Lisinopril 40 mg Tablet, 30-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Angiotensin Converting Enzyme Inhibitor class.
Where does this data come from?
🏭 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 L11K75P92J
A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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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.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1245 | $3.74 / 30 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lisinopril 40 mg 68180-0517-01 | Lupin | 100 tablets | $0.046 | AB | Discontinued | — |
| Lisinopril 40 mg 00591-0409-01 | Actavis | 100 tablets | $0.046 | — | Availability likely | — |
| Lisinopril 40 mg 00904-7200-61 | Major | 100 tablets | $0.046 | AB | Availability likely | — |
| lisinopril 40 mg 23155-0881-01 | Heritage | 100 tablets | $0.046 | AB | Availability likely | — |
| Lisinopril 40 mg 31722-0180-01 | Camber | 100 tablets | $0.046 | AB | Availability likely | — |
| Lisinopril 40 mg 43547-0356-10 | Solco | 100 tablets | $0.046 | AB | Availability likely | — |
| Lisinopril 40 mg 60687-0678-01 | American | 100 tablets | $0.046 | AB | Availability likely | — |
| Lisinopril 40 mg 62135-0645-31 | Chartwell | 300 tablets | $0.046 | AB | Availability likely | — |
| Lisinopril 40 mg 68001-0486-00 | BluePoint | 100 tablets | $0.046 | AB | Availability likely | — |
| Lisinopril 40 mg 68180-0979-01 | Lupin | 100 tablets | $0.046 | AB | Availability likely | — |
| Lisinopril 40 mg 68645-0613-90 | Legacy | 90 tablets | $0.046 | AB | Availability likely | — |
| lisinopril 40 mg 76282-0422-01 | Exelan | 100 tablets | $0.046 | AB | Availability likely | — |
| Lisinopril 40 mg 76282-0733-01 | Exelan | 100 tablets | $0.046 | AB | Availability likely | — |
| Lisinopril 40 mg 82009-0066-10 | Quallent | 1000 tablets | $0.046 | AB | Availability likely | — |
| Lisinopril 40 mg 00615-8405-05 | NCS | 15 tablets | — | AB | FDA listed | — |
| Zestril 40 mg 24979-0243-07 | Upsher-Smith | 90 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 42708-0033-30 | QPharma | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 42708-0096-30 | QPharma, | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 42708-0176-30 | QPharma, | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 43063-0800-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 43063-0815-01 | PD-Rx | 100 tablets | — | AB | FDA listed | — |
| lisinopril 40 mg 43353-0009-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 43547-0419-04 | Solco | 45 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 50090-3763-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 50090-7074-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 50090-7650-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 51655-0146-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 51655-0335-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 55700-0547-30 | Quality | 30 tablets | — | AB | Discontinued | — |
| Lisinopril 40 mg 60760-0360-30 | St. | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mgthis 63187-0237-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 63187-0825-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 65862-0042-00 | Aurobindo | 100 tablets | — | — | FDA listed | — |
| Lisinopril 40 mg 68071-3064-02 | NuCare | 120 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 68071-3220-01 | NuCare | 100 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 68788-7012-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 70518-1565-02 | REMEDYREPACK | 100 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 70518-3166-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 71335-0075-01 | Bryant | 30 tablets | — | AB | Discontinued | — |
| Lisinopril 40 mg 71610-0406-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 71610-0624-45 | Aphena | 45 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 71610-0727-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 72865-0213-01 | XLCare | 100 tablets | — | AB | FDA listed | — |
| Lisinopril 40 mg 76420-0345-00 | Asclemed | 1000 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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63187-0237-30 You're viewing this | 30 TABLET in 1 BOTTLE (63187-237-30) | 2014-11-03 | Active |
| 63187-0237-60 | 60 TABLET in 1 BOTTLE (63187-237-60) | 2014-11-03 | Active |
| 63187-0237-90 | 90 TABLET in 1 BOTTLE (63187-237-90) | 2014-11-03 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 63187-0237-30?
What is the difference between NDC 63187-0237-30 and NDC 63187-0237-60?
What NDC number is used to bill for this package of Lisinopril 40 mg Tablet?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue lisinopril as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: FETAL TOXICITY .
