Lamone 100

Rx

Indications

The treatment of chronic hepatitis B with:

• Compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis.
• Decompensated liver disease.

Dosage

Adults: 100 mg once daily.

Children aged over 2 years: 3 mg/kg once daily to a maximum daily dose of 100 mg.

Patients with concomitant HIV and hepatitis B infection: Use dosage regimen appropriate for HIV.

Administration in renal impairment: (creatinine clearance: ClCr)

• ClCr = 30 – 49 ml/minute: 100 mg for the first dose then 50 mg once daily;
• ClCr = 15 – 29 ml/minute: 100 mg for the first dose then 25 mg once daily;
• ClCr = 5 – 14 ml/minute: 35 mg for the first dose then 15 mg once daily;
• ClCr < 5 ml/minute: 35 mg for the first dose then 10 mg once daily;
• Haemodialysis patients: Accordance with creatinine clearance is required;
• Peritoneal dialysis patients: Not recommended.

Usage

• Lamone 100 is orally taken without regard to meals.

Hypersensitivity to the active substance or to any of the excipients.

Common

• Abdominal pain, nausea, vomiting, diarrhoea,
• Headache, fever,
• Rash, alopecia,
• Malaise, insomnia,
• Cough, nasal symptoms,
• Arthralgia, and musculoskeletal pain,
• Increased serum levels of creatinine phosphokinase and alanine aminotransferase.

Lamone 100 should be stopped in case of:

• Develop abdominal pain, nausea, or vomiting or with abnormal biochemical test results until pancreatitis has been excluded.
• A rapid increase in aminotransferase concentrations, progressive hepatomegaly, or metabolic or lactic acidosis of unknown aetiology.

Lamivudine should be used with caution in patients with hepatomegaly or other risk factors for hepatic disease.

Liver function should be monitored in patients with chronic hepatitis B because of a risk of rebound hepatitis when lamivudine is discontinued.

The possibility of HIV infection should be excluded before beginning lamivudine therapy for hepatitis B.

Lamone 100 should be used during pregnancy only if the potential benefits justify the potential risks to the fetus. The drug should be used during pregnancy only if the potential benefits justify the potential risks to the fetus.

Patients should be aware of how they react to drug before driving or operating machinery.