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Olmesartan and amlodipine oral


Oral formulations of olmesartan with amlodipine.

Drugs List

  • olmesartan medoxomil 20mg and amlodipine 5mg tablets
  • olmesartan medoxomil 40mg and amlodipine 10mg tablets
  • olmesartan medoxomil 40mg and amlodipine 5mg tablets
  • SEVIKAR 20mg+5mg film coated tablets
  • SEVIKAR 40mg+10mg film coated tablets
  • SEVIKAR 40mg+5mg film coated tablets
  • Therapeutic Indications


    Hypertension-not adequately controlled by individual components



    One tablet daily.

    The 20 mg/5 mg formulation may be administered to patients whose blood pressure is not adequately controlled by 20 mg olmesartan or 5 mg amlodipine alone.
    The 40 mg/5 mg formulation may be administered to patients whose blood pressure is not adequately controlled by 20 mg/5 mg formulation.
    The 40 mg/10 mg formulation may be administered to patients whose blood pressure is not adequately controlled by the 40 mg/5 mg formulation.


    (See Dosage; Adults).
    If the patient requires 40 mg olmesartan daily careful monitoring of blood pressure is suggested.

    Patients with Renal Impairment

    Mild to moderate renal impairment (creatinine clearance 20 to 60 ml/minute)
    These patients should not receive more than 20 mg olmesartan daily.
    The potassium levels of patients with moderate renal impairment should be closely monitored throughout treatment.

    Patients with Hepatic Impairment

    Mild to moderate hepatic impairment
    Patients with moderate hepatic impairment should initially receive 10 mg olmesartan once daily, these patients should not receive more that 20 mg olmesartan daily.

    Patients with hepatic impairment who are concomitantly receiving diuretics and/or other antihypertensive agents should be have their blood pressure and renal function closely monitored.

    The half life of amlodipine is increased in patients with hepatic impairment, the manufacturer has not established dosage recommendations in these patients.

    Additional Dosage Information

    Individual dose titration with each of the two components is recommended before changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.


    Children under 18 years
    Biliary obstruction
    Cardiac failure within 1 month of a myocardial infarction
    Cardiogenic shock
    Left ventricular outflow obstruction
    Renal impairment - creatinine clearance below 20ml/minute
    Severe aortic stenosis
    Severe bilateral renal artery stenosis
    Severe hepatic impairment
    Severe hypotension
    Severe unilateral stenosis of solitary functioning kidney

    Precautions and Warnings

    Acute porphyria
    Aortic stenosis
    Bilateral renal artery stenosis
    Cerebrovascular disorder
    Hypertrophic obstructive cardiomyopathy
    Ischaemic heart disease
    Mild hepatic impairment
    Mitral stenosis
    New York Heart Association class III failure
    New York Heart Association class IV failure
    Peripheral vascular disease
    Renal impairment - creatinine clearance 20-60ml/minute
    Renovascular disorder
    Severe congestive cardiac failure
    Severe generalised atherosclerosis
    Unilateral stenosis of solitary functioning kidney

    Patients with primary aldosteronism may not benefit from this treatment
    Reduce dose in patients with hepatic impairment
    Advise ability to drive/operate machinery may be affected by side effects
    Advise patient that first dose hypotension may occur
    Afro-Caribbean or black patients may show reduced response
    Correct volume and/or salt depletion before initiating therapy
    Evaluate renal function before and during treatment
    Monitor serum electrolytes before and during treatment
    Monitor serum potassium regularly
    Increased risk of hyperkalaemia with K+ suppl. and K+ sparing diuretic
    Abrupt withdrawal may be associated with exacerbation of angina
    Discontinue & do not restart if sprue-like enteropathy confirmed by biopsy
    Pregnancy confirmed: Discontinue this medication
    Advise patient not to take NSAIDs unless advised by clinician
    Advise on problems of salt substitutes/high intake of potassium-rich food
    Grapefruit prod increase dihydropyridine Ca channel blocker bioavailability
    Female: Ensure adequate contraception during treatment

    Olmesartan with amlodipine should be used with caution in patients with acute porphyria due to the amlodipine component. Amlodipine is classed as probably not porphyrogenic ( NAPOS, 2010).

    Sprue-like enteropathy
    In very rare cases severe chronic diarrhoea with substantial weight loss has been reported in patients taking olmesartan few months to years after drug initiation, possibly caused by a localized delayed hypersensitivity reaction. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider discontinuation of olmesartan in cases where no other etiology is identified. In cases where symptoms disappear and sprue-like enteropathy is confirmed by biopsy, treatment with olmesartan should not be restarted.

