packaging from a transparent film of PVH/PE/PVDH and printing aluminum foil. On 1 (for 1 tablet) or 5 or 10 (for 6 tablets) planimetric packings together with the instruction for medical use in the state and Russian languages place in a pack cardboard with the hologram of firm – producer. To Store storage conditions at a temperature not over 25 of 0C, in the dry, protected from light place. To store out of children’s reach! A period of storage 3 years not to apply after expiry date Prescription status According to the prescription Republic of Kazakhstan JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer, Almaty, Shevchenko St. 162 E. The owner of the registration certificate of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika the Republic of Kazakhstan the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) and responsible for post-registration observation of safety of medicine: JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Republic of Kazakhstan, Almaty, Shevchenko St. 162 E.
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