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Micardis

Micardis

telmisartan

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Telmisartan
Indications/Uses
Essential HTN in adults. Risk reduction of non-fatal stroke or MI in adults ≥55 yr at high risk of developing major CV events who cannot tolerate ACE inhibitors. High risk of CV events include evidence of CAD, peripheral arterial disease, stroke, transient ischemic attack or DM w/ evidence of end-organ damage.
Dosage/Direction for Use
Adult Essential HTN 40 mg once daily. Max: 80 mg once daily. May be used in combination w/ thiazide-type diuretics eg, hydrochlorothiazide or Ca-channel blockers (eg, amlodipine). Severe HTN Up to 160 mg alone or in combination w/ hydrochlorothiazide 12.5-25 mg daily. CV morbidity reduction 80 mg once daily. Mild to moderate hepatic impairment Max: 40 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Biliary obstructive disorders. Severe hepatic impairment. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Pregnancy (2nd & 3rd trimesters) & lactation.
Special Precautions
Possible hyperkalaemia especially in presence of renal impairment &/or heart failure; monitor serum K in patients at risk. Concomitant use w/ K-sparing diuretics, K supplements, K-containing salt substitutes or other medical products that may increase K level (eg, heparin). Symptomatic hypotension especially after 1st dose, may occur in patients who are vol &/or Na depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Increased risk of severe hypotension & renal insufficiency when patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated w/ medicinal products affecting renin-angiotensin-aldosterone system (RAAS). Periodically monitor serum K & creatinine in patients w/ impaired renal function. Not to be used concomitantly w/ ACE inhibitors & ARBs in patients w/ diabetic nephropathy. Patients whose vascular tone & renal function depend predominantly on the RAAS activity. Not recommended in patients w/ primary aldosteronism. Patients suffering from aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy. May increase risk of fatal MI & unexpected CV death when treated w/ BP lowering agents (eg, ARBs or ACE inhibitors) in diabetics w/ additional CV risk (ie, patients w/ DM & coexistent CAD). Patients w/ ischaemic cardiopathy or CV disease. Contains sorbitol. Not to be taken by patients w/ rare hereditary condition of fructose intolerance. May affect ability to drive & use machines due to occasional syncope or vertigo. Patients w/ biliary obstructive disorders or hepatic insufficiency. May be less effective in lowering BP in Black people than in non-Blacks. Not to be initiated during pregnancy; not recommended during 1st trimester. Potential fetal/neonatal morbidity & mortality; possible oligohydramnios. Childn <18 yr.
Adverse Reactions
Sepsis (including fatal outcome), URTI, UTI, cystitis; thrombocytopenia, anaemia, eosinophilia; anaphylactic reaction, hypersensitivity; hyperkalaemia, hypoglycaemia (in diabetics), hyponatraemia; depression, anxiety, insomnia; syncope; visual impairment; vertigo; bradycardia, tachycardia; hypotension, orthostatic hypotension; dyspnoea; abdominal pain, diarrhoea, vomiting, dyspepsia, dry mouth, flatulence, abdominal discomfort; abnormal hepatic function/liver disorder; angioedema (including fatal outcome), drug & toxic skin eruption, urticaria, eczema, erythema, rash, pruritus, hyperhidrosis; arthralgia, back & tendon pain, pain in extremity, muscle spasms, myalgia; renal impairment (including acute kidney injury); chest pain, asthenia, flu-like illness; increased hepatic enzymes, blood creatinine, blood creatine phosphokinase & blood uric acid & decreased Hb.
Drug Interactions
May increase hypotensive effects of other antihypertensive agents. Increased digoxin median plasma. Reversible increases in serum lithium conc & toxicity. Potential for acute renal insufficiency in dehydrated patients when used concomitantly w/ NSAIDs. Higher frequency of adverse events [eg, hypotension, hyperkalaemia & decreased renal function (including acute renal failure)] in combined use of ACE inhibitors, ARBs or aliskiren.
MIMS Class
Angiotensin II Antagonists
ATC Classification
C09CA07 - telmisartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Micardis tab 40 mg
Packing/Price
30's
Form
Micardis tab 80 mg
Packing/Price
30's
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