    Pregnancy and Lactation


    Olmesartan with amlodipine is contraindicated during pregnancy.

    Animal studies on rats and rabbits reported not teratogenicity at the equivalent to the maximum human dose of olmesartan, however at higher doses rat studies reported decreased pup weight & weight gain, delays in development milestones, and dose related increases in the incidence of renal pelvis dilation (Briggs, 2011). It is not known whether olmesartan crosses the human placenta, however, the molecular weight is low enough that passage to the infant should be expected. Angiotensin II receptor antagonists like olmesartan are associated with similar effects to ACE inhibitors. Foetal toxic effects include; anuria, oligohydramnios, foetal hypocalvaria, intrauterine growth retardation (IUGR), prematurity and patent ductus arteriosus (Briggs, 2011). Oligohydramnios associated with anuria may produce foetal limb contractures, craniofacial deformations and pulmonary hypoplasia. Severe anuria and hypotension that are resistant to treatment may occur in the newborn. Newborn renal function and blood pressure should be closely monitored (Briggs, 2011).

    If pregnancy occurs during treatment, olmesartan must be discontinued immediately and an alternative antihypertensive with greater experience in pregnancy should be considered. If first trimester exposure occurs, a detailed ultrasound examination is recommended to check the kidneys and the skull. Overall exposure during the second or third trimester is not an indication for invasive diagnostic procedure or termination of pregnancy. Long-term exposure during the second or third trimester should led to foetal monitoring for oligohydramnios and foetal growth (Schaefer, 2007). The renal function and blood pressure of the newborn should be monitored. There is insufficient experience of olmesartan during pregnancy, however, drugs that act directly on the renin angiotensin system administered during the second and third trimester have been shown to cause foetal and neonatal injury (hypotension, renal dysfunction, oliguria and/or anuria, oligohydramnios, skull hypoplasia, intrauterine growth retardation, lung hypoplasia, facial abnormalities, limb contracture) and even death (Briggs, 2011).

    Data and experience relating to amlodipine is limited. It is not known whether amlodipine transfers to the foetus, however, the molecular weight is low enough that transfer should be expected. Olmesartan has a greater risk profile than amlodipine so the recommendations regarding olmesartan should be followed for the combination product.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Olmesartan with amlodipine is contraindicated in breastfeeding women. Olmesartan is excreted in the milk of rats, it is unknown if it is excreted in human milk. However, the molecular weights of olmesartan and amlodipine are low enough that excretion in breast milk should be expected (Briggs, 2011). The effects on the newborn are unknown. Schaefer (2007) suggests that accidental administration of a single dose does not require weaning, however, therapy should be changed to an antihypertensive which has been better studied in lactation. The MHRA concludes that the use of angiotensin II receptor antagonists in breastfeeding mothers is not recommended. Alternative antihypertensive treatments with more established safety profiles during breastfeeding are preferable, especially whilst nursing a newborn or preterm baby.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal pain
    Acute renal failure
    Allergic dermatitis
    Altered bowel habit
    Anaphylactic reaction
    Angina pectoris
    Angioneurotic oedema
    Blood urea increased
    Chest pain
    Creatine phosphokinase increased
    Disturbances of gastrointestinal function
    Dry mouth
    Erectile dysfunction
    Erythema multiforme
    Exfoliative dermatitis
    Facial flushing
    Gamma glutamyl transferase (GGT) increased
    Gingival hyperplasia
    Hypersensitivity reactions
    Increased sweating
    Increased uric acid level
    Increases in hepatic enzymes
    Influenza-like symptoms
    Mood changes
    Muscle spasm
    Musculoskeletal pain
    Myocardial infarction
    Orthostatic hypotension
    Painful extremities
    Peripheral neuropathy
    Peripheral oedema
    Postural dizziness
    Quincke's oedema
    Reduced libido
    Reduced plasma potassium levels
    Renal impairment
    Serum creatinine increased
    Skin discolouration
    Sleep disturbances
    Sprue-like enteropathy
    Stevens-Johnson syndrome
    Taste disturbances
    Urinary frequency
    Urinary tract infections
    Visual disturbances
    Weight changes


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: June 2013

    Reference Sources

    British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

    Summary of Product Characteristics: Sevikar 20 mg/5 mg, 40 mg/ 5 mg, 40 mg/ 10 mg Film-Coated Tablets. Daiichi Sankyo UK Limited. Revised November 2014.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Amlodipine. Last revised: October 02, 2012
    Last accessed: June 12, 2013

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Olmesartan. Last revised: September 29, 2009
    Last accessed: June 12, 2013

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