Tritace

/ Sanofi

Hypertension, CCF and reduction of mortality after M.I.: Initial (for patient not on diuretics): 2.5 mg 1 x daily. May increase at intervals of 2-3 weeks up to 5 mg 1 x daily to maximum of 10 mg 1 x daily.
Reducing risk of M.I., stroke or cardiovascular death and/or the need for revascularization procedures: Initial: 2.5 mg 1 x daily. Depending on tolerability, dose should be gradually increased to double after about 1 week of treatment; then, after a further 3 weeks, increase to 10 mg. Maintenance dose: 10 mg 1 x daily. Patients already stabilized on lower doses for other indications where possible should be titrated to 10 mg 1 x daily.
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Hypertension congestive heart failure reduction of mortality in patients after MI with left ventricular dysfunction For reducing the risk of myocardial infarction stoke cardiovascular death or need for revascularization procedures in patients over 55 years or more who have clinical evidence of cardiovascular disease (previous MI unstable angina or multivessel CABG or multivessel PTCA) stroke or peripheral vascular disease. Also for reducing the risk of myocardial infarction stroke cardiovascular death or need for revascularization procedures in diabetic patients of 55 years or more who have one or more of the following clinical findings : hypertension (systolic blood pressure > 160 mmHg or diastolic pressure > 90 mmHg) high total cholesterol (>5.2 mmol/L) low HDL ( <0.9 mmol/L) current smoker known microalbuminuria clinical evidence of previous vascular disease. Prevention of progressive renal failure in patients with persistent  proteinuria in excess of 1g/day.

Hypersensitivity to the active substance, to any of the excipients or any other  (Angiotensin Converting Enzyme) inhibitors. History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors. Extracorporeal treatments leading to contact of blood with negatively charged surfaces.
Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney. The drug is contraindicated during 2nd and 3rdtrimester of pregnancy. Must not be used in patients with hypotensive or haemodynamically unstable states.
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Concomitant use of the drug with antihypertensive  agents may lead to  potentiation of the risk of hypotension Concomitant treatment of ACE inhibitors and NSAIDs may lead to an increased risk of worsening of renal function and to an increase in kalaemia. Hypoglycaemic reactions may occur due to concominant use of antidiabetic agents with ramipril, Blood glucose monitoring is recommended. 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. If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with ramipril.
In hypertensive patients in whom the diuretic is not discontinued, therapy with ramipril should be initiated with a 1.25 mg dose. Renal function and serum potassium should be monitored. The subsequent dosage of ramipril should be adjusted according to blood pressure target.
Hepatic impairment: In patients with hepatic impairment, treatment with the drug  must be initiated only under close medical supervision and the maximum daily dose.
Renal impairment: Daily dose in patients with renal impairment should be based on creatinine clearance.
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Hyperkalaemia, Headache, dizziness Nonproductive tickling cough, bronchitis, sinusitis, dyspnoea, Gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia, diarrhoea, nausea, vomiting, Rash, Blood potassium increased, Hypotension, orthostatic blood pressure decreased, syncope, Chest pain, fatigue.
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Potassium salts, heparin, potassium-retaining diuretics and other plasma potassium increasing active substances (including Angiotensin II antagonists, trimethoprim, tacrolimus, ciclosporin): Hyperkalaemia may occur, therefore close monitoring of serum potassium is required.
Antihypertensive agents (e.g. diuretics) and other substances that may decrease blood pressure (e.g.nitrates, tricyclic antidepressants, anaesthetics, acute alcohol intake, baclofen, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin): Potentiation of the risk of hypotension is to be anticipated.
Vasopressor sympathomimetics and other substances (e.g. isoproterenol, dobutamine, dopamine, epinephrine) that may reduce the antihypertensive effect of ramipril: Blood pressure monitoring is recommended.
Lithium salts: Excretion of lithium may be reduced by ACE inhibitors and therefore lithium toxicity may be increased. Lithium level must be monitored.
Antidiabetic agents including insulin: Hypoglycaemic reactions may occur. Blood glucose monitoring is recommended.
Non-steroidal anti-inflammatory drugs and acetylsalicylic acid: Reduction of the antihypertensive effect of TRITACE is to be anticipated.
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Pregnancy: ACE inhibitors should not be initiated during pregnancy When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
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Lactation: the drug  is not recommended due to insufficient information. See prescribing information for full details. Safety and efficacy has not been proved in patients under 18 years old.

Symptoms: Symptoms associated with overdosage of ACE inhibitors may include excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure.
Management: The patient should be closely monitored and the treatment should be symptomatic and supportive.
Suggested measures include primary detoxification (gastric lavage, administration of adsorbents) and measures to restore haemodynamic stability, including, administration of alpha 1 adrenergic agonists or angiotensin II (angiotensinamide) administration. Ramiprilat, the active metabolite of ramipril is poorly removed from the general circulation by haemodialysis.