Lisinopril Stada

Lisinopril Stada Special Precautions





DCH Auriga
Full Prescribing Info
Special Precautions
It is recommended to initiate lisinopril-therapy under hospital conditions for patients: Undergoing a combined and highly dosed therapy with diuretics (eg. more than 80mg furosemide); with fluid or salt deficit (hypovolemia or hyponatremia: serum sodium less than 130mmol/l); with pre-existing hypotension; with instable cardiac insufficiency; with reduced kidney function; undergoing highly dosed therapy with vasodilators; 70 years or older.
Especially at the initiation of therapy and in high-risk patients (patients with renal insufficiency; with collagen disease) and when immunosuppressives, cytostatics, allopurinol and procainamide are used concomitantly the serum electrolytes and serum creatinine concentrations and the blood count should be checked.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS): There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see Interactions).
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Hypotension: Lisinopril STADA may, especially after the first administration, cause a severe drop of blood pressure. A symptomatic hypotension is rarely seen in patients with uncomplicated hypertension. It is more often seen in patients with an electrolyte or fluid deficit on treatment with diuretics, on a low salt diet, after vomiting or diarrhea or after dialysis and was reported mainly in patients with severe heart failure, with or without resulting renal insufficiency as well as in patients, undergoing treatment with high doses of loop diuretics and patients with sodium depletion (hyponatremia) or reduced kidney function. Therapy with Lisinopril STADA for these patients must be initiated under close medical supervision, preferably under hospital conditions with low doses and careful dosage adjustment. Simultaneously kidney function and the serum potassium level must be monitored. If possible, the treatment with diuretics should be discontinued.
This also applies to patients with angina pectoris or cerebrovascular angiopathy, for which an excessive drop of blood pressure may lead to a heart attack or to a stroke.
If hypotension occurs the patient should be placed in a lying position and possibly given liquids orally or intravenously (volume substitution). For the treatment of associated bradycardia the administration of atropine may be necessary. After a successful treatment of the initial dose caused hypotension, there is no need to abandon a further careful dose adjustment with this medication. Should a non-acute hypotension in patients with heart failure become symptomatic it may become necessary to reduce the dosage and/or discontinue the treatment with the diuretic and/or lisinopril. If possible, the treatment with diuretics should be discontinued 2-3 days prior to the start of therapy with lisinopril.
Hypotension with acute myocardial infarction: Treatment with lisinopril must not be started in patients with acute myocardial infarction, if, because of a prior treatment with a vasodilator, there is a risk of further serious haemodynamic deterioration. This applies to patients with a systolic blood pressure of 100mmHg or less or with cardiogenic shock. The maintenance dose should be reduced to 5mg or temporarily to 2.5mg, if the systolic blood pressure is 100mmHg or lower. Therapy with lisinopril can lead to a severe hypotension in patients with acute myocardial infarction. If the hypotension persists (systolic blood pressure below 90mmHg for more than 1 hour) treatment with lisinopril must be discontinued.
Patients with severe cardiac insufficiency after an acute myocardial infarction should receive lisinopril only, if these patients are haemodynamically stable.
Renovascular hypertension/renal artery stenosis: For patients with renovascular hypertension and existing renal artery stenosis, on either side or one side (single kidney) there is a higher risk for a severe hypotension and renal insufficiency through the use of lisinopril. A therapy with diuretics can add to the risk. Renal failure can be accompanied by only a slight change of the serum creatinine values, even in patients with one sided renal artery stenosis. Therapy of such patients must, therefore, be medically closely monitored in a hospital and initiated with a low dose and dosage carefully increased stepwise. Therapy with diuretics should be discontinued and the kidney function closely monitored during the first week of therapy.
Renal insufficiency: Patients with severe renal insufficiency (creatinine clearance <30ml/min) and dialysis patients must not use lisinopril. Lisinopril should be administered carefully to patients with reduced renal function. For these patients a reduced dose or a prolonged dosing interval may be necessary.
A connection between lisinopril therapy and renal failure has been reported mainly in patients with severely reduced cardiac performance or existing renal dysfunction (including renal artery stenosis). If diagnosed in time and treated correctly, renal failure through lisinopril treatment is usually reversible.
In some hypertensive patients that had no apparent renal impairment, increases in blood urea and creatinine levels were observed when treated with lisinopril and diuretics at the same time. A dose reduction of the ACE inhibitor or discontinuation of the diuretic may be necessary and an undiagnosed renal arterial stenosis should be considered.
Acute myocardial infarction treatment with lisinopril must not be initiated in patients with signs of renal dysfunction, defined as a serum creatinine concentration over 117μmol/l (2.0mg/dl) or above and/or proteinuria with more than 500mg per day. If renal dysfunction develops during treatment with Lisinopril STADA (serum creatinine clearance <30ml/min, or a doubling of the serum creatinine level measured before treatment) lisinopril must be discontinued.
Haemodialysis: For patients on continued haemodialysis lisinopril is contraindicated.
