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AKTO is a brand name for Amlodipine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of hypertension in adults. Ramipril/Amlodipine is indicated as substitution therapy of patients with blood pressure adequately controlled with ramipril and amlodipine given concurrently at the same dose level as in the combination, but as separate tablets.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Ramipril/Amlodipine should not be used for initiating treatment of hypertension. The doses of each component should be individualized according to the patient profile and blood pressure control. If a dose change is required, the dosing regimen should be individually determined using the individual components of ramipril and amlodipine first, and once established, it could be changed to Ramipril/Amlodipine.
The recommended dose is one capsule daily. The maximum daily dose is one capsule 10 mg/10 mg. Special populations Elderly population Lower initial dosage is recommended in the elderly and increase of the dosage should take place with care.
Renal impairment To find the optimal starting dose and maintenance dose of patients with renal impairment, the patients should be individually titrated using the individual components of amlodipine and ramipril. The maximum daily dose of ramipril in patients with renal impairment should be based on creatinine clearance.
• if creatinine clearance is ≥ 60 ml/min, the maximal daily dose is 10 mg • if creatinine clearance is between 10 – 60 ml/min, the maximal daily dose is 5 mg • in haemodialysed hypertensive patients: ramipril is slightly dialysable; the maximal daily dose is 5 mg; the medicinal product should be administered few hours after haemodialysis is performed.
No dosage adjustment of amlodipine is required for patients with renal impairment. Amlodipine is not dialysable. Amlodipine should be administered with particular caution to patients undergoing dialysis. Renal function and serum potassium levels should be monitored during therapy with Ramipril/Amlodipine.
In the case of renal function deterioration, the use of Ramipril/Amlodipine should be discontinued and replaced by the individual components adequately adjusted. 5 mg ramipril. 5 mg ramipril cannot be achieved with Ramipril/Amlodipine.
Paediatric population The safety and efficacy of Ramipril/Amlodipine in children has not been established. 3 but no recommendation on a posology can be made. Method of administration Since food does not affect absorption of ramipril and amlodipine, Ramipril/Amlodipine may be taken irrespective of meals.
It is recommended that Ramipril/Amlodipine is taken at the same time of the day.
The safety profile of ramipril includes persistent dry cough and reactions due to hypotension. Serious adverse reactions include stroke, myocardial infarction, angioedema, hyperkalaemia, renal or hepatic impairment, pancreatitis, severe skin reactions and neutropenia/agranulocytosis.
The most commonly reported adverse reactions during treatment with amlodipine are somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema and fatigue.
Adverse reactions frequency is defined using the following convention:
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). The following adverse drug reactions have been reported during the treatment with ramipril and amlodipine independently.
System organ class Frequency Ramipril Amlodipine Uncommon Eosinophilia Rare White blood cells count decreased(including neturopenia or agranulocytosis), red blood cell count decreased, haemoglobin decreased, platelet count decreased.
Very rare Leukocytopenia, thrombocytopenia. Blood and lymphatic system disorders Not known Bone marrow failure, pancytopenia, Haemolytic anaemia. Immune system Disorders Not known Anaphylactic or anaphylactoid reactions, antinuclear antibody increased.
Common Blood potassium increased. Uncommon Anorexia, decreased appetite. Very rare Hyperglycaemia. Metabolism and nutrition disorders Not known Blood sodium decreased. Endocrine disorders Not known Syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Uncommon Depressed mood, anxiety, nervousness, restlessness, sleep disorder including somnolence Insomnia, mood changes (including anxiety), depression. Psychiatric disorders Rare Confusional state. Confusion Not known Disturbance in attention.
All warnings related to each monocomponent, as listed below, should also apply to the fixed combination of ramipril/amlodipine. Caution is recommended in patients who are being treated concurrently with diuretics since these patients may be volume and/or salt depleted.
Renal function and serum potassium should be monitored. Related to ramipril 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.
Special populations Pregnancy ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
6). Patients at particular risk of hypotension • Patients with strongly activated renin-angiotensin-aldosterone system Patients with strongly activated renin-angiotensin-aldosterone system are at risk of an acute pronounced fall in blood pressure and deterioration of renal function due to ACE inhibition, especially when an ACE inhibitor or a concomitant diuretic is given for the first time or at first dose increase.
g. stenosis of the aortic or mitral valve) • patients with unilateral renal artery stenosis with a second functional kidney • patients in whom fluid or salt depletion exists or may develop (including patients with diuretics) • patients with liver cirrhosis and/or ascites • patients undergoing major surgery or during anaesthesia with agents that produce hypotension Generally, it is recommended to correct dehydration, hypovolaemia or salt depletion before initiating treatment (in patients with heart failure, however, such corrective action must be carefully weighed out against the risk of volume overload).
1. 1). • Concomitant use with sacubitril/valsartan therapy. 5). • History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors or angiotensin II receptor antagonists). 5). • Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney.
6). • Hypotensive or haemodynamically unstable states. Related to amlodipine • Severe hypotension. • Shock (including cardiogenic shock). , 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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Common Headache, dizziness Somnolence, dizziness, headache (especially at the beginning of the treatment). Uncommon Vertigo, paraesthesia, ageusia, dysgeusia. Tremor, dysgeusia, syncope, hypoesthesia, paraesthesia. Rare Tremor, balance disorder.
