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Felodipine with ramipril oral


Modified release tablets containing felodipine and ramipril

Drugs List

  • felodipine 2.5mg and ramipril 2.5mg modified release tablet
  • felodipine 5mg and ramipril 5mg modified release tablet
  • TRIAPIN 2.5mg+2.5mg modified release tablet
  • Therapeutic Indications


    Essential hypertension when stabilised on same same proportions



    2.5mg felodipine and 2.5mg ramipril
    1 to 2 tablets once daily.

    5mg felodipine and 5mg ramipril
    1 tablet once daily.


    (See Dosage; Adults).

    Patients with Renal Impairment

    Caution in patients with mild to moderate renal impairment (creatinine clearance 20 to 60 ml/minute) a dose reduction may be required due to the ramipril content of the product and renal function monitored closely. It is recommended that these patients are treated with felodipine and ramipril as separate products, or alternative drugs.

    Patients with Hepatic Impairment

    Caution in patients with mild to moderately impaired hepatic function. Use the lowest possible dose and monitor hepatic function. It is recommended that these patients are treated with felodipine and ramipril as separate products or alternative drugs.


    Children under 18 years
    Within 36 hours of discontinuing a sacubitril containing product
    Cardiogenic shock
    Haemodialysis with high flux membranes
    Haemodynamic instability
    Haemodynamically significant valvular heart disease
    Hereditary angioneurotic oedema
    History of cerebrovascular accident
    Idiopathic angioneurotic oedema
    Left ventricular outflow obstruction
    Renal artery stenosis
    Renal impairment - creatinine clearance below 20ml/minute
    Second degree atrioventricular block
    Severe aortic stenosis
    Severe hepatic impairment
    Third degree atrioventricular block
    Uncontrolled congestive cardiac failure
    Unstable angina
    Within 1 month of a myocardial infarction

    Precautions and Warnings

    Desensitisation therapy
    Major surgery
    Aortic stenosis
    Cardiac failure
    Cerebral ischaemia
    Cerebrovascular insufficiency
    Collagen vascular disease
    Diabetes mellitus
    Glucose-galactose malabsorption syndrome
    Hepatic disorder
    Hypertrophic obstructive cardiomyopathy
    Ischaemic heart disease
    Lactose intolerance
    Mitral stenosis
    Peripheral vascular disease
    Renal dialysis
    Renal impairment - creatinine clearance 20-60ml/minute
    Renovascular disorder
    Severe left ventricular failure

    Anaesthetist should be made aware patient is taking this medication
    Anaphylactoid reactions possible with haemofiltration or LDL apheresis
    Anaphylactoid reactions possible with highly permeable dialysis membranes
    Anaphylaxis possible with concomitant hyposensitisation to wasp/bee venom
    Advise ability to drive/operate machinery may be affected by side effects
    Afro-Caribbean or black patients may show reduced response
    Exclude renovascular disorder before treatment
    Contains lactose
    Evaluate renal function before and during treatment
    Exclude pregnancy prior to initiation of treatment
    Monitor serum electrolytes before and during treatment
    Consider monitoring white blood cell counts in collagen vascular disease
    Monitor antidiabetic drug treatment
    Monitor blood pressure
    Monitor patients with renovascular disease
    Higher incidence of angioedema in black patients
    Increased risk of hyperkalaemia with K+ suppl. and K+ sparing diuretic
    Increased risk of hypotension with diuretics and other antihypertensives
    Patient to report nausea, vomiting or situations leading to salt/water loss
    Advise patient to seek advice at first indications of pregnancy
    Discontinue if cardiogenic shock develops
    Discontinue if ischaemic pain occurs shortly after starting therapy
    Discontinue if jaundice or other evidence of hepatic impairment occurs
    Discontinue if persistent or symptomatic hypotension occurs
    Discontinue immediately if angioedema involves face/oropharynx/larynx
    Advise patient not to take NSAIDs unless advised by clinician
    Hypotensive effects may be potentiated by alcohol
    Advise on problems of salt substitutes/high intake of potassium-rich food
    Advise patient Seville (sour) orange products may increase plasma level
    Grapefruit prod increase dihydropyridine Ca channel blocker bioavailability
    Female: Ensure adequate contraception during treatment

    Caution when administering felodipine with ramipril to these patients. Only administer if the patient is stable and with careful titration of the dose using felodipine and ramipril as separate products. Patient can then be switched to the fixed combination product if appropriate. Hypertensive patients without cardiac and renal impairment may also experience hypotension, especially patients with hypovolaemia due to diuretic therapy, salt restriction, diarrhoea or vomiting.

    Patients at risk from an undesirably pronounced reduction in blood pressure (e.g. those with cerebrovascular or coronary impairment) should be treated with ramipril and felodipine as separate products. If satisfactory and stable blood pressure control is achieved with the individual doses equivalent to the combined felodipine with ramipril preparations, the patients may be switched to the combination.

    Pregnancy and Lactation


    Felodipine with ramipril is contraindicated in pregnancy.

    Unless treatment with ramipril is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatment with an established safety profile in pregnancy. Guidelines published from NICE recommend that women with chronic hypertension on ACE inhibitors are informed that there is a risk of congenital abnormalities if the drugs are taken during pregnancy and other antihypertensive treatments for management their condition should be discussed if they are planning pregnancy.

