COMPOSITION :

Each tablet contains: Lisinopril dihydrate B.P. equivalent to 5mg , 10mg or 20mg anhydrous Lisinopril.

DESCRIPTION :

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

the kidneys.

INDICATIONS :

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

digitalis.

- 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 :

Contraindications

- 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.

Precautions

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.

DRUG INTERACTIONS:

- When a diuretic is added to the therapy of patient receiving Lisinopril the antihypertensive effect is usually

additive.

- 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.

ADVERSE EFFECTS:

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

and impotence.

OVERDOSAGE :

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.

PRESENTATIONS :

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.