Micardis Plus

Micardis Plus

telmisartan + hydrochlorothiazide

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
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
Indications/Uses
Essential HTN when BP is inadequately controlled by monotherapy w/ telmisartan or hydrochlorothiazide.
Dosage/Direction for Use
Adult 1 tab once daily. Max antihypertensive effect is attained 4-8 wk after initiation. Severe HTN 160 mg alone & in combination w/ hydrochlorothiazide 12.5-25 mg daily. Mild to moderate hepatic impairment Not to exceed 40/12.5 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to telmisartan, hydrochlorothiazide or 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 hepatic impairment, coma hepatricum, hepatic precoma. Severe renal impairment (CrCl <30 mL/min), anuria, acute glomerulonephritis. Pregnancy & lactation.
Special Precautions
Not recommended in primary aldosteronism. Not to be given in patients w/ cholestasis or biliary obstructive disorders. History of allergy or bronchial asthma. Dual blockade of renin-angiotensin-aldosterone system; bilateral renal artery stenosis or artery stenosis to single functioning kidney; severe CHF or underlying renal disease including renal artery stenosis; aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy; hyperuricaemia or frank gout; hyperkalaemia; DM & co-existent CAD; ischaemic cardiopathy or CV disease; SLE exacerbation or activation; choroidal effusion, acute transient myopia & angle-closure glaucoma. May impair glucose tolerance. Correct vol &/or Na depletion prior to administration. Perform periodic determination of serum electrolytes. Increased risk of non-melanoma skin cancer. Avoid sunlight & UV rays exposure. Concomitant use w/ corticosteroids, ACTH, K-sparing diuretics, K supplements, K-containing salt substitutes. Not to be taken by patients w/ fructose & galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Periodically monitor serum K, creatinine & uric acid in patients w/ mild to moderate renal impairment. Not to be used in patients w/ severe renal impairment (CrCl <30 mL/min) or hepatic insufficiency. Recent kidney transplantation. Hepatic impairment, progressive liver disease. Not to be used during pregnancy & lactation. Not recommended in childn & adolescents ≤18 yr. Elderly ≥65 yr.
Adverse Reactions
Bronchitis, pharyngitis, sinusitis; lupus erythematosus; hypokalaemia, hyponatraemia, hyperuricaemia; anxiety, depression; dizziness, syncope/faint, paraesthesia, sleep disorder, insomnia; 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; abnormal hepatic function/liver disorder; angioedema, erythema, pruritus, rash, hyperhidrosis, urticaria; back pain, muscle spasms, myalgia, arthralgia, pain in extremity; renal impairment including renal injury; erectile dysfunction; chest pain, flu-like illness, pain; increased blood uric acid, creatinine & creatine phosphokinase & hepatic enzymes.
Drug Interactions
Telmisartan: Reversible increased in serum lithium conc & toxicity. Potentiated effect w/ drugs associated w/ K loss & hypokalaemia eg, other kaliuretic diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G Na, salicylic acid & derivatives. Increased serum K levels w/ K-sparing diuretics, K supplements, K-containing salt substitutes or other drugs increasing serum K levels eg, heparin Na. Drugs affected by serum K disturbances eg, digitalis glycosides, antiarrhythmics & drugs inducing Torsade de pointes. Reduced diuretic, natriuretic & antihypertensive effects w/ NSAIDs. Increased hypotensive effect of other antihypertensives. Increased median plasma digoxin trough conc. Increased AUC & Cmax of ramipril & ramiprilat. Hydrochlorothiazide: Potentiated antihypertensive effects by other diuretics, antihypertensives, guanethidine, methyldopa, Ca antagonists, ACE inhibitors, ARBs, DRIs, β-blockers, nitrates, barbiturates, phenothiazines, TCAs, vasodilators or alcohol. Reduced effect w/ salicylates, other NSAIDs eg, indomethacin. Increased hypersensitivity reactions of allopurinol. Increased risk of amantadine-related ARs. Attenuated effect of insulin or oral antidiabetics, uric acid-lowering agents, norepinephrine, epinephrine. Potentiated effects of cardiac glycosides. Increased K loss w/ kaliuretic diuretics (eg, furosemide), glucocorticoids, ACTH, carbenoxolone, penicillin G, salicylates, amphotericin B, antiarrhythmics, laxatives. Increased Na loss w/ natriuretic diuretics, antidepressants, antipsychotics, antiepileptics. Reduced renal excretion of cytotoxic agents eg, cyclophosphamide, fluorouracil, methotrexate. Increased bioavailability w/ anticholinergics eg, atropine, biperiden. 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. Reduced response to adrenergic amines eg, norepinephrine.
MIMS Class
Angiotensin II Antagonists / Diuretics
ATC Classification
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.
Presentation/Packing
Form
Micardis Plus 40/12.5 mg tab
Packing/Price
30's
Form
Micardis Plus 80/12.5 mg tab
Packing/Price
30's
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