Micardis/Micardis Plus

Micardis Telmisartan. Micardis Plus 40/12.5 mg tab Telmisartan 40 mg, hydrochlorothiazide 12.5 mg. Micardis Plus 80/12.5 mg tab Telmisartan 80 mg, hydrochlorothiazide 12.5 mg

Essential HTN. Micardis Prevention of CV morbidity & mortality in patients ≥55 yr at high risk of CV disease. Micardis Plus Patients whose BP is not adequately controlled on telmisartan or hydrochlorothiazide alone.

Micardis Essential HTN 40 mg once daily. Max: 80 mg once daily. May be combined w/ thiazide-type diuretics eg, hydrochlorothiazide or Ca channel-blockers eg, amlodipine. Severe HTN Max: 160 mg alone & in combination w/ hydrochlorothiazide 12.5-25 mg daily. Prevention of CV morbidity & mortality 80 mg once daily. Mild to moderate hepatic impairment Not to exceed telmisartan 40 mg once daily. Micardis Plus Adult Take once daily. Severe HTN Max: Telmisartan 160 mg alone & in combination & w/ hydrochlorothiazide 12.5-25 mg daily.

May be taken with or without food.

Hypersensitivity to telmisartan, hydrochlorothiazide, & other sulphonamide-derived substances. Biliary obstructive disorders. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²). Severe hepatic impairment. Pregnancy (2nd & 3rd trimesters). Lactation. Micardis Plus Refractory hypokalaemia, hypercalcaemia; therapy-refractory hyponatraemia; hypovolaemia; symptomatic hyperuricaemia/gout. Cholestasis; coma hepaticum, hepatic precoma. Severe renal impairment (CrCl <30 mL/min or serum creatinine >1.8 mg/100 mL), anuria, or acute glomerulonephritis.

Not recommended in patients w/ primary aldosteronism. Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of artery to single functioning kidney. Symptomatic hypotension, especially after 1st dose in patients who are vol &/or Na depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. May result in MI or stroke w/ excessive BP reduction in patients w/ ischaemic cardiopathy or CV disease. Patients whose vascular tone & renal function depend predominantly on activity of renin-angiotensin-aldosterone system; suffering from aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy. Recent kidney transplant. Correct vol &/or Na depletion before treatment. Perform diagnostic evaluation eg, exercise stress test to detect & treat CAD in patients w/ DM before initiating treatment. Monitor serum K in patients at risk of hyperkalaemia. Black people. Not recommended to use concomitantly w/ ACE-inhibitor or aliskiren. Not to be taken by patients w/ fructose intolerance. Concomitant use w/ K-sparing diuretics, K supplements, K-containing salt substitutes or other medicinal products that may increase serum K. May affect ability to drive & use machines due to occasional dizziness, syncope or vertigo. Not to exceed 40 mg once daily telmisartan dose in patients w/ mild to moderate hepatic impairment. Not recommended during 1st trimester of pregnancy & not to be initiated during pregnancy. Discontinue treatment if pregnancy is diagnosed. Not recommended in childn & adolescents <18 yr. Micardis Plus Hypersensitivity to hydrochlorothiazide in patients w/ or w/o history of allergy or bronchial asthma. Exacerbation or activation of SLE. Discontinue treatment before carrying out parathyroid tests; in case of photosensitivity reactions; if idiosyncratic reaction, resulting in choroidal effusion w/ visual field defect, acute transient myopia & angle-closure glaucoma occur. Not to be administered in patients who previously experienced acute resp distress syndrome. Hyponatraemia accompanied by neurological symptoms eg, nausea, progressive disorientation, apathy; fluid or electrolyte imbalance; hypo- & hyperkalaemia; hypomagnesaemia. Intermittent & slight serum Ca elevation. May impair glucose tolerance; manifest latent DM. Hyperuricaemia; frank gout. Increased risk of non-melanoma skin cancer w/ increased hydrochlorothiazide dose. Perform periodic determination of serum electrolytes. Regularly check & examine suspicious skin lesions potentially including histological exam of biopsies. Protect areas exposed to sun or artificial UVA rays if resumption of treatment is essential. Not to be taken by patients w/ galactose intolerance eg, galactosaemia. Not to be used in patients w/ severe renal impairment (CrCl <30 mL/min); cholestasis, biliary obstructive disorders or severe hepatic insufficiency. Possible renal impairment in elderly ≥65 yr.

