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ARB + CCB + thiazide triple Pregnancy: eMC §4.6: contraindicated during the 2nd and 3rd trimester of pregnancy and not recommended during the first trimester. Angiotensin II receptor antagonist exposure in the 2nd and 3rd trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia); stop treatment immediately when pregnancy is diagnosed and start alternative therapy if appropriate, and observe exposed infants closely for hypotension. Hydrochlorothiazide crosses the placenta and its use in the 2nd and 3rd trimester may compromise foeto-placental perfusion and cause icterus, disturbance of electrolyte balance and thrombocytopenia; it should not be used for gestational oedema, gestational hypertension or pre-eclampsia, and only in rare situations for essential hypertension in pregnancy where no other treatment could be used. (The amlodipine pregnancy paragraph was truncated at source fetch.)

Olmesartan with amlodipine and hydrochlorothiazide

Brand names: Sevikar HCT

This is a triple fixed-dose oral antihypertensive combining olmesartan (an angiotensin-II receptor blocker), amlodipine (a dihydropyridine calcium-channel blocker) and hydrochlorothiazide (a thiazide diuretic) for essential hypertension requiring three agents for control.

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: One tablet per day
Route: Oral - swallow with a sufficient amount of fluid (e.g. one glass of water), do not chew, take at the same time each day; can be taken with or without food
Frequency: Once daily
Max: 40 mg / 10 mg / 25 mg (olmesartan medoxomil / amlodipine / hydrochlorothiazide) per day
eMC §4.2 (Sevikar HCT, UK SPC). ADD-ON THERAPY (strength selection as stated): 20 mg/5 mg/12.5 mg for patients not adequately controlled on olmesartan medoxomil 20 mg plus amlodipine 5 mg as a dual-component combination; 40 mg/5 mg/12.5 mg for patients not adequately controlled on olmesartan medoxomil 40 mg plus amlodipine 5 mg, or not controlled on 20 mg/5 mg/12.5 mg; 40 mg/5 mg/25 mg for patients not controlled on 40 mg/5 mg/12.5 mg; 40 mg/10 mg/12.5 mg for patients not controlled on olmesartan medoxomil 40 mg plus amlodipine 10 mg, or on 40 mg/5 mg/12.5 mg; 40 mg/10 mg/25 mg for patients not controlled on 40 mg/10 mg/12.5 mg or on 40 mg/5 mg/25 mg. A step-wise titration of the dosage of the individual components is recommended before changing to the triple-component combination; when clinically appropriate, direct change from a dual-component combination may be considered. SUBSTITUTION THERAPY: patients controlled on stable doses of the three components taken as a dual-component plus a single-component formulation may be switched to the triple combination containing the same component doses. ELDERLY (65 years or over): caution including more frequent blood pressure monitoring, particularly at the maximum 40 mg/10 mg/25 mg daily dose; increase the dosage with care. Very limited data in patients aged 75 years or older - extreme caution with more frequent blood pressure monitoring. HEPATIC IMPAIRMENT: use with caution in mild impairment; in moderate impairment the maximum dose should not exceed 20 mg/5 mg/12.5 mg once daily, with close monitoring of blood pressure and renal function; amlodipine's half-life is prolonged in impaired liver function and dosage recommendations have not been established, so amlodipine should be initiated at the lowest dose and titrated slowly; use is contraindicated in severe hepatic impairment, cholestasis or biliary obstruction. PAEDIATRIC: not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy - verify any under-18 use against a children's formulary.

Dose adjustments

Renal

§4.2: the maximum dose in mild to moderate renal impairment (creatinine clearance 30-60 mL/min) is 20 mg/5 mg/12.5 mg, owing to limited experience of the 40 mg olmesartan medoxomil dosage in this group; monitoring of serum potassium and creatinine is advised in moderate renal impairment. Use in severe renal impairment (creatinine clearance < 30 mL/min) is contraindicated. §4.4 adds that there is no experience in patients with a recent kidney transplant or end-stage renal impairment (creatinine clearance < 12 mL/min).

