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RAMIPRIL is a brand name for Ramipril. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of hypertension - Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with • manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or • diabetes with at least one cardiovascular risk factor (see…
Verbatim from this product's MHRA label. Tap a section to expand.
Adults Diuretic-Treated patients Hypotension may occur following initiation of therapy with Ramipril; this is more likely in patients who are being treated concurrently with diuretics. Caution is therefore recommended since these patients may be volume and/or salt depleted.
4). 25 mg dose. Renal function and serum potassium should be monitored. The subsequent dosage of Ramipril should be adjusted according to blood pressure target. 4) and blood pressure control. 1). 5 mg daily. Patients with a strongly activated renin-angiotensin-aldosterone system may experience an excessive drop in blood pressure following the initial dose.
4). Titration and maintenance dose The dose can be doubled at interval of two to four weeks to progressively achieve target blood pressure; the maximum permitted dose of Ramipril is 10 mg daily. Usually the dose is administered once daily.
5 mg of Ramipril once daily. Titration and maintenance dose Depending on the patient’s tolerability to the active substance, the dose should be gradually increased. It is recommended to double the dose after one or two weeks of treatment and - after another two to three weeks - to increase it up to the target maintenance dose of 10 mg Ramipril once daily.
See also posology on diuretic treated patients above. 25 mg of Ramipril once daily. Titration and maintenance dose Depending on the patient's tolerability to the active substance, the dose is subsequently increased. 5 mg after two weeks and then to 5 mg after a further two weeks is recommended.
5 mg of Ramipril once daily. Titration and maintenance dose Depending on the patient’s tolerability to the active substance, the dose is subsequently increased. Doubling the daily dose to 5 mg Ramipril after one or two weeks and then to 10 mg Ramipril after a further two or three weeks is recommended.
The target daily dose is 10 mg. In patients with non- diabetic nephropathy as defined by macroproteinuria ≥ 3 g/day. 25 mg of Ramipril once daily. Titration and maintenance dose Depending on the patient’s tolerability to the active substance, the dose is subsequently increased.
5 mg after two weeks and then to 5 mg after a further two weeks is recommended. 25 mg daily. Titration and maintenance dose Ramipril should be titrated by doubling the dose every one to two weeks up to a maximum daily dose of 10 mg. Two administrations per day are preferable.
The safety profile of ramipril includes persistent dry cough and reactions due to hypotension. Serious adverse reactions include angioedema, hyperkalaemia, renal or hepatic impairment, pancreatitis, severe skin reactions and neutropenia/agranulocytosis.
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). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Common Uncommon Rare Very rare Not known Blood and lymphatic system disorders Eosinophilia White blood cell count decreased (including neutropenia or agranulocytosis) , red blood cell count decreased, haemoglobin decreased, platelet count decreased Bone marrow failure, pancytopenia, haemolytic anaemia Common Uncommon Rare Very rare Not known Immune system disorders Anaphylactic or anaphylactoid reactions, antinuclear antibody increased Endocrine disorders Syndrome of inappropriate antidiuretic hormone secretion (SIADH) Metabolism and nutrition disorders Blood potassium increased Anorexia, decreased appetite Blood sodium decreased Psychiatric disorders Depressed mood, anxiety, nervousness, restlessness, sleep disorder including somnolence Confusional state Disturbance in attention Nervous system disorders Headache, dizziness Vertigo, paraesthesia, ageusia, dysgeusia Tremor, balance disorder Cerebral ischaemia including ischaemic stroke and transient ischaemic attack, psychomotor skills impaired, burning sensation, parosmia Eye disorders Visual disturbance including blurred vision Conjunctivitis Ear and labyrinth disorders Hearing impaired, tinnitus Cardiac disorders Myocardial ischaemia including angina pectoris or myocardial infarction, tachycardia, arrhythmia, palpitations, oedema peripheral Common Uncommon Rare Very rare Not known Vascular disorders Hypotension, orthostatic blood pressure decreased, syncope Flushing Vascular stenosis, hypoperfusion, vasculitis Raynaud’s phenomenon Respiratory, thoracic and mediastinal disorders Non-productive tickling cough, bronchitis, sinusitis, dyspnoea Bronchospasm including asthma aggravated, nasal congestion Gastrointestinal disorders Gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia, diarrhoea, nausea, vomiting Pancreatitis (cases of fatal outcome have been very exceptionally reported with ACE inhibitors), pancreatic enzymes increased, small bowel angioedema, abdominal pain including gastritis, constipation, dry mouth Glossitis Aphtous stomatitis Hepatobiliary disorders Hepatic enzymes and/or bilirubin conjugated increased Jaundice cholestatic, hepatocellular damage Acute hepatic failure, cholestatic or cytolytic hepatitis (fatal outcome has been very exceptional).
