ZESTOPRIL 5

ZESTOPRIL 5

- Lisinopril  inhibits the angiotensin converting enzyme (ACE) that catalyses the conversion of 
 angiotensin I, to the vasoconstrictor peptide, angiotensin II. Angiotensin II also stimulates 
 aldosterone secretion by the adrenal cortex. Inhibition of ACE result decreased in concentration of 
 angiotensin II which result decreased in concentration vasopressor activity and 
 reduced aldosterone secretion.
- After oral administration of  Lisinopril peak serum concentration occurs within about 7 hours. 
 Absorption is  not affected by  the presence of food. 
- Lisinopril  does not appear to be bound to serum proteins other than to circulation angiotensin 
 converting enzyme (ACE). Studies in rats indicate that Lisinopril crosses the blood brain barrier 
 poorly. 
- Lisinopril does not metabolized and is excreted entirely unchanged into the urine. Lisinopril cross 
 the placental barrier and appears in cord blood. It is not know whether Lisinopril is secreted in human 
 milk or not. 

- Each tablet of Zestopril® 20 Contains :-
  Lisinopril        20 mg ( as  Lisinopril dihydrate)
- Each tablet of Zestopril® 10 Contains:- 
  Lisinopril        10 mg ( as Lisinopril  dihydrate) 
- Each tablet of  Zestopril® 5 contains :- 
  Lisinopril       5 mg (as Lisinopril  dihydrate)

- Zestopril® is contraindicated in:
- Patients who are hypersensitive to lisihopril or any other angiotensin converting enzyme (ACE ) 
 inhibitor .
- History of angioedema associated with previous ACE inhibitor therapy. 
- Hereditary or idiopathic angioedema.
 

Zestopril® combination with other antihypertensive agents such as beta-blockers and diuretics may 
 increase the antihypertensive efficacy.
- lisinopril minimises the development of thiazide induced hypokalemia and hyperuricemia. 
- Indomethacin may reduces the antihypertensive efficacy of lisinopril when lisinopril taken with it 
 concomitantiy . 
- Zestopril® may results in a further deterioration of renal function in patients with compromised 
 renal function who are being  treated with non-steroidal  anti- inflammatory drugs.
- ACE inhibitors may enhance the effect of insulin and orally administered hypoglycaemic agents. 
 

- Zestopril® is contraindicated during the first trimester and should be not given during the second 
 and third trimester of pregnancy.
- Fetal exposure to ACE inhibitors during the second and third trimesters has been associated with 
 neonatal hypotension , renal failure and hyperkalemia. 
-  It’s not known whether lisinopril is secreted in human breast milk, lisinopril is excreted in to milk of 
 lactating rat. The use of  Zestopril® is not recommended in women who are breast feeding. 
 

- Zestopril® is generally well tolerated and it’s adverse effects are mild and transient in nature. 
  The most frequent side effects are :- dizziness, headache, diarrhea, fatigue, cough, nausea, rach, 
 palpitation, chest pain and  asthenia.

Over dose :
 Limited data are available for ovardose in humans.
 Symptoms associated with overdose of ACE inhibitors may include hypotension, circulatory shock, 
 electrolyte disturbance,  renal failure, hyperventilation, tachycardia, palpitations, bradycardia, 
 dizziness, anxiety and cough. 
 The recommended treatment of overdose is intravenous  infusion of normal saline solution. If 
 hypotension occurs, the patients should be placed  in the shock position. If available, treatment with 
 angiotensin II and/or intravenous catecholamines may also be considered.

- Symptomatic hypotension may occur, particularly in volume depleted patients and congestive heart 
 failure.
- caution should be taken in patients with ischaemic heart or cerebrovascular disease.
- patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increase risk of 
 angioedema.
- In cases of renal impairment "creatinine clearance <80ml/min.the) initial dose should be adjust 
 according to the patients creatine cleararc (see dosage & administration) and then as a function of the 
 patients response to treatment should be monitoring of potasstium and creatinine.
- Desensitisation: patients receiving ACE inhibitors during desensitisation treatment (e.g. 
 hymenoptera venom) have sustained anaphylactoid reaction. In the same patients, these reactions 
 have been avoided when ACE inhibitors were temporarily  withhold but they have reappeared upon 
 inadvertent re-administration of the medicinal product.
- Race : angiotensin converting enzyme inhibitors cause a higher rate of angioedema in black patients 
 than in non-black patients As with other ACE inhibitors Zestopril® may be less affective in lowering 
 blood pressure in black patients than in non-blacks, possibly because of a higher prevalence of 
 low-renin states in the black hypertensive population.
- Cough: cough has been reported with the use of ACE inhibitors. Characteristically, the cough is 
non-productive,  persistent  and resolves after discontinuation of therapy. ACE inhibitor-induced 
 cough  should be considered as part   of the differential diagnosis of cough.
- Surgery/anesthesia : in patients undergoing major surgery or during anesthesia with agent that produce hypotension.Zestopril® 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. 
- Hypotension in acute myocardial infarction:- Zestopril® must not be taken  in acute myocardial 
 infarction patients who are at risk of farther serious hemodynamic deterioration after treatment with 
 vasodilator. These are patients with systolic blood pressure of 100mmHg or lower or cardiogenic 
 shock. During the first 3days following the infarction, the dose should be reduced if the systolic 
 blood pressure is 120mmHg or lower. Maintenance dose should be reduced to 5mg or temporarily to 
 2.5mg if systolic blood pressure is 100mmHg or lower.
- Hypersensitivity/ Angioedema:- angiodema of the face, extermities, lips, tongue, glottis and/or 
 larynx has been reported rarely in patients treated with angiotensin converting enzyme inhibitors, 
 including Zestopril®. This may occur at any time during therapy. In such cases, Zestopril® should  
 be discontinued promptly and appropriate treatment and monitoring should be  instituted to ensure 
 complete resolution of symptoms prior to dismissing the patients.  Even in those instances where 
 swelling of only the tongue is involved, without respiratory distress patients may require  prolonged 
 observation since treatment with antihistamines and corticosteroids may not be sufficient.
 Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of 
 angioedema while receiving an ACE inhibitors. 
 

- Blister of 10 tablets, pack of 2 blisters. 
 

- Store in a dry place at a temperature below  30 °C.