Triplixam Special Precautions

Not suitable for initial therapy.
Dual blockade of RAAS: ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Neutropenia/agranulocytosis/thrombocytopenia/anaemia: Caution if collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or combination of these complicating factors, especially if pre-existing impaired renal function. Monitoring of white blood cell counts.
Renovascular hypertension: Increased risk of hypotension and renal insufficiency in patient with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Diuretics may be a contributory factor. Loss of renal function may occur (minor changes in serum creatinine) even in patients with unilateral renal artery stenosis.
Hypersensitivity/angioedema,intestinal angioedema: Stop treatment and monitor until complete resolution of symptoms. Angioedema associated with laryngeal oedema may be fatal. Combination with sacubitril/valsartan (contraindicated due to the increased risk of angioedema). Sacubitril/valsartan must not be initiated until 36 hours after taking the last dose of perindopril therapy. Perindopril therapy must not be started until 36 hours after the last dose of sacubitril/valsartan. Concomitant use of ACE inhibitors with NEP inhibitors (e.g. racecadotril), mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus) and gliptins (e.g. linagliptin, saxagliptin, sitagliptin, vildagliptin) may lead to an increased risk of angioedema (e.g. swelling of the airways or tongue, with or without respiratory impairment). Caution should be used when starting racecadotril, mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus) and gliptins (e.g. linagliptin, saxagliptin, sitagliptin, vildagliptin) in a patient already taking an ACE inhibitor.
Anaphylactoid reactions during desensitization: Caution in allergic patients treated with desensitization and avoid if venom immunotherapy. Temporarily withdrawal of ACE-inhibitor at least 24 hours before desensitization.
Anaphylactoid reactions during LDL apheresis: Temporarily withholding ACE-inhibitor prior to each apheresis.
Haemodialysis patients: Consideration to use dialysis membranes other than high flux or antihypertensive agents other than ACE inhibitors.
Primary aldosteronism: Use not recommended in patients with primary hyperaldosteronism (not responding to drugs acting through inhibition of the renin-angiotensin system).
Hepatic encephalopathy which can progress to hepatic coma: Stop treatment.
Photosensitivity: Stop treatment.
Hypotension and water and sodium depletion: Risk of sudden hypotension in presence of pre-existing sodium depletion (in particular if renal artery stenosis): Monitoring of plasma electrolytes, re-establish blood volume and pressure, restart treatment at a reduced dose or with only one of the constituents.
Sodium levels: More frequent monitoring in elderly and cirrhotic patients.
Potassium levels: Hyperkalaemia: Monitoring of serum potassium if renal insufficiency, worsening of renal function, age (> 70 years), diabetes mellitus, intercurrent events, in particular dehydration, acute cardiac decompensation, metabolic acidosis and concomitant use of potassium-sparing diuretics, potassium supplements or potassium salts, or other drugs associated with increases in serum potassium and especially aldosterone antagonists or angiotensin-receptor blockers.
Hypokalaemia: High risk for elderly and/or malnourished subjects, cirrhotic patients with oedema and ascites, coronary patients, patients with renal failure or heart failure, long QT interval: Monitoring of serum potassium, may cause muscle disorders and rhabdomyolysis, may favor the onset of Torsades de pointes, which may be fatal: Associated with hypomagnesaemia can be refractory to treatment unless serum magnesium is corrected.
Calcium levels: Hypercalcemia: Stop treatment before investigating the parathyroid function.
Renovascular hypertension: If renal artery stenosis: Start treatment at hospital at low dose; monitor renal function and potassium.
Dry cough.
Atherosclerosis: Start treatment at low dose in patients with ischaemic heart disease or cerebral circulatory insufficiency.
Hypertensive crisis.
Cardiac failure/severe cardiac insufficiency: Caution if heart failure. Severe cardiac insufficiency (grade IV): Start treatment under medical supervision with reduced initial dose.
Aortic or mitral valve stenosis/hypertrophic cardiomyopathy: Caution if obstruction in the outflow tract of the left ventricle.
Diabetic patients: If insulin dependent diabetes mellitus, start treatment under medical supervision with reduced initial dose; monitor blood glucose during the first month and/or in the case of hypokalaemia.
Black people: Higher incidence of angioedema and apparently less effective in lowering blood pressure than in non-blacks.
Surgery/anaesthesia: Stop treatment one day before surgery.
Uric acid: Hyperuricemia: Increased tendency to gout attacks.
Excipients: Sodium-free.
Choroidal effusion, acute myopia and secondary angle-closure glaucoma: Discontinue drug intake as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.
Athletes: May cause positive doping test.
Hepatic impairment: Mild to moderate: Caution. Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. Stop treatment if jaundice or marked elevations of hepatic enzymes.
Renal function: In certain hypertensive patients without pre-existing apparent renal lesions and for whom renal blood tests show renal insufficiency, stop treatment and restart at a low dose or with one constituent only. Monitoring of potassium and creatinine, after two weeks of treatment and then every two months during therapeutic stability period. If bilateral renal artery stenosis or single functioning kidney: not recommended. Risk of arterial hypotension and/or renal insufficiency (in cases of cardiac insufficiency, water and electrolyte depletion, in patients with low blood pressure, renal artery stenosis, congestive heart failure or cirrhosis with oedema and ascites): start treatment at low doses and increase progressively.
Use in Pregnancy: No initiation during pregnancy, stop treatment and start alternative therapy if appropriate.
Use in Children: Should not be used.
Use in the Elderly: Testing of renal function and potassium levels before treatment start. Dosage increase with care.