Adult: Olmesartan 20 mg and amlodipine 5 mg tab Olmesartan 20 mg and amlodipine 10 mg tab Olmesartan 40 mg and amlodipine 5 mg tab Olmesartan 40 mg and amlodipine 10 mg tab
As monotherapy or in combination with other antihypertensives: Initially, 20 mg/5 mg once daily, titrate dose as needed in 1- to 2-week intervals up to Max of 40 mg/10 mg once daily. Dosage is individualised and adjusted based on clinical response. Elderly: ≥75 years Not recommended for initial therapy.
Special Patient Group
Patients taking colesevelam: Administer olmesartan + amlodipine at least 4 hours prior to colesevelam.
Patients taking simvastatin: Limit the dose of simvastatin to 20 mg daily.
Renal Impairment
CrCl (mL/min)
Dosage
<20
Not recommended.
20-60
Max: 20 mg olmesartan once daily.
Hepatic Impairment
Not recommended for initial therapy. Moderate: Max: 20 mg olmesartan once daily. Severe: Contraindicated.
Administration
May be taken with or without food.
Contraindications
Biliary obstruction, severe hypotension, shock (including cardiogenic shock), obstruction of the outflow tract of the left ventricle (e.g. high-grade aortic stenosis), unstable angina pectoris, haemodynamically unstable heart failure after acute MI. Severe hepatic impairment. Pregnancy and lactation. Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m2).
Special Precautions
Patient with hypovolaemia and/or Na depletion (e.g. undergoing vigorous diuretic therapy, dietary salt restriction, diarrhoea, vomiting); predisposing factors for hyperkalaemia (e.g. diabetes mellitus, concomitant use of K supplements, K-containing salt substitutes, K-sparing diuretics); severe CHF, unstented unilateral or bilateral renal artery stenosis; severe obstructive CAD (e.g. angina, acute MI); severe aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy, primary aldosteronism, previous angioedema associated with ACE inhibitor therapy; ischaemic heart or cerebrovascular disease. Black patients. Patient undergoing surgery. Renal and mild to moderate hepatic impairment. Elderly.
Adverse Reactions
Significant: Impaired renal function (e.g. oliguria, progressive azotaemia, acute renal failure); angioedema; hyperkalaemia; orthostatic hypotension; increased angina and/or MI; sprue-like enteropathy symptoms (e.g. severe, chronic diarrhoea with significant weight loss). Blood and lymphatic system disorders: Thrombocytopenia. Cardiac disorders: Palpitations, tachycardia. Ear and labyrinth disorders: Vertigo. Gastrointestinal disorders: Nausea, vomiting, dyspepsia, diarrhoea, constipation, dry mouth, upper abdominal pain. General disorders and administration site conditions: Fatigue, malaise, asthenia, chest pain, oedema, peripheral oedema. Immune system disorders: Anaphylactic reaction. Investigations: Increased blood creatinine, hepatic enzymes. Musculoskeletal and connective tissue disorders: Back pain, pain in extremity. Nervous system disorders: Headache, dizziness, postural dizziness, somnolence, lethargy, paraesthesia, hypoaesthesia. Renal and urinary disorders: Pollakiuria. Reproductive system and breast disorders: Decreased libido, erectile dysfunction, gynaecomastia. Respiratory, thoracic, and mediastinal disorders: Dyspnoea, cough. Skin and subcutaneous tissue disorders: Pruritus, skin rash, exanthema. Vascular disorders: Hypotension, flushing.
This drug may cause dizziness, headache, or nausea, if affected, do not drive, or operate machinery.
Monitoring Parameters
Monitor renal function (serum creatinine, BUN), LFT, serum electrolyte levels (particularly serum K), blood pressure, heart rate. Assess for signs and symptoms of hypotension, peripheral oedema.
Overdosage
Symptoms: Olmesartan: Hypotension, tachycardia, bradycardia. Amlodipine: Excessive peripheral vasodilation, reflex tachycardia, marked prolonged systemic hypotension with possible shock. Rarely, non-cardiogenic pulmonary oedema. Management: Symptomatic and supportive treatment. May perform gastric lavage or give activated charcoal. Monitor heart and lung function, fluid volume, urine output; initiate elevation of extremities. May administer vasopressor if no concurrent contraindication. May give IV Ca gluconate to reverse the effects of Ca channel blockade.
