Micardis Plus

Micardis Plus

telmisartan + hydrochlorothiazide

Manufacturer:

Boehringer Ingelheim

Distributor:

Metro Drug
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. Per 80/25 mg tab Telmisartan 80 mg, hydrochlorothiazide 25 mg
Indications/Uses
Essential HTN. Fixed dose combination in patients whose BP is not adequately controlled on telmisartan or hydrochlorothiazide alone.
Dosage/Direction for Use
Adult 1 tab once daily. Mild to moderate hepatic impairment Should not exceed 40/12.5 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to telmisartan, hydrochlorothiazide or other sulphonamide-derived substances. Cholestasis & biliary obstructive disorders. Severe hepatic & renal impairment (CrCl <30 mL/min). Refractory hypokalemia, hypercalcemia. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Pregnancy (2nd & 3rd trimesters) & lactation.
Special Precautions
Should not be used in patients w/ cholestasis, biliary obstructive disorders or severe hepatic insufficiency. Impaired hepatic function or progressive liver disease. Bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Recent kidney transplant. Vol &/or Na depleted by vigorous diuretic therapy, dietary salt restriction, diarrhea or vomiting. Dual blockade of the renin-angiotensin-aldosterone system. Primary aldosteronism. Aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Latent DM, hyperuricemia or frank gout may manifest during therapy. Perform periodic determination of serum electrolytes. Risk of hypokalemia in patients w/ cirrhosis of liver, those experiencing brisk diuresis, those receiving inadequate oral intake of electrolyte & those 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. Risk of fatal MI & unexpected CV death in diabetic patients w/ an additional CV risk ie, DM & coexistent CAD. Excessive reduction of BP in patients w/ ischemic cardiopathy or CV disease. Fructose & galactose intolerance. History of allergy or bronchial asthma; SLE. Idiosyncratic reaction resulting in acute transient myopia & acute angle-closure glaucoma. May affect ability to drive & operate machinery. Childn <18 yr.
Adverse Reactions
Bronchitis, pharyngitis, sinusitis; exacerbation or activation of SLE; hypokalemia, hyponatremia, hyperuricemia; anxiety, depression; dizziness, syncope/faint, paresthesia, sleep disturbances, insomnia; abnormal vision, transient blurred vision; vertigo; cardiac arrhythmias, tachycardia; hypotension (including orthostatic hypotension); dyspnea, resp distress (including pneumonitis & pulmonary edema); diarrhea, 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, leg cramps; impotence; chest pain, influenza-like symptoms, pain; increase in uric acid, creatinine, liver enzymes & blood creatinine phosphokinase. Telmisartan: Upper resp tract infection, UTI (including cystitis), sepsis; anemia, thrombocytopenia, eosinophilia; anaphylactic reaction, hypersensitivity; hyperkalemia, hypoglycemia; bradycardia; upset stomach; eczema, drug eruption, toxic skin eruption; arthrosis, tendon pain; renal impairment including acute renal failure; asthenia; decreased Hb. Hydrochlorothiazide: Sialadenitis; non-melanoma skin cancer; thrombocytopenia (sometimes w/ purpura), aplastic anemia, hemolytic anemia, bone marrow depression, leukopenia, neutropenia/agranulocytosis; anaphylactic reaction, allergy; loss of diabetic control; cause or exacerbate vol depletion, electrolyte imbalance, anorexia, loss of appetite, hyperglycemia, hypercholesterolemia, hypomagnesemia, hypercalcemia, hypochloremic alkalosis; restlessness; headache, light-headedness; xanthopsia, acute myopia, acute angle-closure glaucoma; necrotizing angiitis (vasculitis); nausea, upset stomach, pancreatitis; jaundice (hepatocellular or cholestatic); toxic epidermal necrolysis, erythema multiforme, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, cutaneous vasculitis, photosensitivity reactions; weakness; interstitial nephritis, renal dysfunction, glycosuria; fever; increase triglycerides.
Drug Interactions
Reversible increases in serum lithium conc & toxicity. Potentiated K-depleting effect by other drugs associated w/ K loss & hypokalemia (eg, other kaliuretic diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid & derivatives). May lead to increases 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). Potential for acute renal insufficiency in dehydrated patients w/ NSAIDs, including ASA, COX-2 inhibitors & non-selective NSAIDs. May reduce the diuretic, natriuretic & antihypertensive effects of thiazide diuretics w/ NSAIDs. Telmisartan: May increase the hypotensive effect of other antihypertensive agents. Increase in median plasma digoxin trough conc. Increased AUC0-24 & Cmax of ramipril & ramiprilat. Hydrochlorothiazides: Potentiation of orthostatic hypotension w/ alcohol, barbiturates, or narcotics. Dosage adjustment of antidiabetic drugs (oral agents & insulins). Risk of lactic acidosis w/ metformin. Impaired absorption w/ cholestyramine & colestipol resins. Onset of digitalis-induced cardiac arrhythmias w/ thiazide-induced hypokalemia or hypomagnesemia. Decreased effect of pressor amines. May potentiate effect of nondepolarizing skeletal muscle relaxants (eg, tubocurarine). May increase incidence of hypersensitivity reaction to allopurinol. May increase serum Ca levels due to the decreased excretion. May enhance hyperglycemic effect of β-blockers & diazoxide. May increase bioavailability w/ anticholinergic agents (eg, atropine, biperiden). May increase risk of adverse effects caused by amantadine. May reduce renal excretion of cytotoxic drugs (eg, cyclophosphamide, methotrexate) & potentiate their myelosuppressive effects.
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 (P694.38/pack)
Form
Micardis Plus 80/12.5 mg tab
Packing/Price
30's (P1,202.14/pack)
Form
Micardis Plus 80/25 mg tab
Packing/Price
30's (P1,202.14/pack)
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