Alzor HCT

Per 20 mg/12.5 mg FC tab Olmesartan medoxomil 20 mg, hydrochlorothiazide 12.5 mg. Per 40 mg/12.5 mg FC tab Olmesartan medoxomil 40 mg, hydrochlorothiazide 12.5 mg

HTN.

Patient w/ BP not adequately controlled w/ olmesartan therapy 40 mg/12.5 mg tab once daily. Patient w/ BP not adequately controlled w/ hydrochlorothiazide monotherapy or those experiencing dose-limiting adverse reactions w/ hydrochlorothiazide 20 mg/12.5 mg tab once daily. All doses should be taken at the same time each day. Moderate hepatic impairment Initially 10 mg olmesartan medoxomil once daily. Max dose: 20 mg once daily.

May be taken with or without food: Swallow whole, do not chew.

Hypersensitivity to olmesartan medoxomil, hydrochlorothiazide or to other sulfonamide-derived substances. Refractory hypokalaemia, hypercalcaemia, hyponatraemia & symptomatic hyperuricaemia. Concomitant use w/ 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, cholestasis & biliary obstructive disorders. Pregnancy (2nd & 3rd trimester).

Symptomatic hypotension may occur in vol- &/or Na-depleted patients. Other conditions w/ stimulation of the renin-angiotensin-aldosterone system (RAAS) (eg, patients w/ severe CHF or underlying renal disease including renal artery stenosis) or treatment w/ medicinal products that affect this system. Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Patients suffering from aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy; ischaemic heart disease or ischaemic cerebrovascular disease. Not recommended in patients w/ primary aldosteronism. Sprue-like enteropathy. Not recommended in concomitant use w/ ACE inhibitors, ARBs or aliskiren; lithium. Coadministration w/ K-sparing diuretics, K supplements or K-containing salt substitutes & other medicinal products that may increase serum K levels (eg, heparin). Periodic monitoring of serum K, creatinine & uric acid levels is recommended. Hepatic impairment. Not recommended during lactation. Childn & adolescents <18 yr. Black patients. Hydrochlorothiazide: Hypersensitivity reactions may occur in patients w/ or w/out history of allergy or bronchial asthma. May impair glucose tolerance; increases in cholesterol & triglyceride levels may occur; hyperuricaemia or frank gout may be precipitated. May cause fluid or electrolyte imbalance; periodic determination of serum electrolytes should be performed at appropriate intervals. Discontinue therapy before carrying out tests for parathyroid function. May cause idiosyncratic reaction resulting in acute transient myopia & acute angle-closure glaucoma. Increased risk of non-melanoma skin cancer & squamous cell carcinoma. Regularly check skin for any new lesions. Limit exposure to sunlight & UV rays. Exacerbation or activation of SLE may occur. False +ve result in anti-doping test.

Hypertriglyceridaemia, hyperuricaemia. Dizziness/light-headedness, headache; abdominal pain, diarrhoea, nausea; asthenia, chest pain, fatigue, peripheral oedema; increased blood urea. Olmesartan: Bronchitis, cough, pharyngitis, rhinitis; dyspepsia, gastroenteritis; arthritis, back pain, skeletal pain; haematuria, UTI; flu-like symptoms, pain; increased blood creatine phosphokinase; increased hepatic enzyme. Hydrochlorothiazide: Hypercholesterolaemia. Glykosuria, hypercalcaemia, hyperglycaemia, hypochloraemia, hypokalaemia, hypomagnesaemia, hyponatraemia, hyperamylasaemia; confusional state; constipation; gastric irritation, meteorism, vomiting; increased blood creatinine.

Reversible increase in serum lithium conc. Potentiated anti-hypertensive effect w/ baclofen, amifostine, other antihypertensive medicinal products. Reduced antihypertensive effect w/ NSAIDs ie, ASA (3 g/day), COX-2 inhibitor & non-selective NSAIDs. Potentiated orthostatic hypotension w/ alcohol, barbiturates, narcotics or antidepressants. Olmesartan: Higher frequency of adverse events eg, hypotension, hyperkalaemia & decreased renal function including acute renal failure w/ ACE inhibitors, ARBs or aliskiren. Increased serum K level w/ K sparing diuretics, K supplements, salt substitutes containing K or other medicinal products that may increase serum K levels (eg, heparin, ACE inhibitors). Reduced systemic exposure & peak plasma conc w/ bile acid sequestering agent colesevelam HCl. Decreased bioavailability w/ antacids. Hydrochlorothiazide: Increased K-depleting effect w/ other medicinal products associated w/ K loss & hypokalaemia (eg, other kaliuretic diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G Na or salicylic acid derivatives). Increased serum Ca levels w/ Ca salts. Impaired absorption w/ cholestyramine & colestipol resins. May cause digitalis-induced cardiac arrhythmias w/ digitalis glycosides. Concomitant use w/ non-depolarizing skeletal muscle relaxants (eg, tubocurarine), β-blockers & diazoxide potentiates their effects. Increased bioavailability w/ anticholinergic agents (eg, atropine, biperiden). Concomitant use w/ antidiabetic medicinal products (eg, oral agents & insulin). Increased risk of lactic acidosis w/ metformin. Decreases effect of pressor amines (eg, noradrenaline). Increased level of serum uric acid w/ medicines used in the treatment of gout (eg, probenecid, sulfinpyrazone & allopurinol). Increases the risk of adverse effects caused by amantadine. Reduced renal excretion & potentiated myelosuppressive effects of cytotoxic medicinal products. Enhanced toxic effect of salicylates. May cause haemolytic anaemia w/ methyldopa. Increased risk of hyperuricaemia & gout-type complications w/ cyclosporine. Increased risk of tetracycline-induced increase in urea w/ tetracyclines.

Angiotensin II Antagonists / Diuretics

C09DA08 - olmesartan medoxomil and diuretics ; Belongs to the class of angiotensin II receptor blockers (ARBs) in combination with diuretics. Used in the treatment of cardiovascular disease.

Rx