Description
Product form
tablets, film-coated
Packing
30 pcs.
Pharmacological action
Baraclude has an antiviral effect.
Indications
Chronic hepatitis B in adults with signs of viral replication and increased activity of serum transaminases (ALT or AST) or in the presence of histological signs of an inflammatory process in the liver.
Contraindications
Hypersensitivity to entecavir or any other component of the drug. Children’s age: up to 18 years.
Use during pregnancy and lactation
Adequate and well-controlled studies in pregnant women have not been conducted.
Baraclude can be taken during pregnancy if the potential benefit of the application outweighs the potential risk to the fetus. There is no data on the penetration of entecavir into breast milk.
Breastfeeding is not recommended when using the drug.
Special instructions
In the treatment of nucleoside analogues with monotherapy and in combination with antiretroviral drugs, cases of lactic acidosis and severe hepatomegaly with steatosis have been described, sometimes leading to death of the patient. Cases of exacerbation of hepatitis after discontinuation of antiviral therapy, including entecavir, are described.
Most of these cases went away without treatment. However, severe exacerbations, including fatal ones, may develop. The causal relationship of these exacerbations with the withdrawal of therapy is unknown.
After discontinuation of treatment, liver function should be periodically monitored. If necessary, antiviral therapy may be resumed. It should be borne in mind that when prescribing entecavir to patients in the case of co-infection with HIV who have not previously received highly active antiretroviral therapy, there may be a risk of developing resistant strains of HIV. Entecavir has not been studied for the treatment of HIV infection and is not recommended for such use,
Patients undergoing liver transplantation. The safety and effectiveness of entecavir in patients undergoing liver transplantation are unknown. Renal function should be carefully monitored before and during entecavir treatment in patients undergoing liver transplantation and receiving immunosuppressants that may affect renal function, such as cyclosporine and tacrolimus.
General patient information. Patients should be informed that entecavir therapy does not reduce the risk of transmission of hepatitis B and therefore appropriate precautions should be taken.
Composition
1 tablet contains entecavir 500 ug
Dosage and administration of
Baraclude should be taken orally on an empty stomach (that is, at least 2 hours after eating and no later than 2 hours before the next meal).
The recommended dose of entecavir is 0.5 mg once daily.
Lamivudine-resistant patients (that is, patients with a history of hepatitis B virus viremia remaining with lamivudine therapy, or patients with confirmed resistance to lamivudine), it is recommended to prescribe 1 mg entecavir once a day.
Patients with renal failure: Entecavir clearance decreases with decreased creatinine clearance.
Recommended dose adjustment of entecavir to patients with creatinine clearance <50 ml / min, including those on hemodialysis and long-term ambulatory peritoneal dialysis. Entecavir should be taken after a hemodialysis session. In patients with hepatic insufficiency, dose adjustment of entecavir is not required. Side effects of the From the digestive system: rarely (? 1/1000, <1/100) - diarrhea, dyspepsia, nausea, vomiting. From the side of the central nervous system: often (? 1/100, <1/10) - headache, rarely fatigue (? 1/1000, <1/100) - insomnia, dizziness, drowsiness. Post-marketing data (frequency cannot be determined) Allergic reactions: anaphylactoid reaction. Dermatological reactions: alopecia, rash. Drug Interactions Since entecavir is excreted primarily by the kidneys, with the simultaneous administration of entecavir and drugs that reduce renal function or compete at the level of tubular secretion, an increase in the concentration of entecavir or these drugs in the serum is possible. With the simultaneous administration of entecavir with lamivudine, adefovir dipivoxil or tenofovir disoproxil fumarate, no significant drug interactions were detected. Interactions of entecavir with other drugs that are excreted by the kidneys or affect kidney function have not been studied. Patients should undergo careful medical monitoring while prescribing entecavir with such drugs. Storage Conditions At a temperature not exceeding 25 ° C. Expiration See packaging. Active ingredient Entecavir conditions granted through pharmacies Prescription lekarstvennaja form tablets
