📌 COMPOSITION

Each tablet contains: Lisinopril dihydrate B.P. equivalent to 5 mg, 10 mg or 20 mg 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 decreased plasma angiotensin II, leading to decreased vasopressor activity and decreased 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 hours. The effect of Lisinopril continues for at least 24 hours after a single daily dose. Lisinopril does not bind to serum proteins other than to circulating ACE. It is excreted unchanged via the kidneys.

📌 INDICATIONS

Lizo is indicated for:

• Treatment of essential hypertension and 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 hours of an acute myocardial infarction.
• Treatment of renal complications in normotensive insulin‑dependent and hypertensive non‑insulin‑dependent diabetes mellitus patients who have incipient nephropathy characterised by albuminuria, since 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 10 mg. The usual effective maintenance dosage is 20 mg as a single daily dose (the maximum dose used in long‑term controlled clinical trials is 80 mg/day).
• Renovascular Hypertension: A starting dose of 2.5 mg or 5 mg 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 diuretic cannot be discontinued, therapy with Lisinopril should be initiated with a 5 mg dose. The subsequent dosage should be adjusted according to blood pressure response; if required, diuretic therapy may be resumed.
• Congestive Heart Failure: As adjunctive therapy with diuretics and, where appropriate, digitalis, the starting dose is 2.5 mg once a day. The usual effective dosage range is 5-20 mg/day as a single daily dose. The effect of the starting dose on blood pressure should be monitored carefully in patients at high risk of symptomatic hypotension.
• Acute Myocardial Infarction: Treatment may be started within 24 hours of the onset of symptoms with 5 mg orally, followed by 5 mg after 24 hours, 10 mg after 48 hours, and then 10 mg once daily. Dosing should continue for 6 weeks. If hypotension occurs, a daily maintenance dose of 5 mg may be given, with temporary reduction to 2.5 mg if needed. If prolonged hypotension occurs, Lisinopril should be withdrawn.
• Renal Complications of Diabetes Mellitus: In normotensive insulin‑dependent diabetes mellitus patients, the daily dose is 10 mg once daily, which can be increased to 20 mg once daily. In hypertensive non‑insulin‑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 follows:

* 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 inhibitor, and in patients with hereditary or idiopathic angioedema.

Precautions

Caution should be exercised in these cases:

• Patients with aortic stenosis or hypertrophic cardiomyopathy.
• Patients with 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 inhibitor 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 who have experienced anaphylactoid reactions should use a different type of dialysis membrane or a 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 breastfeeding.

📌 DRUG INTERACTIONS

• When a diuretic is added to the therapy of a patient receiving Lisinopril, the antihypertensive effect is usually additive.
• ACE inhibitors may potentiate the hypoglycaemic effect of insulin and oral antidiabetic drugs.
• Indomethacin may diminish the antihypertensive efficacy of concomitantly administered Lisinopril.
• In some patients with compromised renal function, co‑administration of Lisinopril with NSAIDs may result in further deterioration of renal function.
• If Lisinopril is given with a potassium‑losing diuretic, induced hypokalaemia may be ameliorated.

📌 ADVERSE EFFECTS

Lisinopril is generally well tolerated and its adverse effects are 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.
• Rare 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. ACE 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.

📌 PHARMACEUTICAL FORMS

• Lizo 5 mg: Pack of 30 tablets and hospital packs of different sizes.
• Lizo 10 mg: Pack of 30 tablets and hospital packs of different sizes.
• Lizo 20 mg: Pack of 30 tablets and hospital packs of different sizes.