    Epidemiology of the risk of teratogenicity following exposure in the first trimester in human has not be conclusive, however, the MHRA recommends that a risk can not be excluded. The MHRA states that the use of ACE inhibitors in late pregnancy has been associated with adverse effects on the kidney and other congenital anomalies, therefore ACE inhibitors should not be used at any stage during of pregnancy unless absolutely necessary and only then after the potential risks and benefits have been discussed with the patient. Briggs (2011) comments that ramipril and other ACE inhibitors appear to be human teratogens when used in the second and third trimester, producing foetal hypocalvaria and renal defects. ACE inhibitor therapy exposure during the second and third trimester is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation). Anuria-associated oligohydramnios may produce pulmonary hypoplasia, limb contractures, persistent patent ductus arteriosus, craniofacial deformation and neonatal death. Interuterine growth retardation, prematurity and severe neonatal hypotension may also been seen.

    Should exposure to ramipril have occurred from the first trimester, an ultrasound check of renal function and skull is recommended. Newborns whose mothers have taken an ACE inhibitor during pregnancy should be closely observed for hypotension, oliguria and hyperkalaemia. Schaefer (2007) states that accidental exposure does not require invasive diagnosis procedures or termination of pregnancy but if there has been long term exposure to ACE inhibitor then it is recommended to monitor for oligohydramnios and foetal growth via an ultrasound.

    Studies on pregnant women exposed to calcium channel blockers have revealed no adverse effects. However, nifedipine or verapamil, are the best studied calcium antagonists during pregnancy and are the preferred first-line drugs of choice in this group for the treatment of hypertension (Schaefer, 2007).

    If exposure to felodipine has occurred during the first trimester Schaefer (2007) recommends a detailed ultrasound diagnosis. Exposure to a calcium antagonist during pregnancy is not considered to be an indication for invasive diagnostic procedures or termination of pregnancy.

    Felodipine is teratogenic in rabbits, producing digital abnormalities in a dose dependent manner within the range of 0.4 to 4 times the maximum recommended human dose. Reproductive studies in rabbits showed dose-related reversible enlargement of the mammary glands of the parent animal. Rats exposed to 4 times the maximum recommended human dose exhibited delayed parturition with difficult labour and an increased incidence of foetal and post natal deaths (Briggs, 2011).

    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 to 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 ( ).


    Felodipine with ramipril is contraindicated in breastfeeding.

    There is insufficient data on ramipril in breastfeeding. Animal studies have indicated that ramiprilat is transferred into milk in concentrations about one third of those found in serum, but animal studies are always high and do not correlate with humans. The MHRA states that ACE inhibitors have a small molecular size so transfer into human breast milk is possible. With the exception of captopril, the active metabolites of ACE inhibitors have long estimated half lives; however these metabolites are poorly absorbed orally.

    Advice on LactMed, via TOXNET, suggests as no information is available on the use of ramipril during breastfeeding, an alternate drug may be preferred, especially whilst nursing a newborn or preterm infant. Schaefer (2007) advises that nursing mothers who are accidentally exposed to ramipril do not need to stop breastfeeding but therapy should be changed.

    Felodipine has been detected in breast milk, but it is unknown whether it has harmful effects on the newborn.

    Hale (2014) suggests that the use of felodipine should be avoided because the numerous studies on other calcium channel blockers makes them a more informed choice.

    Schaefer (2007) concludes that diltiazem, nifedipine and verapamil are the calcium antagonists of choice during breastfeeding. Individual doses of felodipine do not require limitation of breastfeeding, but therapy should be changed.

    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

    Aggravation of existing asthma
    Alterations in pancreatic enzymes
    Bone marrow depression
    Cardiac arrhythmias
    Cardiogenic shock
    Cholestatic jaundice
    Decreased appetite
    Delayed reactions
    Depressed mood
    Dry mouth
    Erythema multiforme
    Exacerbation of psoriasis
    Gastritis-like pain
    GI disorders
    Gingival hyperplasia
    Haemolytic anaemia
    Hearing disturbances
    Hepatic failure
    Hypersensitivity reactions
    Impaired renal function
    Increase in antinuclear antibodies (ANA)
    Increased urinary frequency
    Increases in hepatic enzymes
    Ischaemic stroke
    Muscle cramps
    Myocardial infarction
    Myocardial ischaemia
    Orthostatic hypotension
    Peripheral oedema
    Raynaud's phenomenon
    Reduced platelet count
    Sexual dysfunction
    Sleep disturbances
    Smelling disturbances
    Stevens-Johnson syndrome
    Taste disturbances
    Toxic epidermal necrolysis
    Transient ischaemic attack
    Visual disturbances
    White blood cell count decreased


    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: April 2015.

    Reference Sources

    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.

    Evaluations of Drug Interactions (EDI), The Standard For Drug Interactions, Volume 2 (2008) ed. Zucchero, M.A., Hogan, M.J. and Sommer, C.D. First DataBank, Inc.

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press Accessed on 13 April 2015.

    Martindale: The Complete Drug Reference (online) London: Brayfield A (ed). Pharmaceutical Press Accessed on 13 April 2015.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

    Summary of Product Characteristics: Triapin 2.5mg/2.5mg prolonged release tablets. Sanofi. Revised February 2015.
    Summary of Product Characteristics: Triapin 5mg/5mg prolonged release tablets. Sanofi. Revised February 2015.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Felodipine Last revised: 10 March 2015
    Last accessed: 13 April 2015

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Ramipril Last revised: 10 March 2015
    Last accessed: 13 April 2015

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