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Lisinopril

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Overview

What is Lisinopril?

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What does Lisinopril look like?



What are the available doses of Lisinopril?

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What should I talk to my health care provider before I take Lisinopril?

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There are no data on the effect of lisinopril on blood pressure in pediatric patients under the age 6 or in pediatric patients with glomerular filtration rate less than 30 mL/min/1.73 m (See and , and .)

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In the ATLAS trial of lisinopril in patients with congestive heart failure, 1,596 (50%) were 65 and over, while 437 (14%) were 75 and over. In a clinical study of lisinopril in patients with myocardial infarctions 4,413 (47%) were 65 and over, while 1,656 (18%) were 75 and over.  In these studies, no overall differences in safety or effectiveness were observed between elderly and younger patients, and other reported clinical experiences has not identified differences in responses between the elderly and younger patients (see and ).

Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Pharmacokinetic studies indicate that maximum blood levels and area under the plasma concentration time curve (AUC) are doubled in older patients (see ).

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection.  Evaluation of patients with hypertension, congestive heart failure, or myocardial infarction should always include assessment of renal function (see ).

How should I use Lisinopril?

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 does not have a similar risk. (See ).

In considering the use of lisinopril tablets, 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 ).

Initial Therapy:

Diuretic Treated Patients:

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 and ).

Concomitant administration of lisinopril with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics may lead to increases of serum potassium (See ).

Dosage Adjustment in Renal Impairment:

Heart Failure:

The usual effective dosage range is 5 to 40 mg per day administered as a single daily dose. The dose of lisinopril tablets can be increased by increments of no greater than 10 mg, at intervals of no less than 2 weeks to the highest tolerated dose, up to a maximum of 40 mg daily. Dose adjustment should be based on the clinical response of individual patients.

Dosage Adjustment in Patients with Heart Failure and Renal Impairment or Hyponatremia:

Acute Myocardial Infarction:

Patients with a low systolic blood pressure (≤ 120 mmHg) when treatment is started or during the first 3 days after the infarct should be given a lower 2.5 mg oral dose of lisinopril tablet (see ). If hypotension occurs (systolic blood pressure ≤ 100 mmHg) a daily maintenance( dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure less than 90 mmHg for more than 1 hour) lisinopril tablet should be withdrawn. For patients who develop symptoms of heart failure, see .

Dosage Adjustment in Patients With Myocardial Infarction with Renal Impairment:

Use in Elderly:

Pediatric Hypertensive Patients ≥ 6 years of age:

Lisinopril is not recommend in pediatric patients less than 6 years or in pediatric patients with glomerular filtration rate less than 30 mL/min/1.73 min (see and and ).


What interacts with Lisinopril?

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What are the warnings of Lisinopril?

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What are the precautions of Lisinopril?

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What are the side effects of Lisinopril?

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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:

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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.

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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 (less than 1%).  The following adverse events, mostly related to ACE inhibition, were reported more commonly in the high dose group:  

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Patients treated with lisinopril had a significantly higher incidence of hypotension and renal dysfunction compared with patients not taking lisinopril.

In the GISSI-3 trial, hypotension (9.7%), renal dysfunction (2%), cough (0.5%), post infarction angina (0.3%), skin rash and generalized edema (0.01%), and angioedema (0.01%) resulted in withdrawal of treatment. In elderly patients treated with lisinopril, discontinuation due to renal dysfunction was 4.2%.

Other clinical adverse experiences occurring in 0.3% to 1.0% of patients with hypertension or heart failure treated with lisinopril in controlled clinical trials and rarer, serious, possibly drug-related events reported in uncontrolled studies or marketing experience are listed below, and within each category are in order of decreasing severity:

Body as a Whole

Anaphylactoid reactions (see , ), syncope, orthostatic effects, chest discomfort, pain, pelvic pain, flank pain, edema, facial edema, virus infection, fever, chills, malaise.

Cardiovascular:

Digestive:

Hematologic:

Endocrine:

Metabolic:

Musculoskeletal:

Nervous System/Psychiatric:

Respiratory System:

Skin:

Special Senses:

Urogenital System:

Miscellaneous:

Angioedema:

In rare cases, intestinal angioedema has been reported in post marketing experience.

