Instructions for Albendazole chewable tablets 400 mg No. 3
Composition
active ingredient: albendazole;
1 chewable tablet contains 400 mg of albendazole;
excipients: corn starch, microcrystalline cellulose, sodium starch glycolate, colloidal anhydrous silicon dioxide, orange flavor, aspartame, talc, magnesium stearate.
Pharmaceutical form
Chewable tablets.
Main physicochemical properties: tablets from almost white to gray in color, flat-cylindrical, with a bevel.
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; cystodes - Hymenolepis 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 Echinococcus granulosus and Echinococcus 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 to destroy 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. After internal use, the drug is poorly absorbed (up to 5%) from the digestive tract. Simultaneous use with fatty food increases the absorption of the drug approximately 5 times.
Albendazole is rapidly metabolized in the liver during first-pass metabolism. The main metabolite, albendazole sulfate, retains half the pharmacological activity of the parent compound.
The half-life of albendazole sulfate from blood plasma is approximately 8.5 hours. Albendazole sulfate and other metabolites are excreted mainly in the bile, and only a small part is excreted in the urine. After prolonged use of the drug in high doses, its excretion from the 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, 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, if helminths are prevalent or live forms were found during surgery;
- after percutaneous drainage of cysts for diagnostic or therapeutic purposes;
- alveolar echinococcosis (caused by Echinococcus multilocularis):
- 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;
- capillarosis (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, other benzylidazole derivatives, to other components of the drug. Retinal diseases. Pregnancy and breastfeeding. One menstrual cycle before planned pregnancy. Women of reproductive age should use effective non-hormonal contraceptives during and for 1 month after treatment with the drug. Phenylketonuria.
Interaction with other medicinal products and other types of interactions
Albendazole induces enzymes of the cytochrome P450 system.
When used simultaneously with cimetidine, praziquantel and dexamethasone, an increase in the level of albendazole metabolites in the blood plasma is possible, which may cause its overdose.
Patients should be monitored for treatment effectiveness and alternative dosing regimens or therapies may be necessary.
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.
When albendazole is used simultaneously with theophylline, theophylline levels in the blood should be monitored.
Simultaneous administration of the drug and fatty food leads to increased absorption of albendazole from the digestive tract.
Application features
Short-term treatment of intestinal infections and cutaneous syndrome Larva Migrans.
To prevent Albendazole use during early pregnancy, women of reproductive age should be treated in the first week after menstruation or after a negative pregnancy test. Reliable contraception is required during therapy.
Treatment with albendazole may reveal pre-existing neurocysticercosis, especially in areas with high levels of infection with Taenia solium strains. Patients may develop neurological symptoms, such as seizures, increased intracranial pressure, and focal symptoms due to the inflammatory reaction caused by the death of the parasites in the brain. Symptoms may occur immediately after treatment, so appropriate therapy with corticosteroids and anticonvulsants should be initiated immediately.
Long-term 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. Therefore, liver enzymes should be monitored before each course of treatment and at least every 2 weeks during treatment. If liver enzymes increase significantly (more than 2 times the upper limit of normal), albendazole treatment should be discontinued. Treatment may be resumed after normalization of the enzymes, but the patient should be closely monitored.
Albendazole may 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. If a significant decrease in blood counts occurs, treatment should be discontinued.
To prevent the use of Albendazole in 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. This should be treated with corticosteroids and anticonvulsants. Oral or intravenous corticosteroids are recommended to prevent increased cerebral pressure during the first week of treatment.
Albendazole treatment 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.
This medicinal product contains 9.7 mg of sodium starch glycolate per tablet. Caution should be exercised when used in patients on a controlled sodium diet.
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.
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.
The medicine is taken with food. It is advisable to take it at the same time of day. If there is no improvement after three weeks, a second course of treatment is prescribed.
The tablet can be chewed or crushed and taken with a small amount of water.
Infection // Age // Duration of treatment:
Enterobiasis, hookworm, necatoriasis, ascariasis, trichocephalosis // Adults and children over 3 years of age // 400 mg once a day (1 tablet) once.
For hymenolepidosis // a repeated course of treatment is recommended in the interval from the 10th to the 21st day after the previous course.
Clonorchiasis, opisthorchiasis // Adults and children over 3 years of age // 400 mg (1 tablet) 2 times a day for 3 days.
Cutaneous Larva Migrans Syndrome // Adults and children aged 3 years and over // 400 mg (1 tablet) once a day for 1–3 days.
Giardiasis // Children from 3 to 12 years old // 400 mg (1 tablet) once a day for 5 days.
Systemic helminth infections (long-term treatment with high doses).
The medicine is taken with food.
For use in adults and children aged 6 years and over.
High doses of the drug are not recommended for children under 6 years of age. The dosage regimen is set individually 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. 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.
Infection // Duration of treatment:
Cystic echinococcosis // 28 days. The 28-day cycle can be repeated (a total of 3 times) after a 14-day break.
