LISINOPRIL

Lisinopril should be administered orally in a single daily dose. As with all other medication taken once daily, Lisinopril should be taken at approximately the same time each day. The absorption of Lisinopril is not affected by food.

4). If low doses are required, the 1 mg/ml strength product is the more suitable presentation. If high doses are required, the 4 mg/ml strength product is the more suitable presentation. 1). Starting dose In patients with hypertension the usual recommended starting dose is 10 mg.

Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and /or volume depletion, cardiac decompensation, or severe hypertension) may experience an excessive blood pressure fall following the initial dose.

5-5 mg is recommended in such patients and the initiation of treatment should take place under medical supervision. A lower starting dose is required in the presence of renal impairment (see Table 1 below). Maintenance dose The usual effective maintenance dosage is 20 mg administered in a single daily dose.

In general, if the desired therapeutic effect cannot be achieved in a period of 2 to 4 weeks on a certain dose level, the dose can be further increased. The maximum dose used in long-term, controlled clinical trials was 80 mg/day. Diuretic-treated patients Symptomatic hypotension may occur following initiation of therapy with Lisinopril.

This is more likely in patients who are being treated currently with diuretics. Caution is recommended therefore, 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 Lisinopril.

In hypertensive patients in whom the diuretic cannot be discontinued, therapy with Lisinopril should be initiated with a 5 mg dose. Renal function and serum potassium should be monitored. The subsequent dosage of Lisinopril should be adjusted according to blood pressure response.

5). Dosage adjustment in renal impairment Dosage in patients with renal impairment should be based on creatinine clearance as outlined in Table 1 below. 5-5 mg 31-80 ml/min 5-10 mg * Dosage and/or frequency of administration should be adjusted depending on the blood pressure response.

The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily. 5 mg once daily in patients 20 to <50 kg, and 5 mg once daily in patients ≥50 kg. The dosage should be individually adjusted to a maximum of 20 mg daily in patients weighing 20 to <50 kg, and 40 mg in patients ≥50 kg.

1). In children with decreased renal function, a lower starting dose or increased dosing interval should be considered. Heart failure In patients with symptomatic heart failure, Lisinopril should be used as adjunctive therapy to diuretics and, where appropriate, digitalis or beta-blockers.

5 mg once a day, which should be administered under medical supervision to determine the initial effect on the blood pressure. The dose of Lisinopril should be increased: • By increments of no greater than 10 mg • At intervals of no less than 2 weeks • To the highest dose tolerated by the patient up to a maximum of 35 mg once daily.

Dose adjustment should be based on the clinical response of individual patients. g. patients with salt depletion with or without hyponatraemia, patients with hypovolaemia or patients who have been receiving vigorous diuretic therapy should have these conditions corrected, if possible, prior to therapy with Lisinopril.

4). Posology in Acute myocardial infarction Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin, and beta-blockers. Intravenous or transdermal glyceryl trinitrate may be used together with Lisinopril.

Starting dose (first 3 days after infarction) Treatment with Lisinopril may be started within 24 hours of the onset of symptoms. Treatment should not be started if systolic blood pressure is lower than 100 mm Hg. The first dose of Lisinopril is 5 mg given orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg once daily.

4). In cases of renal impairment (creatinine clearance <80 ml/min), the initial Lisinopril dosage should be adjusted according to the patient's creatinine clearance (see Table 1). Maintenance dose The maintenance dose is 10 mg once daily.

5 mg if needed. If prolonged hypotension occurs (systolic blood pressure less than 90 mm Hg for more than 1 hour) Lisinopril should be withdrawn. Treatment should continue for 6 weeks and then the patient should be re-evaluated. 2). Renal complications of diabetes […]

The following undesirable effects have been observed and reported during treatment with Lisinopril and other ACE inhibitors with the following frequencies: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).

4), haemolytic anaemia, lymphadenopathy, autoimmune disease. Immune system disorders not known anaphylactic/anaphylactoid reaction Metabolism and nutrition disorders very rare: hypoglycaemia. Nervous system and psychiatric disorders common: dizziness, headache uncommon: mood alterations, paraesthesia, vertigo, taste disturbance, sleep disturbances, hallucinations.

rare: mental confusion, olfactory disturbance frequency not known: depressive symptoms, syncope. 4), palpitations, tachycardia, Raynaud's phenomenon. Respiratory, thoracic and mediastinal disorders common: cough uncommon: rhinitis very rare: bronchospasm, sinusitis, allergic alveolitis/eosinophilic pneumonia.

4). 4) very rare: sweating, pemphigus, toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, cutaneous pseudolymphoma. A symptom complex has been reported which may include one or more of the following: fever, vasculitis, myalgia, arthralgia/arthritis, positive antinuclear antibodies (ANA), elevated red blood cell sedimentation rate (ESR), eosinophilia and leucocytosis, rash, photosensitivity or other dermatological manifestations may occur.

