Azoren

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

Essential HTN in patients whose BP is not adequately controlled on olmesartan medoxomil or amlodipine monotherapy.

Adult 1 tab/day. Mild to moderate renal impairment (CrCl 20-60 mL/min) Max olmesartan medoxomil dose: 20 mg once daily. Moderate hepatic impairment Initial olmesartan medoxomil dose: 10 mg once daily. Max olmesartan medoxomil dose: 20 mg once daily.

May be taken with or without food.

Hypersensitivity to olmesartan medoxomil, amlodipine besylate or to dihydropyridine derivatives. Severe hepatic insufficiency & biliary obstruction. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²). Pregnancy (2nd & 3rd trimester). Amlodipine: 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.

Symptomatic hypotension may occur in vol- &/or Na-depleted patients. Conditions w/ stimulation of the renin-angiotensin-aldosterone system; renovascular HTN; sprue-like enteropathy. Possible severe, chronic diarrhoea w/ substantial wt loss. Monitor serum electrolytes periodically. Severe renal (CrCl <20 mL/min) & mild to moderate hepatic impairment. Recent kidney transplantation; end-stage renal impairment (CrCl <12 mL/min). Hyperkalaemia; closely monitor serum K levels in at-risk patients. Concomitant use w/ K supplements, K-sparing diuretics, salt substitutes containing K or other drugs that may increase K levels (eg, heparin); lithium. Aortic or mitral valve stenosis; obstructive hypertrophic cardiomyopathy; primary aldosteronism. May increase risk of future CV events & mortality in patients w/ heart failure. Dual blockade of the RAAS; not recommended for combined use w/ ACE-inhibitors, angiotensin II receptor blockers or aliskiren. Black patients. Excessive BP decrease in patients w/ ischaemic heart disease or ischaemic cerebrovascular disease could result in MI or stroke. Dizziness, headache, nausea or fatigue may impair ability to react, drive or use machines. Not recommended during pregnancy (1st trimester). Not recommended during breast-feeding. Childn & adolescents <18 yr. Elderly.

Peripheral oedema, headache & dizziness. Fatigue, oedema, pitting oedema.

Increased BP lowering effects w/ other antihypertensives (eg, α-blockers, diuretics). Increased serum K levels w/ concomitant use of K-sparing diuretics, K supplements & K-containing salt substitutes or other medicines that may increase serum K levels (eg, heparin & ACE inhibitors). Reversible increase in lithium serum conc & toxicity. Increased risks of hypotension, hyperkalaemia & decreased renal function w/ ACE-inhibitors, angiotensin II receptor blockers or aliskiren. May increase risk of renal function worsening w/ NSAIDs including selective COX-2 inhibitors, acetylsalicylic acid (>3 g/day) & non-selective NSAIDs. Reduced systemic exposure & peak plasma conc by colesevelam HCl. Reduced bioavailability w/ antacid (Al & Mg hydroxide). Amlodipine: Significant increased in amlodipine exposure w/ CYP3A4 inhibitors (eg, PIs, azole antifungals, erythromycin or clarithromycin, verapamil or diltiazem) & lower plasma conc w/ CYP3A4 inducers (ie, rifampicin, Hypericum perforatum). Increased BP lowering effects of amlodipine w/ grapefruit juice. Risk of hyperkalaemia when co-administered w/ verapamil & dantrolene IV. Increased exposure to simvastatin & cyclosporine. May increase exposure of tacrolimus.

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.

POM