Generic
Entecavir
Contraindications
Lactic acidosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals. Exacerbations of hepatitis after discontinuation of treatment: Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Entecavir.
Side Effects
Pediatric: Safety and effectiveness of Entecavir in pediatric patients below the age of 2 years have not been established. Geriatric: Clinical studies of Entecavir did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. But care should be taken in dose selection, and it may be useful to monitor renal function. Dose adjustment in renal impairment: Dose adjustment is recommended for patients with CrCl <50 ml/min including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) as shown below: CrCl ≥50 ml/min: 0.5 mg every 24 hours CrCl 30 to <50 ml/min: 0.5 mg every 48 hours CrCl 10 to <30 ml/min: 0.5 mg every 72 hours CrCl <10 ml/min or Hemodialysis or CAPD: 0.5 mg every 7 days
Pregnancy And Lactation
There is no experience of Entecavir overdosage reported in patients. Healthy subjects who received up to 20 mg daily for up to 14 days and single doses up to 40 mg had no unexpected adverse events. If overdosage occurs, the patient must be monitored for evidence of toxicity and standard supportive treatment as necessary.
Therapeutic
Hepatic viral infections (Hepatitis B)
Storage Conditions
Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.
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