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 sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived drug), or to any of the excipients (§4.3)
  • Severe renal impairment (§4.3)
  • Refractory hypokalaemia, hypercalcaemia, hyponatraemia and symptomatic hyperuricaemia (§4.3)
  • Severe hepatic insufficiency, cholestasis and biliary obstructive disorders (§4.3)
  • 2nd and 3rd trimester of pregnancy (§4.3)
  • Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73 m2) (§4.3)
  • Due to the amlodipine component: shock (including cardiogenic shock), severe hypotension, obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis), and haemodynamically unstable heart failure after acute myocardial infarction (§4.3)

Side effects

  • Peripheral oedema, headache and dizziness - the most commonly reported adverse reactions during treatment with the triple combination
  • Upper respiratory tract infection, nasopharyngitis and urinary tract infection (common)
  • Electrolyte and metabolic disturbances: hypokalaemia (common with hydrochlorothiazide, uncommon with the combination), hyperkalaemia (uncommon), hyponatraemia, hypomagnesaemia, hypochloraemia, hypercalcaemia, hyperuricaemia and hyperglycaemia (common to very common with hydrochlorothiazide)
  • Somnolence, postural dizziness, presyncope, dysgeusia, hypoaesthesia, paraesthesia, syncope; visual disturbance including diplopia and blurred vision; acute myopia and acute angle-closure glaucoma (frequency not known)
  • Anaphylactic reaction (uncommon), thrombocytopenia, leucopenia and (with hydrochlorothiazide) bone marrow depression, neutropenia/agranulocytosis, haemolytic and aplastic anaemia; non-melanoma skin cancer (basal cell and squamous cell carcinoma, frequency not known). The §4.8 table was truncated at source fetch

Interactions

  • Aliskiren, ACE inhibitors and other angiotensin II receptor blockers - dual blockade of the renin-angiotensin-aldosterone system increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure) and is not recommended; ACE inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy (eMC §4.4; concomitant aliskiren is contraindicated in diabetes or renal impairment per §4.3)
  • The eMC §4.5 interaction section was not captured in this bundle (the fetch was truncated within §4.4) - clinician to review §4.5 in the full SPC. The items below are from the US olmesartan/hydrochlorothiazide labelling §7 as a cross-check only (US labelling may differ from the UK SPC and does not cover the amlodipine component)
  • Lithium - increases in serum lithium concentrations and lithium toxicity reported with angiotensin II receptor antagonists or hydrochlorothiazide; monitor serum lithium levels during concomitant use (US label §7.2)
  • NSAIDs including selective COX-2 inhibitors - reduced diuretic, natriuretic and antihypertensive effects and increased risk of renal toxicity, particularly in elderly, volume-depleted or renally impaired patients (US label §7.3); agents increasing serum potassium may result in hyperkalaemia - monitor serum potassium (US label §7.1)
  • Colesevelam hydrochloride - consider administering olmesartan at least 4 hours before the colesevelam dose; cholestyramine and colestipol reduce absorption of thiazides; antidiabetic drugs may require dosage adjustment (US label §7.5, §7.6)

Clinical monograph

How it works

Olmesartan blocks the angiotensin-II type-1 receptor, amlodipine relaxes arterial smooth muscle by blocking L-type calcium channels, and hydrochlorothiazide promotes renal sodium and water loss, giving three complementary blood-pressure-lowering actions.

Prescribing in practice

  • Avoid in pregnancy because the angiotensin-receptor-blocker component is foetotoxic, and use only as substitution therapy once the dose of each component is established rather than for initiation.
  • The thiazide adds risks of hyponatraemia, hypokalaemia and other electrolyte disturbance, gout and dehydration, which can compound the hypotension and renal effects of the renin-angiotensin blocker.
  • Olmesartan has been linked to a rare sprue-like enteropathy, and amlodipine commonly causes ankle oedema; monitor for hyperkalaemia balanced against thiazide-induced potassium loss.

Monitoring

Monitor blood pressure, renal function and serum electrolytes including sodium and potassium after starting and after any change, with closer review in the elderly.

Counselling the patient

  • Take this once daily as directed; it replaces taking the three medicines separately.
  • Report persistent diarrhoea, severe dizziness, muscle cramps or weakness.
  • Tell your doctor immediately if you become pregnant.

Evidence & guidelines

Stepwise addition of a thiazide-type diuretic to a renin-angiotensin blocker plus calcium-channel blocker reflects NICE hypertension step-3 management, with fixed-dose triple therapy aiding 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).

Related

Curated clinical cross-links plus same-class fallbacks.

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