Drug Interactions
Increased hypotensive effects with other antihypertensive drugs.
Olmesartan: Increased risk of hyperkalaemia with K supplements, K-containing salt substitutes, K-sparing diuretics, or other drugs that may increase K level (e.g. heparin, trimethoprim). May increase the serum concentrations and toxicity of lithium. Decreased glomerular filtration and renal function with NSAIDs (including selective COX-2 inhibitors).
Amlodipine: Increased exposure with strong or moderate CYP3A4 inhibitors (e.g. protease inhibitors, azole antifungals, macrolides, verapamil, diltiazem). Decreased serum concentration with strong CYP3A4 inducers (e.g. rifampicin). Risk of hyperkalaemia with dantrolene. May increase the serum concentration of simvastatin, ciclosporin, and mTOR inhibitors (e.g. sirolimus, tacrolimus, temsirolimus, everolimus). Potentially Fatal: Increased risk of hypotension, hyperkalaemia, and reduced renal function (including acute renal failure) with aliskiren and ACE inhibitors.
Food Interaction
Amlodipine: Decreased serum concentration with St. John's wort. Increased bioavailability with grapefruit or grapefruit juice.
Action
Description: Mechanism of Action: Olmesartan is a nonpeptide, benzimidazole derivative, angiotensin II receptor blocker (ARB). It blocks the vasoconstricting and aldosterone-secreting effects of angiotensin II by selectively binding to AT1 receptors.
Amlodipine is a dihydropyridine Ca channel blocker. It selectively inhibits Ca ions transmembrane influx into cardiac and vascular smooth muscle resulting in peripheral arterial relaxation or vasodilation, leading to reduced peripheral vascular resistance and blood pressure. Pharmacokinetics: Absorption: Olmesartan: Bioavailability: Approx 26%. Time to peak plasma concentration: Approx 1-2 hours.
Amlodipine: Well absorbed from the gastrointestinal tract. Bioavailability: 64-90%. Time to peak plasma concentration: 6-12 hours. Distribution: Olmesartan: Volume of distribution: Approx 17 L. Plasma protein binding: 99%.
Amlodipine: Crosses the placenta, enters breast milk. Volume of distribution: 21 L/kg. Plasma protein binding: Approx 98%. Metabolism: Olmesartan: Olmesartan medoxomil undergoes rapid and complete ester hydrolysis in the gastrointestinal tract to active form olmesartan.
Amlodipine: Extensively metabolised in the liver into inactive metabolites. Excretion: Olmesartan: Via urine (35-50%); faeces (50-65%) both as unchanged drug. Terminal elimination half-life: Approx 13 hours.
Amlodipine: Via urine (10% as unchanged drug; 60% as metabolites). Terminal elimination half-life: 30-50 hours.
Chemical Structure
Olmesartan Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 158781, Olmesartan. https://pubchem.ncbi.nlm.nih.gov/compound/Olmesartan. Accessed Oct. 24, 2023.
Amlodipine Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 2162, Amlodipine. https://pubchem.ncbi.nlm.nih.gov/compound/Amlodipine. Accessed Oct. 26, 2023.
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.
References
Anon. Amlodipine and Olmesartan. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/09/2023.Anon. Amlodipine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 06/09/2023.Anon. Amlodipine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/10/2023.Anon. Olmesartan. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 06/09/2023.Anon. Olmesartan. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/10/2023.Azor Tablet, Film Coated (Cosette Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 06/09/2023.Azoren 20 mg/5 mg, 40 mg/5 mg, 40 mg/10 mg Film-coated Tablets (Pfizer [Malysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/09/2023.Buckingham R (ed). Amlodipine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/09/2023.Buckingham R (ed). Olmesartan Medoxomil. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/09/2023.Joint Formulary Committee. Olmesartan with Amlodipine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/09/2023.Sevikar 40 mg/10 mg Film-coated Tablets (Daiichi Sankyo UK Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 06/09/2023.
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