Micardis Plus

Per 40/12.5 mg tab Telmisartan 40 mg, hydrochlorothiazide 12.5 mg. Per 80/12.5 mg tab Telmisartan 80 mg, hydrochlorothiazide 12.5 mg

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

Adult 1 tab once daily. Severe HTN Max daily dose: Telmisartan 160 mg alone & w/ hydrochlorothiazide 12.5-25 mg. Max effect attained 4-8 wk after the start of treatment. Mild to moderate hepatic impairment Max: 40/12.5 mg once daily.

May be taken with or without food.

Hypersensitivity to telmisartan & hydrochlorothiazide or other sulphonamide-derived substances. Cholestasis & biliary obstructive disorders. 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). Severe renal impairment (CrCl <30 mL/min) or serum creatinine >1.8 mg/100 mL, anuria, or acute glomerulonephritis. Severe hepatic impairment, coma hepatricum, hepatic precoma. Pregnancy & lactation.

Hypersensitivity reactions may occur in patients w/ or w/o history of allergy or bronchial asthma. Possible exacerbation or activation of SLE w/ thiazide use. Discontinue use if photosensitivity reaction occurs during treatment; if treatment resumption is essential, protect areas exposed to the sun or artificial UVA rays. Possible symptomatic hypotension, especially after the 1st dose, in patients who are vol &/or Na depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting; correct these conditions prior to treatment. Possible hyponatraemia accompanied by neurological symptoms (eg, nausea, progressive disorientation, apathy) w/ hydrochlorothiazide use. Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis. Dual blockade of renin-angiotensin-aldosterone system (RAAS) through combined use of ACE inhibitors, ARBs or aliskiren is not recommended. Not to be used concomitantly w/ ACE inhibitors in patients w/ diabetic nephropathy. Patients whose vascular tone & renal function depend predominantly on the activity of the RAAS. Not recommended in patients w/ primary aldosteronism. Patients suffering from aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy. Metabolic & endocrine effects; thiazide therapy may impair glucose tolerance, may precipitate frank gout, or may cause occurrence of hyperuricaemia. Perform periodic determination of serum electrolytes at appropriate intervals. Concomitant use w/ K-sparing diuretics, K supplements or K-containing salt substitutes. Possible hypomagnesaemia. Discontinue thiazides before carrying out parathyroid function tests. Not to be taken by patients w/ rare hereditary condition of fructose intolerance; galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Patients w/ DM & CAD. May excessively reduce BP in patients w/ ischaemic cardiopathy or ischaemic CV disease. May cause idiosyncratic reaction resulting in choroidal effusion w/ visual field defect, acute transient myopia & acute angle-closure glaucoma. Increased risk of non-melanoma skin cancer; regularly check skin for any new lesions; limit exposure to sunlight & UV rays. W/draw use & administer appropriate therapy if acute resp distress syndrome (ARDS) is suspected; not for use in patients who experienced ARDS following hydrochlorothiazide intake. Dizziness, syncope or vertigo may occur when driving vehicles or operating machinery. Periodically monitor K, creatinine & uric acid serum levels in patients w/ mild to moderate renal impairment; thiazide diuretic-associated azotaemia may occur in patients w/ impaired renal function; telmisartan is not removed from blood by hemofiltration & is not dialyzable. Patients w/ impaired hepatic function or progressive liver disease. Not recommended during 1st trimester & should not be initiated during pregnancy. Childn & adolescents <18 yr.

Bronchitis, pharyngitis, sinusitis; thrombocytopenia; hypokalaemia, hyponatraemia, hyperuricaemia; anxiety, depression, insomnia; dizziness, syncope, paraesthesia, sleep disorder; visual impairment, blurred vision; vertigo; arrhythmia, 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 (w/ 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, blood creatinine, hepatic enzyme & blood creatine phosphokinase. Telmisartan: URTI, UTI, cystitis, sepsis (including fatal outcome); anaemia, eosinophilia; anaphylactic reaction, hypersensitivity; hyperkalaemia, hypoglycaemia (in diabetic patients); bradycardia; eczema, drug eruption, toxic skin eruption; tendon pain (tendonitis-like symptoms); decreased Hb. Hydrochlorothiazide: Basal cell carcinoma, squamous cell carcinoma of the skin & lip; thrombocytopenic purpura, aplastic & haemolytic anaemia, bone marrow failure, leukopenia, agranulocytosis; hypovolaemia, electrolyte imbalance, decreased appetite, hyperglycaemia, hyperlipidaemia, hypomagnesaemia, hypercalcaemia, hypochloraemic alkalosis, inadequate DM control; restlessness; headache; angle-closure glaucoma, choroidal effusion; necrotising vasculitis; ARDS; pancreatitis, nausea; jaundice, cholestasis; TEN, lupus-like syndrome, cutaneous lupus erythematosus, photosensitivity reaction, erythema multiforme; glycosuria; pyrexia.

Telmisartan: May increase the hypotensive effect of other antihypertensives. May increase digoxin plasm conc. Reversible increase in serum lithium conc & toxicity. Possible synergistic effects w/ compd acting on the renin-angiotensin-system. Reduced effect of antihypertensives w/ NSAIDs. Higher frequency of adverse events eg, hypotension, hyperkalaemia & decreased renal function (including acute renal failure) during combination use w/ ACE inhibitors or aliskiren. Hydrochlorothiazide: Antihypertensive effect may be potentiated by other diuretics, antihypertensives, guanethidine, methyldopa, Ca antagonists, ACE inhibitors, ARBs, dopamine reuptake inhibitors, β-receptor blockers, nitrates, barbiturates, phenothiazines, TCAs, vasodilators or by alcohol consumption. Antihypertensive & diuretic effect may be reduced by salicylates & other NSAIDs (eg, indomethacin). May increase frequency of hypersensitivity reactions of allopurinol. Possible increased risk of amantadine-related AR. Increased risk of hyperglycaemia onset w/ β-receptor blockers. May attenuate the effects of insulin or oral antidiabetics, uric acid-lowering agents, as well as norepinephrine & epinephrine. May potentiate effects & adverse effects of cardiac glycosides. May increase K loss when used concomitantly 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 high-dose iodinated contrast products, in the event of dehydration caused by diuretics; rehydrate before administration of the iodinated product. May increase Na loss when used concomitantly w/ natriuretic diuretics, antidepressants, antipsychotics or antiepileptics. May reduce renal excretion of cytotoxic agents (eg, cyclophosphamide, fluorouracil, MTX); increased bone-marrow toxicity. Bioavailability may be increased by anticholinergics (eg, atropine, biperiden). Increased plasma lithium levels. May potentiate or prolong the effect of curare-like muscle relaxants. Reduced hydrochlorothiazide absorption by cholestyramine or colestipol. May reduce Ca excretion via urine & potentiate increased serum Ca when used concomitantly w/ vit D. Hypercalcaemia may occur when co-administered w/ Ca salts. May increase risk of hyperuricemia & gout-like complications w/ ciclosporin. Increased hyperglycaemic effect of diazoxide. Possible haemolysis when used concomitantly w/ methyldopa. May reduce response to adrenergic amines (eg, norepinephrine). Serum K may be increased during concomitant use w/ K-sparing diuretics, K supplements, K-containing salt substitutes or other drugs that may increase serum K levels (eg, heparin Na). Drugs affected by serum K disturbances (eg, digitalis glycosides, anti-arrhythmics & drugs known to induce 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.

POM