Plot 1 Junaid Dosunmu Street,Central Business District, Alausa, P.0. Box 3560 Ikeja, Lagos, Nigeria.
Tel: + 234-1-774-1205
AstraZeneca, Silk Court, Silk Road Business Park, Park Road, Macclesfield, Cheshire SK10 2NA, UK.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablets (NRN: 04-0010): Lisinopril (as the dihydrate) 5 mg, 10 mg, 20 mg
Essential and renovascular hypertension. Congestive heart failure (CHF) as an adjunctive treatment with diuretics and, where appropriate, digitalis. Haemodynamically stable patients within 24 hours of an acute myocardial infarction (AMI). Renal complications of Diabetes Mellitus
Hypersensitivity to any component of this product. Angio-oedema associated with ACE inhibitors. Idiopathic or hereditary angio-oedema.
Symptomatic hypotension may occur, particularly in volume depleted patients and congestive heart failure. Caution in patients with ischaemic heart or cerebrovascular disease, aortic stenosis, hypertrophic cardiomyopathy, and those at risk of symptomatic hypotension and patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. Patients with a history of angio-oedema, or black hypertensive patients, may be at increased risk of angio-oedema with an ACE inhibitor.
Anaphylactoid reactions have been seen during desensitisation treatment and in patients undergoing certain haemodialysis procedures. Cough has been reported with ACE inhibitors. Renal impairment (usually reversible) may occur in some CHF patients who experience hypotension on starting Zestril. ACE inhibitors may potentiate the hypoglycaemic effect of insulin and oral antidiabetic drugs.
Hypotension may occur during surgery/anaesthesia. Use in pregnancy not recommended. Discontinue as soon as possible unless considered life-saving for the mother. Caution in women who are breast feeding. No paediatric experience.
The antihypertensive effect of Zestril and diuretics (and other antihypertensives) is usually additive. Symptomatic hypotension can be minimised by discontinuing diuretic prior to Zestril. Caution in the concomitant use of potassium sparing diuretics, potassium containing salt substitutes, indomethacin (and other NSAIDs in patients with compromised renal function) and lithium.
Mostly mild and transient: dizziness, headache, diarrhoea, fatigue, cough, nausea, rash, orthostatic effects, asthenia. Angioneurotic oedema also rarely reported; discontinue Zestril promptly.
Side effects which have been reported rarely include myocardial infarction or cerebrovascular accident possibly secondary to excessive hypotension in high risk patients, palpitations, tachycardia, abdominal pain and indigestion, dry mouth, hepatitis, jaundice, pancreatitis, vomiting, mood alterations, mental confusion, paraesthesia, vertigo, taste disturbance, sleep disturbance, alopecia, pruritus, urticaria.
Bronchospasm, rhinitis, sinusitis, diaphoresis, uraemia, oliguria/anuria, renal dysfunction, acute renal failure, impotence, a symptom complex which may include one or more of: fever, vasculitis, myalgia, arthralgia/arthritis, positive ANA, elevated ESR, eosinophilia, leucocytosis, rash, photosensitivity or other dermatological manifestations. Psoriasis and severe skin disorders have been reported including pemphigus toxic epidermal neurolysis, Stevens-Johnson Syndrome and erythema multiforme.
Increases (usually reversible) in blood urea, serum creatinine, liver enzymes and serum bilirubin. Rarely, haemolytic anaemia has been reported. Small decreases in haemoglobin and haematocrit have occurred. Bone marrow depression, manifest as anaemia, and/or leucopenia and/or thrombocytopenia. Agranulocytosis has rarely been reported, casual relationship has not been established. Hyperkalaemia. Hyponatraemia.
Dosage & Administration
Hypertension: Usual maintenance dose:- 20 mg once daily. If possible discontinue prior diuretic therapy. 10 mg once daily can be used as a starting dose. Lower starting dose required in patients with renal impairment, renovascular hypertension, volume or salt depleted patients, when diuretics cannot be discontinued and some elderly patients. Adjust dosage according to blood pressure. Maximum 80 mg/day.
CHF: 5 to 20 mg once daily. Starting dose 2.5 mg once daily. (Adjust according to response).
AMI: First dose of 5 mg followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg once daily thereafter.
Complications of Diabetes Mellitus: 10 to 20 mg once daily
Overdosage: There are no data on overdosage in humans. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution. Lisinopril may be removed from general circulation by haemodialysis.
Store at room temperature.