Aldazol film-coated tablets 400 mg blister No. 3

Instructions Aldazol film-coated tablets 400 mg blister No. 3

Composition

active ingredient: albendazole;

1 tablet contains 400 mg of albendazole;

excipients: corn starch, sodium lauryl sulfate, povidone, gelatin, talc, colloidal anhydrous silicon dioxide, sodium starch glycolate (type A), magnesium stearate;

shell: Opadry II White film coating mixture (hydroxypropylmethylcellulose, lactose monohydrate, polyethylene glycol, titanium dioxide (E 171), triacetin).

Dosage form

Film-coated tablets.

Main physicochemical properties: round tablets with a biconvex surface, coated with a white or almost white film coating.

Pharmacotherapeutic group

Anthelmintic agents. Agents used in nematodoses. Benzimidazole derivatives. ATC code P02C A03.

Pharmacological properties

Pharmacodynamics.

Albendazole is an antiprotozoal and anthelmintic drug from the benzimidazole carbomate group. The drug acts on both intestinal and tissue parasites in the form of eggs, larvae and adult helminths. The anthelmintic effect of albendazole is due to the inhibition of tubulin polymerization, which leads to metabolic disorders and the death of helminths.

Albendazole is active against the following intestinal parasites: nematodes - Ascaris lumbricoides, Trichuris trichiura, Enterobius vermicularis, Ancylostoma duodenale, Necator americanus, Strongyloides stercoralis, Cutaneus Larva Migrans; cestodes - Hymenolepsis nana, Taenia solium, Taenia saginata; trematodes - Opisthorchis viverrini, Clonorchis sinensis; protozoa - Giardia lamblia (intestinalis or duodenalis).

Albendazole is active against tissue parasites, including cystic and alveolar echinococcosis caused by Echinococcosus granulosus and Echinococcosus multilocularis, respectively. Albendazole is effective in the treatment of neurocysticercosis caused by larval Taenia solium, capillariasis caused by Capillaria philippinensis, and gnathostomiasis caused by Gnathostoma spinigerum.

Albendazole destroys cysts or significantly reduces their size (up to 80%) in patients with granular echinococcosis. After treatment with albendazole, the number of nonviable cysts increases to 90% compared with 10% in untreated patients. After the use of albendazole for the treatment of cysts caused by Echinococcus multilocularis, complete recovery was observed in a minority of patients, and in the majority - improvement or stabilization of the condition.

Pharmacokinetics.

When taken orally, albendazole is poorly absorbed (less than 5%). Systemic action increases if the dose of the drug is taken with fatty food, which increases the absorption of the drug by 5 times. It is rapidly metabolized in the liver during the first pass. The main metabolite is albendazole sulfate, which is the main effective substance in the treatment of tissue infections. The half-life is 8.5 hours. Albendazole sulfate and its metabolites are mainly excreted in the bile and only a small part in the urine. It has been established that with prolonged use of the drug in high doses, its elimination from cysts lasts several weeks.

Indication

Intestinal forms of helminthiasis and cutaneous syndrome Larva Migrans (short-term treatment with low doses): enterobiasis, hookworm and necatoriasis, hymenolepidosis, teniasis, strongyloidiasis, ascariasis, trichocephalosis, clonorchiasis, opisthorchiasis, cutaneous syndrome Larva Migrans, giardiasis in children.

Systemic helminth infections (long-term treatment with high doses):

cystic echinococcosis (caused by Echinococcus granulosus):

if surgical intervention is not possible;

before surgery;

after surgery, if preoperative treatment was short, when helminths are prevalent or live forms were found during surgery;

after percutaneous cyst drainage for diagnostic or therapeutic purposes;

Alveolar echinococcosis (caused by Echinococcus multiocularis):

in inoperable disease, particularly in cases of local or distant metastases;

after palliative surgery;

after radical surgery or liver transplantation;

Neurocysticercosis (caused by Taenia solium larvae):

in the presence of single or multiple cysts or granulomatous brain lesions;

with arachnoid or intraventricular cysts;

with racemose cysts;

capillariasis (caused by Capillaria philippinensis), gnathostomiasis (caused by Gnathostoma spinigerum and related species), trichinosis (caused by Trichinella spiralis and T. pseudospiralis), toxocariasis (caused by Toxocara canis and related species).

Contraindication

Hypersensitivity to albendazole or to any component of the drug.