Hypotension:

Fetal/Neonatal Morbidity and Mortality:

Cough:

Pediatric Patients:

PERCENT OF PATIENTS IN CONTROLLED STUDIES
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)
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 PainAbdominal Pain 3.4 (0.2)2.2 (0.7) 1.3 (0.0)1.9 (0.0)
Hypotension 4.4 (1.7) 0.6 (0.6)
Diarrhea 3.7 (0.5) 1.9 (0.0)
DizzinessHeadache 11.8 (1.2)4.4 (0.2) 4.5 (1.3)3.9 (0.0)
Upper Respiratory Infection 1.5 (0.0) 1.3 (0.0)
Rash 1.7 (0.5) 0.6 (0.6)
Dizziness 18.9 12.1
Hypotension 10.8 6.7
Creatinine-increased 9.9 7.0
Hyperkalemia 6.4 3.5
NPN* increased 9.2 6.5
Syncope 7.0 5.1



What should I look out for while using Lisinopril?

Sorry No records found


What might happen if I take too much Lisinopril?

Lisinopril can be removed by hemodialysis (See ).


How should I store and handle Lisinopril?

10 mg Bottles of 30              NDC 67296-0622-1Bottles of 60              NDC 67296-0622-2 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.Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United States.  Manufactured by:Lupin LimitedGoa 403 722INDIA.OrLupin LimitedPithampur (M.P.) 454 775INDIA.Revised: 15 April 2011                                                                  ID#: 22465210 mg Bottles of 30              NDC 67296-0622-1Bottles of 60              NDC 67296-0622-2 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.Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United States.  Manufactured by:Lupin LimitedGoa 403 722INDIA.OrLupin LimitedPithampur (M.P.) 454 775INDIA.Revised: 15 April 2011                                                                  ID#: 22465210 mg Bottles of 30              NDC 67296-0622-1Bottles of 60              NDC 67296-0622-2 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.Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United States.  Manufactured by:Lupin LimitedGoa 403 722INDIA.OrLupin LimitedPithampur (M.P.) 454 775INDIA.Revised: 15 April 2011                                                                  ID#: 22465210 mg Bottles of 30              NDC 67296-0622-1Bottles of 60              NDC 67296-0622-2 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.Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United States.  Manufactured by:Lupin LimitedGoa 403 722INDIA.OrLupin LimitedPithampur (M.P.) 454 775INDIA.Revised: 15 April 2011                                                                  ID#: 22465210 mg Bottles of 30              NDC 67296-0622-1Bottles of 60              NDC 67296-0622-2 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.Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United States.  Manufactured by:Lupin LimitedGoa 403 722INDIA.OrLupin LimitedPithampur (M.P.) 454 775INDIA.Revised: 15 April 2011                                                                  ID#: 22465210 mg Bottles of 30              NDC 67296-0622-1Bottles of 60              NDC 67296-0622-2 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.Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United States.  Manufactured by:Lupin LimitedGoa 403 722INDIA.OrLupin LimitedPithampur (M.P.) 454 775INDIA.Revised: 15 April 2011                                                                  ID#: 22465210 mg Bottles of 30              NDC 67296-0622-1Bottles of 60              NDC 67296-0622-2 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.Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United States.  Manufactured by:Lupin LimitedGoa 403 722INDIA.OrLupin LimitedPithampur (M.P.) 454 775INDIA.Revised: 15 April 2011                                                                  ID#: 22465210 mg Bottles of 30              NDC 67296-0622-1Bottles of 60              NDC 67296-0622-2 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.Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United States.  Manufactured by:Lupin LimitedGoa 403 722INDIA.OrLupin LimitedPithampur (M.P.) 454 775INDIA.Revised: 15 April 2011                                                                  ID#: 22465210 mg Bottles of 30              NDC 67296-0622-1Bottles of 60              NDC 67296-0622-2 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.Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United States.  Manufactured by:Lupin LimitedGoa 403 722INDIA.OrLupin LimitedPithampur (M.P.) 454 775INDIA.Revised: 15 April 2011                                                                  ID#: 22465210 mg Bottles of 30              NDC 67296-0622-1Bottles of 60              NDC 67296-0622-2 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.Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United States.  Manufactured by:Lupin LimitedGoa 403 722INDIA.OrLupin LimitedPithampur (M.P.) 454 775INDIA.Revised: 15 April 2011                                                                  ID#: 22465210 mg Bottles of 30              NDC 67296-0622-1Bottles of 60              NDC 67296-0622-2 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.Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United States.  Manufactured by:Lupin LimitedGoa 403 722INDIA.OrLupin LimitedPithampur (M.P.) 454 775INDIA.Revised: 15 April 2011                                                                  ID#: 22465210 mg Bottles of 30              NDC 67296-0622-1Bottles of 60              NDC 67296-0622-2 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.Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United States.  Manufactured by:Lupin LimitedGoa 403 722INDIA.OrLupin LimitedPithampur (M.P.) 454 775INDIA.Revised: 15 April 2011                                                                  ID#: 22465210 mg Bottles of 30              NDC 67296-0622-1Bottles of 60              NDC 67296-0622-2 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.Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United States.  Manufactured by:Lupin LimitedGoa 403 722INDIA.OrLupin LimitedPithampur (M.P.) 454 775INDIA.Revised: 15 April 2011                                                                  ID#: 22465210 mg Bottles of 30              NDC 67296-0622-1Bottles of 60              NDC 67296-0622-2 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.Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United States.  Manufactured by:Lupin LimitedGoa 403 722INDIA.OrLupin LimitedPithampur (M.P.) 454 775INDIA.Revised: 15 April 2011                                                                  ID#: 22465210 mg Bottles of 30              NDC 67296-0622-1Bottles of 60              NDC 67296-0622-2 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.Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United States.  Manufactured by:Lupin LimitedGoa 403 722INDIA.OrLupin LimitedPithampur (M.P.) 454 775INDIA.Revised: 15 April 2011                                                                  ID#: 22465210 mg Bottles of 30              NDC 67296-0622-1Bottles of 60              NDC 67296-0622-2 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.Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United States.  Manufactured by:Lupin LimitedGoa 403 722INDIA.OrLupin LimitedPithampur (M.P.) 454 775INDIA.Revised: 15 April 2011                                                                  ID#: 22465210 mg Bottles of 30              NDC 67296-0622-1Bottles of 60              NDC 67296-0622-2 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.Lupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United States.  Manufactured by:Lupin LimitedGoa 403 722INDIA.OrLupin LimitedPithampur (M.P.) 454 775INDIA.Revised: 15 April 2011                                                                  ID#: 224652


