Lisinopril 2.5 mg Tablet, 90-count
Past resolved recalls for this product (1)
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Angiotensin Converting Enzyme Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Lisinopril is mainly prescribed to treat high blood pressure — it relaxes your blood vessels so your heart doesn't have to work as hard. It's also used to help manage heart failure...
- Good news — food doesn't affect how lisinopril works, so you can take it with or without a meal. What matters most is taking it at roughly the same time each day. Once a day is the...
- Can I take lisinopril with food, or does it have to be on an empty stomach?
- Yes, that cough is one of the most well-known side effects of ACE inhibitors like lisinopril. It happens because the medicine also affects a chemical in the lungs called bradykinin...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Lisinopril — tap one for details:
Lisinopril may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII O7TSZ97GEP
A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
5 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.014 | $1.28 / 90 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.1160 | $10.44 / 90 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.1245 | $11.21 / 90 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lisinopril 2.5 mg 00591-0405-01 | Actavis | 100 tablets | $0.014 | — | Availability likely | — |
| lisinopril 2.5 mg 23155-0876-01 | Heritage | 100 tablets | $0.014 | AB | Availability likely | — |
| Lisinopril 2.5 mg 31722-0172-01 | Camber | 100 tablets | $0.014 | AB | Availability likely | — |
| Lisinopril 2.5 mg 43547-0414-10 | Solco | 100 tablets | $0.014 | AB | Availability likely | — |
| Lisinopril 2.5 mg 60687-0656-21 | American | 30 tablets | $0.014 | AB | Availability likely | — |
| Lisinopril 2.5 mg 62135-0640-31 | Chartwell | 300 tablets | $0.014 | AB | Availability likely | — |
| Lisinopril 2.5 mg 68001-0332-00 | BluePoint | 100 tablets | $0.014 | AB | Availability likely | — |
| Lisinopril 2.5 mg 68180-0512-01 | Lupin | 100 tablets | $0.014 | AB | Availability likely | — |
| Lisinopril 2.5 mgthis 68645-0608-90 | Legacy | 90 tablets | $0.014 | AB | Availability likely | — |
| lisinopril 2.5 mg 76282-0417-01 | Exelan | 100 tablets | $0.014 | AB | Availability likely | — |
| Lisinopril 2.5 mg 76282-0728-01 | Exelan | 100 tablets | $0.014 | AB | Availability likely | — |
| Lisinopril 2.5 mg 82009-0062-05 | Quallent | 500 tablets | $0.014 | AB | Availability likely | — |
| Lisinopril 2.5 mg 00615-8252-05 | NCS | 15 tablets | — | AB | FDA listed | — |
| Zestril 2.5 mg 24979-0238-07 | Upsher-Smith | 90 tablets | — | AB | FDA listed | — |
| Lisinopril 2.5 mg 43063-0810-01 | PD-Rx | 100 tablets | — | AB | FDA listed | — |
| lisinopril 2.5 mg 43353-0270-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Lisinopril 2.5 mg 43547-0351-03 | Solco | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 2.5 mg 50090-2431-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 2.5 mg 50090-6860-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Lisinopril 2.5 mg 51655-0729-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| Lisinopril 2.5 mg 51655-0999-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| Lisinopril 2.5 mg 63187-0780-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 2.5 mg 63629-5247-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 2.5 mg 63629-8736-01 | Bryant | 500 tablets | — | AB | FDA listed | — |
| Lisinopril 2.5 mg 63629-8823-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Lisinopril 2.5 mg 65862-0037-00 | Aurobindo | 100 tablets | — | — | FDA listed | — |
| Lisinopril 2.5 mg 68071-1894-03 | NuCare | 30 tablets | — | — | FDA listed | — |
| Lisinopril 2.5 mg 68071-5046-01 | NuCare | 100 tablets | — | — | FDA listed | — |
| Lisinopril 2.5 mg 68788-6820-01 | Preferred | 100 tablets | — | — | FDA listed | — |
| Lisinopril 2.5 mg 70518-1316-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 2.5 mg 70518-1790-01 | REMEDYREPACK | 100 tablets | — | — | Discontinued | — |
| Lisinopril 2.5 mg 71335-0498-01 | Bryant | 30 tablets | — | AB | Discontinued | — |
| Lisinopril 2.5 mg 71335-1380-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| lisinopril 2.5 mg 71335-3008-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 2.5 mg 71610-0726-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 2.5 mg 71610-0741-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 2.5 mg 71610-0748-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 2.5 mg 72789-0101-01 | PD-Rx | 100 tablets | — | AB | FDA listed | — |
| Lisinopril 2.5 mg 72865-0208-01 | XLCare | 100 tablets | — | AB | FDA listed | — |
| Lisinopril 2.5 mg 76420-0340-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 68645-0608-90 You're viewing this | 90 TABLET in 1 BOTTLE (68645-608-90) | 2023-03-01 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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)]. 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)
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Lisinopril tablets are 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)
1.1Hypertension Lisinopril tablets are 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Lisinopril tablets may be administered alone or with other antihypertensive agents [see Clinical Studies (14.1)].