Pregnancy and breastfeeding.

Contraindicated in women planning to become pregnant. Women of reproductive age should use effective non-hormonal contraceptives during and for 1 month after treatment with the drug.

Interaction with other medicinal products and other types of interactions

Drugs that may slightly reduce the effectiveness of albendazole: anticonvulsants (e.g. phenytoin, fosphenytoin, carbamazepine, phenobarbital, primidone), levomizol, ritonavir. Patients should be monitored for efficacy and alternative dosing regimens or therapies may be required.

Cimetidine, praziquantel and dexamethasone increase plasma levels of the albendazole metabolite, which is responsible for the systemic activity of the drug, which, in turn, may lead to an increase in the level of adverse reactions.

Grapefruit juice also increases the plasma levels of albendazole sulfoxide.

Due to possible disruption of cytochrome P450 activity, there is a theoretical risk of interaction with the following drugs: oral contraceptives, anticoagulants, oral hypoglycemic agents, theophylline.

Application features

Treatment of intestinal forms of helminthiasis and cutaneous syndrome Larva Migrans.

To prevent Aldazole from being taken during early pregnancy, women of reproductive age should be treated in the first week of menstruation or after a negative pregnancy test. Reliable contraception is required during treatment.

Treatment with albendazole may reveal pre-existing neurocysticercosis, especially in areas with high levels of infection with Tenia solium strains. Patients may develop neurological symptoms, such as seizures, increased intracranial pressure, and focal symptoms due to the inflammatory response caused by the death of the parasites in the brain. Symptoms may occur rapidly after treatment, so appropriate therapy with corticosteroids and anticonvulsants should be initiated immediately.

Treatment of systemic helminth infections.

Albendazole treatment is associated with mild to moderate elevations in liver enzymes, which usually return to normal after discontinuation of treatment. Cases of hepatitis have been reported. Therefore, liver enzymes should be monitored before each course of treatment and at least every 2 weeks during treatment. If liver enzymes are significantly elevated (more than 2 times the upper limit of normal), albendazole treatment should be discontinued. Treatment may be resumed after enzyme levels have returned to normal, but the patient should be closely monitored.

Albendazole can cause bone marrow suppression, so the patient's blood tests should be performed both at the beginning of treatment and every 2 weeks during the 28-day cycle. Patients with liver disease, including hepatic echinococcosis, are more prone to bone marrow suppression, resulting in pancytopenia, aplastic anemia, agranulocytosis and leukemia, which necessitates careful monitoring of blood counts. In the event of a significant decrease in blood counts, treatment should be discontinued (see sections "Method of administration and dosage" and "Adverse reactions").

To avoid taking albendazole during early pregnancy, women of reproductive age should:

start treatment only after a negative pregnancy test;

use effective contraception during treatment with the drug and for a month after its discontinuation.

Patients with neurocysticercosis treated with albendazole may experience symptoms (e.g., seizures, increased intracranial pressure, and focal symptoms) related to the inflammatory response caused by the death of the parasites. Such adverse reactions should be treated with corticosteroids and anticonvulsants. Oral or intravenous corticosteroids are recommended to prevent cases of increased cerebral pressure during the first week of treatment.

Albendazole treatment may also reveal pre-existing neurocysticercosis, especially in areas with high levels of infection with Tenia solium strains. Patients may develop neurological symptoms, such as seizures, increased intracranial pressure, and focal symptoms due to the inflammatory response caused by the death of the parasites in the brain. Symptoms may occur rapidly after treatment, so appropriate therapy with corticosteroids and anticonvulsants should be initiated immediately.

This medicinal product contains lactose and should not be administered to patients with rare hereditary forms of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Use during pregnancy or breastfeeding

The drug is contraindicated for use during pregnancy or breastfeeding and for the treatment of women planning to become pregnant (see section "Contraindications").

Ability to influence reaction speed when driving vehicles or other mechanisms

Given the presence of such a side effect as dizziness, it is recommended to refrain from driving or operating other mechanisms during the period of use of albendazole.

Method of administration and doses

Intestinal infections and cutaneous Larva Migrans syndrome.

Some patients, especially children, may have difficulty swallowing a whole tablet - in this case, the tablet can be chewed with a small amount of water or crushed.

For use in adults and children aged 3 years and over.

* For children aged 2 to 3 years, use other dosage forms of albendazole.

