안국약품(주)

1) Composition
2.5mg of s-amlodipine besylate + 80mg of Valsartan
2.5mg of s-amlodipine besylate + 160mg of Valsartan
5mg of s-amlodipine besylate + 160mg of Valsartan

2) Dosage & Administration
The recommended dose is one tablet per day, with water. Levosartan can be used with or without food. Individual dose titration with the components(i.e. amlodipine and valsartan) is recommended before changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy to the fixed-dose combination may be considered.

2.5/80mg may be administered in patient s whose blood pressure is not adequately controlled with s-amlodipine 2.5mg(amlodipine 5mg) or valsartan 80mg alone.
2.5/160mg may be administered in patient s whose blood pressure is not adequately controlled with s-amlodipine 2.5mg(amlodipine 5mg) or valsartan 160mg alone.
5/160mg may be administered in patient s whose blood pressure is not adequately controlled with s-amlodipine 5mg(amlodipine 10mg) or valsartan 160mg alone.

For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules maybe switched to Levosartan containing the same component dose.

Renal Impairment: No dosage adjustment is required for patients(creatinine clearance≥10mL/min) with mild to moderate renal impairment. There are no available clinical data in severely renally impaired patients. Monitoring of potassium levels and creatinine is advised in moderate renal impairment.

Hepatic Impairment:
In patients with mild to moderate hepatic impairment, the maximum recommended dose is 80mg valsartan. No dosage adjustment of Levosartan tablet is required for patients with mild to moderate renal impairment, biliary cirrhotic liver, hepatic impairment, biliary obstruction disorders and cholestasis.


3) Storage
Preserve in tight containers. Store at room temperature(1-30℃). 24 months from manufactured date.

4)Package
30T/300T