Instructions for Albela tablets 400 mg blister No. 3
Composition
active ingredient: albendazole;
1 tablet contains 400 mg of albendazole;
excipients: lactose monohydrate, corn starch, sodium lauryl sulfate, croscarmellose sodium, povidone, microcrystalline cellulose, sodium saccharin, magnesium stearate, colloidal anhydrous silicon dioxide, "Orange" flavoring.
Dosage form
Pills.
Main physicochemical properties: white or almost white capsule-shaped biconvex tablets with a specific odor, smooth on both sides.
Pharmacotherapeutic group
Anthelmintic agents. Agents used in nematodoses. Benzimidazole derivatives.
ATX 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 - 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 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.
Elderly patients.
Some clinical data suggest that pharmacokinetics in elderly patients are similar to those in young healthy volunteers.
Kidney failure.
The pharmacokinetics of albendazole in this group of patients have not been studied.
Liver failure.
The pharmacokinetics of albendazole in this group of patients have not been studied.
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, if helminths are prevalent or live forms were found during surgery;
after percutaneous cyst drainage 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 or to any component of the drug.
Pregnancy or breastfeeding.
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. The effectiveness of the treatment of patients should be monitored, and alternative dosage regimens or therapies should be used if necessary.
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 frequency 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 of albendazole 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 early pregnancy, women of reproductive age should be treated during the first week of menstruation or after a negative pregnancy test. Reliable contraception is required during treatment with albendazole and for one month after its discontinuation.
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 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 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, therefore 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 case of significant deterioration of blood counts, treatment should be discontinued (see sections "Method of administration and dosage" and "Adverse reactions").
To prevent taking Albela® in early pregnancy, women of reproductive age should:
start treatment only after a negative pregnancy test;
warn about the need to use effective contraception during treatment with the drug and for a month after its discontinuation.
Patients with neurocysticercosis treated with albendazole may experience symptoms related to the inflammatory response caused by the death of the parasites (e.g. convulsions, increased intracranial pressure and focal symptoms). 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 Taenia solium infection. 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.
Excipients: This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
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 the tablet whole. In this case, the tablet can be chewed with a little water or crushed.
For use in adults and children aged 3 years and over.
| Infection | Patient age | Dosage and duration of administration |
|---|
Enterobiasis, hookworm, nekatorose, ascariasis, trichocephalosis | Adults and children aged from 3 years* | 400 mg (1 tablet) once/day as a single dose. |
Strongyloidiasis, taeniasis, hymenolepidosis | Adults and children aged from 3 years* | 400 mg (1 tablet) once a day for 3 days. 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 aged from 3 years* | 400 mg (1 tablet) 2 times/day for 3 days. |
| Cutaneous Larva Migrans Syndrome | Adults and children aged from 3 years* | 400 mg (1 tablet) once a day for 1-3 days. |
| Giardiasis | Only children aged 3 to 12 years* | 400 mg (1 tablet) once a day for 5 days. |
* For children aged 2 to 3 years, use another form of the drug - a suspension for oral administration.
Elderly patients.
Experience in the elderly is limited. No dose adjustment is required, but albendazole should be used with caution in 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) should be closely monitored when starting albendazole.
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.
High doses of the drug are not recommended for 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. 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. Maximum daily dose – 800 mg.
| Infection | Duration of reception | |
|---|
| 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. Longer treatment may be required for cysts in other locations (bone or brain). | |
| 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 should be administered after surgery, separated by a 14-day break in drug use. Similarly, if viable cysts are found or helminth dissemination has occurred, two full cycles of treatment should be administered. | |
Alveolar echinococcosis | 28 days. The second 28-day course should be repeated after a two-week break in the use of the drug. Treatment can be extended for several months or years. | |
| Neurocysticercosis** | The duration of treatment is from 7 to 30 days. The second course can be repeated after a two-week break in the use of the drug. | |
| 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. | |
| Racemose cysts | The usual course of treatment is 28 days, but may be 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 cerebral hypertension during the first week of treatment.
| Infection | Dosage and duration of administration |
| Capillariasis | 400 mg once daily for 10 days***. |
| Gnathostomiasis | 400 mg once daily for 10-20 days***. |
| 400 mg 2 times a day for 5-10 days***. |
***Usually one course of treatment is required, but additional courses may be required if parasitological examination results remain positive.
Elderly patients.
Experience in the elderly is limited. No dose adjustment is required, but albendazole should be used with caution in 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) should be carefully monitored before starting albendazole. In the event of a significant increase in transaminases or clinically significant deterioration in blood parameters, treatment should be discontinued (see sections 4.4 and 4.8).
Children.
The drug is intended for use in children aged 3 years and older. For the treatment of children aged 2 to 3 years, another dosage form is recommended – a suspension for oral administration.
Administer to children according to the information provided in the “Method of administration and dosage” section.
Term of use
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. Longer treatment may be required for cysts in other locations (bone or brain).
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 should be administered after surgery, separated by a 14-day break in drug use.
Similarly, if viable cysts are found or helminth dissemination has occurred, two full cycles of treatment should be administered.
Alveolar
echinococcosis
28 days. The second 28-day course should be repeated after a two-week break in the use of the drug. Treatment can be extended for several months or years.
Neurocysticercosis**
The duration of treatment is from 7 to 30 days. The second course can be repeated after a two-week break in the use of the drug.
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.
Racemose cysts
The usual course of treatment is 28 days, but may be 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 cerebral hypertension during the first week of treatment.
| Infection | Dosage and duration of administration |
| Capillariasis | 400 mg once daily for 10 days***. |
| Gnathostomiasis | 400 mg once daily for 10-20 days***. |
| Trichinosis, toxocariasis | 400 mg 2 times a day for 5-10 days***. |
***Usually one course of treatment is required, but additional courses may be required if parasitological examination results remain positive.
Elderly patients.
Experience in the elderly is limited. No dose adjustment is required, but albendazole should be used with caution in 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) should be carefully monitored before starting albendazole. In the event of a significant increase in transaminases or clinically significant deterioration in blood parameters, treatment should be discontinued (see sections 4.4 and 4.8).
Children
The drug is intended for use in children aged 3 years and older.
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.
From the nervous system: headache, dizziness.
Gastrointestinal: upper gastrointestinal symptoms (e.g. epigastric pain, nausea, vomiting), 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: Upper gastrointestinal symptoms (e.g. epigastric pain, nausea, vomiting), diarrhea. These events have been associated with albendazole treatment of patients with echinococcosis.
Hepatobiliary system: mild to moderate elevation of liver enzymes, hepatitis.
Skin and subcutaneous tissue disorders: erythema multiforme, Stevens-Johnson syndrome, reversible alopecia (hair thinning and moderate hair loss).
General disorders: fever.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
1 tablet in a blister; 1 or 3 blisters in a cardboard box.
3 tablets in a blister; 1 blister in a cardboard box.
Vacation category
According to the recipe.
Producer
"KUSUM FARM" LLC.
Address
40020, Ukraine, Sumy region, Sumy city, Skryabina st., 54.
