Description
How Supplied :
Lisirex tablets are presented as forms that containing 5 , 10 , 20 mg lisinopril (as lisinopril dihydrate). 10 tablets per blister pack , 3 blisters with a leaflet in a box.
Category :
Antihypertensive;vasodilator, congestive heart failure.
Mechanism of action:
Antihypertensive Exact mechanism of antihypertensive action is unknown but is thought to be related to competitive inhibition of angiotensin I – converting enzyme (ACE) activity, resulting in a decreased rate of conversion of angiotensin I to angiotensin II, which is a potent vasoconstrictor. Decreased angiotensin II concentrations results in a secondary increase in plasma renin activity (PRA)
vasodilator, congestive heart failure: Decrease in peripheral vascular resistance,pulmonary capillary wedge pressure and pulmonary vascular resistance;and improved cardiac output and exercise tolerance.
Pharmacokinetics :
- Absorption : Approximately 25%, but widely variable between individuals (6 to 60%); not affected by the presence of food
- Half – Life : 12 hours; increased in renal failure
- Elimination : Renal – 100% unchanged ;In dialysis : lisinopril is removable by hemodialysis.
Pregnancy and breast feeding :
FDA pregnancy category C for first trimester and FDA pregnancy category D for second and third trimester,and it is not known whether lisirex is distributed into breast milk.
Precautions :
- Making regular visits to physician to check progress.
- Caution when driving or doing other things requiring alertness because of possible dizziness.
- Checking with physician if sever nausea, vomiting or diarrhea, extremely swelling, difficulty in swallowing or breathing and signs and symptoms of jaundice or signs of infection occurs.
- Caution if any kind of surgery is required.
- Not taking other medication,especially nonprescription sympathomimethics,unless discussed with physician.
- Caution when exercising or during exposure to hot weather because of the risk of dehydration.
Drug interaetion :
Inform your doctor if you are taking any of the following medicines : alcohol ; diuretics; Hypotension producing medication;antacids ; nonsteroidal anti – inflammatory drugs like Indomethacin;lood from blood bank;cyclosporine;Diuretics, potassium – containing medications or supplements;salt substitutes; Allopurinol;cytosttic agents; procainamide ; systemic corticosteroids ;bone marrow depressants; Lithium ;sympathomimethics.
Dosage and administration :
Usual adult dose:
- Antihypertensive: initial-10 mg once a day, the dosage being adjusted according to clinical response.Maintenance – 20 to 40 mg once a day.
Note : An initial dose of 5 mg should be used in patients who are sodium – and water – depleted as a result of prior diuretic therapy. Patients continuing to receive diuretic therapy, or patients with renal failure .An initial dose of 2.5 mg should be used in patients with a creatinine clearance less than 10 ml per minute.
- Vasodilator, congestive heart failure :Initial – 5 mg per day, the dosage being adjusted according to clinical response.Maintenance – 5 to 20 mg per day.
Note : An initial dose of 2.5 mg per day should be used in patients with hyponatremia or who have moderate to severe renal impairment.
- Acute myocardial infarction :Initial -5 mg within 24 hours of onest of an acute myocardial infarction, followed by 5 mg after 24 hours, 10 mg after 48 hours, than 10 mg per day. Maintenance – 10 mg per day for six weeks.
Note : In patients with low systolic blood pressure an initial dose of 2.5 mg should be used when treatment begins, or during the first three days after the infarction. If hypotension occurs a daily maintenance dose of 5 mg may be given with temporary reduction to 2.5 mg if needed.
Usual adult prescribing limits: Dose up to 80 mg per have been used.
Usual pediatric dose:
- Antihypertensive
Children 6 to 16 years of age : initially 0.07 mg per kg of body weight per day adjusted according to blood pressure response up to 5 mg per day.
Children younger than 6 years of age – safety and efficacy have not been established.
Note : lisirex should not be administered to pediatric patients with creatinine clearance less than 30 ml per minute per 1.73 m2 .
Usual pediatric prescribing limits : 0.61 mg per kg of body weight per day or 40 mg per day.
Side effects :
Those indicating need for medical attention:Hypotension;skin rash, with or without itching, fever, joint pain; Angioedema of the extremities, face lips, mucous membranes, tongue, glottis, larynx;chest pain; hyperkalemia; intestinal angioedema; neutropenia, agranulocytosis; pancreatitis
Those indicating need for medical attention only if they continue or are bothersome :
cough, dry, persistent; headache; diarrhea; dysgeusia; fatigue
Storage :
Store below 30° C,protect from light and moisture. keep out of reach of children.
Date of revision :october 2013
Manufactured by Pursina pharmaceutical Co. Tehran – IRAN