ARB + CCB Pregnancy: Not recommended during the first trimester of pregnancy and contraindicated during the second and third trimesters. There are no data on the use of Sevikar in pregnant patients. Exposure to angiotensin II antagonists during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia); when pregnancy is diagnosed treatment should be stopped immediately and alternative therapy started. Breast-feeding: not recommended - amlodipine is excreted in human milk and alternative treatments with better established safety profiles are preferable, especially while nursing a newborn or preterm infant.

Olmesartan with amlodipine

Brand names: Sevikar

Used in: Hypertension

This is a fixed-dose oral combination of olmesartan, an angiotensin-II receptor blocker, with amlodipine, a dihydropyridine calcium-channel blocker, used to treat essential hypertension not adequately controlled on either component alone.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 1 tablet per day. Sevikar 20 mg/5 mg (olmesartan medoxomil 20 mg with amlodipine 5 mg) may be given to patients whose blood pressure is not adequately controlled by 20 mg olmesartan medoxomil or 5 mg amlodipine alone

Route: Oral - swallowed with a sufficient amount of fluid (e.g. one glass of water); the tablet should not be chewed

Frequency: Once daily, at the same time each day; can be taken with or without food

Max: Sevikar 40 mg/10 mg (olmesartan medoxomil 40 mg with amlodipine 10 mg) is the highest strength described in §4.2, for patients whose blood pressure is not adequately controlled by Sevikar 40 mg/5 mg

UP-TITRATION SEQUENCE stated in §4.2: Sevikar 40 mg/5 mg may be given to patients not adequately controlled on Sevikar 20 mg/5 mg; Sevikar 40 mg/10 mg may be given to patients not adequately controlled on Sevikar 40 mg/5 mg. A step-wise titration of the dosage of the individual components is recommended before changing to the fixed combination; when clinically appropriate, a direct change from monotherapy to the fixed combination may be considered. Patients receiving olmesartan medoxomil and amlodipine from separate tablets may be switched to Sevikar tablets containing the same component doses. ELDERLY (65 years or over): no adjustment of the recommended dose is generally required, but increase of the dosage should take place with care; if up-titration to the maximum dose of 40 mg olmesartan medoxomil daily is required, blood pressure should be closely monitored. HEPATIC IMPAIRMENT: use with caution in mild to moderate hepatic impairment; in 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, with close monitoring of blood pressure and renal function in hepatically-impaired patients already receiving diuretics and/or other antihypertensives; amlodipine's half-life is prolonged in impaired liver function, dosage recommendations have not been established, and amlodipine should be initiated at the lowest dose and titrated slowly; use in severe hepatic impairment is contraindicated. PAEDIATRIC: safety and efficacy in children and adolescents below 18 years has not been established and no data are available. SOURCE NOTE: the openFDA record in this bundle is for olmesartan medoxomil with HYDROCHLOROTHIAZIDE - a different fixed combination - and was NOT used for any figure on this page; its 40/12.5 mg and 20/12.5 mg starting doses must not be applied to olmesartan with amlodipine.

Dose adjustments

Renal

The maximum dose of olmesartan medoxomil in patients with mild to moderate renal impairment (creatinine clearance 20-60 mL/min) is 20 mg once daily, owing to limited experience of higher dosages in this group. Use of Sevikar in patients with severe renal impairment (creatinine clearance less than 20 mL/min) is not recommended. Monitoring of potassium levels and creatinine is advised in patients with moderate renal impairment.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substances, to dihydropyridine derivatives or to any of the excipients
Second and third trimesters of pregnancy
Severe hepatic insufficiency and biliary obstruction
Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR less than 60 mL/min/1.73 m2)
Due to the amlodipine component: severe hypotension; shock (including cardiogenic shock); obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis); haemodynamically unstable heart failure after acute myocardial infarction

Side effects

Peripheral oedema (11.3%) - the most commonly reported reaction with the combination
Headache (5.3%)
Dizziness (4.5%)
Hypotension and orthostatic hypotension (uncommon)
Gastrointestinal - nausea, abdominal pain, altered bowel habits including diarrhoea and constipation, dyspepsia
The §4.8 table is truncated at the source-fetch limit and interleaves frequencies for the combination and for the individual components olmesartan and amlodipine in separate columns, which cannot be reliably attributed from the fetched text - verify frequencies against the full SPC §4.8

Interactions

Aliskiren-containing products - concomitant use is contraindicated in patients with diabetes mellitus or renal impairment (GFR less than 60 mL/min/1.73 m2) (UK SPC §4.3)
The fetched eMC bundle contains no §4.5 section, and the openFDA record in this bundle is for a different combination (olmesartan with hydrochlorothiazide) so its interaction table was not used - the full UK SPC §4.5 for Sevikar must be reviewed

Clinical monograph

How it works

Olmesartan blocks the angiotensin-II type-1 receptor to reduce vasoconstriction and aldosterone-driven sodium retention, while amlodipine inhibits vascular L-type calcium channels to relax arterial smooth muscle; the two lower blood pressure by complementary mechanisms.

Prescribing in practice

Avoid in pregnancy because the angiotensin-receptor-blocker component is foetotoxic; counsel women of childbearing potential and stop promptly if pregnancy is planned or confirmed.
Olmesartan has been associated with a rare severe sprue-like enteropathy presenting as chronic diarrhoea and weight loss, which resolves on withdrawal; consider this in unexplained chronic diarrhoea.
Amlodipine commonly causes dose-related ankle oedema and flushing, and the combination can cause symptomatic hypotension and hyperkalaemia, particularly in volume depletion or renal impairment.

Monitoring

Monitor blood pressure, renal function and serum potassium after initiation and following any dose change.

Counselling the patient

Report any persistent severe diarrhoea or unexplained weight loss to your doctor.
Ankle swelling and flushing are common and relate to the amlodipine component.
Tell your prescriber straight away if you become pregnant or plan to.

Evidence & guidelines

Combining a renin-angiotensin blocker with a calcium-channel blocker is supported by NICE hypertension guidance as a rational step-up, and fixed-dose combinations improve adherence.

Reference: NICE NG136; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

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Pathways