Sepsis including fatal outcome, UTI, URTI, cystitis; anaemia, thrombocytopenia, eosinophilia; anaphylactic reaction, hypersensitivity; hyperkalaemia, hypoglycaemia (in diabetic patients), hyponatraemia; depression, anxiety, insomnia; syncope; visual impairment; vertigo; bradycardia, tachycardia; hypotension, orthostatic hypotension; dyspnoea; abdominal pain & discomfort, diarrhoea, vomiting, dyspepsia, dry mouth, flatulence; abnormal hepatic function/liver disorder; angioedema including fatal outcome, drug & toxic skin eruption, urticaria, eczema, erythema, rash, pruritus, hyperhidrosis; arthralgia, back, leg & tendon pain, muscle spasms, myalgia; renal impairment including acute kidney injury; chest pain, asthenia, flu-like illness; increased hepatic enzyme, blood creatinine, creatine phosphokinase & uric acid, decreased Hb. Micardis Plus Bronchitis, pharyngitis, sinusitis; basal cell, squamous skin cell & lip squamous cell carcinoma; thrombocytopenic purpura; aplastic & haemolytic anaemia, bone marrow failure, leukopenia, agranulocytosis; hypokalaemia, hyperuricaemia, decreased appetite, hyperglycaemia, hypomagnesaemia, hypercalcaemia, alkalosis hypochloraemic, hyperlipidaemia, inadequately controlled DM; dizziness, paraesthesia, sleep disorder, headache; blurred vision, angle-closure glaucoma, choroidal effusion; arrhythmia; necrotising vasculitis; resp distress, pneumonitis, pulmonary oedema, acute resp distress syndrome; constipation, gastritis, pancreatitis, nausea; jaundice, cholestasis; TEN, lupus-like syndrome, cutaneous lupus erythematosus, photosensitivity reaction, erythema multiforme; SLE; glycosuria; erectile dysfunction; pain, pyrexia.

May increase hypotensive effect of other antihypertensives. Increased median plasma digoxin trough conc. Increased AUC_0-24 & C_max of ramipril & ramiprilat. Reversible increase in serum lithium conc & toxicity. Reduced antihypertensive effect w/ NSAIDs. Potential acute renal insufficiency in dehydrated patients w/ NSAIDs. Micardis Plus Hydrochlorothiazide: Potentiated antihypertensive effect w/ other diuretics, antihypertensives, guanethidine, methyldopa, Ca antagonists, ACE inhibitors, ARBs, DRIs, β-receptor blockers, nitrates, barbiturates, phenothiazines, TCAs, vasodilators or by alcohol consumption. Reduced anithypertensive & diuretic effect w/ salicylates & other NSAIDs eg, indomethacin. Potentiated toxic effect of salicylates on CNS. Increased frequency of hypersensitivity reactions to allopurinol. Increased risk of amantadine-related adverse reactions. Increased risk for onset of hyperglycaemia w/ β-receptor blockers. Attenuated effect of insulin or oral antidiabetics, uric acid-lowering agents, norepinephrine & epinephrine. Increased myocardial sensitivity to cardiac glycosides. Increased K loss w/ kaliuretic diuretics (eg, furosemide), glucocorticoids, ACTH, carbenoxolone, penicillin G, salicylates, amphotericin B, antiarrhythmics or laxatives. Increased risk of acute functional renal failure, particularly during use of iodinated contrast products. Increased Na loss w/ antidepressants, antipsychotics or antiepileptics. Reduction in renal excretion & increased bone marrow toxicity of cytotoxic agents w/ cyclophosphamide, fluorouracil, MTX. Increased bioavailability w/ anticholinergic agents eg, atropine, biperiden. Reduced bioavailability w/ prokinetic medicinal products eg, cisapride. Increased plasma lithium levels. Potentiated or prolonged effect of curare-like muscle relaxants. Reduced absorption w/ cholestyramine or colestipol. Reduced Ca excretion w/ vit D. Hypercalcaemia w/ Ca salts. Increased risk of hyperuricaemia & gout-like complications w/ ciclosporin. Increased hyperglycaemic effect of diazoxide. Haemolysis w/ methyldopa. Reduced response to adrenergic amines eg, norepinephrine. Attenuated K-depleting effect of telmisartan. Increased serum K levels w/ K-sparing diuretics, K supplements, K-containing salt substitutes or other drugs that may increase serum K eg, heparin Na. Concomitant use w/ drugs affected by serum K disturbances eg, digitalis glycosides, anti-arrhythmic agents & drugs inducing torsades de pointes.

Angiotensin II Antagonists / Diuretics

C09DA07 - telmisartan and diuretics ; Belongs to the class of angiotensin II receptor blockers (ARBs) in combination with diuretics. Used in the treatment of cardiovascular disease.
C09CA07 - telmisartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.

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