the International unlicensed
name Albendazole Dosage Form of the Tablet of 400 mg
One tablet contains
active agent albendazole of 400 mg,
excipients: lactoses monohydrate, starch corn, K 30 polyvinylpirrolidone (PVP K30), sodium lauryl sulfate, sodium saccharin, gland (III) oxide red, sodium of starch glikolit type A (Explotab), cellulose microcrystalline PH 102, dense vanilla fragrance, orange fragrance, magnesium stearate
of the Tablet of oblong shape, with a biconvex surface, mramorno – pink color, from risky on one party
Anthelminthic drugs. Drugs for treatment of a nematodosis. Benzimidazole derivatives.
The ATX P02CA03 code
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.
ALBEZOL pharmacodynamics – antiprotozoan and anthelminthic drug of a broad spectrum of activity, derivative carbamate benzimidazole.
ALBEZOL 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, Trichinella spiralis,
– Cestoidea (tape-worms): Hymenolepsis nana (dwarfish tapeworm), Taenia solium (pork tapeworm), Taenia saginata (bull tapeworm),
– Trematodae (flukes): Opisthorchius viverrini, Clonorchis sinensis,
– Pretosae (elementary): Giardia lamblia (intestinal or duodenal).
ALBEZOL is active against tissue parasites, Echinococcus granulosus and Echinococcus multilocularis defiant cystous and alveolar echinococcosis of ALBEZOL 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. ALBEZOL is effective concerning all stages of development of an ascarid, a trichinella. The efficiency is 95100%.
– an enterobiosis
– ankilostomidoz and a necatoriasis
– a hymenolepiasis
– a teniosis
– a strongyloidosis
– an ascaridosis
– a trichuriasis
– a clonorchosis
– an opisthorchosis
– a skin syndrome of Larva Migrans
– a giardiasis at children
– cystous echinococcosis
– alveolar echinococcosis
– 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 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. 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 Enterobiosis, ankilostomidoz, nekatorioz,
an ascaridosis, pinworms,
400 mg of 1 times/days (1 tablet) once
the Strongyloidosis, a teniosis, a hymenolepiasis
400 mg of 1 times/days (1 tablet) within 3 days.
At a hymenolepiasis the repeated course of treatment lasting from 10 days up to 21 days is recommended.
A clonorchosis, an opisthorchosis
1 tablet a day within 3 days.
A skin syndrome of Larva Migrans
1 tablet of 1 times a day. Duration of reception is from 1 day up to 3 days.
System gelmintny infections
(long treatment 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.
28 days. At an inoperable form three 28-day cycles of treatment divided by a 14-day break in administration of drug are recommended.
Before operation two 28-day cycles divided by a 14-day break in administration of drug are recommended. 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.
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.
Duration of reception is from 7 days up to 31 days. The second year can be repeated after a two-week break in administration of drug.
of 400 mg of 1 times a day within 10 days
of 400 mg of 1 times a day within 10-20 days
the Trichinosis, toksokaroz
400 mg 2 times a day a course of 5-10 days
– allergic reactions: rash, an itching, urticaria, an erythema, including Stephens’s syndrome – Johnson
– a headache, dizziness
– nausea, vomiting, an abdominal pain, diarrhea
– increase in level of hepatic enzymes, hepatitis
– a leukopenia, a pancytopenia
– increase in arterial blood pressure
the Contraindication renal failure
– 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
Cimetidinum, a praziquantel and dexamethasone increase plasma levels of a metabolite of the albendazole responsible for system efficiency of a product. Increase in concentration of albendazole in bile and in echinococcal cysts is revealed at simultaneous use with Cimetidinum.
to avoid reception ALBEZOLA during 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.
Perhaps weak or moderate increase in level of hepatic enzymes which are normalized after the termination of reception ALBEZOLA. 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, ALBEZOL needs to be cancelled. Treatment is repeated when indicators of function of a liver are normalized.
ALBEZOL 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 57 days) and aminotransferases in the same terms is necessary.
If necessary patients with neurotsistitsirkozy, 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.
With care to appoint sick diabetes.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
does not influence.
Symptoms: so far cases of overdose of drug are not described.
Treatment: in case of overdose – gastric lavage, intake of activated carbon.
The form of release and packing
On 1 tablet place in blister strip packaging from a formatura aluminum / films of transparent PVH/PE/PVDH and printing aluminum foil.
1 planimetric packing together with the instruction for medical use in the state and Russian languages is placed in a pack cardboard with the hologram of firm of the producer.
In the dry, protected from light place at a temperature not over 25 of 0C.
To store out of children’s reach!
A period of storage
not to apply after the storage expiration
According to the prescription
JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Respublika Kazakhstan Producer,
Almaty, Shevchenko St. 162 E.