Baraclude instructions for use
This drug is considered an antiviral agent. It is prescribed to patients with a diagnosis of hepatitis B. The active ingredient of the tablets is entecavir. This component selectively acts on HBV polymerase. After taking Baraclude inside the components are quickly absorbed. Peak plasma levels are reached after one and a half hours. Equilibrium levels can be achieved after a week of entecavir therapy.
Release form and composition
Means Baraclude is produced in the form of triggol film-coated tablets. They have almost white or white shade. On one side is labeled "BMS". At the same time on the other side of the tablet - the inscription "1611". The content of entecavir in one tablet reaches 500 micrograms. Additional substances include microcrystalline cellulose, lactose monohydrate, polysorbate, hypromellose, titanium dioxide, magnesium stearate, crospovidone, the coloring component Opadry, and povidone.
There is a tablet form of Baraclude with a dosage of 1 mg. These are pink tablets in the form of a triangle with markings on two sides “BMS” and “1612”. Additional substances: hypromellose, macrogol, lactose, povidone, titanium in the form of dioxide, pink dye, crospovidone and red iron oxide dye.
Blister has 10 tablets. In the secondary cardboard packaging contains 3 blisters.
Indications for use
Baraclude is prescribed in the treatment of patients with chronic hepatitis B, accompanied by decompensated and compensated liver damage.
The use of Baraclia is prohibited until the patient reaches the age of 18 years. In addition, the drug should not be treated in the presence of hypersensitivity to the components, lactose intolerance, lactase deficiency. With great care, Baracud is prescribed for HIV infection.
Dosing and Administration
Recommended reception on an empty stomach. The tool should be used no earlier than 2 hours after meals. After taking Baraclude, it is also impossible to eat 2 to 3 hours. With a compensated lesion, the dosage should be 500 mcg once every 24 hours. In the presence of lamivudine resistance, it is better to take Baraclude at a dose of 1 mg per day.
Therapy of patients with decompensated lesion is carried out by consuming 1 mg of the drug per day.
A special regimen is required for people with renal insufficiency. A decrease in creatinine clearance leads to a decrease in entecavir clearance. The dosage is selected by the doctor strictly after receiving the results of biochemical parameters of plasma. Such a regimen of taking Baraclude is usually recommended by patients who have not previously taken nucleoside drugs:
- at the level of creatinine up to 50 ml / min, 500 mcg 1 time in 24 hours;
- if creatinine is in the range of 30-50 ml / min, 500 mcg of Baraclude every 2 days;
- creatinine clearance from 10 to 30 ml / min 500 µg every 72 hours;
- with indicators of creatinine less than 10 ml per minute - 500 µg Baraclyad once a week.
- With decompensated hepatic lesions and lamivudine resistance, taking Baraclyud is as follows:
- with creatinine clearance to 10 ml / min, the dose is 1 mg per week;
- indicator 10 - 30 ml / min - 1 mg every 72 hours;
- creatinine in the range of 30 to 50 ml / min - 1 mg every two days;
- creatinine clearance over 50 ml / min - 1 mg per day.
Elderly patients use baracud in the usual dose.
Baraclude may have some side effects:
- vomiting or constant feeling of nausea;
- upset stool. More common diarrhea;
- hair loss;
- rash on the skin;
- anaphylaxis reactions;
- insomnia, headache;
- fatigue, accompanied by sleepiness;
- change in transaminase activity;
- abdominal pain;
- weight reduction;
- muscle weakness;
- accelerated breathing;
With decompensated hepatic lesion, there were cases of dramatic changes in the parameters in the biochemical analysis of blood.
Baracdus therapy can be performed for long periods, sometimes more than a year.
When therapy is carried out using nucleoside analogues (and entecavir), there is an increased likelihood of lactic acidosis. The appearance of hepatomegaly with steatosis can be fatal. It is necessary to pay attention to the appearance of symptoms indicating lactic acidosis: weakness, shortness of breath, a change in the frequency of respiratory contractions, fatigue, epigastric pain.
The risk factors include patients with obesity, female patients, a history of hepatomegaly.
There have been cases of exacerbation of the underlying disease during treatment with Baraclude. Most of them did not require treatment and disappeared on their own. However, the risk of death remains elevated. After the end of the course of treatment with the drug control of blood parameters is obligatory.
In HIV-infected patients who do not conduct antiretroviral treatment, there is a risk of the emergence of resistant strains of HIV.
There is no data on the treatment of people who are carriers of other forms of hepatitis.
Special control is required when prescribing Baracamel to patients with decompensated hepatic lesions of class C according to the Child-Pugh characteristics. There is an extremely high probability of serious complications. Therapy should be carried out under constant medical supervision.
Dose adjustment is required for people with kidney malfunction.
The safety of Baraclude during liver transplantation therapy is unproved. Particular attention is paid to patients taking tacrolimus and cyclosporine in parallel.
Patients should be aware of the information that Baracade does not in any way reduce the possibility of other people getting infected with Hepatitis B.
Elderly patients do not need dosage adjustment.
Cases of overdose are unknown. Therapy is to monitor the patient and eliminate the symptoms that have occurred.
Terms and conditions of storage
Baraclude can be stored for 2 years. It is necessary to limit access to a preparation of children. Storage is carried out at ambient temperatures of 15 to 25 degrees Celsius.
Baraclude tablets, film-coated 0.5 mg, 30 pcs. - from 7370 rubles.
Baraclude tablets, film-coated 1 mg, 30 pcs. - from 11,000 rubles.