Ramipril and Felodipine interacts in the following cases:
Renal function should be monitored, particularly in the initial weeks of treatment with ACE inhibitors. Caution should be observed in patients with an activated renin-angiotensin system.
Individual dose titration with the components can be recommended and when clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Individual dose titration with the components can be recommended and when clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Individual dose titration with the components can be recommended and when clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Felodipine/ramipril combination is contra-indicated in pregnancy.
Calcium antagonists may inhibit contractions of the uterus during labour. Definite evidence that labour is prolonged in full-term pregnancy is lacking. Risk of foetal hypoxia may occur if the mother is hypotensive and perfusion of the uterus is reduced due to redistribution of the blood-flow through peripheral vasodilatation. In animal experiments, calcium antagonists have caused embryotoxic and/or teratogenic effects, especially in the form of distal skeletal malformations in several species.
Appropriate and well-controlled studies with ramipril have not been done in humans. ACE inhibitors cross the placenta and can cause foetal and neonatal morbidity and mortality when administered to pregnant women. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
ACE inhibitor/Angiotensin II Receptor Antagonist (AIIRA) therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). Should exposure to ACE inhibitor have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Newborns whose mothers have taken ACE inhibitors should be closely observed for hypotension, oliguria and hyperkalaemia.
In animals, ramipril is excreted in milk. No information is available on whether or not ramipril is excreted in human breast-milk. Felodipine is excreted in human breast-milk.
Women must not breast-feed during treatment with felodipine/ramipril.
No data on male and female fertility in patients are available.
Some undesirable effects (e.g. some symptoms of reduction in blood pressure such as dizziness) may be accompanied by an impairment of the ability to concentrate and react. This may constitute a risk in situations where these abilities are of special importance, e.g., when driving a car or operating machinery.
The frequencies used in the tables throughout this section are: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10 000, <1/1000) and very rare (<1/10 000), not known (cannot be estimated from the available data).
The following undesirable effects may occur in connection with felodipine treatment:
| Frequencies/ Organ System | Very Common | Common | Uncommon | Rare | Very rare |
|---|---|---|---|---|---|
| Immune system disorders | Hypersensitivity reactions | ||||
| Metabolism and nutrition disorders | Hyperglycaemia | ||||
| Psychiatric disorders | Impotence/ sexual dysfunction | ||||
| Nervous system disorders | Headache | Dizziness, paraesthesiae | Syncope | ||
| Cardiac disorders | Tachycardia, palpitations | ||||
| Vascular disorders | Flush | Hypotension | Leucocytoclastic vasculitis | ||
| Gastrointestinal disorders | Nausea, abdominal pain | Vomiting | Gingival hyperplasia, gingivitis | ||
| Hepatobiliary disorders | Increased liver | ||||
| Skin and subcutaneous tissue disorders | Rash, pruritus | Urticaria | Photosensitivity reactions, angioedema | ||
| Musculoskeletal and connective tissue disorders | Arthralgia, myalgia | ||||
| Renal and urinary disorders | Pollakisuria | ||||
| General disorders and administration site conditions | Peripheral oedema | Fatigue | Fever |
The following undesirable effects may occur in connection with ramipril treatment:
| Frequencies/ Organ System | 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 | ||
| Immune system disorders | Anaphylactic or anaphylactoid reactions, antinuclear antibody increased | ||||
| 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 | ||||
| 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 upper 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). | ||
| Skin and subcutaneous tissue disorders | Rash in particular 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 |
| Musculoskeletal and connective tissue disorders | Muscle spasms, myalgia | Arthralgia | |||
| Endocrine disorders | Syndrome of inappropriate antidiuretic hormone secretion (SIADH) | ||||
| 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 |
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