Baraclud, 0.5 mg 30 pcs

Liver damage, Hepatitis

Chronic hepatitis B in adults with signs of viral replication and elevated serum transaminase activity (ALT or AST) or in the presence of histological signs of inflammatory process in the liver.

Active ingredient

Composition

1 tablet contains entecavir 500 mcg

How to take, the dosage

Baraclud should be taken orally on an empty stomach (that is, at least 2 hours after a meal 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 persisting on lamivudine therapy or patients with confirmed lamivudine resistance) are recommended to receive 1 mg of entecavir once daily.

Patients with renal impairment: the clearance of entecavir decreases as creatinine clearance decreases.

The dose adjustment of entecavir is recommended in 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. No dose adjustment of entecavir is required in patients with hepatic impairment.

Interaction

Because entecavir is primarily excreted by the kidneys, concomitant administration of entecavir and drugs that reduce renal function or compete at the level of tubular secretion may increase serum concentrations of entecavir or these drugs.

No significant drug interactions have been identified when concomitant administration of entecavir with lamivudine, adefovir dipivoxil or tenofovir disoproxil fumarate.

The interactions of entecavir with other drugs that are excreted by the kidneys or affect renal function have not been studied.

Patients should be closely monitored when entecavir is prescribed concomitantly with these drugs.

Special Instructions

In treatment with nucleoside analogues as monotherapy and in combination with antiretroviral drugs, there have been cases of lactoacidosis and marked hepatomegaly with steatosis, sometimes leading to patient death. Cases of exacerbation of hepatitis after withdrawal of antiviral therapy, including entecavir, have been described. Most of these cases passed without treatment. However, severe exacerbations, including fatal ones, can develop. The causal relationship of these exacerbations to withdrawal of therapy is unknown. Liver function should be monitored periodically after treatment discontinuation. If necessary, antiviral therapy may be resumed. Note that when entecavir is prescribed to patients with HIV co-infection 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 who have had a liver transplant. The safety and efficacy of entecavir in liver transplant patients is unknown. Renal function should be monitored carefully before and during treatment with entecavir in patients who have undergone liver transplantation and are receiving immunosuppressants that may affect renal function, such as cyclosporine and tacrolimus.
General information for patients. Patients should be informed that therapy with entecavir does not reduce the risk of hepatitis B transmission and, therefore, appropriate precautions should be taken.

Contraindications

Side effects

Gastrointestinal system disorders: rare (≥ 1/1000, < 1/100) – diarrhea, dyspepsia, nausea, vomiting.

CNS disorders: frequently (≥1/100, < 1/10) – headache, fatigue; rarely (≥1/1000, < 1/100) – insomnia, dizziness, somnolence.

Postmarketing data (frequency cannot be determined)

Allergic reactions: anaphylactoid reaction.

Dermatological reactions: alopecia, rash.

Overdose

There are limited data on cases of overdose of Baraclud in patients.

There have been no unexpected adverse reactions in healthy volunteers who received the drug in doses of up to 20 mg/day for up to 14 days or in single doses of up to 40 mg.

Treatment: In case of overdose, close medical monitoring of the patient is required.

If necessary, standard supportive therapy is given.

Pregnancy use

There have been no adequate and well-controlled studies in pregnant women.

Baraclud may be taken during pregnancy if the potential benefit from use exceeds the potential risk to the fetus.

There are no data on the penetration of entecavir into women’s milk.

Breast-feeding when using the drug is not recommended.