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Hypertension Lisinopril tablets USP are indicated for the treatment of hypertension 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 including lisinopril.
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 USP may be administered alone or with other antihypertensive agents.
Heart Failure Lisinopril tablets USP are indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis. Acute Myocardial Infarction Lisinopril tablets USP are indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers.
In using lisinopril tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril tablets USP does not have a similar risk. (See WARNINGS ). In considering the use of lisinopril tablets USP, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in Black patients than in non-Blacks.
In addition, ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients (see WARNINGS, Anaphylactoid and Possibly Related Reactions ).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Hypertension Initial Therapy: In patients with uncomplicated essential hypertension not on diuretic therapy, 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 to 40 mg per day administered in a single daily dose.
The antihypertensive effect may diminish toward the end of the dosing interval regardless of the administered dose, but most commonly with a dose of 10 mg daily. This can be evaluated by measuring blood pressure just prior to dosing to determine whether satisfactory control is being maintained for 24 hours. If it is not, an increase in dose should be considered.
Doses up to 80 mg have been used but do not appear to give greater effect. If blood pressure is not controlled with lisinopril tablet alone, a low dose of a diuretic may be added. Hydrochlorothiazide, 12.5 mg has been shown to provide an additive effect.
After the addition of a diuretic, it may be possible to reduce the dose of lisinopril. Diuretic Treated Patients: In hypertensive patients who are currently being treated with a diuretic, symptomatic hypotension may occur occasionally following the initial dose of lisinopril tablet. The diuretic should be discontinued, if possible, for two to three days before beginning therapy with lisinopril tablet to reduce the likelihood of hypotension (See WARNINGS ).
The dosage of lisinopril tablet should be adjusted according to blood pressure response. If the patient's blood pressure is not controlled with lisinopril tablet alone, diuretic therapy may be resumed as described above. If the diuretic cannot be discontinued, an initial dose of 5 mg should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (See WARNINGS and PRECAUTIONS, Drug Interactions ).
Concomitant administration of lisinopril with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics may lead to increases of serum potassium (See PRECAUTIONS ). Dosage Adjustment in Renal Impairment: The usual dose of lisinopril tablet (10 mg) is recommended for patients with creatinine clearance > 30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance ≥ 10 mL/min ≤ 30 mL/min (serum creatinine ≥ 3 mg/dL), the first dose is 5 mg once daily.
For patients with creatinine clearance < 10 mL/min (usually on hemodialysis) the recommended initial dose is 2.5 mg. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily. Renal Status Creatinine Clearance mL/min Initial Dose mg/day Normal Renal Function to Mild Impairment >30 10 Moderate to Severe Impairment ≥10 ≤30 5 Dialysis Patients See WARNINGS, Anaphylactoid Reactions During Membrane Exposure. <10
2.5Dosage or dosing interval should be adjusted depending on the blood pressure response. Heart Failure: Lisinopril tablet is indicated as adjunctive therapy with diuretics and (usually) digitalis. The recommended starting dose is 5 mg once a day.
When initiating treatment with lisinopril in patients with heart failure, the initial dose should be administered under medical observation, especially in those patients with low blood pressure (systolic blood pressure below 100 mmHg). The mean peak blood pressure lowering occurs six to eight hours after dosing. Observation should continue until blood pressure is stable.
The concomitant diuretic dose should be reduced, if possible, to help minimize hypovolemia which may contribute to hypotension. (See WARNINGS and PRECAUTIONS, Drug Interactions ). The appearance of hypotension after the initial dose of lisinopril tablet does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
The usual effective dosage range is 5 to 40 mg per day administered as a single daily dose. The dose of lisinopril can be increased by increments of…
⛔ Contraindications ▾
CONTRAINDICATIONS Lisinopril tablets are contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema.
⚠️ Warnings ▾
WARNINGS Anaphylactoid and Possibly Related Reactions Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including lisinopril) may be subject to a variety of adverse reactions, some of them serious. Head and Neck Angioedema Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with angiotensin converting enzyme inhibitors, including lisinopril.