1.2Heart Failure Lisinopril tablets are indicated to reduce signs and symptoms of heart failure in patients who are not responding adequately to diuretics and digitalis [see Clinical Studies (14.2)].
1.3Reduction of Mortality in Acute Myocardial Infarction Lisinopril tablets are indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see Clinical Studies (14.3)].
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Hypertension: Initiate adults at 10 mg (monotherapy) or 5 mg (on a diuretic) once daily. Titrate up to 40 mg daily based on response. Initiaa dose in patients 6 years of age and older is 0.07 mg/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 to 30 mL/min, halve usual initial dose. For creatinine clearance < 10 mL/min or on hemodialysis, initiate 2.5 mg (2.4)
2.1Hypertension Initial Therapy in adults: The recommended initial dose is 10 mg once a day. Adjust dosage 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 tablets alone, a low dose of a diuretic may be added (e.g., hydrochlorothiazide, 12.5 mg). The recommended starting dose in adult patients with hypertension taking diuretics is 5 mg once per day. [see Drug Interactions (7.1)].
Pediatric Patients 6 years of Age and Older with Hypertension For pediatric patients with glomerular filtration rate > 30 mL/min/1.73m 2 , the recommended starting dose is 0.07 mg/kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response up to a maximum of 0.61 mg/kg (up to 40 mg) once daily. Doses above 0.61 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients [see Clinical Pharmacology (12.3)].
Lisinopril tablets are not recommended in pediatric patients < 6 years or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73m 2 [see Use in Specific Populations (8.4)and Clinical Studies (14.1)].
2.2Heart Failure The recommended starting dose for lisinopril tablets, when used with diuretics and (usually) digitalis as adjunctive therapy for systolic heart failure, is 5 mg once daily. The recommended starting dose in these patients with hyponatremia (serum sodium < 130 mEq/L) is 2.5 mg once daily. Increase as tolerated to a maximum of 40 mg once daily.
Diuretic dose may need to be adjusted to help minimize hypovolemia, which may contribute to hypotension [see Warnings and Precautions (5.4), and Drug Interactions (7.1)]. The appearance of hypotension after the initial dose of lisinopril tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
2.3Acute Myocardial Infarction In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, give lisinopril tablets 5 mg orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg once daily. Dosing should continue for at least 6 weeks. Initiate therapy with 2.5 mg in patients with a low systolic blood pressure (100 to 120 mmHg)) during the first 3 days after the infarct [see Warnings and Precautions (5.4)].
If hypotension occurs (systolic blood pressure ≤ 100 mmHg) consider doses of 2.5 or 5 mg. If prolonged hypotension occurs (systolic blood pressure < 90 mmHg for more than 1 hour) discontinue lisinopril tablets.
2.4Dose in Patients with Renal Impairment No dose adjustment of lisinopril tablet is required in patients with creatinine clearance > 30 mL/min. In patients with creatinine clearance 10 to 30 mL/min, reduce the initial dose of lisinopril tablets to half of the usual recommended dose (i.e., hypertension, 5 mg; heart failure or acute MI, 2.5 mg). For patients on hemodialysis or creatinine clearance <10 mL/min, the recommended initial dose is 2.5 mg once daily [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 2.5 mg are white colored, round, flat faced beveled edge tablets, debossed with "E 1" on one side and plain on the other side. 5 mg are pink colored, round, flat faced beveled edge tablets, debossed with "E 2" and separated by scored line on one side and plain on the other side. 10 mg are pink colored, round, flat faced beveled edge tablets, debossed with "E 3" on one side and plain on the other side.
20 mg are red colored, round, flat faced beveled edge tablets, debossed with "E 4" on one side and plain on the other side. 30 mg are red colored, round, flat faced beveled edge tablets, debossed with "E 5" on one side and plain on the other side. 40 mg are yellow colored, round, biconvex tablets, debossed with "E 6" on one side and plain on the other side.
Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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 coadminister aliskiren with lisinopril tablets in patients with diabetes [see Drug Interactions (7.4)]. Lisinopril tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril).
Do not administer lisinopril tablets within 36 hours of switching to or from sacubitril/valsartan, a product containing a neprilysin inhibitor [see Warnings and Precautions (5.2) and Drug Interactions (7.8)]. • 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) • Lisinopril tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer lisinopril tablets within 36 hours of switching to or from sacubitril/valsartan, a product containing a neprilysin inhibitor (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Angioedema: Discontinue lisinopril tablets (5.2) • Renal impairment: Monitor renal function periodically (5.3) • Hypotension: Monitor blood pressure after initiation. 5.4) • Hyperkalemia: Monitor serum potassium periodically (5.5) • Cholestatic jaundice and hepatic failure: Discontinue lisinopril tablets (5.6)
5.1Fetal Toxicity 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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.
Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue lisinopril as soon as possible [see Use in specific Populations (8.1)].
5.2Angioedema and Anaphylactoid Reactions Angioedema Head and Neck Angioedema Angioedema of the face, extremities, lips, tongue, glottis and/or larynx, including some fatal reactions, have occurred in patients treated with angiotensin converting enzyme inhibitors, including lisinopril, at any time during treatment. Patients with involvement of the tongue, glottis or larynx are likely to experience airway obstruction, especially those with a history of airway surgery. Lisinopril should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms of angioedema has occurred.
Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor [see Contraindications (4)]. ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients. Patients receiving concomitant ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema [see Drug Interactions (7.7)].
Patients receiving concomitant ACE inhibitor and neprilysin inhibitor therapy may be at increased risk for angioedema [see Contraindications (4) and Drug Interactions (7.8)]. Intestinal Angioedema Intestinal angioedema has occurred in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal.
In some cases, the angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Anaphylactoid Reactions Anaphylactoid Reactions During Desensitization Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. Anaphylactoid Reactions During Dialysis Sudden and potentially life threatening anaphylactoid reactions have occurred in some patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor.
In such patients, dialysis must be stopped immediately, and aggressive therapy for anaphylactoid reactions must be initiated. Symptoms have not been relieved by antihistamines in these situations. In these patients, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.
Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.
5.3Impaired Renal Function Monitor renal function periodically in patients treated with lisinopril. Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal art…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Common adverse reactions (events 2% greater than placebo): • 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 Camber Pharmaceuticals, Inc. at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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. Hypertension The following adverse reactions (events 2% greater on lisinopril than on placebo) were observed with lisinopril vs placebo: headache (5.7% vs 1.9%), dizziness (5.4% vs 1.9%), cough (3.5% vs 1.0%). Heart Failure In controlled studies in patients with heart failure, therapy was discontinued in 8.1% of patients treated with lisinopril for 12 weeks, compared to 7.7% of patients treated with placebo for 12 weeks.
The following adverse reactions (events 2% greater on lisinopril than on placebo) were observed with lisinopril vs placebo: hypotension (4.4% vs 0.6%), chest pain (3.4% vs 1.3%). In the ATLAS trial [see Clinical Studies (14.2)] in heart failure patients, withdrawals for adverse reactions were similar in the low- and high-dose groups. The following adverse reactions, mostly related to ACE inhibition, were reported more commonly in the high dose group: Table 1 Dose-related Adverse Drug Reactions: ATLAS trial High Dose (n=1568) Low Dose (n=1596) Dizziness 19% 12% Hypotension 11% 7% Creatinine increased 10% 7% Hyperkalemia 6% 4% Syncope 7% 5% Acute Myocardial Infarction Patients in the GISSI-3 study, treated with lisinopril, had a higher incidence of hypotension (9.0% vs 3.7%) and renal dysfunction (2.4% vs 1.1%) compared with patients not taking lisinopril.
Other clinical adverse reactions occurring in 1% or higher of patients with hypertension or heart failure treated with lisinopril in controlled clinical trials and do not appear in other sections of labeling are listed below: Body as a whole: Fatigue, asthenia, orthostatic effects. Digestive: Pancreatitis, constipation, flatulence, dry mouth, diarrhea. Hematologic: Rare cases of bone marrow depression, hemolytic anemia, leukopenia/neutropenia and thrombocytopenia.
