Each tablet contains: Lisinopril dihydrate B.P. equivalent to 5mg , 10mg or 20mg anhydrous Lisinopril.
Lizo (Lisinopril) is an antihypertensive agent. It is an oral long-acting angiotensin converting enzyme (ACE)
inhibitor, it inhibits the enzyme that catalyses the conversion of angiotensin I to the vasoconstrictor
angiotensin II which results in decrease plasma angiotensin II which leads to decreased vasopressor activity
and to decrease aldosterone secretion. Lisinopril absorption is not affected by the presence of food in the
gastrointestinal tract, and following oral administration the peak serum concentration occurs within about 7
hrs. The effect of Lisinopril continues for at least 24 hrs after single daily dose. Lisinopril does not bind to
serum proteins other than to circulation angiotensin converting enzyme (ACE). It is excreted unchanged via
Lizo is indicated for :
- Treatment of essential hypertension and in renovascular hypertension. It may be used alone or
concomitantly with other antihypertensive agents.
- Management of congestive heart failure as an adjunctive treatment with diuretics and where appropriate
- Treatment of haemodynamically stable patients within 24 hrs of an acute myocardial infarction.
- Treatment of renal complications in normotensive insuline-dependent and hypertensive
non-insuline-dependent diabetes mellitus patients who have incipient nephropathy characterized by
albuminurea sience Lisinopril reduces urinary albumin excretion rate.
DOSAGE & ADMINISTRATION:
Lisinopril may be administered before, during or after meals in a single daily dose, approximately at the same
time each day.
- Essential Hypertension : The usual recommended starting dose is 10mg. The usual effective maintenance
dosage is 20mg as single daily dose.
( The maximum dose used in long – term controlled clinical trials is 80 mg / day ).
- Renovascular Hypertension : A starting dose of 2.5mg or 5mg is recommended. The dosage may be
adjusted according to the blood pressure response.
- Diuretic Treated patients : The diuretic should be discontinued 2 to 3 days before beginning therapy with
Lisinopril, in hypertensive patients in whom the diuretics can not be discontinued, therapy with Lisinopril
should be initiated with 5mg dose, the subsequent dosage of Lisinopril should be adjusted according to blood
pressure response, if required, diuretic therapy may be resumed.
- Congestive Heart Failure : As an adjunctive therapy with diuretic and where appropriate digitalis, the
starting dose is 2.5mg once a day. The usual effective dosage range is 5-20mg per day as single daily dose.
The effect of the starting dose of Lisinopril on blood pressure should be monitored carefully in patients at
high risk of symptomatic hypotension.
- Acute Myocardial Infarction : Treatment may be started within 24 hrs of the onset of symptoms by 5mg
orally, followed by 5mg after 24 hrs, 10mg after 48 hrs and then 10mg once daily. Dosing should continue
for 6 weeks. If hypotension occurs, a daily maintenance dose of 5mg may be given with temporary reduction
to 2.5mg if needed. If prolonged hypotension occurs, Lisinopril should be withdrawn.
- Renal complications of Diabetes Mellitus : In normotensive insuline-dependent diabetes mellitus patients,
the daily dose is 10mg Lisinopril once daily which can be increased to 20mg once daily, in hypertensive
non-insuline-dependent diabetes mellitus patients, the dose schedule is as above.
- Dosage Adjustment in renal impairment:
Dosage should be adjusted in renal impairment patients according to creatinine clearance as follow :
* The dosage and frequency of administration should be adjusted depending on the blood pressure response.
(Maximum dose is 40 mg daily).
RESTRICTIONS ON USE :
- Hypersensitivity to Lisinopril.
- Patients with a history of angioedema relating to previous treatment with an ACE inhibitors and in patients
with hereditary or idiopathic angioedema.
Caution should be exercised in these cases:
- Patients with aortic stenosis or hypertrophic cardiomyopathy.
- Patients of normal or high blood pressure with congestive heart failure or volume depleted patients ,
because symptomatic hypotension may occur.
- Patients with acute myocardial infarction with evidence of renal dysfunction or low systolic blood pressure,
should not initiate treatment with Lisinopril.
- Patients with a history of angioedema unrelated to ACE inhibitors therapy may be at increased risk of
angioedema while receiving ACE inhibitors.
- ACE inhibitors cause a higher rate of angioedema in black patients than in non-black patients.
- Haemodialysis patients treated concomitantly with ACE inhibitors and subjected to anaphylactoid
reaction should be using a different type of dialysis membrane or different class of antihypertensive agent.
Use in pregnancy and lactation
The use of Lisinopril during pregnancy is not recommended unless it is considered life-saving for the
mother. Caution should be exercised if Lisinopril is given to women who are breast feeding.
- When a diuretic is added to the therapy of patient receiving Lisinopril the antihypertensive effect is usually
- ACE inhibitors may potentiate hypoglycaemic effect of insuline and oral anti-diabetic drugs.
- Indomethacin may diminish the antihypertensive efficacy of concomitantly administered Lisinopril.
- In some patients with compromised renal function the co-administration of Lisinopril with non-steroidal
anti-inflammatory drugs (NSAIDs) may result in further deterioration in renal function.
- If Lisinopril given with a potassium-losing diuretic induced hypokalaemia may be ameliorate.
Lisinopril is generally well tolerated and its adverse effect is mild and transient in nature.
- The Most frequent side effects : dizziness, headache, diarrhoea, fatigue, cough and nausea.
- Less frequent side effects : orthostatic effects (including hypotension), rash and asthenia.
- Rarely frequent side effects : angioedema , palpitation, abdominal pain, urticaria, dry mouth
The symptoms of overdosage may include severe hypotension, electrolyte disturbance and renal failure.
After ingestion of an overdose, the patient should be kept under very close supervision. Therapeutic
measures depend on the nature and severity of the symptoms. Measures to prevent absorption and methods
to speed elimination should be employed. If severe hypotension occurs, the patient should be placed in the
shock position and an intravenous infusion of normal saline should be given rapidly. Treatment with
angiotensin II (if available) may be considered. Angiotensin converting enzyme inhibitors may be removed
from the circulation by haemodialysis. The use of high-flux polyacrylonitrile dialysis membranes should
be avoided. Serum electrolytes and creatinine should be monitored frequently.
STORAGE INSTRUCTIONS :
Store below 30°C in a dry place.
Lizo 5 mg : Pack of 30 tablets and hospital packs of different sizes.
Lizo 10mg : Pack of 30 tablets and hospital packs of different sizes.
Lizo 20mg : Pack of 30 tablets and hospital packs of different sizes.