Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Lisinopril tablets, USP are available as uncoated tablets in bottles of 90 and 300. Strength Color Shape Scored Side 1 Bottle Count NDC 2.5 mg White Round No Y11 90 Tablets 62135-640-90 2.5 mg White Round No Y11 300 Tablets 62135-640-31 5 mg Yellow Capsule shape Yes Y12 90 Tablets 62135-641-90 5 mg Yellow Capsule shape Yes Y12 300 Tablets 62135-641-31 10 mg Yellow Round No Y13 90 Tablets 62135-642-90 10 mg Yellow Round No Y13 300 Tablets 62135-642-31 20 mg Yellow Round No Y14 90 Tablets 62135-643-90 20 mg Yellow Round No Y14 300 Tablets 62135-643-31 30 mg Yellow Round No Y15 90 Tablets 62135-644-90 30 mg Yellow Round No Y15 300 Tablets 62135-644-31 40 mg Pink Round No Y16 90 Tablets 62135-645-90 40 mg Pink Round No Y16 300 Tablets 62135-645-31 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Lisinopril Tablets, USP 2.5mg - NDC 62135-640-90- 90's Bottle Label Lisinopril Tablets, USP 2.5mg - NDC 62135-640-31- 300's Bottle Label Lisinopril Tablets, USP 5mg - NDC 62135-641-90- 90's Bottle Label Lisinopril Tablets, USP 5mg - NDC 62135-641-31- 300's Bottle Label Lisinopril Tablets, USP 10mg - NDC 62135-642-90- 90's Bottle Label Lisinopril Tablets, USP10mg - NDC 62135-642-31- 300's Bottle Label Lisinopril Tablets, USP 20mg - NDC 62135-643-90- 90's Bottle Label Lisinopril Tablets, USP 20mg - NDC 62135-643-31- 300's Bottle Label Lisinopril Tablets, USP 30mg - NDC 62135-644-90- 90's Bottle Label Lisinopril Tablets, USP 30mg - NDC 62135-644-31- 300's Bottle Label Lisinopril Tablets, USP 40mg - NDC 62135-645-90- 90's Bottle Label Lisinopril Tablets, USP 40mg - NDC 62135-645-31- 300's Bottle Label "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description"
- 16 HOW SUPPLIED/STORAGE AND HANDLING Lisinopril tablets, USP are available as uncoated tablets in bottles of 90 and 300. Strength Color Shape Scored Side 1 Bottle Count NDC 2.5 mg White Round No Y11 90 Tablets 62135-640-90 2.5 mg White Round No Y11 300 Tablets 62135-640-31 5 mg Yellow Capsule shape Yes Y12 90 Tablets 62135-641-90 5 mg Yellow Capsule shape Yes Y12 300 Tablets 62135-641-31 10 mg Yellow Round No Y13 90 Tablets 62135-642-90 10 mg Yellow Round No Y13 300 Tablets 62135-642-31 20 mg Yellow Round No Y14 90 Tablets 62135-643-90 20 mg Yellow Round No Y14 300 Tablets 62135-643-31 30 mg Yellow Round No Y15 90 Tablets 62135-644-90 30 mg Yellow Round No Y15 300 Tablets 62135-644-31 40 mg Pink Round No Y16 90 Tablets 62135-645-90 40 mg Pink Round No Y16 300 Tablets 62135-645-31 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Lisinopril Tablets, USP 2.5mg - NDC 62135-640-90- 90's Bottle Label Lisinopril Tablets, USP 2.5mg - NDC 62135-640-31- 300's Bottle Label Lisinopril Tablets, USP 5mg - NDC 62135-641-90- 90's Bottle Label Lisinopril Tablets, USP 5mg - NDC 62135-641-31- 300's Bottle Label Lisinopril Tablets, USP 10mg - NDC 62135-642-90- 90's Bottle Label Lisinopril Tablets, USP10mg - NDC 62135-642-31- 300's Bottle Label Lisinopril Tablets, USP 20mg - NDC 62135-643-90- 90's Bottle Label Lisinopril Tablets, USP 20mg - NDC 62135-643-31- 300's Bottle Label Lisinopril Tablets, USP 30mg - NDC 62135-644-90- 90's Bottle Label Lisinopril Tablets, USP 30mg - NDC 62135-644-31- 300's Bottle Label Lisinopril Tablets, USP 40mg - NDC 62135-645-90- 90's Bottle Label Lisinopril Tablets, USP 40mg - NDC 62135-645-31- 300's Bottle Label "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description"
Overview
Lisinopril, USP is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, USP a synthetic peptide derivative, is chemically described as (S)-1-[N 2 -(1-carboxy-3-phenylpropyl)-L-lysyl]-L- proline dihydrate. Its empirical formula is C 21 H 31 N 3 O 5 2H 2 O and its structural formula is: Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients: Lisinopril tablets, USP 2.5 mg - dibasic calcium phosphate dihydrate, mannitol, pregelatinized starch-1500, magnesium stearate. Lisinopril tablets, USP 5 mg and 10 mg – dibasic calcium phosphate dihydrate, mannitol, pregelatinized starch-1500, yellow iron oxide, magnesium stearate. Lisinopril Tablets, USP 20 and 30 mg - corn starch, croscarmellose sodium, dibasic calcium phosphate, magnesium sterate, mannitol, yellow iron oxide. Lisinopril Tablets, USP 40 mg - corn starch, croscarmellose sodium, dibasic calcium phosphate, magnesium sterate, mannitol, red iron oxide. "Image Description"
Indications & Usage
Lisinopril tablets 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 )
Dosage & Administration
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 ( 2.1 ) 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 ( 2.1 ) Heart Failure: Initiate with 5 mg once daily. Increase dose as tolerated to 40 mg daily ( 2.2 ) Acute Myocardial Infarction (MI): Give 5 mg within 24 hours of MI. Followed by 5 mg after 24 hours, then 10 mg once daily ( 2.3 ) 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 ( 2.4 )
Warnings & Precautions
Angioedema: Discontinue Lisinopril Tablets, 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 )
Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue lisinopril tablets as soon as possible [see Warnings and Precautions (5.1) ] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) ] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue lisinopril tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )
Contraindications
Lisinopril tablets are contraindicated in combination with a neprilysin (e.g., sacubitril). Do not administer lisinopril tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warning and Precaution (5.2) ]. Lisinopril tablets are contraindicated in patients with: a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme inhibitor hereditary or idiopathic angioedema Do not co-administer aliskiren with lisinopril tablets in patients with diabetes [see Drug Interactions (7.4) ]. Angioedema or a history of hereditary or idiopathic angioedema ( 4 ) Hypersensitivity ( 4 ) Co-administration of aliskiren with Lisinopril Tablets in patients with diabetes ( 4 , 7.4 )
Adverse Reactions
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 Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
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 ).
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