Micardis Plus

Per 40/12.5 mg tab Telmisartan 40 mg, hydrochlorothiazide 12.5 mg. Per 80/12.5 mg tab Telmisartan 80 mg, hydrochlorothiazide 12.5 mg

Essential HTN in adults whose BP is inadequately controlled on telmisartan alone.

Adult 1 tab once daily. Patient w/ mild to moderate hepatic impairment Max: One 40/12.5 mg 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 of aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²). Severe renal impairment (CrCl <30 mL/min). Severe hepatic impairment. Pregnancy (2nd & 3rd trimesters).

Patients w/ renovascular HTN; intravascular hypovolaemia; other conditions w/ stimulation of the renin-angiotensin-aldosterone system (RAAS); aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy. Combined use of ACE inhibitors, ARBs or aliskiren is not recommended due to dual blockade of RAAS. Not recommended in patients w/ primary aldosteronism. Metabolic & endocrine effects (eg, impaired glucose tolerance). Electrolyte imbalance (eg, hypo/hyperkalaemia, hyponatraemia, hypochloraemic alkalosis, hypercalcaemia, hypomagnesaemia). Risk of MI or stroke in case of excessive BP reduction in patients w/ ischaemic cardiopathy or ischaemic CV disease. Hypersensitivity & photosensitivity reactions w/ hydrochlorothiazide. Reports of exacerbation or activation of SLE w/ thiazide diuretics. Hydrochlorothiazide can cause idiosyncratic reaction resulting in choroidal effusion w/ visual field defect, acute transient myopia & acute angle-closure glaucoma. Risk of non-melanoma skin cancer in patients taking hydrochlorothiazide. Hydrochlorothiazide should not be administered to patients who previously experienced acute resp distress syndrome following hydrochlorothiazide intake. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Can have influence on the ability to drive & use machines. Patients w/ impaired hepatic function or progressive liver disease; renal impairment; kidney transplantation. Should not be initiated during pregnancy. Not recommended during pregnancy (1st trimester) & breast-feeding. Safety & efficacy in childn & adolescents <18 yr have not been established. Ethnic differences. 40/12.5 mg tab: Contains 169 mg sorbitol per tab. 80/12.5 mg tab: Contains 338 mg sorbitol per tab. Should not be taken by patients w/ hereditary fructose intolerance.

Dizziness.

Co-administration w/ lithium is not recommended. Medicinal products associated w/ K loss & hypokalaemia may potentiate the effect of hydrochlorothiazide on serum K. Co-administration w/ medicinal products that may increase K levels or induce hyperkalaemia may lead to increases in serum K. Periodic monitoring of serum K & ECG is recommended when co-administered w/ medicinal products affected by serum K disturbances. Thiazide-induced hypokalaemia or hypomagnesaemia favours the onset of digitalis-induced arrhythmia. Increased digoxin peak plasma conc & trough conc. Telmisartan may increase the hypotensive effect of other antihypertensive agents. Higher frequency of adverse events w/ combined use of ACE inhibitors, ARBs or aliskiren. Dose adjustment of antidiabetics (oral agents & insulin) may be required. Metformin should be used w/ precaution. Impaired hydrochlorothiazide absorption in the presence of anionic exchange resins (eg, cholestyramine & colestipol resins). Reduced effects w/ NSAIDs. Decreased effect of pressor amines (eg, noradrenaline). Potentiated effect of nondepolarizing skeletal muscle relaxant (eg, tubocurarine) by hydrochlorothiazide. Dose adjustment of uricosuric medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid. Co-administration of thiazide may increase the incidence of hypersensitivity reactions of allopurinol. Monitor serum Ca levels & adjust Ca dose accordingly if Ca supplement or Ca-sparing medicinal product (eg, vit D) is prescribed. Hyperglycaemic effect of β-blockers & diazoxide may be enhanced by thiazides. Increased thiazide bioavailability w/ anticholinergic agents (eg, atropine, biperiden). Thiazides may increase risk of adverse effects caused by amantadine. Thiazides may reduce the renal excretion of cytotoxic medicinal products & potentiate their myelosuppressive effects. Baclofen & amifostine may potentiate hypotensive effect. Orthostatic hypotension may be aggravated by 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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