Amlotel Dosage/Direction for Use

DOSAGE: Adults: AMLOTEL should be taken once daily. The maximum recommendation dose is AMLOTEL 80 mg/10 mg one tablet per day.
Replacement Therapy: Patients receiving telmisartan and amlodipine from separate tablets can instead receive AMLOTEL containing the same component doses in one tablet once daily, e.g. to enhance convenience or compliance.
Add on therapy: AMLOTEL may be administered in patients whose blood pressure is not adequately controlled with amlodipine or telmisartan alone.
Patients treated with 10 mg amlodipine who experience any dose limiting adverse reactions such as oedema, may be switched to AMLOTEL 40/5 mg once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response.
Individual dose titration with the components (ie. amlodipine and telmisartan) is recommended before changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy to the fixed dose combination may be considered.
Initial therapy: A patient may be initiated on AMLOTEL if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose of AMLOTEL is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started on AMLOTEL 80/5 mg once daily.
If additional blood pressure lowering is needed after at least 2 weeks of therapy, the dose may be titrated up to a maximum of 80/10 mg once daily.
Initial therapy with AMLOTEL is not recommended in patients ≥75 years old or with hepatic impairment. Correct imbalances on intravascular volume- or salt-depletion, before initiating therapy with AMLOTEL tablets.
AMLOTEL can be administered with other antihypertensive drugs.
Special populations: Geriatric patients: No dose adjustment is necessary for geriatric patients. Little information is available in the very elderly patients. Normal amlodipine dosage regimens are recommended in the elderly, but increase of dosage should take place with care.
Paediatric patients: AMLOTEL is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
Renal impairment: No posology adjustment is required for patients with renal impairment, including those on haemodialysis. Limited experience is available with severe renal impairment or haemodialysis. Caution is advised when using AMLOTEL in such patients as amlodipine and telmisartan are not dialysable. Telmisartan is not removed from blood by hemofiltration and is not dialyzable. Amlodipine is not dialyzable.
Hepatic impairment: In patients with mild to moderate hepatic impairment AMLOTEL should be administered with caution. For telmisartan the posology should not exceed 40 mg once daily.
Method of administration: AMLOTEL tablets are for once-daily oral administration and should be swallowed whole with liquid. AMLOTEL can be taken with or without food.
Handling Instructions: Due to the hygroscopic property of the tablets they should be taken out of the sealed blister shortly before administration.