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Cerebrovascular disease or ischaemic heart disease - Reduction in blood pressure could aggravate these conditions and may result in myocardial infarction and cerebrovascular accidents. |
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Volume depleted patients (e.g. by diuretic therapy, dietary salt restriction, dialysis, diarrhoea or vomiting) - Although it may occur in normo volumic patients, hypotension is more likely in volume depleted patients. A sudden reduction in angiotensin II may result in sudden and severe hypotension. There is also an increased risk of RAMPIL induced renal failure, especially in those with congestive heart failure. |
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Patients at a high risk of symptomatic hypotension e.g. patients with salt or volume depletion with or without hyponatraemia should have these conditions corrected before therapy with RAMPIL. Monitoring is required after initiating therapy. |
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Severe autoimmune disease, especially systemic lupus erythematosus, other collagen vascular disease or scleroderma: Increase the risk for development of neutropenia or agranulocytosis. |
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In acute myocardial infarction, treatment with RAMPIL should not be initiated in patients with evidence of renal dysfunction (serum creatinine concentrations exceeding 177 micromol/L or proteinuria exceeding 500 mg/24 hours). If renal dysfunction develops during treatment (serum creatinine concentrations exceeding 177 micromol/L or doubling of the pre-treatment value) then RAMPIL may need to be withdrawn (see also contra-indications). |
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In acute myocardial infarction, patients may develop persistent hypotension and/or impaired renal function. |
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Hypotension in acute myocardial infarction - Treatment with RAMPIL must not be initiated in acute myocardial infarction patients who are at risk of further serious haemodynamic deterioration after treatment with a vasodilator. These include patients with systolic blood pressure of 99,98 mmHg or lower or cardiogenic shock. During the first 3 days following the infarction, the dose should be reduced if the systolic blood pressure is 119,93 mmHg or lower. Maintenance doses should be reduced to 5 mg or temporarily to 2,5 mg if systolic blood pressure is 99,98 mmHg or lower. If hypotension persists (systolic blood pressure less than 89,93 mmHg or more than 1 hour) then RAMPIL should be withdrawn. |
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Bone marrow depression - Increased risk of agranulocytosis and neutropenia. |
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Diabetes mellitus - Increased risk of hyperkalaemia, as well as hypoglycaemia may occur. |
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Hyperkalaemia -RAMPIL may cause an increase in serum potassium levels. |
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Renovascular disease -RAMPIL should not be used in patients with renovascular disease or suspected renovascular disease but it may be used cautiously in severe resistant hypertension in such patients. In this instance RAMPIL should only be used under specialist supervision. The elderly, patients with peripheral vascular diseases or generalised atherosclerosis may have asymptomatic renovascular disease. (SEE DOSAGE AND DIRECTIONS FOR USE) |
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Renal artery stenosis, bilateral or in one kidney or renal transplant - Increased risk of renal function impairment may increase blood urea and serum creatinine concentrations, which may be reversible upon discontinuation of therapy. There is also an increased risk of agranulocytosis and neutropenia when immunosuppressants are concurrently administered. |
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Renal function impairment - Decreased elimination of RAMPIL resulting in an increased risk of hyperkalaemia. These patients may require lower doses. |
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Anaphylactoid reactions have occurred in patients using ACE inhibitors during desensitising protocols involving for example, hymenoptera venom. |
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Anaphylactoid reactions have been reported in patients exposed to either high-flux membrane dialysis or low-density lipoprotein apheresis with dextran sulfate absorption. |
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Hypersensitivity/Angioedema - If Angioedema of the face, extremities, lips, tongue, glottis and/or larynx is observed in patients treated with RAMPIL, RAMPIL should be discontinued promptly. These patients should be monitored to ensure complete resolution of symptoms. |
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Angioedema associated with laryngeal oedema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate emergency therapy should be administered. This may include the administration of adrenaline and/or the maintenance of a patent airway. The patient should be under close medical supervision until complete and sustained resolution of symptoms has occurred. These patients should never receive any RAMPIL again. |
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RAMPIL causes a higher rate of angioedema in black patients than in non-black patients. |
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Safety and efficacy in children have not been established. |
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Concomitant therapy with potassium sparing diuretics such as spironolactone, triamterene, amiloride may lead to hyperkalaemia, which may be severe and lead to cardiac conduction abnormalities, dysarrythmias and cardiac arrest. |
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Myocardial infarction and cerebrovascular accidents may be due to severe falls in blood pressure in high-risk patients e.g. those with ischaemic heart disease or cerebrovascular disease. |
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In volume depleted patients or patients with ischaemic heart disease or cerebrovascular disease, therapy should be monitored especially when the dose of RAMPIL or diuretic is adjusted. |
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If hypotension occurs, the patient should be placed in the supine position and if necessary receive an intravenous infusion of 0,9% saline. |
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Increases in blood urea and serum creatinine have been seen in patients with no apparent pre-existing vascular disease, especially when RAMPIL has been given concomitantly with a diuretic. Dosage reduction or discontinuation of RAMPIL or the diuretic may be required. |
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Signs of facial or extremity swelling or difficulty in swallowing or breathing, requires immediate medical attention, because of the risk of angioedema. |
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Caution when driving or performing tasks requiring alertness because of possible dizziness. |
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In patients undergoing major surgery or during anaesthesia with agents that produce hypotension, RAMPIL may block angiotension II formation secondary to complementary rennin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion. |
RAMPIL 1,25 MG CAPSULE