Special populations Pregnancy:
ACE inhibitors such as ramipril, or Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless continued ACE inhibitor/ AIIRAs 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).
- Transient or persistent heart failure post MI - 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.
6) - Ramipril must not be used in patients with hypotensive or haemodynamically unstable states. 5). 1).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 mg twice daily for three days. 5 mg and 5 mg twice a day. 5 mg twice a day the treatment should be withdrawn. See also posology on diuretic treated patients above. Titration and maintenance dose The daily dose is subsequently increased by doubling the dose at intervals of one to three days up to the target maintenance dose of 5 mg twice daily.
The maintenance dose is divided in 2 administrations per day where possible. 5 mg twice a day treatment should be withdrawn. Sufficient experience is still lacking in the treatment of patients with severe (NYHA IV) heart failure immediately after myocardial infarction.
25 mg once daily and that particular caution be exercised in any dose increase. 25 mg/day and the maximal daily dose is 5 mg; the medicinal product should be administered few hours after haemodialysis is performed. 5 mg Ramipril. Older people Initial doses should be lower and subsequent dose titration should be more gradual because of greater chance of undesirable […]
Skin and subcutaneous tissue disorders Rash inparticular maculo-papular Angioedema; very exceptionally, the airway obstruction resulting from angioedema may have a fatal outcome; pruritus, hyperhidrosis Exfoliative dermatitis, urticaria, onycholysis Photosensitivity reaction Toxic epidermal necrolysis, Stevens- Johnson syndrome, erythema multiforme, pemphigus, psoriasis aggravated, dermatitis psoriasiform, pemphigoid or lichenoid exanthema or enanthema, alopecia Common Uncommon Rare Very rare Not known Musculoskeleta l connective tissue disorders Muscle spasms, myalgia Arthralgia Renal and urinary disorders Renal impairment including renal failure acute, urine output increased, worsening of a pre-existing proteinuria, blood urea increased, blood creatinine increased Reproductive system and breast disorders Transient erectile impotence, libido decreased Gynaecomastia General disorders and administration site conditions Chest pain, fatigue Pyrexia Asthenia Paediatric population The safety of ramipril was monitored in 325 children and adolescents, aged 2- 16 years old during 2 clinical trials.
e. ≥ 1/1,000 to < 1/100) in adult population. e. ≥ 1/10,000 to < 1/1,000) in adult population. ie. e. ≥ 1/10,000 to < 1/1,000) in adult population. The overall safety profile for ramipril in paediatric patients does not differ significantly from the safety profile in adults.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.
8). 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 desensitization 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 desensitization. Serum Potassium / Hyperkalaemia Hyperkalaemia may occur during treatment with an ACE inhibitor including Ramipril because they inhibit the release of aldosterone.
The effect is usually not significant in patients with normal renal function. g. heparin, co-trimoxazole also known as trimethoprim/sulfamethoxazole) and especially aldosterone antagonists or angiotensin-receptor blockers; or conditions such as dehydration, acute cardiac decompensation, metabolic acidosis.
5). Neutropenia/agranulocytosis Neutropenia/agranulocytosis, as well as thrombocytopenia and anaemia, have been rarely seen and bone marrow depression has also been reported. It is recommended to monitor the white blood cell count to permit detection of a possible leucopoenia.
g. 8). Ethnic differences ACE inhibitors cause higher rate of angioedema in black patients than in non black patients. As with other ACE inhibitors, ramipril may be less effective in lowering blood […]