This may occur at any time during treatment. ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients. Lisinopril should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms has occurred.
Even in those instances where swelling of only the tongue is involved, without respiratory distress, patients may require prolonged observation since treatment with antihistamines and corticosteroids may not be sufficient. Very rarely, fatalities have been reported due to angioedema associated with laryngeal edema or tongue edema. Patients with involvement of the tongue, glottis or larynx are likely to experience airway obstruction, especially those with a history of airway surgery.
Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, e.g., subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) and/or measures necessary to ensure a patent airway should be promptly provided (See ADVERSE REACTIONS ). Intestinal Angioedema Intestinal angioedema has been reported 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.
The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound or at surgery and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain. Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor (see also INDICATIONS AND USAGE and CONTRAINDICATIONS ).
Anaphylactoid Reactions During Desensitization Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. In the same patients, these reactions were avoided when ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge. Anaphylactoid Reactions During Membrane Exposure Sudden and potentially life-threatening anaphylactoid reactions have been reported in some patients dialyzed with high-flux membranes (e.g., AN69 ® *) 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. *AN69 ® is a registered trademark of Hospal Ltd. Hypotension Excessive hypotension is rare in patients with uncomplicated hypertension treated with lisinopril alone. Patients with heart failure given lisinopril commonly have some reduction in blood pressure, with peak blood pressure reduction occurring 6 to 8 hours post dose.
Evidence from the two-dose ATLAS trial suggested that incidence of hypotension may increase with dose of lisinopril in heart failure patients. Discontinuation of therapy because…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Lisinopril has been found to be generally well tolerated in controlled clinical trials involving 1969 patients with hypertension or heart failure. For the most part, adverse experiences were mild and transient. Hypertension In clinical trials in patients with hypertension treated with lisinopril, discontinuation of therapy due to clinical adverse experiences occurred in 5.7% of patients.
The overall frequency of adverse experiences could not be related to total daily dosage within the recommended therapeutic dosage range. For adverse experiences occurring in greater than 1% of patients with hypertension treated with lisinopril or lisinopril plus hydrochlorothiazide in controlled clinical trials, and more frequently with lisinopril and/or lisinopril plus hydrochlorothiazide than placebo, comparative incidence data are listed in the table below: PERCENT OF PATIENTS IN CONTROLLED STUDIES Lisinopril (n=1349) Incidence (discontinuation) Lisinopril/ Hydrochlorothiazide (n=629) Incidence (discontinuation) Placebo (n=207) Incidence (discontinuation) Body as a Whole Fatigue 2.5 (0.3) 4.0 (0.5) 1.0 (0.0) Asthenia 1.3 (0.5) 2.1 (0.2) 1.0 (0.0) Orthostatic Effects 1.2 (0.0) 3.5 (0.2) 1.0 (0.0) Cardiovascular Hypotension 1.2 (0.5) 1.6 (0.5) 0.5 (0.5) Digestive Diarrhea 2.7 (0.2) 2.7 (0.3) 2.4 (0.0) Nausea 2.0 (0.4) 2.5 (0.2) 2.4 (0.0) Vomiting 1.1 (0.2) 1.4 (0.1) 0.5 (0.0) Dyspepsia 0.9 (0.0) 1.9 (0.0) 0.0 (0.0) Musculoskeletal Muscle Cramps 0.5 (0.0) 2.9 (0.8) 0.5 (0.0) Nervous/Psychiatric Headache 5.7 (0.2) 4.5 (0.5) 1.9 (0.0) Dizziness 5.4 (0.4) 9.2 (1.0) 1.9 (0.0) Paresthesia 0.8 (0.1) 2.1 (0.2) 0.0 (0.0) Decreased Libido 0.4 (0.1) 1.3 (0.1) 0.0 (0.0) Vertigo 0.2 (0.1) 1.1 (0.2) 0.0 (0.0) Respiratory Cough 3.5 (0.7) 4.6 (0.8) 1.0 (0.0) Upper Respiratory Infection 2.1 (0.1) 2.7 (0.1) 0.0 (0.0) Common Cold 1.1 (0.1) 1.3 (0.1) 0.0 (0.0) Nasal Congestion 0.4 (0.1) 1.3 (0.1) 0.0 (0.0) Influenza 0.3 (0.1) 1.1 (0.1) 0.0 (0.0) Skin Rash 1.3 (0.4) 1.6 (0.2) 0.5 (0.5) Urogenital Impotence 1.0 (0.4) 1.6 (0.5) 0.0 (0.0) Chest pain and back pain were also seen, but were more common on placebo than lisinopril.
