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.
Dosage/Direction for Use
Adult 1 tab once daily. Max antihypertensive effect is attained 4-8 wk after initiation. Severe HTN 160 mg alone or 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. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Severe hepatic & renal impairment (CrCl <30 mL/min). 2nd & 3rd trimesters of 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. Increased risk of non-melanoma skin cancer. 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; acute transient myopia & angle-closure glaucoma. May impair glucose tolerance. Correct vol &/or Na depletion prior to administration. Perform periodic determination of serum electrolytes. Avoid sunlight & UV rays exposure. Concomitant use w/ corticosteroids, ACTH, K-sparing diuretics, K supplements, K-containing salt substitutes. Fructose & galactose intolerance. May affect ability to drive & use machines. Periodically monitor serum K, creatinine & uric acid in patients w/ mild to moderate renal impairment. Recent kidney transplant. Hepatic impairment, progressive liver disease. Not to be used in patients w/ severe renal impairment (CrCl <30 mL/min). Not recommended during 1st trimester of pregnancy. Childn & adolescents ≤18 yr.
Adverse Reactions
Bronchitis, pharyngitis, sinusitis; SLE exacerbation or activation; hypokalaemia, hyponatraemia, hyperuricaemia; anxiety, depression; dizziness, syncope/faint, paraesthesia, sleep disturbances, insomnia; abnormal/transient blurred vision; vertigo; cardiac arrhythmias, tachycardia; hypotension; dyspnoea, resp distress; diarrhoea, dry mouth, flatulence, abdominal pain, constipation, dyspepsia, vomiting, gastritis; abnormal hepatic function/liver disorder; angioedema, erythema, pruritus, rash, increased sweating, urticaria; back pain, muscle spasm, myalgia, arthralgia, leg pain & cramps; impotence; chest pain, flu-like symptoms, pain; increased uric acid, creatinine, liver enzymes & blood creatine phosphokinase.
Drug Interactions
Reversible increased in serum lithium conc & toxicity. 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. Potentiated orthostatic hypotension w/ alcohol, barbiturates or narcotics. Dosage adjustment of antidiabetics eg, oral agents & insulins. Risk of lactic acidosis w/ metformin. Impaired absorption w/ anionic exchange resins. Digitalis-induced cardiac arrhythmias w/ digitalis glycosides. Decreased effect of pressor amines eg, noradrenaline. Potentiated effect of nondepolarizing skeletal muscle relaxants eg, tubocurarine. Increased hypersensitivity reactions of allopurinol. Increased serum Ca levels. Enhanced hyperglycaemic effect of β-blockers & diazoxide. Increased bioavailability w/ anticholinergics eg, atropine, biperiden. Increased risk of adverse effects by amantadine. Reduced renal excretion & potentiated myelosuppressive effects of cytotoxic agents eg, cyclophosphamide, methotrexate.
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 80/12.5 mg tab
Packing/Price
30's
Form
Micardis Plus 40/12.5 mg tab
Packing/Price
30's
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