Lisinopril

Visa No.: 893110832424

Product: Lizetric 10mg

API: Lisinopril

Product Category: Cardiovascular & Metabolism

Version approved leaflet: 41/QĐ-QLD_06/02/2017_157

INDICATIONS

• Treatment of hypertension: Used as monotherapy or in combination with other antihypertensive agents such as thiazide diuretics, alpha-blockers, or calcium channel blockers.
• Treatment of heart failure: Lisinopril is used in combination with cardiac glycosides and diuretics for the treatment of congestive heart failure in patients who have not responded to treatment with cardiac glycosides or diuretics alone..
• Acute myocardial infarction with stable hemodynamics: Lisinopril is used in combination with thrombolytic agents, aspirin, and/or beta-blockers to improve survival in patients with acute myocardial infarction who are hemodynamically stable. Lisinopril should be initiated within 24 hours after the occurrence of myocardial infarction. 
• Treatment of diabetic nephropathy
   

DOSAGE AND ADMINISTRATION

Adult
- Treatment of hypertension:
Initial dose: 5–10 mg/day, with dose adjustment according to the patient’s clinical response. Maintenance dose: 20–40 mg/day.
- As a vasodilator for the treatment of congestive heart failure:
Initial dose: 2.5–5 mg/day, with dose adjustment according to the patient’s clinical response. Maintenance dose: 10–20 mg/day.
- Myocardial infarction: Used in combination with thrombolytic agents, low-dose aspirin, and beta-blockers.
Initial dose: 5 mg within 24 hours after the onset of myocardial infarction symptoms, followed by equivalent doses of 5 mg and 10 mg at 24 and 48 hours, respectively. Maintenance dose: 10 mg/day, continued for 6 weeks; if cardiac failure is present, treatment should be continued for more than 6 weeks.
- Treatment of hypertension associated with renal impairment:

Table 1: Dose adjustment in patients with renal impairment.
Thereafter, the dose should be adjusted according to drug tolerability and the patient’s blood pressure response, but must not exceed 40 mg/day.

• Treatment of hypertension in patients with type 2 diabetes mellitus: 10 mg/day; if necessary, increase to 20 mg/day to achieve a target sitting diastolic blood pressure below 90 mmHg.
• Treatment of heart failure with hyponatremia: In patients with serum sodium levels < 130 mEq/L, or creatinine clearance < 30 mL/min, or serum creatinine > 3 mg/dL, the initial dose should be reduced to 2.5 mg. After the first dose, the patient should be monitored for 6–8 hours until blood pressure stabilizes.
• Treatment of myocardial infarction with renal impairment: (serum creatinine > 2 mg/dL), lisinopril should be initiated with caution. If renal failure occurs (serum creatinine > 3 mg/dL) or if serum creatinine increases by 100% compared with baseline during treatment, lisinopril must be discontinued.
   

CONTRAINDICATIONS

Lisinopril should not be used in patients with aortic valve stenosis, obstructive cardiomyopathy, bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, or in patients with hypersensitivity to angiotensin-converting enzyme (ACE) inhibitors or to any component of the product.
Renal impairment with serum creatinine ≥ 250 mmol/L or serum potassium ≥ 5 mmol/L.
Not to be used during pregnancy.
 

WARNINGS AND PRECAUTIONS

Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children