Alzor CCB

Per 20 mg/5 mg FC tab Olmesartan medoxomil 20 mg, amlodipine besilate 5 mg. Per 20 mg/10 mg FC tab Olmesartan medoxomil 20 mg, amlodipine besilate 10 mg. Per 40 mg/5 mg FC tab Olmesartan medoxomil 40 mg, amlodipine besilate 5 mg. Per 40 mg/10 mg FC tab Olmesartan medoxomil 40 mg, amlodipine besilate 10 mg

Monotherapy or in combination w/ other antihypertensive agents for the treatment of HTN.

Adult Initially 1 tab (20 mg/5 mg) once daily, may be increased after 1-2 wk of therapy. Max dose: 40 mg/10 mg once daily. Patients w/ mild to moderate renal impairment (CrCl 20-60 mL/min) 20 mg of olmesartan medoxomil once daily. Moderate hepatic impairment Initially 10 mg of 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, amlodipine or dihydropyridine derivatives. Patients w/ severe hypotension; shock (including cardiogenic shock); obstruction of the outflow tract of the left ventricle (eg, high grade aortic stenosis); haemodynamically unstable heart failure after acute MI. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR < 60 mL/min/1.73 m²). Severe hepatic insufficiency & biliary obstruction. Pregnancy (2nd & 3rd trimesters).

Vol- &/or Na-depleted patients, other conditions w/ stimulation of the renin-angiotensin-aldosterone 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. Hyperkalaemia; closely monitor serum K in at-risk patients. Patients w/ aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy, primary aldosteronism, sprue-like enteropathy, ischaemic heart disease or ischaemic cerebrovascular disease. Not recommended in combination w/ ACE-inhibitors, ARBs or aliskiren; lithium. Patients w/ rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption. Minor or moderate influence on the ability to drive & use machine. Not recommended in patients w/ severe renal (CrCl <20 mL/min) & hepatic impairment. Should not be initiated during pregnancy. Not recommended during breastfeeding. Childn & adolescents <18 yr. Black patients.

Oedema. Dizziness, headache; abdominal pain; dyspepsia, nausea; fatigue; peripheral/pitting oedema. Olmesartan: Hypertriglyceridaemia, hyperuricaemia; bronchitis, cough, pharyngitis, rhinitis; diarrhoea; gastroenteritis; increased hepatic enzyme; arthritis; back pain, skeletal pain; haematuria; UTI; chest pain; flu-like symptoms, pain; increased blood urea, increased blood creatine phosphokinase. Amlodipine: Somnolence; visual disturbance (including diplopia); palpitations; flushing; dyspnoea; altered bowel habits (including diarrhoea & constipation); ankle swelling, muscle spasm; asthenia.

Increased BP lowering effect w/ other antihypertensive (eg, α-blockers, diuretics). May cause higher frequency of adverse events (eg, hypotension, hyperkalaemia & decreased renal function including acute renal failure) w/ ACE inhibitors, ARBs or aliskiren. Increase in K serum w/ K-sparing diuretics, K supplements, salt substitutes containing K or other drugs that may increase serum K levels (eg, heparin). Reversible increase in serum lithium conc. May increase the risk of worsening of renal function & may lead to an increase in serum K w/ NSAIDs. Reduced systemic exposure & peak plasma conc w/ bile acid sequestering agent colesevelam HCl. Decreased bioavailability w/ antacids. Amlodipine: Increased exposure w/ strong or moderate CYP3A4 inhibitors (PIs, azole antifungals, macrolides eg, erythromycin or clarithromycin, verapamil or diltiazem). Decreased plasma conc w/ CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Increased bioavailability w/ grapefruit or grapefruit juice. Concomitant use w/ simvastatin increases exposure to simvastatin. Coadministration w/ tacrolimus increases tacrolimus blood level. Concomitant use w/ cyclosporine may increase exposure to cyclosporine.

Angiotensin II Antagonists / Calcium Antagonists

C09DB02 - olmesartan medoxomil and amlodipine ; Belongs to the class of angiotensin II receptor blockers (ARBs) and calcium channel blockers. Used in the treatment of cardiovascular disease.

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