Telzyd H

Telmisartan 40 mg, hydrochlorothiazide 12.5 mg

Essential HTN. Adult whose BP is not adequately controlled on telmisartan alone.

1 tab once daily.

May be taken with or without food.

Hypersensitivity telmisartan, hydrochlorothiazide, or to other sulphonamide-derived substances. Cholestasis & biliary obstructive disorders; refractory hypokalaemia, hypercalcaemia. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²). Severe hepatic impairment. Pregnancy (2nd or 3rd trimester).

Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Symptomatic hypotension especially after the 1st dose in vol- &/or Na-depleted patients by vigorous diuretic therapy, diuretic salt restriction, diarrhoea, or vomiting. Dual blockade of the RAAS. Severe CHF or underlying renal disease including renal artery stenosis. Do not use in patients w/ primary aldosteronism. Aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy. Diabetic patients under insulin or antidiabetic therapy. Risk of hypokalaemia in patients w/ liver cirrhosis, brisk diuresis, or patients receiving inadequate oral intake of electrolytes & those receiving concomitant therapy w/ corticosteroids or ACTH. Risk of hyperkalaemia in renal insufficiency &/or heart failure, & DM. Concomitant use w/ K supplements or K-containing salt substitutes. Hypercalcaemia, hypomagnesaemia. Fructose intolerance &/or w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Excessive reduction of BP in patients w/ ischaemic cardiomyopathy or ischaemic CV disease could result in MI or stroke. Monitor K, creatinine, & uric acid serum levels periodically. Impaired renal & hepatic function or progressive liver disease. Do not use in patients w/ severe renal impairment (CrCl <30 mL/min). Recent kidney transplant. Do not initiate during pregnancy. Black patients. Hydrochlorothiazide: W/ or w/o history of allergy or bronchial asthma. Exacerbation of SLE. Photosensitivity reactions. Choroidal effusion w/ visual field defect, acute transient myopia & acute angle-closure glaucoma. Risk of nonmelanoma skin cancer; regularly check skin for any new lesions & promptly report any suspicious skin lesions. Not recommended during lactation.

Dizziness, dose related orthostatic hypotension. Impaired renal function & rarely, rash, angioedema, & raised liver enzyme values. GI disturbances. Telmisartan: Resp tract disorders, back pain, GI disturbances, fatigue, & neutropenia. Hydrochlorothiazide: Electrolyte imbalances, glycosuria, hyperglycaemia, hyperuricemia & weakness; headache, photosensitivity, reactions, postural, hypotension, paraesthesia, xanthopsia, hypersensitivity, cholestatic, jaundice, pancreatitis & blood dyscrasias.

Increase serum conc & toxicity of lithium. Increased serum K w/ ACE inhibitors, K-sparing diuretics, K supplements, salt substitutes containing K, cyclosporine or heparin Na. Hypokalaemia w/ medicinal products affected by serum K disturbances (eg, digitalis glycosides, antiarrhythmics) & torsades de pointes inducing medicinal products eg, class Ia (eg, quinidine, hydroquinidine, disopyramide), class III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, some antipsychotics (eg, thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol), others (eg, bepridil, cisapride, diphemanil, erythromycin IV, halofantrine, mizolastine, pentamidine, sparfloxacin, terfenadine, vincamine IV). Antidiabetic medicinal products (eg, oral agents & insulin). Reduced diuretic, natriuretic & antihypertensive effects w/ NSAIDs (ie, ASA, COX-2 inhibitors & nonselective NSAIDs). Decreased effect of pressor amines. Aggravated orthostatic hypotension w/ alcohol, barbiturates, narcotics or antidepressants. Telmisartan: Increase peak plasma & trough conc of digitoxin. Increase hypotensive effect of other antihypertensive agents. Dual blockade of the RAAS through combined use of ACE inhibitors, ARBs or aliskiren. Further deterioration of renal function including possible acute renal failure w/ agents that inhibit cyclooxygenase. Increased AUC & C_max of ramipril & ramiprilat. May potentiate hypotensive effects w/ baclofen & amifostine. Hydrochlorothiazide: May potentiate the effect on serum K w/ eg, kaliuretic diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G Na, salicylic acid & derivatives. Thiazide induced hypokalaemia or hypomagnesaemia w/ digitalis glycosides. Risk of lactic acidosis w/ metformin. Impaired absorption w/ cholestyramine & colestipol resins. Potentiated effect of nondepolarizing skeletal muscle relaxants. Probenecid, sulfinpyrazone & allopurinol. May increase Ca levels w/ Ca supplements of Ca-sparing medicinal products (eg, vit D therapy). Enhanced hyperglycaemic effect of β-blockers & diazoxide. Increased bioavailability w/ atropine, biperiden. May increase risk of adverse effects of amantadine. May reduce renal excretion & potentiate myelosuppressive effects of cytotoxic agents (eg, cyclophosphamide, methotrexate).

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