Telatraz Plus

Essential HTN in patients w/ BP inadequately controlled on telmisartan alone.

Patient w/ BP inadequately controlled by telmisartan 40 mg or hydrochlorothiazide 40 mg/12.5 mg once daily. Patient w/ BP inadequately controlled by telmisartan 80 mg or by 40 mg/12.5 mg tab 80 mg/12.5 mg once daily. Patient w/ BP inadequately controlled by 80 mg/12.5 mg tab 80 mg/25 mg once daily. Patient w/ 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 hypokalaemia, hypercalcaemia. Patients w/ rare hereditary condition of galactose intolerance eg, galactosaemia; or fructose intolerance. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²). Severe hepatic & renal (CrCl <30 mL/min) impairment. Pregnancy (2nd & 3rd trimesters) & lactation.

Hypersensitivity reactions to hydrochlorothiazide may occur in patients w/ or w/o history of allergy or bronchial asthma. Discontinue use as rapidly as possible in case of acute transient myopia & acute angle-closure glaucoma. 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. Risk of acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure in patients whose vascular tone & renal function depend predominantly on activity of the renin-angiotensin-aldosterone system (RAAS) eg, patients w/ severe CHF or underlying renal disease, including renal artery stenosis. Thiazides may impair glucose tolerance; increase cholesterol & triglyceride levels; cause hyperuricaemia, or precipitate frank gout; cause fluid or electrolyte imbalance. Risk of fatal MI & unexpected CV death may be increased in diabetic patients w/ an additional CV risk ie, coexistent CAD. Excessive reduction of BP in patients w/ ischaemic cardiopathy or CV disease could result in MI or stroke. Reports of exacerbation or activation of SLE w/ thiazide diuretics. Correct vol- &/or Na-depletion (eg, in patients w/ vigorous diuretics therapy, dietary salt restriction, diarrhoea or vomiting) prior to administration. Limit dual blockade of the RAAS (eg, by adding ACE inhibitor or aliskiren) to individually defined cases w/ close monitoring of renal function. Perform periodic determination of serum electrolytes at appropriate intervals. Regularly check skin for any new lesions & promptly report any suspicious skin lesions. Limit exposure to sunlight & UV rays. Periodic monitoring of K, creatinine & uric acid serum levels is recommended in patients w/ mild to moderate renal impairment. Caution in patients w/ aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy; hepatic impairment or progressive liver disease. No experience in patients w/ recent kidney transplant. Thiazide diuretic-associated azotaemia may occur in patients w/ renal impairment. Can influence ability to drive & use machines. Safety & efficacy in childn & adolescents up to 18 yr have not been established. Telmisartan: Not recommended during 1st trimester of pregnancy & should not be initiated during pregnancy. Hydrochlorothiazide: Limited experience during pregnancy, especially 1st trimester. Not to be used for gestational oedema or HTN, or preeclampsia w/o beneficial effect on course of disease; essential HTN in pregnant women except when no other treatment could be used.

Bronchitis, pharyngitis, sinusitis; exacerbation or activation of SLE; hypokalaemia, hyponatraemia, hyperuricaemia; anxiety, depression; dizziness, syncope/faint, paraesthesia, sleep disturbances, insomnia; abnormal & transient blurred vision; vertigo; cardiac arrhythmias, tachycardia; hypotension (including orthostatic hypotension); dyspnoea, resp distress (including pneumonitis & pulmonary oedema); diarrhoea, dry mouth, flatulence, abdominal pain, constipation, dyspepsia, vomiting, gastritis; abnormal hepatic function/liver disorder; angiooedema, 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.

Reversible increases in serum conc & toxicity of lithium. May increase serum K w/ medicinal products that may increase K levels or induce hyperkalaemia eg, ACE inhibitors, K-sparing diuretics, K supplements, K-containing salt substitutes, cyclosporin or heparin Na. Perform periodic monitoring of serum K & ECG when concomitantly used w/ medicinal products affected by serum K disturbances (eg, digitalis glycosides, antiarrhythmics) & torsades de pointes-inducing drugs 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, halofantrin, mizolastin, pentamidine, sparfloxacine, terfenadine, vincamine IV. Dose adjustment of antidiabetic medicinal products may be required. Diuretic, natriuretic & antihypertensive effects may be reduced w/ NSAIDs ie, ASA at anti-inflammatory doses, COX-2 inhibitors & non-selective NSAIDs. May decrease effect of pressor amines eg, noradrenaline. Hydrochlorothiazide: Effect on serum K may be potentiated w/ medicinal products associated w/ K loss & hypokalaemia eg, other 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/ anionic exchange resins eg, cholestyramine & colestipol. May potentiate effect of nondepolarizing skeletal muscle relaxants eg, tubocurarine. Increase in dose of uricosuric medications (eg, probenecid, sulfinpyrazone, allopurinol) may be necessary. May increase incidence of hypersensitivity reactions of allopurinol. May increase serum levels of Ca. May enhance hyperglycaemic effect of β-blockers & diazoxide. Bioavailability may be increased w/ anticholinergics eg, atropine, biperiden. May increase risk of adverse effects of amantadine. May reduce renal excretion of cytotoxics & potentiate their myelosuppressive effects. Telmisartan: Increased peak plasma & trough conc of digoxin. May increase hypotensive effect of other antihypertensives. Risk of further renal function deterioration w/ COX inhibitors in patients w/ compromised renal function. Hypotensive effects may be potentiated w/ baclofen, amifostine. Orthostatic hypotension may be aggravated w/ alcohol, barbiturates, narcotics or antidepressants.

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.

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