In concomitant use of lisinopril and poly(acrylonitrile, sodium-2-methylallysulfo-nate)-high-flux-membrane (eg. AN 69) in dialysis or haemofiltration there is a risk of a hypersensitivity reaction (anaphylactoid reaction) up to shock. First signs of this anaphylaxis are facial swelling, flush, hypotension and dyspnea. The symptoms usually appear within a few minutes after starting haemodialysis. It is advisable, therefore, to use a different dialysis membrane or a different medicine for the treatment of the high blood pressure or reduced cardiac performance.
Increased serum potassium level (hyperkalemia): Especially for patients with pre-existing reduced kidney or heart function treatment with lisinopril could lead to an increased potassium level (hyperkalemia). Treatment with potassium sparing diuretics or potassium preparations as supplementary therapy is not advisable, since this could lead to a significant increase of the serum potassium level. However, should concomitant treatment with the previously mentioned preparation seem indicated, the serum potassium level should be monitored regularly during therapy.
Primary hyperaldosteronism: Patients suffering from primary hyperaldosteronism usually do not respond to antihypertensives, which efficacy is based on the inhibition of the renin-angiotensin-system. Therefore, the use of lisinopril is not advisable.
Proteinuria: There have been rare cases of patients, especially with reduced kidney functions or after the administration of fairly high doses of lisinopril, developing proteinuria. With clinically relevant proteinuria (more than 1g/day) Lisinopril STADA should be used only after critically weighing expected benefits against potential risks and with regular monitoring of the clinical and laboratory parameters.
LDL lipid apheresis/Desensitisation: During a LDL (low-density lipoprotein) apheresis with dextran sulfate, concomitant use of an ACE inhibitor can lead to life-threatening anaphylactic reactions. Life-threatening anaphylactic reactions (eg. drop of blood pressure, dyspnea, vomiting, allergic skin reactions) can also appear if lisinopril is administered during a desensitisation therapy against insect stings (eg. bees/wasps).
Should a LDL apheresis or a desensitisation therapy against insect stings become necessary, lisinopril should be temporarily replaced by a different medicine (but no ACE inhibitor) against hypertension or myocardial insufficiency.
Tissue swelling/angioneurotic oedema: There have been rare reports of tissue swelling of the face, the extremities, the lips, the tongue, the glottis and/or the larynx in patients treated with ACE inhibitors, including lisinopril. They can appear at any time during therapy. In such cases treatment with Lisinopril STADA must be discontinued immediately, and suitable monitoring of the patient should be instituted.
In cases where the swelling is limited to the face and lips the condition usually clears up without treatment, although antihistamines are beneficial in relieving the symptoms.
Patients with an anamnestically known angioneurotic oedema not associated with ACE inhibitor treatment could be at a higher risk of developing an angioneurotic oedema during ACE inhibitor treatment.
Angioneurotic oedema involving the tongue, glottis or larynx can be life threatening. Emergency treatment including an immediate subcutaneous administration of 0.3-0.5 mg epinephrine or a slow intravenous administration of 0.1 mg epinephrine (please follow dilution instruction) should be initiated with ECG and blood pressure monitoring. The patients must be hospitalized. A suitable monitoring for at least 12 to 24 hours must follow, to ensure that all symptoms have regressed completely before releasing the patient.
Aortic stenosis/hypertrophic myocardiopathy: ACE inhibitors should be used with caution in patients with an obstruction in the left-ventricular emission tract. Should the obstruction be haemodynamically relevant lisinopril is contraindicated.
Neutropenia/agranulocytosis: Rare cases of hypertensive patients with neutropenia or agranulocytosis were observed during treatment with ACE inhibitors. This occurred rarely in patients with an uncomplicated course of hypertension, but more often in patients with impaired renal function, especially if they also suffered from a disorder of the vascular or connective tissue system (eg. systemic lupus erythematosus or dermatosclerosis) or under concurrent immunosuppressive therapy. For these patients the white blood count must be controlled regularly. Neutropenia and agranulocytosis are reversible after discontinuation of the ACE inhibitor.
Should fever, swelling of the lymphatic glands and/or sore throat occur during therapy with Lisinopril STADA, the white blood count should be checked immediately.
Operation/anaesthesia: Lisinopril blocks the formation of angiotensin II as a consequence of the compensating secretion of renin in patients, who undergo a major operation or are anaesthetised with substances that lower the blood pressure. The resulting increased lowering of the blood pressure can be corrected by volume expansion.
Effects on ability to drive and use machines: Studies on the effect of this medication on the ability to drive a car are not available. It should, however, be taken into consideration that the ability to drive a car, to use machines or to work without a firm support can be effected through the sometimes occurring dizziness and fatigue.
Use in Children: The efficacy and safety of lisinopril in children has not been sufficiently documented, therefore, the treatment of children is not advised.
Use in the Elderly: The response to ACE inhibitors of elderly patients is possibly better than that of younger patients. Elderly patients should therefore, be treated cautiously. For patients 65 years or older initial dose of daily 2.5mg lisinopril as well as monitoring of blood pressure and kidney function is advised.
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