Telmez HCT

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

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

1 tab once daily. Mild to moderate hepatic impairment Not to exceed 40 mg/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 hypokalemia, hypercalcemia. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²). Severe hepatic & renal (CrCl <30 mL/min) impairment. 2nd & 3rd trimesters of pregnancy.

Do not use w/ ACE inhibitors in patients w/ diabetic nephropathy. Impaired hepatic function or progressive liver disease. Bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Recent kidney transplantation. Diuretic-associated azotemia in patients w/ impaired renal function. Vol &/or Na depleted by vigorous diuretic therapy, dietary salt restriction, diarrhea or vomiting. Dual blockade of the renin-angiotensin-aldosterone system (RAAS). Patients w/ severe CHF or underlying renal disease. Primary aldosteronism. Aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Latent DM may manifest, hyperuricemia may occur or frank gout may be precipitated during therapy. Perform periodic determination of serum electrolytes at appropriate intervals. Risk of hypokalemia in patients w/ cirrhosis of liver, experiencing brisk diuresis, who are receiving inadequate oral intake of electrolyte & receiving concomitant therapy w/ corticosteroids or ACTH. Concomitant use w/ K-sparing diuretics, K supplements or K-containing salt substitutes. Discontinue before carrying out tests for parathyroid function. Hypomagnesemia. Less effective in lowering BP in Black patients. Excessive reduction of BP in patients w/ ischemic cardiopathy or CV disease. History of allergy or bronchial asthma; SLE; photosensitivity. Idiosyncratic reaction resulting in acute transient myopia & acute angle-closure glaucoma. Risk of non-melanoma skin cancer; regularly check the skin for any new lesions & promptly report any suspicious skin lesions. Limit exposure to sunlight & UV rays. Correct Na or vol depletion before treatment commencement. Monitor K, creatinine & uric acid serum levels periodically. May influence ability to drive & use machines. Not to be initiated during pregnancy; when pregnancy is diagnosed, discontinue treatment immediately & alternative therapy should be started. Not recommended during pregnancy (1st trimester) & lactation. Childn <18 yr.

Dizziness.

Reversible increases in serum lithium conc & toxicity. May potentiate effect of hydrochlorothiazide on serum K w/ medicinal products associated w/ K loss & hypokalemia (eg, kaliuretic diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G Na, salicylic acid & derivatives. May increase K levels or hyperkalemia w/ ACE inhibitors, K-sparing diuretics & K supplements, salt substitutes containing K, cyclosporin or other medicinal products eg, heparin Na. Medicinal products affected by serum K disturbances (eg, digitalis glycosides, antiarrhythmics) & torsades de pointes inducing medicinal products including class Ia antiarrythmics (eg, quinidine, hydroquinidine, disopyramide); class III antiarrythmics (eg, amiodarone, sotalol, dofetilide, ibutilide); some antipsychotics (eg, thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol); & bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin, pentamidine, sparfloxacine, terfenadine, vincamine IV. Higher frequency of hypotension, hyperkalemia & decreased renal function (including acute renal failure) w/ dual blockade RAAS-acting agent (ACE inhibitors, ARBs or aliskiren). May require dosage adjustment of antidiabetic medicinal products (oral agents & insulin). May reduce diuretic, natriuretic & antihypertensive effects of thiazide diuretics, & antihypertensive effects of AIIA w/ NSAIDs ie, ASA, COX-2 inhibitors, non-selective NSAIDs). May decrease effect of pressor amines eg, noradrenaline. Orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics or antidepressants. Telmisartan: Monitor digoxin levels in order to maintain levels w/in therapeutic range when initiating, adjusting, & discontinuing telmisartan. May increase hypotensive effect of other antihypertensive agents. Hypotensive effects may be potentiated w/ baclofen, amifostine. Hydrochlorothiazide: Thiazide-induced hypokalemia or hypomagnesemia may onset digitalis-induced arrhythmia of digitalis glycosides. Risk of lactic acidosis induced by possible functional renal failure w/ metformin. Impaired absorption w/ cholestyramine or colestipol resins. May potentiate effect of nondepolarizing skeletal muscle relaxants eg, tubocurarine. May increase serum uric acid level w/ uricosuric drugs eg, probenecid, sulfinpyrazone & may increase incidence of hypersensitivity reactions of allopurinol. Increased serum Ca levels due to decreased excretion w/ Ca salts, Ca supplements or Ca sparing medicinal products (eg, vit D therapy). May enhance hyperglycemic effect of β-blockers & diazoxide. Increased bioavailability by decreasing GI motility & stomach emptying rate w/ anticholinergic agents (eg, atropine, biperiden). May increase risk of adverse effects caused by amantadine. May reduce renal excretion & potentiate myelosuppressive effects of cytotoxic agents (eg, cyclophosphamide, MTX).

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