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

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.

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 levels increase, time to peak concentration increases and time to attain steady state is prolonged. Older patients, on average, have (approximately doubled) higher blood levels and area under the plasma concentration time curve (AUC) than younger patients. (See ). Lisinopril can be removed by hemodialysis.

Studies in rats indicate that lisinopril crosses the blood-brain barrier poorly. Multiple doses of lisinopril in rats do not result in accumulation in any tissues. Milk of lactating rats contains radioactivity following administration of C lisinopril. By whole body autoradiography, radioactivity was found in the placenta following administration of labeled drug to pregnant rats, but none was found in the fetuses.

2

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 ). 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.  

In some patients achievement of optimal blood pressure reduction may require two to four weeks of therapy.

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.

Two dose-response studies utilizing a once-daily regimen were conducted in 438 mild to moderate hypertensive patients not on a diuretic. Blood pressure was measured 24 hours after dosing. An antihypertensive effect of lisinopril was seen with 5 mg in some patients; however, in both studies blood pressure reduction occurred sooner and was greater in patients treated with 10, 20 or 80 mg of lisinopril. In controlled clinical studies, lisinopril 20-80 mg has been compared in patients with mild to moderate hypertension to hydrochlorothiazide 12.5-50 mg and with atenolol 50-200 mg; and in patients with moderate to severe hypertension to metoprolol 100-200 mg. It was superior to hydrochlorothiazide in effects on systolic and diastolic pressure in a population that was 3/4 Caucasian. Lisinopril was approximately equivalent to atenolol and metoprolol in effects on diastolic blood pressure, and had somewhat greater effects on systolic blood pressure.

