Telmirin Plus

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

Patient whose BP is not adequately controlled by telmisartan 40 mg 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 hypokalaemia, hypercalcaemia. 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).

Hypersensitivity reactions to hydrochlorothiazide may occur in patients w/ or w/o history of allergy or bronchial asthma. Discontinue use in case of photosensitivity reaction; acute transient myopia & acute angle-closure glaucoma; acute resp distress syndrome. Not to be given to patients w/ cholestasis, biliary obstructive disorders or severe hepatic insufficiency. Not to be used concomitantly w/ ACE inhibitors in patients w/ diabetic nephropathy. Not recommended in patients w/ primary aldosteronism. Dual blockade of renin-angiotensin-aldosterone system (RAAS) through combination w/ ACE-inhibitors or aliskiren is not recommended. Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure in patients whose vascular tone & renal function depend predominantly on the activity of the 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. Excessive BP reduction in patients w/ ischaemic cardiopathy or CV disease could result in MI or stroke. Reports of exacerbation or activation of SLE w/ thiazide diuretics. Caution in patients w/ hepatic impairment or progressive liver disease; suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Less effective in lowering BP in black patients. Correct vol- &/or Na-depletion (eg, in patients w/ vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting) prior to administration. Perform periodic determination of serum electrolytes at appropriate intervals. Limit exposure to sunlight & UV rays. Regularly check skin for any new lesions & promptly report any suspicious skin lesions. Periodic monitoring of K, creatinine & uric acid serum levels is recommended in patients w/ mild to moderate renal impairment. No experience in patients w/ recent kidney transplantation. Thiazide diuretic-associated azotaemia may occur in patients w/ renal impairment. Not recommended during lactation. 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.

Dizziness.

Reversible increases in serum lithium conc & toxicity. 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 other medicinal products (eg, heparin Na). Periodic monitoring of serum K & ECG is recommended w/ medicinal products affected by serum K disturbances (eg, digitalis glycosides, antiarrhythmics) & drugs known to induce torsades de pointes 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 inflammatory dose regimens, COX-2 inhibitors & non-selective NSAIDs). Decreased effect of pressor amines (eg, noradrenaline). Telmisartan: Increased peak plasma & trough conc of digoxin. May increase hypotensive effect of other antihypertensive agents. Higher frequency of adverse events (eg, hypotension, hyperkalaemia & decreased renal function including acute renal failure) associated w/ dual blockade of the RAAS through combination w/ ACE inhibitors or aliskiren. Hypotensive effects may be potentiated w/ baclofen, amifostine. Orthostatic hypotension may be aggravated w/ alcohol, barbiturates, narcotics or antidepressants. 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 resins. May result in further deterioration of renal function, including possible acute renal failure, w/ COX inhibitors in some patients w/ compromised renal function (eg, dehydrated patients or elderly). May potentiate effect of nondepolarizing skeletal muscle relaxants (eg, tubocurarine). May increase incidence of hypersensitivity reactions of allopurinol. May increase serum Ca levels. May enhance hyperglycaemic effect of β-blockers & diazoxide. Bioavailability may be increased w/ anticholinergic agents (eg, atropine, biperiden). May increase risk of adverse effects of amantadine. May reduce renal excretion of cytotoxic medicinal products (eg, cyclophosphamide, MTX) & potentiate their myelosuppressive effects.

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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