Twynsta

Add-on therapy for essential HTN in adults whose BP is inadequately controlled. Replacement therapy for essential HTN in adults who are receiving telmisartan & amlodipine from separate tab.

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

May be taken with or without food: Take w/ liqd. Take out of blister shortly before administration.

Hypersensitivity to telmisartan & amlodipine besilate, or to dihydropyridine derivatives. Shock (including 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 medicinal products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²). Biliary obstructive disorders & severe hepatic impairment. 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. Periodically monitor K & creatinine serum levels in patients w/ impaired renal function. No experience in patients w/ recent kidney transplant. Correct vol &/or Na depletion before administration of treatment. Dual blockade of renin-angiotensin-aldosterone system (RAAS) through combined use of ACE inhibitors, ARBs or aliskiren is not recommended. ACE inhibitors & ARBs should not be used concomitantly in patients w/ diabetic nephropathy. Risk of acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure in patients whose vascular tone & renal function depend predominantly on RAAS activity. Not recommended in patients w/ primary aldosteronism. Special caution in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. No data to support use in unstable angina pectoris & during or w/in 1 mth of MI. Caution in patients w/ heart failure. Consider appropriate blood glucose monitoring in diabetic patients treated w/ insulin or antidiabetics. Risk of hyperkalaemia. Excessive BP reduction in patients w/ ischaemic cardiomyopathy or ischaemic CV disease could result in MI or stroke. Contains sorbitol. Not recommended in patients w/ hereditary fructose intolerance. Moderate influence on the ability to drive & use machines. Caution in patients w/ severe renal impairment or haemodialysis; patients w/ mild to moderate hepatic impairment. Not recommended during the 1st trimester of pregnancy; during breast-feeding. Safety & efficacy in childn <18 yr have not been established. Elderly.

Dizziness, peripheral oedema.

Potentiated hypotensive effect w/ baclofen, amifostine, neuroleptics, antidepressants, or other antihypertensives. Aggravated orthostatic hypotension w/ alcohol. Reduced antihypertensive effect w/ systemic corticosteroids. Telmisartan: Significant increase in serum K w/ K-sparing diuretics (eg, spironolactone, eplerenone, triamterene, amiloride), K supplements, or K-containing salt substitutes. Reversible increase in serum conc & toxicity of lithium. Higher frequency of adverse events w/ combined use of ACE inhibitors, ARBs or aliskiren. Reduced antihypertensive effect w/ NSAIDs. Increased AUC_0-24 & C_max of ramipril & ramiprilat. Increased peak plasma conc & trough conc of digoxin. Amlodipine: Significant increase in exposure w/ strong or moderate CYP3A4 inhibitors (eg, PIs, azole antifungals, erythromycin, clarithromycin, verapamil, diltiazem). Varied plasma conc w/ strong CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Risk of hyperkalemia w/ IV dantrolene. Increased bioavailability w/ grapefruit or grapefruit juice. Increased blood levels of tacrolimus. Increased trough conc of cyclosporine in renal transplant patients. Increased exposure of mTOR inhibitors (eg, sirolimus, temsirolimus, everolimus); simvastatin.

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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