Lisinopril had similar effectiveness and adverse effects in younger and older (> 65 years) patients. It was less effective in Blacks than in Caucasians.

In hemodynamic studies in patients with essential hypertension, blood pressure reduction was accompanied by a reduction in peripheral arterial resistance with little or no change in cardiac output and in heart rate. In a study in nine hypertensive patients, following   administration of lisinopril, there was an increase in mean renal blood flow that was not significant. Data from several small studies are inconsistent with respect to the effect of lisinopril on glomerular filtration rate in hypertensive patients with normal renal function, but suggest that changes, if any, are not large.

In patients with renovascular hypertension lisinopril has been shown to be well tolerated and effective in controlling blood pressure (See ).

Pediatric Patients

In a clinical study involving 115 hypertensive pediatric patients 6 to 16 years of age, patients who weighed less than 50 kg received either 0.625, 2.5 or 20 mg of lisinopril daily and patients who weighed ≥ 50 kg received either 1.25, 5, or 40 mg of lisinopril daily. At the end of 2 weeks, lisinopril administered once daily lowered trough blood pressure in a dose-dependent manner with consistent antihypertensive efficacy demonstrated at doses > 1.25 mg (0.02 mg/kg). This effect was confirmed in a withdrawal phase, where the diastolic pressure rose by about 9 mmHg more in patients randomized to placebo than it did in patients who were randomized to remain on the middle and high doses of lisinopril. The dose-dependent antihypertensive effect of lisinopril was consistent across several demographic subgroups: age, Tanner stage, gender, and race. In this study, lisinopril was generally well tolerated.

In the above pediatric studies, lisinopril was given either as tablets or in a suspension for those children and infants who were unable to swallow tablets or who required a lower dose than is available in tablet form.

In two placebo controlled, 12-week clinical studies using doses of lisinopril upto 20 mg, lisinopril as adjunctive therapy to digitalis and diuretics improved the following signs and symptoms due to congestive heart failure: edema, rales, paroxysmal nocturnal dyspnea and jugular venous distention. In one of the studies, beneficial response was also noted for: orthopnea, presence of third heart sound and the number of patients classified as NYHA Class III and IV. Exercise tolerance was also improved in this study. The once-daily dosing for the treatment of congestive heart failure was the only dosage regimen used during clinical trial development and was determined by the measurement of hemodynamic response. A large (over 3000 patients) survival study, the ATLAS Trial, comparing 2.5 and 35 mg of lisinopril in patients with heart failure, showed that the higher dose of lisinopril had outcomes at least as favorable as the lower dose.

The protocol excluded patients with hypotension (systolic blood pressure ( 100 mmHg), severe heart failure, cardiogenic shock, and renal dysfunction (serum creatinine >2 mg/dL and/or proteinuria > 500 mg/24 h). Doses of lisinopril were adjusted as necessary according to protocol (see ).

Study treatment was withdrawn at six weeks except where clinical conditions indicated continuation of treatment.

The primary outcomes of the trial were the overall mortality at 6 weeks and a combined end point at 6 months after the myocardial infarction, consisting of the number of patients who died, had late (day 4) clinical congestive heart failure, or had extensive left ventricular damage defined lisinopril (n=9646), alone or with nitrates, had an 11% lower risk of death (2p [two-tailed] = 0.04) compared to patients receiving no lisinopril (n=9672) (6.4% vs. 7.2%, respectively) at six weeks. Although patients randomized to receive lisinopril for up to six weeks also fared numerically better on the combined end point at 6 months, the open nature of the assessment of heart failure, substantial loss to follow-up echocardiography, and substantial excess use of lisinopril between 6 weeks and 6 months in the group randomized to 6 weeks of lisinopril, preclude any conclusion about this end point.

Patients with acute myocardial infarction, treated with lisinopril, had a higher (9% versus 3.7%) incidence of persistent hypotension (systolic blood pressure less than 90 mmHg for more than 1 hour) and renal dysfunction (2.4% versus 1.1%) in-hospital and at six weeks (increasing creatinine concentration to over 3 mg/dL or a doubling or more of the baseline serum creatinine concentration). See .

Non-Clinical Toxicology
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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).