Very rare Hypertonia, peripheral neuropathy. Nervous system Disorders Not known Cerebral ischemia including ischaemic stroke and transient ischaemic attack, psychomotor skills impaired, burning sensation, parosmia. Extrapyramidal disorder.
Uncommon Visual disturbance including blurred vision. Visual disturbance (including diplopia). Eye disorders Rare Conjunctivitis. Ear and labyrinth disorders Uncommon Tinnitus. Rare Hearing impaired, tinnitus. Common Palpitations. Uncommon Myocardial ischemia including angina pectoris or myocardial infarction, tachycardia, arrhythmia, palpitations, oedema peripheral.
Arrhythmia, (including bradycardia, ventricular tachycardia and atrial fibrillation). Cardiac disorders Very rare Myocardial infarction. Common Hypotension, orthostatic blood pressure decreased, syncope. Flushing. Uncommon Flushing. Hypotension Rare Vascular stenosis, hypoperfusion, vasculitis.
Very rare Vasculitis. Vascular disorders Not known Raynaud's phenomenon Respiratory, Common Non-productive tickling cough, bronchitis, sinusitis, dyspnoea. Uncommon Bronchospasm including asthma aggravated, nasal congestion. Dyspnoea, rhinitis.
thoracic and mediastinal disorders Very rare Cough. Common Gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia, diarrhoea, nausea, vomiting. Abdominal pain, nausea, dyspepsia, altered bowel habits (including diarrhoea and constipation).
Uncommon Pancreatitis (cases of fatal outcome have been very exceptionally reported with ACE inhibitors), pancreatic enzymes increased, small bowel angioedema, abdominal pain upper including gastritis, constipation, dry mouth. Vomiting, dry mouth.
Rare Glossitis. Very rare Pancreatitis, gastritis, gingival hyperplasia Gastrointestinal Disorders Not known Aphthous stomatitis. Uncommon Hepatic enzymes and/or bilirubin conjugated increased. Rare Jaundice cholestatic, hepatocellular damage.
Very rare Hepatitis, jaundice, hepatic enzymes increased*. Hepatobiliary Disorders Not known Acute hepatic failure, cholestatic or cytolytic hepatitis (fatal outcome has been very exceptional). Skin and subcutaneous Common Rash in particular maculo- papular.
Uncommon Angioedema; very exceptionally, the airway obstruction resulting from angioedema may have a fatal outcome, pruritus, hyperhidrosis. Alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, rash, exanthema urticaria.
Rare Exfoliative dermatitis, urticaria, onycholysis. Very rare Photosensitivity reaction. Angioedema, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke oedema, photosensitivity. tissue disorders Not known Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, psoriasis aggravated, dermatitis psoriasiform, pemphigoid or lichenoid exanthema or enanthema, alopecia.
Toxic epidermal necrolysis. Common Muscle spasms, myalgia Ankle swelling, muscle cramps. Musculoskeletal and connective tissue disorders Uncommon Arthralgia. Arthralgia, myalgia, back pain. Renal and urinary disorders Uncommon Renal impairment including renal failure acute, urine output increased, worsening of a preexisting proteinuria, blood urea increased, blood creatinine increased.
Micturition disorder, nocturia, increased urinary frequency. Reproductive system and breast disorders Uncommon Transient erectile impotence, libido decreased. Impotence, Gynaecomastia. Not known Gynaecomastia. Very common Oedema. Common Chest pain, fatigue.
Fatigue, asthenia. General disorders and administration site conditions Uncommon Pyrexia. Chest pain, pain, malaise. Rare Asthenia. Investigations Uncommon Weight increase, weight decrease. * most commonly with cholestasis Paediatric population Related to ramipril The safety of ramipril was monitored in 325 children and adolescents, aged 2- 16 years old, during 2 clinical […]
• Transient or persistent heart failure post myocardial infarction. • Patients at risk of cardiac or cerebral ischemia in case of acute hypotension. The initial phase of treatment requires special medical supervision. 2. Surgery It is recommended that treatment with angiotensin converting enzyme inhibitors such as ramipril should be discontinued where possible one day before surgery.
Monitoring of renal function Renal function should be assessed before and during treatment and dosage adjusted especially in the initial weeks of treatment. 2). There is a risk of impairment of renal function, particularly in patients with congestive heart failure or after a renal transplant.
8). Concomitant use of ACE inhibitors with sacubitril/valsartan is contraindicated due to the increased risk of angioedema. Treatment with sacubitril/valsartan must not be initiated earlier than 36 hours after the last dose of ramipril.
5). g. g. 5). g. sirolimus, everolimus, temsirolimus) and vildagliptin in a patient already taking an ACE inhibitor. In case of angioedema, ramipril must be discontinued. Emergency therapy should be instituted promptly. Patient should be kept under observation for at least 12 to 24 hours and discharged after complete resolution of the symptoms.
8). These patients presented with abdominal pain (with or without nausea or vomiting). Anaphylactic reactions during desensitisation The likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom and other allergens are increased under ACE inhibition.
A temporary discontinuation of ramipril should be considered prior to desensitisation.
Electrolyte monitoring:
Hyperkalaemia ACE inhibitors, including ramipril, can cause hyperkalaemia because they inhibit the release of aldosterone. The effect is usually not significant in patients with normal renal function. g. heparin, trimethoprim or co […]