Micardis Plus

Essential HTN. Fixed dose combination in patients whose BP is not adequately controlled on telmisartan or hydrochlorothiazide alone.

Adult 1 tab once daily. Patient w/ severe HTN Telmisartan at doses up to 160 mg alone & in combination w/ hydrochlorothiazide 12.5-25 mg daily. Mild to moderate hepatic impairment Should not exceed once daily.

May be taken with or without food. Swallow whole w/ liqd.

Hypersensitivity to telmisartan, hydrochlorothiazide or other sulphonamide-derived substances. Cholestasis & biliary obstructive disorders. Severe hepatic & renal (CrCl <30 mL/min or serum creatinine >1.8 mg/100 mL) impairment, coma hepaticum, hepatic precoma; anuria, or acute glomerulonephritis. Refractory hypokalaemia, hypercalcaemia. Therapy-refractory hyponatraemia. Hypovolaemia. Symptomatic hyperuricaemia/gout. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²). Pregnancy & lactation.

Symptomatic hypotension in patients who are vol &/or Na depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Correct Na or vol depletion before treatment commencement. Hyponatraemia accompanied by neurological symptoms (nausea, progressive disorientation, apathy) w/ hydrochlorothiazide. Impaired hepatic function or progressive liver disease. Renovascular HTN; increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of artery to single functioning kidney treated w/ medicinal products that affect renin-angiotensin-aldosterone system. Recent kidney transplant. Periodic monitoring of renal function; K, creatinine & uric acid serum levels. Thiazide diuretic-associated azotaemia in patients w/ impaired renal function. Telmisartan is not removed from blood by hemofiltration & is not dialyzable. Dual blockade of renin-angiotensin-aldosterone system. Patients w/ severe CHF or underlying renal disease. Not recommended in patients w/ primary aldosteronism. Patients suffering from aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy. May impair glucose tolerance & manifest latent DM; hyperuricemia may occur, or frank gout may be precipitated during thiazide therapy. Perform periodic determination of serum electrolytes at appropriate intervals. Risk of hypokalaemia in patients w/ cirrhosis of liver, experiencing brisk diuresis, receiving inadequate oral intake of electrolytes & receiving concomitant therapy w/ corticosteroids or ACTH. Concomitant use w/ K-sparing diuretics, K supplements or K-containing salts substitutes. Discontinue before carrying out tests for parathyroid function. Thiazides increase urinary excretion of Mg, resulting in hypomagnesaemia. Increased risk of fatal MI & unexpected CV death in diabetic patients w/ additional CV risk ie, DM & coexistent CAD. Excessive reduction of BP in patients w/ ischemic cardiopathy or CV disease. History of allergy or bronchial asthma; exacerbation or activation of SLE. Discontinue treatment in the event of photosensitivity reaction occurring during treatment. Protect areas exposed to sun or artificial UVA rays if resumption of treatment is essential. Idiosyncratic reaction resulting in choroidal effusion w/ visual field defect, acute transient myopia & acute angle-closure glaucoma. Risk of non-melanoma skin cancer; regularly check skin for any new lesions & promptly report any suspicious skin lesions. Limit exposure to sunlight & UV rays. Acute resp toxicity, including acute resp distress syndrome. Contains sorbitol; not recommended in patients w/ hereditary fructose intolerance. Contains lactose; not to be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Avoid potentially hazardous tasks eg, driving or operating machinery if patients experience dizziness, syncope or vertigo. Mild to moderate hepatic impairment. Not recommended in childn & adolescents <18 yr.

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

Increased risk of lithium toxicity. Increased in serum K w/ K-sparing diuretics, K supplements, salt substitutes containing K or other drugs that may increase serum K levels (eg, heparin Na). Periodic monitoring of serum K w/ drugs affected by serum K disturbances eg, digitalis glycosides, anti-arrhythmic agents & drugs known to induce torsades de pointes. Telmisartan: May increase hypotensive effect of other antihypertensive agents. Increase in median plasma digoxin trough conc. Increased AUC_0-24 & C_max of ramipril & ramiprilat. Reversible increases in serum lithium conc & toxicity. Potential for acute renal insufficiency in patients who are dehydrated w/ NSAIDs (ie, ASA at anti-inflammatory dosage regimens, COX-2 inhibitors & non-selective NSAIDs). Reduced effect by inhibition of vasodilating prostaglandins w/ NSAIDs. Hydrochlorothiazide: Antihypertensive effect can be potentiated by other diuretics, antihypertensive agents, guanethidine, methyldopa, Ca antagonists, ACE inhibitors, ARBs, DRIs, β-receptor blockers, nitrates, barbiturates, phenothiazines, TCAs, vasodilators or alcohol consumption. May reduce diuretic, natriuretic & antihypertensive effects w/ NSAIDs; salicylates & other NSAIDs (eg, indomethacin). Toxic effect of salicylates on CNS may be potentiated in patients taking high-dose salicylates. NSAIDs may trigger acute renal failure in patients developing hypovolaemia during treatment. May possibly increase frequency of hypersensitivity reactions to allopurinol. May possibly increase risk of amantadine-related AR. Increased risk for onset of hyperglycaemia w/ β-receptor blockers. May attenuate effect of insulin or oral antidiabetics, uric acid-lowering agents, norepinephrine & epinephrine. Increased myocardial sensitivity to cardiac glycosides by any hypokalaemia &/or hypomagnesaemia that develops during therapy, thereby potentiating effects & adverse effects of 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 in the event of dehydration caused by diuretics particularly during use of high doses of iodinated contrast products. Increased Na loss w/ natriuretic diuretics & antidepressants, antipsychotics or antiepileptics. Reduction in renal excretion of cytotoxic agents (eg, cyclophosphamide, fluorouracil, MTX) & increased bone marrow toxicity (especially granulocytopenia). Bioavailability may be increased by anticholinergic agents (eg, atropine, biperiden) due to decrease in GI motility & gastric emptying rate. May reduce bioavailability w/ prokinetic medicinal products eg, cisapride. Reduced renal clearance of lithium; increase plasma lithium levels; potentiation of cardio- & neurotoxic effects of lithium due to decreased lithium excretion. Potentiated or prolonged effect of curare-like muscle relaxants. Reduced absorption w/ cholestyramine or colestipol. May reduce excretion of Ca via urine & potentiate increase of Ca in serum w/ vit D. Hypercalcaemia may occur due to increase in tubular Ca reuptake w/ Ca salts. May increase risk of hyperuricaemia & gout-like complications w/ ciclosporin. Increased hyperglycaemic effect of diazoxide. Haemolysis caused by formation of Ab w/ methyldopa. May reduce response to adrenergic amines eg, norepinephrine.

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.

Rx