Endocrine: Diabetes mellitus, inappropriate antidiuretic hormone secretion. Metabolic: Gout. Skin: Urticaria, alopecia, photosensitivity, erythema, flushing, diaphoresis, cutaneous pseudolymphoma, toxic epidermal necrolysis, Stevens -Johnson syndrome, and pruritus.
Special Senses: Visual loss, diplopia, blurred vision, tinnitus, photophobia, taste disturbances, olfactory disturbance. Urogenital: Impotence. Miscellaneous: A symptom complex has been reported which may include a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia, fever, vasculitis, eosinophilia, leukocytosis, paresthesia and vertigo.
Rash, photosensitivity or other dermatological manifestations may occur alone or in combination with these symptoms. Clinical Laboratory Test Findings Serum Potassium: In clinical trials hyperkalemia (serum potassium greater than 5.7 mEq/L) occurred in 2.2% and 4.8% of lisinopril-treated patients with hypertension and heart failure, respectively [see Warnings and Precautions (5.5)]. Creatinine, Blood Urea Nitrogen: Minor increases in blood urea nitrogen and serum creatinine, reversible upon discontinuation of therapy, were observed in about 2% of patients with hypertension treated with lisinopril alone.
Increases were more common in patients receiving concomitant diuretics and in patients with renal artery stenosis [see Warnings and Precautions (5.4)]. Reversible minor increases in blood urea nitrogen and serum creatinine were observed in 11.6% of patients with heart failure on concomitant diuretic therapy. Frequ…
🔄 Drug Interactions ▾
7 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, syncope, and hyperkalemia (7.4) • Lithium: Symptoms of lithium toxicity (7.5) • Gold: Nitritoid reactions (7.6)
7.1Diuretics Initiation of lisinopril in patients on diuretics may result in excessive reduction of blood pressure. The possibility of hypotensive effects with lisinopril can be minimized by either decreasing or discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with lisinopril. If this is not possible, reduce the starting dose of lisinopril [see Dosage and Administration (2.2) and Warnings and Precautions (5.4)].
Lisinopril attenuates potassium loss caused by thiazide-type diuretics. Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) can increase the risk of hyperkalemia. Therefore, if concomitant use of such agents is indicated, monitor the patient’s serum potassium frequently.
7.2Antidiabetics Concomitant administration of lisinopril and antidiabetic medicines (insulins, oral hypoglycemic agents) may cause an increased blood-glucose-lowering effect with risk of hypoglycemia.
7.3Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including lisinopril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving lisinopril and NSAID therapy.
The antihypertensive effect of ACE inhibitors, including lisinopril, may be attenuated by NSAIDs.
7.4Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. The Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial enrolled 1448 patients with type 2 diabetes, elevated urinaryalbumin- to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 ml/min), randomized them to lisinopril or placebo on a background of losartan therapy and followed them for a median of 2.2 years.
Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end stage renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on lisinopril and other agents that affect the RAS.
Do not co-administer aliskiren with lisinopril in patients with diabetes. Avoid use of aliskiren with lisinopril in patients with renal impairment (GFR <60 ml/min).
7.5Lithium Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs, which cause elimination of sodium, including ACE inhibitors. Lithium toxicity was usually reversible upon discontinuation of lithium and the ACE inhibitor. Monitor serum lithium levels during concurrent use.
7.6Gold Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including lisinopril.
7.7Mammalian Target of Rapamycin (mTOR) Inhibitors Patients taking concomitant mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Pregnancy: Discontinue lisinopril if pregnancy is detected. (5.1, 8.1) • Pediatrics: Safety and effectiveness have not been established in patients < 6 years of age or with glomerular filtration rate < 30 mL/min/7.73m 2 (8.4) • Race: Less antihypertensive effect in Blacks than non-Blacks (8.6)
8.1Pregnancy 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. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.
When pregnancy is detected, discontinue lisinopril as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the general U.S. population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly.
Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia and skeletal deformations, including skull hypoplasia, hypotension, and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus.
In patients taking lisinopril during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation. If oligohydramnios is observed, discontinue lisinopril, unless it is considered lifesaving for the mother.
Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to lisinopril for hypotension, oliguria, and hyperkalemia. In neonates with a history of in utero exposure to lisinopril, if oliguria or hypotension occurs, support blood pressure and renal perfusion.
Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.
8.2Lactation Risk Summary No data are available regarding the presence of lisinopril in human milk or the effects of lisinopril on the breast fed infant or on milk production. Lisinopril is present in rat milk. Because many drugs are secretsed in human milk, and because of the potential for serious adverse reactions in the brestfed infants from ACE inhibitors, discontinue breastfeeding or discontinue lisinopril.