Elderly patients. Experience in the use of the drug in the treatment of elderly patients is limited. No dose adjustment is required, however, albendazole should be used with caution in the treatment of elderly patients with impaired liver function.

Renal failure. Since albendazole is excreted by the kidneys in very small quantities, dose adjustment is not required for the treatment of this category of patients, however, if there are signs of renal failure, such patients should be closely monitored.

Hepatic impairment: Since albendazole is extensively metabolized in the liver to a pharmacologically active metabolite, hepatic impairment may have a significant effect on its pharmacokinetics. Therefore, patients with altered liver function (elevated transaminases) at the beginning of albendazole therapy should be closely monitored.

Systemic helminth infections (long-term treatment with high doses).

Take the drug with food.

For use in adults and children aged 6 years and over.

It is not recommended to prescribe the drug in high doses to children under 6 years of age. The dosage regimen is set individually by the doctor depending on age, body weight, and the severity of the infection.

The dose for patients with a body weight of more than 60 kg is 400 mg (1 tablet) 2 times a day. For patients with a body weight of less than 60 kg, the drug is prescribed at the rate of 15 mg/kg/day. This dose should be divided into 2 doses. The maximum daily dose is 800 mg.

** Appropriate corticosteroid and anticonvulsant therapy should be administered when treating patients with neurocysticercosis. Oral and intravenous corticosteroids are recommended to prevent the onset of cerebral hypertension during the first week of treatment.

Elderly patients. Experience in the use of the drug in the treatment of elderly patients is limited. No dose adjustment is required, however, albendazole should be used with caution in the treatment of elderly patients with impaired liver function.

Renal failure. Since albendazole is excreted by the kidneys in very small quantities, dose adjustment is not required for the treatment of this category of patients, however, if there are signs of renal failure, such patients should be closely monitored.

Hepatic impairment. Since albendazole is extensively metabolized in the liver to a pharmacologically active metabolite, hepatic impairment may have a significant effect on its pharmacokinetics. Therefore, patients with altered liver function (increased transaminase levels) should be carefully monitored at the start of albendazole treatment - in the event of a significant increase in transaminase levels or a clinically significant decrease in blood counts, treatment should be discontinued (see sections "Special warnings and precautions for use" and "Adverse reactions").

Children

The medicine is intended for use in children aged 3 years and over.

For the treatment of children aged 2 to 3 years, other dosage forms of albendazole should be used.

Use in children according to the recommendations in the "Method of administration and dosage" section.

Overdose

Symptoms: Depending on the dose of the drug taken, overdose may cause diarrhea, nausea, vomiting, tachycardia, and increased transaminase levels.

Treatment: symptomatic, according to the clinical condition.

Side effects

Side effects occurring during short-term treatment of intestinal infections and cutaneous syndrome Larva Migrans.

Immune system disorders: hypersensitivity reactions including rash, pruritus and urticaria.

Nervous system: headache and dizziness.

Gastrointestinal: upper gastrointestinal symptoms (e.g. epigastric pain, nausea, vomiting) and diarrhea.

On the part of the hepatobiliary system: increased levels of liver enzymes.

Skin and subcutaneous tissue disorders: erythema multiforme, Stevens-Johnson syndrome.

Side effects that occur during long-term treatment of systemic helminth infections.

From the blood and lymphatic system: leukopenia, pancytopenia, aplastic anemia, agranulocytosis.

Patients with liver disease, including hepatic echinococcosis, are more susceptible to bone marrow suppression (see sections “Method of administration and dosage” and “Special warnings and precautions for use”).

Immune system disorders: hypersensitivity reactions including rash, pruritus and urticaria.

From the nervous system: headache, dizziness.

Gastrointestinal: Gastrointestinal disorders (abdominal pain, nausea, vomiting). These phenomena are associated with the treatment of patients with echinococcosis with albendazole.

Hepatobiliary system: mild to moderate elevation of liver enzymes, hepatitis.

Skin and subcutaneous tissue disorders: reversible alopecia (hair thinning and moderate hair loss), erythema multiforme, Stevens-Johnson syndrome.

General disorders: fever.

Expiration date

4 years.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging

3 tablets in a blister; 1 blister in a pack.

Vacation category

According to the recipe.

Producer

JSC "KYIV VITAMIN FACTORY".

Address

04073, Ukraine, Kyiv, Kopylivska St., 38.

Website: www.vitamin.com.ua.