Lisirex Tablet

Lisirex Tablet


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

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