Telarb Plus

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

1 tab once daily.

May be taken with or without food.

Hypersensitivity to telmisartan, hydrochlorothiazide or 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 & 3rd trimester).

Not be given to patients w/ cholestasis or biliary obstructive disorders. Not recommended in patients w/ primary aldosteronism. 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 1st dose may occur in vol- &/or Na-depleted patients by vigorous diuretic therapy, diuretic salt restriction, diarrhoea or vomiting. Severe CHF or underlying renal disease including renal artery stenosis. Aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Glucose tolerance may be impaired & hypoglycaemia may occur in diabetic patients under insulin or antidiabetic therapy. Risk of hypokalaemia in patients w/ liver cirrhosis, brisk diuresis or those receiving inadequate oral intake of electrolytes & receiving concomitant therapy w/ corticosteroids or ACTH. Risk factors for hyperkalaemia. Hyponatraemia. Hypercalcaemia. Hypomagnesaemia. Excessive reduction of BP in patients w/ ischaemic cardiomyopathy or ischaemic CV disease could result in MI or stroke. Concomitant use w/ K-sparing diuretics, K supplements or K-containing salt substitutes. Periodically monitor K, creatinine & uric acid serum levels. Not to be taken by patients w/ fructose intolerance &/or w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not to be given in severe hepatic & renal (CrCl <30 mL/min) impairment. Hepatic impairment or progressive liver disease. Recent kidney transplantation. Not to be initiated during pregnancy. Not recommended during lactation. Telmisartan: Dual blockade of the RAAS through combined use w/ ACE inhibitors or aliskiren is not recommended. Not to be concomitantly used w/ ACE inhibitors in patients w/ diabetic nephropathy. Black patients. Hydrochlorothiazide: Hypersensitivity in patients w/ or w/o history of allergy or bronchial asthma. Increased cholesterol & triglyceride levels. Hyperuricaemia may occur or frank gout may be precipitated. Exacerbation of SLE. Photosensitivity reactions. Choroidal effusion w/ visual field defect, acute transient myopia & acute angle-closure glaucoma. Increased risk of non-melanoma skin cancer; regularly check skin for any new lesions & promptly report any suspicious skin lesions.

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

Reversible increases in serum conc & toxicity of lithium. May increase 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) & III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, some antipsychotics (eg, thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol), bepridil, cisapride, diphemanil, erythromycin IV, halofantrine, mizolastine, pentamidine, sparfloxacin, terfenadine, vincamine IV. Antidiabetic medicinal products eg, oral agents & insulin. Diuretic, natriuretic & antihypertensive effects may be reduced w/ NSAIDs ie, ASA at anti-inflammatory doses, COX-2 inhibitors & nonselective NSAIDs. Increased AUC_0-24 & C_max of ramipril & ramiprilat. Decreased effect of pressor amines. May aggravate orthostatic hypotension w/ alcohol, barbiturates, narcotics or antidepressants. Telmisartan: Increased peak plasma & trough conc of digoxin. May increase hypotensive effect of other antihypertensive agents. Higher frequency of adverse events from dual blockade of the RAAS through combined use w/ ACE inhibitors or aliskiren. Further deterioration of renal function including possible acute renal failure w/ agents that inhibit COX. Increased AUC & Cmax of ramipril & ramiprilat. Hypotensive effects may be potentiated w/ baclofen & amifostine. Hydrochlorothiazide: May potentiate effect on serum K w/ kaliuretic diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G Na, salicylic acid & derivatives. Thiazide-induced hypokalaemia or hypomagnesaemia favours onset of digitalis-induced arrhythmia. Risk of lactic acidosis w/ metformin. Impaired absorption w/ cholestyramine & colestipol resins. May potentiate effect of nondepolarizing skeletal muscle relaxants. Probenecid, sulfinpyrazone. May increase incidence of hypersensitivity reactions of allopurinol. May increase serum Ca levels w/ Ca supplements or Ca-sparing medicinal products (eg, vit D therapy). May enhance hyperglycemic effect of β-blockers & diazoxide. Bioavailability may be increased 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