Atevir tablets

Dexa Medica

Ingredients in every tablet

Entecavir 0.5 mg

Each package contains

1 blister of 10 tablets

Other details

Dosage form:Tablet; coated
Flavour None

W.H.O. classification

ATC Level 1 J - Antiinfectives for systemic use
ATC Level 2 J05 - Antivirals for Systemic Use
ATC Level 3 J05A - Direct Acting Antivirals

Warnings

Pregnancy

CONSULT YOUR DOCTORSafety of this item for use during pregnancy has not been established. Please consult your doctor.

Lactation

CONSULT YOUR DOCTORSafety of this item for use during lactation has not been established. Please consult your doctor.

Alcohol

CONSULT YOUR DOCTORSafety of this item for use with alcohol has not been established. Please consult your doctor.

Machinery

CAUTIONThis item may not be safe for use while operating heavy machinery. Use with caution and after consultation with your doctor.

Available in

Indonesia

Dosage information

0 TO 16 YEARS OLD
Safety and effectiveness of entecavir in pediatric patients below the age of 16 years have not been established

Entecavir should be administered on an empty stomach (at least 2 hours after a meal and at least 2 hours before the next meal).

16 YEARS OLD AND ABOVE
For chronic hepatitis B virus infection:
0.5 mg once daily

If there is a history of hepatitis B viremia while receiving lamivudine or with known lamivudine resistance mutations:
1 mg daily

Entecavir should be administered on an empty stomach (at least 2 hours after a meal and at least 2 hours before the next meal).

65 YEARS OLD AND ABOVE
Entecavir is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function

Entecavir should be administered on an empty stomach (at least 2 hours after a meal and at least 2 hours before the next meal).

RENAL IMPAIRMENT
Dosage adjustment is recommended for patients with creatinine clearance <50 ml/minute, including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD)

Indication

Entecavir is indicated for the treatment of chronic hepatitis B virus infection in Adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferase (ALT or AST) or histologically active disease.
This indication is based on efficacy and safety data in nucleoside-treatment-naive and lamivudine-refractory Adults patients with HBeAg-positive or HbeAg-negative chronic HBV infection with compensated liver disease and on more limited data in Adults patients with HIV/HBV co-infection who have received prior lamivudine therapy.