8.4Pediatric Use Antihypertensive effects and safety of lisinopril have been established in pediatric patients aged 6 to 16 years [see Dosage and Administration (2.1) and Clinical Studies (14.1)]. 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…
🤰 Pregnancy ▾
8.1Pregnancy 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. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.
When pregnancy is detected, discontinue lisinopril as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the general U.S. population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly.
Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia and skeletal deformations, including skull hypoplasia, hypotension, and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus.
In patients taking lisinopril during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation. If oligohydramnios is observed, discontinue lisinopril, unless it is considered lifesaving for the mother.
Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to lisinopril for hypotension, oliguria, and hyperkalemia. In neonates with a history of in utero exposure to lisinopril, if oliguria or hypotension occurs, support blood pressure and renal perfusion.
Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.
🧒 Pediatric Use ▾
8.4Pediatric Use Antihypertensive effects and safety of lisinopril have been established in pediatric patients aged 6 to 16 years [see Dosage and Administration (2.1) and Clinical Studies (14.1)]. 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 Clinical Pharmacology (12.3), and Clinical Studies (14.1)].
🧓 Geriatric Use ▾
8.5Geriatric Use 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. No other differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
🆘 Overdosage ▾
10 OVERDOSAGE 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 Warnings and Precautions (5.2)].
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Lisinopril inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex.
The beneficial effects of lisinopril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin II which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase of serum potassium.
In hypertensive patients with normal renal function treated with lisinopril alone for up to 24 weeks, the mean increase in serum potassium was approximately 0.1 mEq/L; however, approximately 15% of patients had increases greater than 0.5 mEq/L and approximately 6% had a decrease greater than 0.5 mEq/L. In the same study, patients treated with lisinopril and hydrochlorothiazide for up to 24 weeks had a mean decrease in serum potassium of 0.1 mEq/L; approximately 4% of patients had increases greater than 0.5 mEq/L and approximately 12% had a decrease greater than 0.5 mEq/L [see Warnings and Precautions (5.5)].
Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity. ACE is identical to kininase, an enzyme that degrades bradykinin. Whether increased levels of bradykinin, a potent vasodepressor peptide, play a role in the therapeutic effects of lisinopril remains to be elucidated.
While the mechanism through which lisinopril lowers blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, lisinopril is antihypertensive even in patients with low-renin hypertension. Although lisinopril was antihypertensive in all races studied, Black hypertensive patients (usually a low-renin hypertensive population) had a smaller average response to monotherapy than non Black patients. Concomitant administration of lisinopril and hydrochlorothiazide further reduced blood pressure in Black and non-Black patients and any racial differences in blood pressure response were no longer evident.
12.2Pharmacodynamics Hypertension Adult Patients: Administration of lisinopril to patients with hypertension results in a reduction of both supine and standing blood pressure to about the same extent with no compensatory tachycardia. Symptomatic postural hypotension is usually not observed although it can occur and should be anticipated in volume and/or salt-depleted patients [see Warnings and Precautions (5.3)]. When given together with thiazide-type diuretics, the blood pressure lowering effects of the two drugs are approximately additive.
In most patients studied, onset of antihypertensive activity was seen at one hour after oral administration of an individual dose of lisinopril, with peak reduction of blood pressure achieved by 6 hours. Although an antihypertensive effect was observed 24 hours after dosing with recommended single daily doses, the effect was more consistent and the mean effect was considerably larger in some studies with doses of 20 mg or more than with lower doses; however, at all doses studied, the mean antihypertensive effect was substantially smaller 24 hours after dosing than it was 6 hours after dosing.
The antihypertensive effects of lisinopril are maintained during long-term therapy. Abrupt withdrawal of lisinopril has not been associated with a rapid increase in blood pressure, or a significant increase in blood pressure compared to pretreatment levels.
12.3Pharmacokinetics Adult Patients: Following oral administration of lisinopril, peak serum concentrations of lisinopril occur within about 7 hours, although there was a trend to a small delay in time taken to reach peak serum concentrations in acute myocardial infarction patients. Food does…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Lisinopril inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex.
The beneficial effects of lisinopril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin II which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase of serum potassium.