Heart Failure In patients with heart failure treated with lisinopril for up to four years, discontinuation of therapy due to clinical adverse experiences occurred in 11% of patients. 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 table lists those adverse experiences which occurred in greater than 1% of patients with heart failure treated with lisinopril or placebo for up to 12 weeks in controlled clinical trials, and more frequently on lisinopril than placebo.
Controlled Trials Lisinopril (n=407) Incidence (discontinuation) 12 weeks Placebo (n=155) Incidence (discontinuation) 12 weeks Body as a Whole Chest Pain Abdominal Pain 3.4 (0.2) 2.2 (0.7) 1.3 (0.0) 1.9 (0.0) Cardiovascular Hypotension 4.4 (1.7) 0.6 (0.6) Digestive Diarrhea 3.7 (0.5) 1.9 (0.0) Nervous/Psychiatric Dizziness Headache 11.8 (1.2) 4.4 (0.2) 4.5 (1.3) 3.9 (0.0) Respiratory Upper Respiratory Infection 1.5 (0.0) 1.3 (0.0) Skin Rash 1.7 (0.5) 0.6 (0.6) Also observed at > 1% with lisinopril but more frequent or as frequent on placebo than lisinopril in controlled trials were asthenia, angina pectoris, nausea, dyspnea, cough, and pruritus.
Worsening of heart failure, anorexia, increased salivation, muscle cramps, back pain, myalgia, depression, chest sound abnormalities, and pulmonary edema were also seen in controlled clinical trials, but were more common on placebo than lisinopril. In the two-dose ATLAS trial in heart failure patients, withdrawals due to adverse events were not different between the low and high groups, either in total number of discontinuation (17-18%) or in rare specific events (<1%). The following adverse events, mostly related to ACE inhibition, were reported more commonly in…
🔄 Drug Interactions ▾
Drug Interactions Hypotension - Patients on Diuretic Therapy Patients on diuretics and especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with lisinopril. The possibility of hypotensive effects with lisinopril can be minimized by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with lisinopril. If it is necessary to continue the diuretic, initiate therapy with lisinopril at a dose of 5 mg daily, and provide close medical supervision after the initial dose until blood pressure has stabilized (See WARNINGS , and DOSAGE AND ADMINISTRATION ).
When a diuretic is added to the therapy of a patient receiving lisinopril, an additional antihypertensive effect is usually observed. Studies with ACE inhibitors in combination with diuretics indicate that the dose of the ACE inhibitor can be reduced when it is given with a diuretic. (See DOSAGE AND ADMINISTRATION ).
Antidiabetics Epidemiological studies have suggested that concomitant administration of ACE inhibitors and antidiabetic medicines (insulins, oral hypoglycemic agents) may cause an increased blood-glucose-lowering effect with risk of hypoglycemia. This phenomenon appeared to be more likely to occur during the first weeks of combined treatment and in patients with renal impairment. In diabetic patients treated with oral antidiabetic agents or insulin, glycemic control should be closely monitored for hypoglycemia, especially during the first month of treatment with an ACE inhibitor.
Non-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, co-administration 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. Dual 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. 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). Other Agents Lisinopril has been used concomitantly with nitrates and/or digoxin without evidence of clinically significant adverse interactions.
This included post myocardial infarction patients who were receiving intravenous or transdermal nitroglycerin. No clinically important pharmacokinetic interactions occurred when lisinopril was used concomitantly with propranolol or hydrochlorothiazide. The presence of food in the stomach does not alter the bioavailability of lisinopril.
Agents Increasing Serum Potassium Lisinopril attenuates potassium loss caused by thiazide-type diuretics. Use of lisinopril with potassium-sparing diuretics (e.g., spironolactone, eplerenone, triamterene or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. Therefore, if concomitant use of these agents is indicated because of demonstrated hypokalemia, they should be used with caution and with frequent monitoring of serum potassium.
