Generic Name: Telmisartan

Regulatory Class: Rx

Formulations: 40mg, 80mg Tablet

Indications or Uses: Essential HTN in adults. Reduction of the risk of MI, stroke, or death from CV causes in patient ≥55 yr at high risk of developing major CV events who are unable to take ACE inhibitors.

Dosage or Directions for use: Essential Hypertension 40 mg once daily. Max: 80 mg once daily. Severe Hypertension Up to 160 mg alone or in combination w/ hydrochlorothiazide 12.5-25 mg daily. Cardiovascular prevention 80 mg once daily. Mild to moderate hepatic impairment Do not exceed 40 mg once daily.

Administration: take w/ or w/o food. 

Contraindications: Hypersensitivity. Biliary obstructive disorders. Severe hepatic impairment. Patients w/ DM using aliskiren-containing products or renal impairment (GFR <60 mL/min/1.73 m2). 2nd & 3rd trimesters of pregnancy. Childn & adolescents <18 yrs.

Special Precautions: Not to be given in patients w/ cholestasis, biliary obstructive disorders or severe hepatic impairment. 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 in patients w/ impaired renal function. Intravascular hypovolaemia. Increased risk of hypotension, hyperkalaemia & decreased renal function (including acute renal failure). Frequent close monitoring of renal function, electrolytes & BP if dual blockade therapy is considered & necessary. Patients w/ Congestive Heart Failure or underlying renal disease including renal artery stenosis. Primary aldosteronism. Patients suffering from aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy. Hypoglycaemia. Hyperkalaemia. Black hypertensive patients. Excessive reduction of BP in patients w/ ischemic cardiopathy or cardiovascular disease. Concomitant use w/ salt substitutes containing K, K-sparing diuretics, ACE inhibitors, AIIA, NSAIDs (including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), & trimethoprim. May affect ability to drive or operating machinery. Not to be initiated during pregnancy. Not recommended during breast-feeding.

Adverse Reaction: Anaphylactic reaction, angioedema (rare); acute renal failure.

Interactions: Monitor digoxin levels when initiating, adjusting & discontinuing telmisartan. Increased risk of hyperkalaemia w/ salt substitutes containing K, K-sparing diuretics, ACE inhibitors, AIIA, NSAIDs (including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), & trimethoprim. Not recommended in concomitant use w/ K sparing diuretics or K supplements, lithium. Use w/ caution w/ NSAIDs. May cause vol depletion & risk of hypotension w/ thiazide or loop diuretics. Concomitant use w/ other hypertensive agents may increase BP lowering effect. May potentiate hypotensive effect w/ baclofen, amifostine. Reduced antihypertensive effect w/ corticosteroid (systemic route).

Presentation or Packaging: Tablet 40mg x 30's; 80mg x 30's

For more information on this product, please see the product insert.