Baraklyud instructions for use
This drug is considered an antiviral agent. It is prescribed to patients who are diagnosed with hepatitis B. The active substance of the tablets is entecavir. This component selectively acts on HBV polymerase. After taking Baracluda, the components are rapidly absorbed. Peak plasma levels are reached after an hour and a half. Equilibrium levels can be achieved after a week of therapy with entecavir.
Form of issue and composition
The drug Baraclad is available in the form of triangular, film-coated tablets. They have a practically white or white shade. On one side there is a marking "BMS". At the same time on the other side of the tablet - the inscription "1611". The content of entecavir in one tablet reaches 500 μg. Additional substances include microcrystalline cellulose, lactose monohydrate, polysorbate, hypromellose, titanium dioxide, magnesium stearate, crospovidone, the coloring component of Opadry and povidone.
There is a tablet form of Baracluda with a dosage of 1 mg. These are pink tablets in the form of a triangle with markings on the two sides of "BMS" and "1612". Additional substances: hypromellose, macrogol, lactose, povidone, titanium in the form of dioxide, dye pink, crospovidone and red iron oxide.
The blister has 10 tablets. The secondary carton contains 3 blisters.
Indications for use
Baraklyud is prescribed in the treatment of patients with chronic hepatitis B, accompanied by decompensated and compensated liver damage.
Application Baraklyuda prohibited until the patient reaches the age of 18 years. In addition, should not be treated with the drug in the presence of hypersensitivity to components, lactose intolerance, lactase deficiency. With great care, Baraklad is prescribed for HIV infection.
Dosing and Administration
It is recommended to take an empty stomach. The drug should be consumed no earlier than 2 hours after eating. After taking Baraklyud also it is impossible to eat 2 - 3 hours. With compensated lesions, the dosage should be 500 μg once every 24 hours. In the presence of resistance to lamivudine, it is better to take Baracluda at a dose of 1 mg per day.
Therapy of patients with decompensated lesions is carried out by consuming 1 mg of the drug per day.
A special scheme of admission is required for people who have kidney failure. Lowering the clearance of creatinine leads to a decrease in clearance of entecavir. Dosage is selected by the doctor strictly after receiving the results of biochemical parameters of the plasma. It is usually recommended that such a scheme for taking Barakluka patients who have not previously taken nucleoside means:
- with a creatinine level of up to 50 ml / min 500 μg 1 time in 24 hours;
- if creatinine is within 30-50 ml / min 500 mg of Baraclad drug every 2 days;
- clearance of creatinine from 10 to 30 ml / min 500 μg of agent every 72 hours;
- with a creatinine score of less than 10 ml per minute - 500 μg Baraccluda once a week.
- With decompensated hepatic lesions and resistance to lamivudine, the use of Baraklyud is as follows:
- with a creatinine clearance of up to 10 ml / min, the dose is 1 mg per week;
- the indicator 10 - 30 ml / min - 1 mg after 72 hours;
- Creatinine in the range of 30 to 50 ml / min - 1 mg after two days;
- Creatinine clearance above 50 ml / min - 1 mg per day.
Elderly patients use Baracluda in the usual dose.
Baraklad can give some side effects:
- vomiting or a constant feeling of nausea;
- stool disorder. Diarrhea is more common;
- hair loss;
- rash on the skin;
- reactions of anaphylaxis;
- insomnia, headache;
- fatigue, accompanied by drowsiness;
- change in the activity of transaminases;
- pain in the peritoneum;
- weight reduction;
- weakness in the muscles;
- accelerated breathing;
In case of decompensated hepatic damage, there were cases of abrupt changes in parameters in the biochemical analysis of blood.
Therapy Baraklodom can be made for long periods, sometimes more than a year.
In therapy with nucleoside analogs (and entecavir), there is an increased likelihood of lactic acidosis. The appearance of hepatomegaly with steatosis can lead to fatal outcomes. It is necessary to pay attention to the appearance of symptoms that indicate lactic acidosis: weakness, dyspnea, changes in the frequency of respiratory contractions, fatigue, epigastric pain.
The risk factors include obese patients, female patients, hepatomegaly in the anamnesis.
There were recorded cases of exacerbation of the underlying disease in the treatment of Baraklyudom. Most of them did not demand treatment and disappeared on their own. However, the risk of death remains elevated. After the termination of the course of treatment with the drug, it is mandatory to monitor the blood counts.
In HIV patients who do not receive antiretroviral treatment, there is a risk of developing resistant strains of HIV.
There is no data on the therapy of people who are carriers of other forms of hepatitis.
Special control is required for the appointment of Baraclades to patients with decompensated hepatic damage of class C according to Child-Pugh characterization. There is an extremely high likelihood of serious complications. Therapy should be carried out under constant medical supervision.
Correction of the dose is required for people with malfunctioning of the kidneys.
Baraklyud's safety is unproven in therapy after liver transplantation. Particular attention is paid to patients taking tacrolimus and cyclosporine in parallel.
Patients should know that Baraklid does not in any way reduce the possibility of hepatitis B infection by others from the patient.
In elderly patients, dosage adjustment is not needed.
Cases of overdose are unknown. Therapy consists of monitoring the patient and eliminating the symptoms.
Terms and conditions of storage
Baraklad can be stored for 2 years. Access to the drug should be restricted. Storage is carried out at an ambient temperature of 15 to 25 degrees Celsius.
Baraclad tablets, film-coated 0.5 mg, 30 pcs. - from 7370 rubles.
Baraclad tablets, film-coated 1 mg, 30 pcs. - from 11000 rubles.