Inoperable and multiple cysts. Up to three 28-day cycles for the treatment of hepatic, pulmonary and peritoneal cysts. For cysts in other locations (bone or brain), longer treatment may be required.
Before surgery: Two 28-day cycles are recommended before surgery. If surgery is to be performed before these cycles are completed, treatment should be continued as long as possible before surgery.
After surgery.
After percutaneous cyst drainage. If a short course of treatment (less than 14 days) was received before surgery or if emergency surgery was performed, two 28-day cycles are administered after surgery, separated by a 14-day break.
Similarly, if viable cysts are found or helminth dissemination has occurred, two full cycles of treatment are performed.
Alveolar echinococcosis // 28 days. A second 28-day course is repeated after a two-week break. Treatment can be continued for several months or years.
Neurocysticercosis* // Duration of treatment is from 7 to 30 days. The second course can be repeated after a two-week break.
Parenchymal cysts and granulomas // The usual duration of treatment is from 7 days (minimum) to 28 days.
Arachnoid and intragastric cysts // The usual course of treatment is 28 days.
Racemic cysts // The usual course of treatment is 28 days. The course may last longer. The duration of treatment is determined by the clinical and radiological response to treatment.
* Appropriate corticosteroid and anticonvulsant therapy should be administered in patients with neurocysticercosis. Oral and intravenous corticosteroids are recommended to prevent the onset of cerebral hypertension during the first week of treatment.
Infection // Doses and duration of administration:
Capillariasis 400 mg once a day for 10 days**.
Gnathostomiasis 400 mg once daily for 10–20 days**.
Trichinellosis, toxocariasis 400 mg 2 times a day for 5–10 days**.
**Usually one course of treatment is required, but further courses may be required if parasitological examination results remain positive.
Elderly patients
Experience with the drug in the treatment of the elderly is limited. No dose adjustment is required, however, albendazole should be used with caution in the treatment of elderly patients with impaired liver function.
Kidney failure
Since albendazole is excreted by the kidneys in very small amounts, 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.
Liver failure
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 use should be carefully monitored - in the event of a significant increase in transaminases or clinically significant changes in blood parameters, treatment should be discontinued.
Children.
The drug is contraindicated for the treatment of children under 3 years of age in this dosage form. For the treatment of children aged 2 to 3 years, another dosage form is recommended - a suspension for oral administration.
Overdose
Symptoms: nausea, vomiting, diarrhea, tachycardia, drowsiness, visual disturbances, visual hallucinations, speech disorders, dizziness, loss of consciousness, liver enlargement, increased transaminase levels, jaundice; respiratory distress, brown-red or orange discoloration of the skin, urine, sweat, saliva, tears and feces in proportion to the dose of the drug used.
Treatment: gastric lavage and symptomatic and supportive therapy are used.
Adverse reactions
Adverse reactions were classified according to their frequency of occurrence.
The following classification of the frequency of adverse reactions is used: very common (≥ 1/10); common (≥ 1/100 and < 1/10); uncommon (≥ 1/1000 and < 1/100); rare (≥ 1/10000 and < 1/1000) and very rare (< 1/10000).
Side effects occurring during short-term treatment of intestinal infections and cutaneous syndrome Larva Migrans.
Rare: hypersensitivity reactions including rash, itching and urticaria.
Nervous system.
Uncommon: headache and dizziness.
Gastrointestinal tract.
Uncommon: upper gastrointestinal symptoms (e.g. epigastric pain, nausea, vomiting) and diarrhoea.
Hepatobiliary system.
Rare: increased liver enzymes.
Skin and subcutaneous tissue.
Very rare: erythema multiforme, Stevens-Johnson syndrome.
Side effects that occur during long-term treatment of systemic helminth infections.
Blood and lymphatic system.
Uncommon: leukopenia.
Very rare: pancytopenia, aplastic anemia, agranulocytosis.
Patients with liver disease, including hepatic echinococcosis, are more prone to bone marrow suppression.
Immune system.
Uncommon: hypersensitivity reactions including rash, pruritus and urticaria.
Nervous system.
Very common: headache.
Common: dizziness.
Gastrointestinal tract.
Common: gastrointestinal disorders (abdominal pain, nausea, vomiting). These phenomena are associated with the treatment of patients with echinococcosis with albendazole.
Hepatobiliary system.
Very common: mild to moderate elevations in liver enzymes.
Uncommon: hepatitis.
Skin and subcutaneous tissue.
Common: reversible alopecia (hair thinning and moderate hair loss).
Very rare: erythema multiforme, Stevens-Johnson syndrome.
General disorders.
Common: fever.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
3 tablets in a blister; 1 blister in a cardboard pack.
Vacation category
According to the recipe.
Manufacturer/Applicant
"Ternofarm" LLC.
Location of the manufacturer and its business address/location of the applicant.
Ukraine, 46010, Ternopil, Fabrychna St., 4.
Phone/fax: (0352) 521-444, www.ternopharm.com.ua