Renal and urinary disorders common: renal dysfunction rare: uraemia, acute renal failure very rare: oliguria/anuria. Endocrine disorders rare: syndrome of inappropriate antidiuretic hormone secretion (SIADH). Reproductive system and breast disorders uncommon: impotence rare: gynaecomastia.

General disorders and administration site conditions uncommon: fatigue, asthenia. Investigations uncommon: increases in blood urea, increases in serum creatinine, increases in liver enzymes, hyperkalaemia rare: increases in serum bilirubin, hyponatraemia.

Safety data from clinical studies suggest that lisinopril is generally well tolerated in hypertensive paediatric patients, and that the safety profile in this age group is comparable to that seen in adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Symptomatic hypotension Symptomatic hypotension is seen rarely in uncomplicated hypertensive patients. g. 8). In patients with heart failure, with or without associated renal insufficiency, symptomatic hypotension has been observed. This is most likely to occur in those patients with more severe degrees of heart failure, as reflected by the use of high doses of loop diuretics, hyponatraemia or functional renal impairment.

In patients at increased risk of symptomatic hypotension, initiation of therapy and dose adjustment should be closely monitored. Similar considerations apply to patients with ischaemic heart or cerebrovascular disease in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident.

If hypotension occurs, the patient should be placed in the supine position and, if necessary, should receive an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further doses, which can be given usually without difficulty once the blood pressure has increased after volume expansion.

In some patients with heart failure who have normal or low blood pressure, additional lowering of systemic blood pressure may occur with Lisinopril. This effect is anticipated and is not usually a reason to discontinue treatment. If hypotension becomes symptomatic, a reduction of dose or discontinuation of Lisinopril may be necessary.

Hypotension in acute myocardial infarction Treatment with Lisinopril must not be initiated in acute myocardial infarction patients who are at risk of further serious haemodynamic deterioration after treatment with a vasodilator. These are patients with systolic blood pressure of 100 mm Hg or lower, or those in cardiogenic shock.

During the first 3 days following the infarction, the dose should be reduced if the systolic blood pressure is 120 mm Hg or lower. 5 mg if systolic blood pressure is 100 mm Hg or lower. If hypotension persists (systolic blood pressure less than 90 mm Hg for more than 1 hour) then Lisinopril should be withdrawn.

Aortic and mitral valve stenosis / hypertrophic cardiomyopathy As with other ACE inhibitors, Lisinopril should be given with caution to patients with mitral valve stenosis and obstruction in the outflow of the left ventricle such as aortic stenosis or hypertrophic cardiomyopathy.

2), and then as a function of the patient's response to treatment. Routine monitoring of potassium and creatinine is part of normal medical practice for these patients. In patients with heart failure, hypotension following the initiation of therapy with ACE inhibitors may lead to some further impairment in renal function.

Acute renal failure, usually reversible, has been reported in this situation. In some patients with bilateral renal artery stenosis or with a stenosis of the artery to a solitary kidney, who have been treated with angiotensin-converting enzyme inhibitors, increases in blood urea and serum creatinine, usually reversible upon discontinuation of therapy, have been seen.

This is especially likely in patients with renal insufficiency. If renovascular hypertension is also present there is an increased risk of severe hypotension and renal insufficiency. In these patients, treatment should be started under close medical supervision with low doses and careful dose titration.

Since treatment with diuretics may be a contributory factor to the above, they should be discontinued and renal function should be monitored during the first weeks of Lisinopril therapy. Some hypertensive patients with no apparent pre-existing renal vascular disease have developed increases in blood urea and serum creatinine, usually minor and transient, especially when Lisinopril has been given concomitantly with a diuretic.

This is more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of the diuretic and/or Lisinopril may be required. In acute myocardial infarction, treatment with Lisinopril should not be initiated in patients with evidence of renal dysfunction, defined as serum creatinine concentration exceeding 177 micromol/l and/or proteinuria exceeding 500 mg/24 h.

If renal dysfunction develops during treatment with Lisinopril (serum creatinine concentration exceeding 265 micromol/l or a doubling from the pre-treatment value) then the physician should consider withdrawal of Lisinopril. Hypersensitivity/Angioedema Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported rarely in patients treated with angiotensin-converting enzyme inhibitors, including Lisinopril.

This may occur at any time during therapy. In such cases, Lisinopril should be discontinued promptly and appropriate treatment and monitoring should be instituted to ensure complete resolution of symptoms prior to dismissing the patients.

Even in those instances where swelling of only the tongue is involved, without respiratory distress, patients may require prolonged observation since treatment with antihistamines and corticosteroids may not be sufficient. Very rarely, fatalities have been reported due to angioedema associated with laryngeal oedema or tongue oedema.

Patients with involvement of the tongue, glottis or larynx, are likely to experience airway obstruction, especially those with a history of airway surgery. In such cases emergency therapy should be administered promptly. This may include […]

1 or any other angiotensin converting enzyme (ACE) inhibitor. • History of angioedema associated with previous ACE inhibitor therapy. • Concomitant use of Lisinopril with sacubitril/valsartan therapy. 5). • Hereditary or idiopathic angioedema.

6). 1).