Hybip-165 Dosage/Direction for Use

Posology: The recommended dose of Valsartan and Amlodipine Tablets is one tablet per day.
Valsartan and Amlodipine Tablets 10 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Valsartan and Amlodipine Tablets 5 mg/160 mg.
Valsartan and Amlodipine Tablets 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.
For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Valsartan and Amlodipine Tablets containing the same component doses.
Renal impairment: There are no available clinical data in severely renally impaired patients.
No dosage adjustment is required for patients with mild to moderate renal impairment. Monitoring of potassium levels and creatinine is advised in moderate renal impairment.
Hepatic impairment: Valsartan and Amlodipine Tablets is contraindicated in patients with severe hepatic impairment.
Caution should be exercised when administering Valsartan and Amlodipine Tablets to patients with hepatic impairment or biliary obstructive disorders. In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan. Amlodipine dosage recommendations have not been established in patients with mild to moderate hepatic impairment. When switching eligible hypertensive patients with hepatic impairment to amlodipine or Valsartan and Amlodipine Tablets, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Elderly (age 65 years or over): In elderly patients, caution is required when increasing the dosage. When switching eligible elderly hypertensive patients to amlodipine or Valsartan and Amlodipine Tablets, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Paediatric population: The safety and efficacy of Valsartan and Amlodipine Tablets in children aged below 18 years have not been established. No data are available.
Method of administration: Oral use.
It is recommended to take Valsartan and Amlodipine Tablets with some water.