Entecavir Stella

Entecavir Stella Dosage/Direction for Use

entecavir

Manufacturer:

Stellapharm

Distributor:

Stadpharm
Full Prescribing Info
Dosage/Direction for Use
Administration: Entecavir STELLA 0.5 mg film-coated tablet should be taken orally.
Dosage: Compensated liver disease: Nucleoside naïve patients: The recommended dose of Entecavir STELLA is 0.5 mg orally once daily with or without food.
Lamivudine-refractory patients (i.e., history of hepatitis B viremia while receiving lamivudine therapy or known lamivudine resistance [LVDr, commonly called YMDD] mutations): The recommended dose is 1 mg once daily. Entecavir STELLA should be taken orally, on an empty stomach (empty means at least 2 hours before and at least 2 hours after meal).
Decompensated liver disease: The recommended dose for patients with decompensated liver disease is 1 mg once daily, which must be taken on an empty stomach (empty means at least 2 hours before and at least 2 hours after a meal).
Special population: Patients with renal impairment: Entecavir is predominantly eliminated by the kidney. The clearance of entecavir decreases with impaired (decreasing) creatinine clearance. Dosage adjustment of Entecavir STELLA is recommended for patients who have a creatine clearance < 50 ml/min, including those on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), as shown in table. (See table.)

Click on icon to see table/diagram/image

Do not split tablets.
On hemodialysis days, administer Entecavir STELLA after hemodialysis.
CAPD = continuous ambulatory peritoneal dialysis.
Patients with hepatic impairment: No dosage adjustment of Entecavir STELLA is required in patients with hepatic impairment.
Pediatric and adolescent patients: The safety and efficacy of Entecavir STELLA in patients < 16 years of age have not been established.
Geriatric patients: No dosage adjustment of Entecavir STELLA based on age is required.
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