Dosage: Adults: Telmisartan + Amlodipine besilate (TWYNSTA) should be taken once daily.
Replacement therapy: Patients receiving telmisartan and amlodipine besilate from separate tablets can instead receive Telmisartan + Amlodipine besilate (TWYNSTA) containing the same component doses in one tablet once daily, e.g. to enhance convenience or compliance.
Add on therapy: Telmisartan + Amlodipine besilate (TWYNSTA) 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 Telmisartan + Amlodipine besilate (TWYNSTA) 40/5mg once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response.
Initial therapy: A patient may be initiated on Telmisartan + Amlodipine besilate (TWYNSTA) if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose of Telmisartan + Amlodipine besilate (TWYNSTA) is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started on Telmisartan + Amlodipine besilate (TWYNSTA) 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.
Telmisartan + Amlodipine besilate (TWYNSTA) can be administered with other antihypertensive drugs.
Special populations: Geriatric patients: No dose adjustment is necessary for geriatric patients.
Normal amlodipine dosage regimens are recommended in the elderly, but increase of dosage should take place with care (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Paediatric patients: Telmisartan + Amlodipine besilate (TWYNSTA) 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. 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 Telmisartan + Amlodipine besilate (TWYNSTA) should be administered with caution. For telmisartan the posology should not exceed 40 mg once daily (see Contraindications).
Method of Administration: Telmisartan + Amlodipine besilate (TWYNSTA) tablets are for once-daily oral administration and should be swallowed whole with liquid.
Telmisartan + Amlodipine (TWYNSTA) 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.
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