Telsat AM

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

Treatment of essential HTN. Replacement therapy in patients who are receiving telmisartan & amlodipine from separate tab. Add on therapy in patients whose BP is inadequately controlled on amlodipine monotherapy.

Adult 40/5 mg tab once daily or the same component doses from separated tab before. Max recommended dose: One 80/10 mg tab daily. Mild to moderate hepatic impairment Not to exceed telmisartan 40 mg once daily.

May be taken with or without food.

Hypersensitivity to telmisartan, amlodipine & dihydropyridine derivatives. Biliary obstructive disorders, severe hypotension, shock eg, cardiogenic shock, left ventricle outflow tract obstruction eg, high grade aortic stenosis, haemodynamically unstable heart failure after acute MI. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²). Severe hepatic impairment. 2nd & 3rd trimesters of pregnancy. 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. 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 is not recommended. Patients whose vascular tone & renal function depend predominantly on the activity of the RAAS. Not recommended in patients w/ primary aldosteronism. Special caution in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Unstable angina pectoris, acute MI; hyperkalemia. Increased reports of pulmonary edema in patients w/ NYHA III & IV heart failure of nonischemic etiology. Patients w/ DM should undergo appropriate diagnostic evaluation, eg, exercise stress testing, to detect & to treat CAD accordingly before initiating treatment. Black patients (low renin population). Caution when driving a car or operating machinery. Periodic monitoring of K & creatinine serum levels in patients w/ renal impairment. Patients w/ recent kidney transplant. Hepatic impairment. Not recommended during pregnancy & lactation. Not recommended in childn <18 yr.

Dizziness & peripheral oedema.

Increased BP lowering effect w/ other antihypertensive medicinal products. Potentiated hypotensive effects by baclofen, amifostine. Aggravated orthostatic hypotension by alcohol, barbiturates, narcotics or antidepressants. Reduced antihypertensive effect w/ systemic corticosteroids. Significant increase in serum K w/ K-sparing diuretics (eg, spironolactone, eplerenone, triamterene, or amiloride), K supplements, or K-containing salt substitutes. Reversible increases of serum lithium conc & toxicity. Reduced antihypertensive effects w/ NSAIDs. Increased AUC_0-24 & C_max of ramipril & ramiprilat. Amlodipine: Increased BP lowering effects w/ grapefruit or grapefruit juice. Increased plasma conc w/ strong CYP3A4 inhibitors (eg, erythromycin, ketoconazole, itraconazole, ritonavir). May lead to a lower plasma conc of amlodipine w/ CYP3A4 inducers (ie, rifampicin, Hypericum perforatum). Increase in simvastatin exposure w/ amlodipine. May increase systemic exposure of ciclosporin or tacrolimus.

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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