Potassium -sparing agents should generally not be used in patients with heart failure who are receiving lisinopril. Lithium Lithium toxicity has been rep…
🆘 Overdosage ▾
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, Anaphylactoid Reactions During Membrane Exposure ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism 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 PRECAUTIONS ). 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. Pharmacokinetics and Metabolism 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. Declining serum concentrations exhibit a prolonged terminal phase which does not contribute to drug accumulation.
This terminal phase probably represents saturable binding to ACE and is not proportional to dose. Lisinopril does not appear to be bound to other serum proteins. Lisinopril does not undergo metabolism and is excreted unchanged entirely in the urine.
Based on urinary recovery, the mean extent of absorption of lisinopril is approximately 25%, with large intersubject variability (6%-60%) at all doses tested (5-80 mg). Lisinopril absorption is not influenced by the presence of food in the gastrointestinal tract. The absolute bioavailability of lisinopril is reduced to 16% in patients with stable NYHA Class II-IV congestive heart failure, and the volume of distribution appears to be slightly smaller than that in normal subjects.
The oral bioavailability of lisinopril in patients with acute myocardial infarction is similar to that in healthy volunteers. Upon multiple dosing, lisinopril exhibits an effective half-life of accumulation of 12 hours. Impaired renal function decreases elimination of lisinopril, which is excreted principally through the kidneys, but this decrease becomes clinically important only when the glomerular filtration rate is below 30 mL/min.
Above this glomerular filtration rate, the elimination half-life is little changed. With greater impairment, however, peak and trough lisinopril…
🧬 Mechanism of Action ▾
Mechanism 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 PRECAUTIONS ). 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 ▾
HOW SUPPLIED Lisinopril Tablets, USP are available as: 10 mg tablet is a pink coloured, round, biconvex, uncoated, tablet with "LUPIN" debossed on one side and "10" on other side. They are available as follows: Bottles of 30 NDC 63187-098-30 Bottles of 60 NDC 63187-098-60 Bottles of 90 NDC 63187-098-90 20 mg tablet is a pink coloured, round, biconvex, uncoated, tablet with "LUPIN" debossed on one side and "20" on other side. They are available as follows: Bottles of 30 NDC 63187-257-30 Bottles of 60 NDC 63187-257-60 Bottles of 90 NDC 63187-257-90 40 mg tablet is a yellow coloured, round, biconvex, uncoated, tablet with "LUPIN" debossed on one side and "40" on other side.
They are available as follows: Bottles of 30 NDC 63187-237-30 Bottles of 60 NDC 63187-237-60 Bottles of 90 NDC 63187-237-90 Storage: Store at 20º to 25ºC (68º to 77ºF)[see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.
📋 Description ▾
DESCRIPTION Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, 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 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: 2.5 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, starch.
5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, red iron oxide, starch. 40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, starch, yellow iron oxide. Lisinopril USP
💬 Information for Patients ▾
Information for Patients Angioedema Angioedema, including laryngeal edema, may occur at any time during treatment with angiotensin-converting enzyme inhibitors, including lisinopril. Patients should be so advised and told 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 Patients should be cautioned to report lightheadedness especially during the first few days of therapy.
If actual syncope occurs, the patient should be told to discontinue the drug until they have consulted with the prescribing physician. All patients should be cautioned 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; patients should be advised to consult with their physician.
Hyperkalemia Patients should be told not to use salt substitutes containing potassium without consulting their physician. Hypoglycemia Diabetic patients treated with oral antidiabetic agents or insulin starting an ACE inhibitor should be told to closely monitor for hypoglycemia, especially during the first month of combined use. (See PRECAUTIONS, Drug Interactions .) Leukopenia/Neutropenia Patients should be told to report promptly any indication of infection (e.g., sore throat, fever) which may be a sign of leukopenia/neutropenia.
Pregnancy Female patients of childbearing age should be told about the consequences of exposure to lisinopril during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
NOTE: As with many other drugs, certain advice to patients being treated with lisinopril is warranted. 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.