Lisinopril

Lisinopril tablet USP is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older ( 1.1 ) Adjunct therapy for heart failure ( 1.2 ) Treatment of Acute Myocardial Infarction ( 1.3 ) 1.1 Hypertension Lisinopril tablet USP is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. …

• Hypertension: Initial adult dose is 10 mg once daily
• Titrate up to 40 mg daily based on blood pressure response
• Initiate patients on diuretics at 5 mg once daily
• Pediatric patients with glomerular filtration rate > 30 mL/min/1.73m 2 : Initial dose in patients 6 years of age and older is 0.07 mg per kg (up to 5 mg total) once daily Heart Failure: Initiate with 5 mg once daily
• Increase dose as tolerated to 40 mg daily Acute Myocardial Infarction (MI): Give 5 mg within 24 hours of MI
• Followed by 5 mg after 24 hours, then 10 mg once daily Renal Impairment: For patients with creatinine clearance > 10 mL/min and < 30 mL/min, halve usual initial dose
• For patients with creatinine clearance < 10 mL/min or on hemodialysis, the recommended initial dose is 2.5 mg Hypertension Initial Therapy
• In adults: The recommended initial dose is 10 mg once a day
• Dosage should be adjusted according to blood pressure response
• The usual dosage range is 20 mg to 40 mg per day administered in a single daily dose
• Doses up to 80 mg have been used but do not appear to give greater effect
• Use with Diuretics
• In Adults If blood pressure is not controlled with lisinopril alone, a low dose of a diuretic may be added (e.g, hydrochlorothiazide, 12.5 mg)
• After the addition of a diuretic, it may be possible to reduce the dose of lisinopril

Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg ( 3 ) 2.5 mg tablet is a white to off-white, round, biconvex, uncoated tablet with "LUPIN" debossed on one side and "2.5" on other side. 5 mg tablet is a pink coloured, round, biconvex, uncoated tablet with "5" debossed on one side and breakline on other side. …

• Antihypertensive effects and safety of lisinopril have been established
• In pediatric patients aged 6 to 16 years [see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES ]
• No relevant differences between the adverse reaction profile for pediatric patients and adult patients were identified
• Safety and effectiveness of lisinopril have not been established
• In pediatric patients under the age 6 or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73 m 2 [see DOSAGE AND ADMINISTRATION , CLINICAL PHARMACOLOGY , and CLINICAL STUDIES ] . …

No dosage adjustment with lisinopril is necessary in elderly patients. In a clinical study of lisinopril in patients with myocardial infarctions (GISSI-3 Trial) 4,413 (47%) were 65 and over, while 1,656 (18%) were 75 and over. In this study, 4.8 % of patients aged 75 years and older discontinued lisinopril treatment because of renal dysfunction vs. 1.3% of patients younger than 75 years. …

• NOTE: This information is intended to aid in the safe and effective use of this medication
• It is not a disclosure of all possible adverse or intended effects
• Pregnancy Advise pregnant women and females of reproductive potential of the potential risk to a fetus
• Advise females of reproductive potential to notify their healthcare provider with a known or suspected pregnancy [see WARNINGS AND PRECAUTIONS and USE IN SPECIFIC POPULATIONS ]
• Angioedema Angioedema, including laryngeal edema may occur at any time during treatment with angiotensin converting enzyme inhibitors, including lisinopril. …

• Angioedema or a history of hereditary or idiopathic angioedema Hypersensitivity Co-administration of aliskiren with lisinopril in patients with diabetes Lisinopril is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril)
• Do not administer Lisinopril tablet USP within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see WARNINGS and PRECAUTIONS ]. …

Diuretics: Excessive drop in blood pressure ( 7.1 ) NSAIDS: Increased risk of renal impairment and loss of antihypertensive efficacy ( 7.3 ) Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia ( 7.4 ) Lithium: Symptoms of lithium toxicity ( 7.5 ) Gold: Nitritoid reactions have been reported ( 7.6 ) Concomitant mTOR inhibitor or neprilysin inhibitor use may increase angioedema risk ( 7.7 , 7.8 ) 7.1 Diuretics Initiation of lisinopril in patients on diuretics may result in excessive reduction of blood pressure. …

Angioedema: Discontinue lisinopril, provide appropriate therapy and monitor until resolved ( 5.2 ) Renal impairment: Monitor renal function periodically ( 5.3 ) Hypotension: Patients with other heart or renal diseases have increased risk, monitor blood pressure after initiation ( 5.4) Hyperkalemia: Monitor serum potassium periodically ( 5.5 ) Cholestatic jaundice and hepatic failure: Monitor for jaundice or signs of liver failure ( 5.6 ) 5.1 Fetal Toxicity Lisinopril can cause fetal harm when administered to a pregnant woman. …

Common adverse reactions (events 2% greater than placebo) by use: Hypertension: headache, dizziness and cough ( 6.1 ) Heart Failure: hypotension and chest pain ( 6.1 ) Acute Myocardial Infarction: hypotension ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. …

8.1 Pregnancy Risk Summary Lisinopril can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. …

Following a single oral dose of 20 g/kg no lethality occurred in rats, and death occurred in one of 20 mice receiving the same dose. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution. Lisinopril can be removed by hemodialysis [see CLINICAL PHARMACOLOGY ( 12.3 )] .

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.