RiteMed Telmisartan + Hydrochlorothiazide

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 in adults whose BP is not adequately controlled on telmisartan alone (40 mg/12.5 mg tab), or on 40 mg/12.5 mg tab or adults who have been previously stabilized on telmisartan & hydrochlorothiazide given separately (80 mg/12.5 mg tab).

Patient whose BP is not adequately controlled by telmisartan 40 mg 40 mg/12.5 mg once daily. Patients whose BP is not adequately controlled by telmisartan 80 mg or who have been previously stabilized on telmisartan & hydrochlorothiazide given separately 80 mg/12.5 mg once daily. Mild to moderate hepatic impairment Not to exceed 40 mg/12.5 mg once daily.

May be taken with or without food: Take w/ liqd.

Hypersensitivity to telmisartan, hydrochlorothiazide or other sulphonamide-derived substances. Cholestasis & biliary obstructive disorders; refractory hypokalemia, hypercalcemia. 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. 2nd & 3rd trimesters of pregnancy.

Hypersensitivity reactions to hydrochlorothiazide may occur in patients w/ or w/o history of allergy or bronchial asthma. Discontinue use if photosensitivity reaction occurs. Not to be given to patients w/ cholestasis, biliary obstructive disorders. 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 is not recommended. Metabolic & endocrine effects; electrolyte imbalance; exacerbation or activation of SLE; idiosyncratic reaction resulting in acute transient myopia & acute angle-closure glaucoma. Patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney; whose vascular tone & renal function depend predominantly on activity of renin-angiotensin-aldosterone system eg, severe CHF or underlying renal disease including renal artery stenosis; suffering from aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy; ischemic cardiopathy or CV disease. Black patients. Correct vol &/or Na depletion prior to administration. Perform periodic determination of serum electrolytes. Protect exposed areas to sun or artificial UVA. Not to be taken by patients w/ fructose intolerance &/or galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May influence ability to drive & use machines. Not indicated in severe hepatic impairment. Hepatic impairment or progressive liver disease. Not to be used in severe renal impairment (CrCl <30 mL/min). Periodically monitor K, creatinine & uric acid serum levels in mild to moderate renal impairment. Recent kidney transplantation. Not recommended during 1st trimester of pregnancy, & lactation. Childn & adolescents ≤18 yr.

Dizziness.

Reversible increases in serum lithium conc & toxicity. May increase serum K w/ medicinal products that may increase K levels or induce hyperkalemia eg, ACE inhibitors, K-sparing diuretics, K supplements, K-containing salt substitutes, cyclosporin or heparin Na. Concomitant use w/ medicinal products affected by serum K disturbances (eg, digitalis glycosides, antiarrhythmics) & inducing 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; antidiabetics eg, oral agents & insulin. 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 & hypokalemia eg, other kaliuretic diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G Na, salicylic acid & derivatives. Thiazide-induced hypokalemia or hypomagnesaemia favors 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. Concomitant use w/ medicinal products for gout eg, probenecid, sulfinpyrazone & allopurinol; Ca supplements or sparing medicinal products eg, vit D therapy. May increase incidence of hypersensitivity reactions of allopurinol. May enhance hyperglycemic effect of β-blockers & diazoxide. Bioavailability may be increased w/ anticholinergics eg, atropine, biperiden. May increase risk of adverse effects by 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. 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.

Rx