Essential HTN: As replacement therapy in patients receiving telmisartan & amlodipine besilate from separate tab; add-on therapy in patients whose BP is not adequately controlled on telmisartan or amlodipine monotherapy; or as initial therapy in patients who are likely to need multiple drugs to achieve BP goals.
Adult Replacement therapy 1 tab once daily containing same component doses as from separate tab. Add-on therapy 40 mg/5 mg once daily may be given to patients treated w/ 10 mg amlodipine who experience any dose-limiting adverse reactions eg, oedema. Initial therapy Usual starting dose: 40 mg/5 mg once daily, or 80 mg/5 mg once daily in patients requiring larger BP reductions. May be titrated up to a max of 80 mg/10 mg once daily after at least 2 wk if additional BP lowering is needed. Patient w/ mild to moderate hepatic impairment Telmisartan: Should not exceed 40 mg once daily.
Hypersensitivity to telmisartan, amlodipine, or dihydropyridine derivatives. Biliary obstructive disorders; severe hepatic impairment; cardiogenic shock. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Rare hereditary conditions that may be incompatible w/ an excipient of the product. Pregnancy (2nd & 3rd trimesters) & lactation.
Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Periodic monitoring of K & creatinine serum levels is recommended in patients w/ impaired renal function. Monitor serum K in patients at risk of hyperkalaemia. Risk of symptomatic hypotension, especially after 1st dose, in patients who are vol- &/or Na-depleted eg, by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Correct hypovolaemia or salt depletion before administration. Dual blockade of the renin-angiotensin-aldosterone system (RAAS) is not recommended. Risk of acute hypotension, hyperazotemia, oliguria, or rarely acute renal failure in patients whose vascular tone & renal function depend predominantly on RAAS activity (eg, patients w/ severe CHF or underlying renal disease, including renal artery stenosis). Caution in patients w/ biliary obstructive disorders or hepatic insufficiency; aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy; mild to moderate hepatic impairment. No data to support use in unstable angina pectoris & during or w/in 1 mth of MI. Increased reports of pulmonary oedema in patients w/ NYHA III & IV heart failure of non-ischaemic aetiology. Risk of fatal MI & unexpected CV death may be increased in DM patients w/ co-existent CAD & treated w/ BP-lowering agents eg, ARBs or ACE inhibitors. Not recommended in patients w/ primary aldosteronism. Excessive BP reduction in patients w/ ischaemic cardiopathy or ischaemic CV disease could result in MI or stroke. Cautiously co-administer telmisartan w/ K-sparing diuretics, K supplements, salt substitutes containing K or other medicinal products that may increase K level (eg, heparin). May cause syncope, somnolence, dizziness, or vertigo which may affect ability to drive & use machines. No experience in patients w/ recent kidney transplant. Not dialyzable. Not recommended during 1st trimester of pregnancy & should not be initiated during pregnancy. Discontinue nursing during treatment or discontinue treatment. Not recommended in patients <18 yr. Caution when increasing amlodipine dose in elderly.
Increased BP-lowering effect w/ other antihypertensive medicinal products. Agents w/ BP-lowering potential (eg, baclofen or amifostine) may potentiate hypotensive effects. Orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics, or antidepressants. Reduced antihypertensive effect w/ corticosteroids (systemic route). Telmisartan: Increased hypotensive effect of other antihypertensive agents. Increased median plasma trough conc of digoxin. Increased AUC0-24 & Cmax of ramipril & ramiprilat. Reports of reversible increases in serum conc & toxicity of lithium.
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.
Sign Out
