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Alzor CCB

Alzor CCB Dosage/Direction for Use

olmesartan + amlodipine

Manufacturer:

Ajanta Pharma Phil

Distributor:

Ajanta Pharma Phil
Full Prescribing Info
Dosage/Direction for Use
Adults: The recommended dosage of Olmesartan medoxomil plus Amlodipine combination is 1 tablet per day.
The usual starting dose is 20/5mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to maximum dose of 40/10mg tablet once daily as needed to control blood pressure.
For convenience, patients receiving Olmesartan medoxomil and amlodipine from separate tablets may be switched to Olmesartan medoxomil plus Amlodipine combination tablets containing the same component doses.
Olmesartan medoxomil plus Amlodipine combination can be taken with or without food.
Elderly (age 65 years or over): No adjustment of the recommended dose is generally required for elderly people but increase of the dosage should take place with care.
If up-titration to the maximum dose of 40 mg olmesartan medoxomil daily is required, blood pressure should be closely monitored.
Renal impairment: The maximum dose of Olmesartan medoxomil in patients with mild to moderate renal impairment (creatinine clearance of 20 - 60 mL/min) is 20 mg Olmesartan medoxomil once daily, owing to limited experience of higher dosages in this patient group. The use of Olmesartan medoxomil plus Amlodipine combination in patients with severe renal impairment (creatinine clearance < 20 mL/min) is not recommended.
Monitoring of potassium levels and creatinine is advised in patients with moderate renal impairment.
Hepatic impairment: Olmesartan medoxomil plus Amlodipine combination should be used with caution in patients with mild to moderate hepatic impairment.
In patients with moderate hepatic impairment, an initial dose of 10 mg Olmesartan medoxomil once daily is recommended and the maximum dose should not exceed 20 mg once daily. Close monitoring of blood pressure 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's half-life is prolonged in patients with impaired liver function and dosage recommendations have not been established. Olmesartan medoxomil plus Amlodipine combination should therefore be administered with caution in these patients. The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment.
Amlodipine should be initiated at the lowest dose and titrated slowly in patients with impaired liver function. Use of Olmesartan medoxomil plus Amlodipine combination in patients with severe hepatic impairment is contraindicated.
Paediatric population: The safety and efficacy of Olmesartan medoxomil plus Amlodipine combination in children and adolescents below 18 years has not been established. No data are available.
Method of administration: The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The tablet should not be chewed and should be taken at the same time each day.
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