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OLMESARTAN/AMLODIPINE is a brand name for Amlodipine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of essential hypertension. Olmesartan/amlodipine is indicated in adult patients whose blood pressure is not adequately controlled on olmesartan medoxomil or amlodipine monotherapy (see sections 4.2 and 5.1).
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults The recommended dosage of olmesartan/amlodipine is 1 tablet per day. Olmesartan/amlodipine 20 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled by 20 mg olmesartan medoxomil or 5 mg amlodipine alone.
Olmesartan/amlodipine 40 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled by olmesartan/amlodipine 20 mg/5 mg. Olmesartan/amlodipine 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled by olmesartan/amlodipine 40 mg/5 mg.
A stepwise titration of the dosage of the individual components is recommended before changing to the fixed combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered. For convenience, patients receiving olmesartan medoxomil and amlodipine from separate tablets may be switched to olmesartan/amlodipine tablets containing the same component doses.
Olmesartan/amlodipine can be taken with or without food. 2). If up-titration to the maximum dose of 40 mg olmesartan medoxomil daily is required, blood pressure should be closely monitored. Renal impairment The maximum dose of olmesartan medoxomil in patients with mild to moderate renal impairment (creatinine clearance of 20 – 60 mL/min) is 20 mg olmesartan medoxomil once daily, owing to limited experience of higher dosages in this patient group.
2). Monitoring of potassium levels and creatinine is advised in patients with moderate renal impairment. 2). In patients with moderate hepatic impairment, an initial dose of 10 mg olmesartan medoxomil once daily is recommended and the maximum dose should not exceed 20 mg once daily.
Close monitoring of blood pressure and renal function is advised in hepatically-impaired patients who are already receiving diuretics and/or other antihypertensive agents. There is no experience of olmesartan medoxomil in patients with severe hepatic impairment.
As with all calcium antagonists, amlodipine's half-life is prolonged in patients with impaired liver function and dosage recommendations have not been established. Olmesartan/amlodipine should therefore be administered with caution in these patients.
The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initiated at the lowest dose and titrated slowly in patients with impaired liver function. 3). Paediatric population The safety and efficacy of olmesartan/amlodipine in children and adolescents below 18 years has not been established.
5%). Adverse reactions from olmesartan medoxomil/amlodipine in clinical trials, post- authorisation safety studies and spontaneous reporting are summarised in the below table as well as adverse reactions from the individual components Olmesartan medoxomil and amlodipine based on the known safety profile of these substances.
The following terminologies have been used in order to classify the occurrence of adverse reactions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
FrequencyMedDRA System Organ Class Adverse reactions Olmesartan/ amlodipine combination Olmesartan Amlodipine Leukocytopenia – – Very rareBlood and lymphatic system disorders Thrombocytopenia – Uncommon Very rare Allergic reaction / Drug hypersensitivity Rare – Very rareImmune system disorders Anaphylactic reaction – Uncommon – Hyperglycaemia – – Very rare Hyperkalaemia Uncommon Rare – Hypertriglyceridemia – Common – Metabolism and nutrition disorders Hyperuricaemia – Common – Confusion – – Rare Depression – – Uncommon Insomnia – – Uncommon Irritability – – Uncommon Libido decreased Uncommon – – Psychiatric disorders Mood changes (including – – Uncommon anxiety) Dizziness Common Common Common Dysgeusia – – Uncommon Extrapyramidal disorder – – Not known Headache Common Common Common (especially a the beginning of treatment) Hypertonia – – Very rare Hypoesthesia Uncommon – Uncommon Lethargy Uncommon – – Paraesthesia Uncommon – Uncommon Peripheral neuropathy – – Very rare Postural dizziness Uncommon – – Sleep disorder – – Uncommon Somnolence – – Common Syncope Rare – Uncommon Nervous system disorders Tremor – – Uncommon Eye disorders Visual disturbance (including diplopia) – – Common Tinnitus – – UncommonEar and labyrinth disorders Vertigo Uncommon Uncommon – Angina pectoris – Uncommon Uncommon (incl.
Patients with hypovolaemia or sodium depletion Symptomatic hypotension may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting, especially after the first dose.
Correction of this condition prior to administration of olmesartan/amlodipine or close medical supervision at the start of the treatment is recommended. g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with other medicinal products that affect this system, such as angiotensin II receptor antagonists, has been associated with acute hypotension, azotaemia, oliguria or, rarely, acute renal failure.
Renovascular hypertension There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin- aldosterone system.
