Dosage: Adults: Recommended Dose: 1 tab/day.
Normetec 5 mg/20 mg may be administered in patients whose BP is not adequately controlled by 5 mg amlodipine alone or 20 mg olmesartan medoxomil. Normetec 5 mg/40 mg may be administered in patients whose BP is not adequately controlled by Normetec 5 mg/20 mg. Normetec 10 mg/40 mg may be administered in patients whose BP is not adequately controlled by Normetec 5 mg/40 mg.
A step-wise titration of the dosage of the individual components is recommended before changing to the fixed combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
For convenience, patients receiving olmesartan medoxomil and amlodipine from separate tablets may be switched to Normetec tablets containing the same component doses.
Elderly ≥65 years: No adjustment of the recommended dose is generally required for elderly patients (see Pharmacokinetics under Actions). If up-titration to the maximum dose of olmesartan medoxomil 40 mg daily is required, BP should be closely monitored.
Children and Adolescents: Normetec is not recommended for use in children and adolescents <18 years due to a lack of data on safety and efficacy (see Pharmacokinetics under Actions).
Renal Impairment: The maximum dose of olmesartan medoxomil in patients with mild to moderate renal impairment [creatinine clearance (CrCl) of 20-60 mL/min] is olmesartan medoxomil 20 mg once daily, owing to limited experience of higher dosages in this patient group. The use of Normetec in patients with severe renal impairment (CrCl <20 mL/min) is not recommended (see Pharmacokinetics under Actions and Precautions).
Monitoring of potassium levels and creatinine is advised in patients with moderate renal impairment.
Hepatic Impairment: Normetec should be used with caution in patients with mild to moderate hepatic impairment (see Pharmacokinetics under Actions and Precautions). In patients with moderate hepatic impairment, an initial dose of olmesartan medoxomil 10 mg once daily is recommended and the maximum dose should not exceed 20 mg once daily. Close monitoring of BP and renal function is advised in hepatically-impaired patients who are already receiving diuretics and/or other antihypertensive agents. There is no experience of olmesartan medoxomil in patients with severe hepatic impairment. As with all calcium antagonists, amlodipine t½ is prolonged in patients with impaired liver function and dosage recommendations have not been established. Normetec should therefore be administered with caution in these patients.
Administration: The tablet should be swallowed with a sufficient amount of fluid (eg, 1 glass of water). The tablet should not be chewed and should be taken at the same time each day. Normetec can be taken with or without food.