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Cardiovascular Agents

Lisinopril STADA® 10 mg

 

Pack size:

Box of 10 blisters x 10 tablets.


Composition:

Each tablet contains lisinopril (as lisinopril dihydrate) 10 mg.


Shelf-life:

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Protect from moisture. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

Only administered orally.

In adults

  • Hypertension: Lisinopril is used alone or in combination with other classes of antihypertensive agents (e.g., thiazide diuretics) in the management of hypertension.
    In adults not receiving a diuretic: The usual initial dosage of lisinopril is 5–10 mg once daily. Dosage of the drug should be adjusted according to the patient's peak and trough blood pressure responses. The usual maintenance dosage of lisinopril in adults is 20–40 mg daily, given as a single dose.
    In a patient already receiving a diuretic: It is recommended that diuretic therapy be discontinued, if possible, 2–3 days before initiating lisinopril. If diuretic therapy cannot be discontinued, sodium intake can be increased prior to initiating lisinopril to minimize the risk of hypotension, and lisinopril should be initiated in adults at a dosage of 5 mg daily under close medical supervision for at least 2 hours and until blood pressure has stabilized.
  • Congestive heart failure: Lisinopril also is used in conjunction with cardiac glycosides and diuretics in the management of symptomatic congestive heart failure resistant to or inadequately controlled by cardiac glycosides and diuretics.
    The usual initial lisinopril dosage for the management of congestive heart failure in adults with normal renal function and serum sodium concentration is 2.5–5 mg daily. The usual effective dosage of lisinopril in adults is 5–40 mg daily, given as a single dose.
  • Acute myocardial infarction: Lisinopril may be used in conjunction with thrombolytic agents, aspirin, and/or b-adrenergic blocking agents to improve survival in patients with acute myocardial infarction who are hemodynamically stable.
    A 5 mg dose of lisinopril should be given within 24 hours of onset of symptoms of myocardial infarction followed by a 5 and 10 mg dose 24 and 48 hours later, respectively. Thereafter, a maintenance dosage of 10 mg daily should be used; lisinopril therapy should be continued for 6 weeks.
  • Diabetic nephropathy.
    The initial dose is 2.5 mg once daily. In normotensive type 1 diabetics the maintenance dose is 10 mg daily, increased to 20 mg daily if necessary to achieve a sitting diastolic blood pressure below 75 mmHg. In hypertensive type 2 diabetics, the dose should be adjusted to achieve a sitting diastolic blood pressure below 90 mmHg.


In children

  • Children aged 6 to 12 years:
    A starting dose for lisinopril of 70 micrograms/kg (up to 5 mg) once daily. This dose may be increased at intervals of 1 to 2 weeks to a maximum of 600 micrograms/kg or 40 mg once daily.
  • Children between 12 and 18 years of age:
    An initial dose of 2.5 mg daily increased as necessary to a maximum of 40 mg daily.

In patients with renal impairment:

  • In adult patient with renal impairment, the initial dose of lisinopril should be reduced depending on the creatinine clearance (CC) as follows:
    CC 31 to 80 ml/minute: 5 to 10 mg once daily.
    CC 10 to 30 ml/minute: 2.5 to 5 mg once daily.
    CC less than 10 ml/minute or on dialysis: 2.5 mg once daily.
    The dose should be adjusted according to response, to a maximum of 40 mg once daily.
    Lisinopril should not be given to children with a glomerular filtration rate of less than 30 ml/minute per 1.73 m2.

Or as prescribed by physicians.

 

  • Patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme inhibitor.
  • Patients with hereditary or idiopathic angioedema.
  • Patients with aortic stenosis or hypertropic cardiomyopathy, unilateral or bilateral renal artery stenosis.
  • Known hypersensitivity to lisinopril, other ACE inhibitors, or to any ingredient of the drug.
     

Common:

  • Headache.
  • Cough (dry, continuing).

Less common:

  • Nausea, dysgeusia (loss of taste), diarrhoea.
  • Hypotension.
  • Skin rash, maculopapular, urticarial rash, with or without itching.
  • Fatigue, proteinuria, fever or joint pain.

Rare:

  • Angioedema.
  • Hyperkalemia.
  • Confusion, nervousness, numbness or tingling in hand, feet or lips.
  • Shortness of breath, difficult breathing, chest pain.
  • Neutropenia, agranulocytosis.
  • Hepatotoxicity, jaundice, cholestasis, hepatic necrosis and hepatocellular injury.
  • Pancreatitis.

     

  • Aortic stenosis/hypertrophic cardiomyopathy: Like other vasodilators, lisinopril should be administered with caution in patients with obstruction in the outflow tract of the left ventricle (e.g., aortic stenosis, hypertrophic cardiomyopathy)
  • Renal effects: Inhibition of the renin-angiotensin-aldosterone (RAA) system may cause renal impairment and rarely renal failure and/or death in susceptible patients (e.g., those whose renal function depends on the activity of the RAA system such as patients with severe congestive heart failure). Renal artery stenosis, preexisting renal impairment, and concomitant diuretic therapy also are risk factors for renal impairment during ACE inhibitor therapy. In patients with acute myocardial infarction who have evidence of renal dysfunction (i.e., serum creatinine concentration exceeding 2 mg/dl), consider discontinuance of lisinopril if serum creatinine exceeds 3 mg/dl or doubles from pretreatment value.
  • Effects on potassium: Hyperkalemia can develop, especially in those with renal impairment or diabetes mellitus and those receiving drugs that can increase serum potassium concentration (e.g., potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes). Hyperkalemia can result in serious, potentially fatal, cardiac arrhythmias.
  • Hypoglycemia: Hypoglycemia can develop in patients receiving concomitant therapy with ACE inhibitors and insulin or oral antidiabetic agents, especially during the initial weeks of combined therapy or in patients with renal impairment.
  • Cough: Persistent and nonproductive cough reported with all ACE inhibitors; resolves after drug discontinuance.
  • Surgery/anesthesia: Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension.
  • Pregnancy: When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, lisinopril should be discontinued as soon as possible.
  • Lactation: It is not known whether the drug is distributed into milk in humans. Because of the potential for serious adverse reactions to ACE inhibitors in nursing infants, a decision should be made whether to discontinue nursing or lisinopril, taking into account the importance of the drug to the woman.
  • When driving vehicles or operating machines it should be taken into account that occasionally dizziness or tiredness may occur.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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