In hypertensive patients with normal renal function treated with lisinopril alone for up to 24 weeks, the mean increase in serum potassium was approximately 0.1 mEq/L; however, approximately 15% of patients had increases greater than 0.5 mEq/L and approximately 6% had a decrease greater than 0.5 mEq/L. In the same study, patients treated with lisinopril and hydrochlorothiazide for up to 24 weeks had a mean decrease in serum potassium of 0.1 mEq/L; approximately 4% of patients had increases greater than 0.5 mEq/L and approximately 12% had a decrease greater than 0.5 mEq/L [see Warnings and Precautions (5.5)].
Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity. ACE is identical to kininase, an enzyme that degrades bradykinin. Whether increased levels of bradykinin, a potent vasodepressor peptide, play a role in the therapeutic effects of lisinopril remains to be elucidated.
While the mechanism through which lisinopril lowers blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, lisinopril is antihypertensive even in patients with low-renin hypertension. Although lisinopril was antihypertensive in all races studied, Black hypertensive patients (usually a low-renin hypertensive population) had a smaller average response to monotherapy than non Black patients. Concomitant administration of lisinopril and hydrochlorothiazide further reduced blood pressure in Black and non-Black patients and any racial differences in blood pressure response were no longer evident.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Lisinopril Tablets USP 2.5 mg are white colored, round, flat faced beveled edge tablets, debossed with "E 1" on one side and plain on the other side. Unit of Use Bottles of 90: 2.5mg (NDC 68645-608-90) Lisinopril Tablets USP 5 mg are pink colored, round, flat faced beveled edge tablets, debossed with "E 2" and separated by scored line on one side and plain on the other side. Unit of Use Bottles of 90: 5mg (NDC 68645-609-90) Lisinopril Tablets USP 10 mg are pink colored, round, flat faced beveled edge tablets, debossed with "E 3" on one side and plain on the other side.
Unit of Use Bottles of 90: 10mg (NDC 68645-610-90) Lisinopril Tablets USP 20 mg are red colored, round, flat faced beveled edge tablets, debossed with "E 4" on one side and plain on the other side. Unit of Use Bottles of 90: 20mg (NDC 68645-611-90) Lisinopril Tablets USP 30 mg are red colored, round, flat faced beveled edge tablets, debossed with "E 5" on one side and plain on the other side. Unit of Use Bottles of 90: 30mg (NDC 68645-612-90) Lisinopril Tablets USP 40 mg are yellow colored, round, biconvex tablets, debossed with "E 6" on one side and plain on the other side.
Unit of Use Bottles of 90: 40mg (NDC 68645-613-90) 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.
📋 Description ▾
11 DESCRIPTION Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as 1-[N2-[( S )-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 is a white crystalline powder, with a molecular weight of 441.52.
It is soluble in water, sparingly soluble in methanol, practically insoluble in alcohol, in acetone, in acetonitrile and in chloroform. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, mannitol and pregelatinized starch (maize).
In addition 5 mg, 10 mg, 20 mg and 30 mg tablets contain ferric oxide red, and 40 mg tablets contain ferric oxide yellow. structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION 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: Tell female patients of childbearing age about the consequences of exposure to lisinopril during pregnancy.
Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible. Angioedema: Angioedema, including laryngeal edema, may occur at any time during treatment with angiotensin converting enzyme inhibitors, including lisinopril.
Tell patients to report immediately any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing) and to take no more drug until they have consulted with the prescribing physician. Symptomatic Hypotension: Tell patients to report light-headedness especially during the first few days of therapy. If actual syncope occurs, tell the patient to discontinue the drug until they have consulted with the prescribing physician.
Tell patients that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume. Other causes of volume depletion such as vomiting or diarrhea may also lead to a fall in blood pressure; advise patients accordingly. Hyperkalemia: Tell patients not to use salt substitutes containing potassium without consulting their physician.
Hypoglycemia: Tell diabetic patients treated with oral antidiabetic agents or insulin starting an ACE inhibitor to monitor for hypoglycaemia closely, especially during the first month of combined use [see Drug Interactions (7.2)]. Leukopenia/Neutropenia: Tell patients to report promptly any indication of infection (e.g., sore throat, fever), which may be a sign of leukopenia/neutropenia. Manufactured for: Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854. Manufactured by: Evaric Pharmaceuticals Inc. 155 Commerce Drive, Hauppauge, New York 11788, United States (USA).
Distributed by: Wal-Mart Bentonville, AR 72716 Packaged by: Legacy Pharmaceutical Packaging LLC 13333 Lakefront Drive Earth City, MO 63045 Revised: 02/2022 camberlogo