Entecavir Capsules

Entecavir Capsules


[Drug Name]
Common name: Entecavir capsules
[Ingredients] The main ingredients: Entecavir.
Chemical name: 2-Amino-9-[(1S, 3R, 4S)-4-hydroxy-3-(hydroxymethyl)
-2-methylenecyclopentyl] -1, 9-dihydro -6H-purin-6-one
Structural formula:
           
Molecular formula: C12H15N5O3 .H2O
Molecular weight: 295.3   
[Character] The product is capsule; content in capsule is off white powder.
[Indications] The product is suitable for treatment of chronic adult hepatitis B patients who has active viral replication, continually raising serum alanine aminotransferase (ALT) or activity lesion showed by liver histology.
[Dosage] Patients should use the product under the guidance of experienced doctors.
Recommended dosage:
For adults and adolescents with age more than 16 years: oral administration; once per day, 0.5mg per time. For the patient who has Viraemia during Lamivudine therapy or Lamivudine-resistant mutations, once per day, 1mg per time.
This product should be took when have an empty stomach (at least 2 hours before or after meals).
Renal Insufficiency: for patients with renal insufficiency, the Entecavir‘s apparent oral clearance rate decrease alone with the decreasing creatinine clearance rate (See the Pharmacokinetics, Special populations). Creatinine clearance rate <50ml/min patients [including these patients who receive hemodialysis or continuous ambulatory peritoneal dialysis (CAPD)] should adjust the dosage.
Table 1  Entecavir recommended administration interval adjustment

Creatinine Clearance Rate(ml/min) Common dosage (0.5mg) Lamivudine failure treatment
≥50 1 time per day,
0.5mg per time
1 time per day,
1mg per time
30~<50 1 time every 48 hours, 0.5mg per time 1 time every 48 hours, 1mg per time
10~<30 1 time every 72 hours, 0.5mg per time 1 time every 72 hours, 1mg per time
<10 hemodialysis * or CAPD 1 time every 5~7days, 0.5mg per time 1 time every 5~7days, 1mg per time
 
* For patients who accept hemodialysis, please take the drug after hemodialysis.
For patients with renal insufficiency, the dosage does not need to be adjusted.   
The best treatment time of this product, as well as the relationship with long-term treatment outcomes, such as cirrhosis, liver cancer is not yet clear. 
[Storage] sealed.
[Package] 7capules /plate*1plate/box (polyvinyl chloride (PVC) solid tablet for drug /aluminum foil. 
[Expiry date] 2 years