Cilzec-A

Essential HTN as add-on therapy in adults whose BP is not adequately controlled on amlodipine 5 mg alone or as replacement therapy in adults receiving telmisartan & amlodipine from separate tab.

Adult 1 tab daily. Max: One 80 mg/10 mg tab daily. Add-on therapy Patient treated w/ amlodipine 10 mg who experiences any dose-limiting adverse reactions eg, oedema May be switched to Cilzec-A once daily. Replacement therapy Receive same component doses in 1 tab once daily. Patient w/ mild to moderate hepatic impairment Telmisartan should not exceed 40 mg once daily.

May be taken with or without food: Take w/ some liqd.

Hypersensitivity to telmisartan, amlodipine, or dihydropyridine derivatives. Shock (including cardiogenic shock). Obstruction of the outflow tract of the left ventricle (eg, high grade aortic stenosis). Hemodynamically 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. 2nd & 3rd trimesters of pregnancy.

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 (eg, by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting) prior to administration. Dual blockade of renin-angiotensin-aldosterone system (RAAS) through combined use of ACE inhibitors, ARBs or aliskiren is not recommended. Acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure in patients whose vascular tone & renal function depend predominantly on the activity of RAAS (eg, patients w/ severe CHF or underlying renal disease, including renal artery stenosis). Caution in patients suffering from aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy. No data on use in unstable angina pectoris & during or w/in 1 mth of an MI. May cause hyperkalaemia; closely monitor serum K in patients w/ risk factors for hyperkalaemia. Excessive BP reduction in patients w/ ischaemic cardiomyopathy or ischaemic CV disease could result in MI or stroke. Contains sorbitol. Avoid potentially hazardous tasks (eg, driving or using machines) if patients experience syncope, somnolence, dizziness, or vertigo during treatment. Caution in patients w/ hepatic impairment. Limited experience in patients w/ severe renal impairment or haemodialysis. Periodic monitoring of K & creatinine serum levels is recommended in patients w/ impaired renal function. No experience on administration in patients w/ recent kidney transplant. Not recommended during breast-feeding. Safety & efficacy in childn <18 yr have not been established. Little information is available in the very elderly patients. Telmisartan: Consider appropriate blood glucose monitoring in diabetic patients treated w/ insulin or antidiabetics. Not recommended in patients w/ primary aldosteronism. Should not be used concomitantly w/ ACE inhibitors in patients w/ diabetic nephropathy. Not recommended during 1st trimester of pregnancy. Amlodipine: Caution in patients w/ CHF. Concomitant use w/ grapefruit or grapefruit juice is not recommended. Safety in human pregnancy has not been established.

Dizziness; peripheral oedema. Amlodipine: Visual disturbance (including diplopia); altered bowel habits (including diarrhoea & constipation); ankle swelling.

Increased BP-lowering effect w/ other antihypertensives. Hypotensive effects may be potentiated w/ baclofen, amifostine, neuroleptics or antidepressants. Orthostatic hypotension may be aggravated by alcohol. Reduced antihypertensive effect w/ corticosteroids (systemic route). Telmisartan: Attenuates diuretic-induced K loss. May lead to significant increase in serum K w/ K-sparing diuretics (eg, spironolactone, eplerenone, triamterene, or amiloride), K supplements, or K-containing salt substitutes. Reversible increases in serum lithium conc & toxicity. Dual blockade of RAAS through combined use of ACE inhibitors, ARBs or aliskiren is associated w/ higher frequency of adverse events eg, hypotension, hyperkalaemia & decreased renal function. Antihypertensive effect may be reduced w/ NSAIDs (ie, ASA at anti-inflammatory doses, COX-2 inhibitors & non-selective NSAIDs). May result in further deterioration of renal function, including possible acute renal failure, which is usually reversible, w/ COX inhibitors in some patients w/ compromised renal function (eg, dehydrated patients or elderly w/ compromised renal function). Increased AUC_0-24 & C_max of ramipril & ramiprilat. Median increases in digoxin peak plasma & trough conc. Amlodipine: Strong or moderate CYP3A4 inhibitors (PIs, azole antifungals, macrolides like erythromycin or clarithromycin, verapamil or diltiazem) may increase amlodipine exposure resulting in an increased risk of hypotension. Plasma conc may vary w/ strong CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Risk of hyperkalemia w/ IV dantrolene. Bioavailability may be increased resulting to increased BP-lowering effect w/ grapefruit or grapefruit juice. Risk of increased tacrolimus blood levels. Variable trough conc increases of cyclosporine in renal transplant patients. May increase exposure of mTOR inhibitors (eg, sirolimus, temsirolimus, everolimus). Increased exposure to 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.

Rx