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Atevir tablets

Dexa Medica

Ingredients in every tablet

Entecavir 0.5 mg

Each package contains

1 blister of 10 tablets

Dosage form

tablet

Dosage formTablet; coated

Flavour

None

W.H.O. classification

J05A
J05A

A.T.C. Level 1

Anatomical Main group

J - Antiinfectives for systemic use
J05A

A.T.C. Level 2

Therapeutic subgroup

J05 - Antivirals for Systemic Use
J05A

A.T.C. Level 3

Pharmacological subgroup

J05A - Direct Acting Antivirals

Available in

Indonesia

Warnings

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.

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.

Indication

Chronic Hepatitis B virus infection
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 adult patients with HIV/HBV co-infection who have received prior lamivudine therapy.

Dosage

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

16 YEARS OLD AND ABOVE
— Patients with chronic hepatitis B virus infection:
0.5 mg once daily

— Patients with a history of hepatitis B viremia while receiving lamivudine or with known lamivudine resistance mutations:
1 mg daily

ELDERLY PATIENTS
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

OTHER DETAILS
Entecavir should be used on an empty stomach (at least 2 hours after food and at least 2 hours before the next meal)

PATIENTS WITH RENAL IMPAIRMENT
In patients with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased. Dosage adjustment is recommended for patients with creatinine clearance <50 ml/minute, including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD)

PATIENT WITH HEPATIC IMPAIRMENT
No dosage adjustment is necessary for patients with hepatic impairment