Renal impairment and kidney transplantation When olmesartan/amlodipine is used in patients with impaired renal function, periodic monitoring of serum potassium and creatinine levels is recommended. 2). e. creatinine clearance < 12 mL/min).
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
1. 6). 2). 1). Due to the component amlodipine, olmesartan/amlodipine is also contraindicated in patients with: severe hypotension. shock (including cardiogenic shock). g. high grade aortic stenosis). haemodynamically unstable heart failure after acute myocardial infarction.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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No data are available. g. one glass of water). The tablet should not be chewed and should be taken at the same time each day.
4) – Very rare – Upper abdominal pain Uncommon – – Vomiting Uncommon Uncommon Uncommon Hepatic enzymes increased – Common Very rare (mostly consistent with cholestasis) Hepatitis – – Very rare Hepatobiliary disorders Jaundice – – Very rare Autoimmune hepatitis* Not known Allergic dermatitis – Uncommon – Alopecia – – Uncommon Angioneurotic oedema – Rare Very rare Erythema multiforme – – Very rare Exanthema – Uncommon Uncommon Exfoliative dermatitis – – Very rare Hyperhidrosis – – Uncommon Photosensitivity – – Very rare Pruritus – Uncommon Uncommon Purpura – – Uncommon Quincke oedema – – Very rare Rash Uncommon Uncommon Uncommon Skin discoloration – – Uncommon Stevens-Johnson syndrome – – Very rare Skin and subcutaneous tissue disorders Urticaria Rare Uncommon Uncommon Toxic epidermal necrolysis – – Not known Ankle swelling – – Common Arthralgia – – Uncommon Arthritis – Common – Back pain Uncommon Common Uncommon Muscle spasm Uncommon Rare Common Myalgia – Uncommon Uncommon Pain in extremity Uncommon – – Musculoskeletal and connective tissue disorders Skeletal pain – Common – Acute renal failure – Rare – Haematuria – Common – Increased urinary frequency – – Uncommon Micturition disorder – – Uncommon Nocturia – – Uncommon Pollakiuria Uncommon – – Renal insufficiency – Rare – Renal and urinary disorders Urinary tract infection – Common – Erectile dysfunction/impotence Uncommon – UncommonReproductive system and breast disorders Gynecomastia – – Uncommon Asthenia Uncommon Uncommon Common Chest pain – Common Uncommon Face oedema Rare Uncommon – Fatigue Common Common Common Influenza-like symptoms – Common – Lethargy – Rare – Malaise – Uncommon Uncommon Oedema Common – Very common Pain – Common Uncommon Peripheral oedema Common Common – General disorders and administration site conditions Pitting oedema Common – – Blood creatinine increased Uncommon Rare – Blood creatine phosphokinase increased – Common – Blood potassium decreased Uncommon – – Blood urea increased – Common – Blood uric acid increased Uncommon – – Gamma glutamyl transferase increased Uncommon – – Weight decrease – – Uncommon Investigations Weight increase – – Uncommon *Cases of autoimmune hepatitis with a latency of few months to years have been reported post-marketing, that were reversible after the withdrawal of olmesartan.
Single cases of rhabdomyolysis have been reported in temporal association with the intake of angiotensin II receptor blockers. Single cases of extrapyramidal syndrome have been reported in patients treated with amlodipine. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via […]
2). Care should be taken when olmesartan/amlodipine is administered in patients with mild to moderate hepatic impairment. 2). In patients with impaired hepatic function, amlodipine should be initiated at the lower end of the dosing range and caution should be used, both on initial treatment and when increasing the dose.
3). 5). Close monitoring of serum potassium levels in at-risk patients is recommended. ) should be undertaken with caution and with frequent monitoring of potassium levels. 5). Aortic or mitral valve stenosis; obstructive hypertrophic cardiomyopathy Due to the amlodipine component of olmesartan/amlodipine, as with all other vasodilators, special caution is indicated in patients suffering from aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy.
Primary aldosteronism Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system. Therefore, the use of olmesartan/amlodipine is not recommended in such patients.
Heart failure As a consequence of the inhibition of the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients with severe heart failure whose renal function may depend on the activity of the renin- angiotensin-aldosterone system, treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotaemia and (rarely) with acute renal failure and/or death.
Patients with heart failure should be treated with caution. 1). Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.
8). These patients presented with abdominal pain, nausea, vomiting and diarrhoea. Symptoms resolved after discontinuation of angiotensin II receptor antagonists. If intestinal angioedema is diagnosed, olmesartan should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred.
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