Lace (lisinopril, USP) a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme (ACE) inhibitor, inhibits ACE, resulting in decreased plasma angiotensin II and decreased aldosterone excretion, the consequence of which is a reduction of blood pressure in hypertensive patients and improvement in the signs and symptoms of congestive heart failure.

PRESENTATION:
Lace 5 : Pack of 2 x 10’s tablets.
Lace 10 : Pack of 2 x 10’s tablets.

COMPOSITION:
Lace 5 mg :
Each tablet contains lisinopril dihydrate USP equivalent to lisinopril anhydrous.

Lace 10 mg:
Each tablet contains lisinopril dihydrate USP equivalent to lisinopril anhydrous .

INDICATION:
Lace is indicated in the treatment of essential hypertension and in renovascular hypertension. Lace is indicated in the management of heart failure as adjunctive treatment with diuretics and where appropriate, digitalis. Lace is indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to prevent the subsequent development of left ventricular dysfunction or heart failure and improve survival.

Dosage and Administration:
Since absorption of tablet Lace is not affected by food, the tablets may be administered before, during or after meals. Lace should be administered in a single daily dose. As with all single dailydose medications, Lace should be taken at approximately the same time each day.

Essential Hypertension:
In patients with essential hypertension the usual recommended starting dose is 10 mg. The usual effective maintenance dosage is 20 mg administered in a single daily dose.

Diuretic Treated Patients:
Symptomatic hypotension may occur following initiation of therapy with Lace,this is more likely in patients who are being treated currently with diuretics. Caution is recommended, therefore, these patients may be volume and / or salt depleted.

Renovascular Hypertension:
Some patients with renovascular hypertension, especially those with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, may develop an exaggerated response to the first dose of Lace. Therefore, a lower starting dose of 2.5 or 5 mg is recommended. Therefore, the dosage may be adjusted according to the blood pressure response.Congestive

Heart Failure:
The initial dose of Lace in patients with heart failure is 2.5 mg given once a day. The usual effective dosage range is 5 to 20 mg per day administered in a single daily dose.

Acute Myocardial Infarction:
Treatment with Lace may be started within 24 hours of the onset of symptoms. The first dose of Lace is 5 mg given orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg once daily thereafter.

SIDE-EFFECTS:
Lace has been found in controlled clinical trials to be generally well tolerated.The most frequent clinical side effets of Lace in controlled trials were dizziness, headache, diarrhea, fatigue, cough and nausea. Other side effects occurring less frequently were orthostatic effects (including hypotension), rash, and asthenia.

Hypersensitivity/Angioneurotic Edema:
Angioneurotic edema of the face, extremities, lips, ,tongue, glottis, and larynx has been reported rarely.

Respiratory: Bronchospasm

Cardiovascular: Hypotension, palpitation, tachycardia.

Neurological: Mood alterations, mental confusion, paresthesia.

Digestive: Abdominal pain, dry mouth, pancreatitis, hepatitis.

Urogenital: Uremia, oliguria, impotence.

Dermatological: urticaria, pruritus, alopecia.

Haemopoietic:
Bone marrow depression, manifest as anemia and thrombocytopenia and leukopenia, has been reported.

Hyperkalemia and hyponatremia have occurred.


CONTRA-INDICATION:
Lace is contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioneurotic oedema relating to previous treatment with an angiotensin-converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema.

PRECAUTIONS:
Symptomatic hypotension:
Symptomatic hypotension was seen rarely in uncomplicated hypertensive patients. In hypertensive patients receiving Lace, hypotension is more likely to occur if the patient has been volume-depleted, e.g. by diuretic therapy, dietary salt restriction, dialysis, diarrhoea or vomiting. In patients with congestive heart failure, with or without associated renal insufficiency symptomatic hypotension has been observed.

Hypotension in Acute Myocardial infarction:
Treatment with lace must not be initiated in acute myocardial infarction patients who are at risk of further serious hemodynamic deterioration after treatment with a vasodilator.

Aortic Stenosis/Hypertrophic Cardiomyopathy:
As with all vasodilators, ACE inhibitors should be given with caution to patients with obstruction in the outflow tract of the left ventricle.

Renal Function Impairment:
In patients with congestive 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. Increase of blood urea and serum creatinine usually reversible upon discontinuation of therapy, have been reported.

Hypersensitivity/Angioneurotic Oedema:
Angioneurotic oedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported rarely in patients treated with angiotensin converting enzyme inhibitors including Lace. Angioneurotic oedema associated with laryngeal oedema may be fatal.

Hemodialysis Patients:
Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. In these patients consideration should be given to use a different type of dialysis membrane or a different class of antihypertensive agent.

Cough:
Cough has been reported with the use of ACE inhibitors. Characteristically, the cough is non-productive, persistent and resolves after discontinuation of therapy.

Surgery / Anesthesia:
In patients undergoing major surgery or during anesthesia with agents that produce potension, Lace may block angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.

Use in Pregnancy and Lactation:
The use of Lace during pregnancy is not recommended.
Caution should be exercised if Lace is given to a nursing mother.

Drug Interactions:
Diuretics:
When a diuretic is added to the therapy of a patient receiving Lace, the antihypertensive effect is usually additive.

Other Agents:
Indomethacin may diminish the antihypertensive efficacy of concomitantly administered lace. In some patients, with compromised renal function who are being treated with non-steroidal anti-inflammatory drugs, the co-administration of ACE inhibitors may result in a further deterioration of renal function.

Serum Potassium:
Although in clinical trials, serum potassium usually remained within normal limits, hyperkalemia did occur in some cases. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and concomitant use of potassium sparing diuretics (e.g. spironolactone triamterene or amiloride), potassium supplements, or potassium containing salt substitutes.

Overdosage:
The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution, if available, angiotensin II may be beneficial. Lisinopril may be removed from the general circulation by hemodialysis.

Storage:
Store below 30 C.
Protect from moisture.