Twynsta

Per 40/5 mg tab Telmisartan 40 mg, amlodipine besilate 5 mg. Per 40/10 mg tab Telmisartan 40 mg, amlodipine besilate 10 mg. Per 80/5 mg tab Telmisartan 80 mg, amlodipine besilate 5 mg. Per 80/10 mg tab Telmisartan 80 mg, amlodipine besilate 10 mg

Add on therapy in adults w/ essential HTN whose BP is inadequately controlled on amlodipine alone. Replacement therapy in adult patients w/ essential HTN who are receiving telmisartan & amlodipine from separate tablets.

1 tab daily. Max: One 80/10 mg-tab daily.

May be taken with or without food.

Hypersensitivity to telmisartan, amlodipine besilate &/or dihydropyridine derivatives. Biliary obstructive disorders & severe hepatic impairment. Shock eg, cardiogenic shock. Obstruction of the outflow tract of the left ventricle (eg, high grade aortic stenosis). Haemodynamically unstable heart failure after acute MI. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²). Pregnancy (2nd & 3rd trimester).

Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Correct vol &/or Na depletion prior to treatment administration. Dual blockade of renin-angiotensin-aldosterone system (RAAS) through combined use of ACE inhibitors, AIIA or aliskiren. Patients whose vascular tone & renal function depend predominantly on the activity of the RAAS. Not recommended in patients w/ primary aldosteronism. Special caution is advised in patients w/ aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Risk of hyperkalaemia; MI or stroke in patients w/ ischaemic cardiomyopathy or ischaemic CV disease. Patients w/ heart failure/CHF. Diabetic patients treated w/ insulin or antidiabetics. Moderate influence on the ability to drive & use machines. Hepatic impairment. Periodic monitoring of K & creatinine serum levels is recommended in patients w/ impaired renal function. Patients w/ recent kidney transplant. Not recommended during 1st trimester of pregnancy. Lactation. Childn <18 yr. Elderly.

Dizziness, peripheral oedema.

Increased BP lowering effect w/ other antihypertensive medicinal products, baclofen, amifostine, neuroleptics or antidepressants. Aggravated orthostatic hypotension w/ alcohol. Reduced antihypertensive effects w/ systemic corticosteroids. Telmisartan: Significant increase in serum K w/ K-sparing diuretics (eg, spirinolactone, eplerenone, triamterene, or amiloride), K supplements, or K-containing salt substitutes. Reversible increases of serum lithium conc & toxicity. Higher frequency of adverse events w/ combined use of ACE inhibitors, AIIA or aliskiren. Reduced antihypertensive effects w/ NSAIDs. May increase AUC_0-24 & C_max of ramipril & ramiprilat. Increases in peak plasma & trough conc of digoxin. Amlodipine: Increased plasma conc w/ strong CYP3A4 inhibitors (eg, erythromycin, ketoconazole, itraconazole, ritonavir). Varied plasma conc w/ strong CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Increased bioavailability w/ grapefruit or grapefruit juice. Increased blood levels of tacrolimus. Increased exposure of mTOR inhibitors (eg, sirolimus, temsirolimus, everolimus); simvastatin. Increased trough conc of cyclosporine in renal transplant patients.

Angiotensin II Antagonists / Calcium Antagonists

C09DB04 - telmisartan and amlodipine ; Belongs to the class of angiotensin II receptor blockers (ARBs) and calcium channel blockers. Used in the treatment of cardiovascular disease.

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