Leruze is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce the risk of strokes and heart attacks.
Leruze works by blocking a substance in the body that causes the blood vessels to tighten. As a result, Leruze relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.
Leruze is also used to help treat heart failure. It is also used in some patients after a heart attack. After a heart attack, some of the heart muscle is damaged and weakened. The heart muscle may continue to weaken as time goes by. This makes it more difficult for the heart to pump blood. Leruze may be started within 24 hours after a heart attack to increase survival rate.
Leruze is available only with your doctor's prescription.
Leruze indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Hypertension
Leruze is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal 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.
Leruze may be administered alone or with other antihypertensive agents.
Heart Failure
Leruze is indicated to reduce signs and symptoms of systolic heart failure.
Reduction Of Mortality In Acute Myocardial Infarction
Leruze is 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.
How should I use Leruze?
Use Leruze as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Leruze by mouth with or without food.
Taking Leruze at the same time each day will help you remember to take it.
Drink plenty of fluids while taking Leruze. Not drinking enough fluids or excessive sweating, diarrhea, or vomiting can lead to light-headedness or fainting.
Continue to take Leruze even if you feel well. Do not miss any doses.
If you miss a dose of Leruze, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Leruze.
Uses of Leruze in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Leruze is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. It is also used to treat heart failure and to improve survival after a heart attack.
Leruze belongs to a class of drugs known as ACE inhibitors. It works by relaxing blood vessels so blood can flow more easily.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used to help protect the kidneys from harm due to diabetes.
How to use Leruze
Take this medication by mouth with or without food as directed by your doctor, usually once daily.
Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
The dosage is based on your medical condition and response to treatment. For children, the dosage is also based on weight.
To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Keep taking this medication even if you feel well. Most people with high blood pressure do not feel sick.
For the treatment of high blood pressure, it may take 2 to 4 weeks before you get the full benefit of this medication. For the treatment of heart failure, it may take weeks to months before you get the full benefit of this medication. Tell your doctor if your condition does not get better or if it gets worse (for example, your blood pressure readings remain high or increase).
Leruze description
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Leruze is a potent, competitive inhibitor of angiotensin-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I (ATI) to angiotensin II (ATII). ATII regulates blood pressure and is a key component of the renin-angiotensin-aldosterone system (RAAS). Leruze may be used to treat hypertension and symptomatic congestive heart failure, to improve survival in certain individuals following myocardial infarction, and to prevent progression of renal disease in hypertensive patients with diabetes mellitus and microalbuminuria or overt nephropathy.
Leruze dosage
Leruze Dosage
Generic name: Leruze 5mg
Dosage form: tablet
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Hypertension
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 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 a greater effect.
Use with Diuretics in Adults
If blood pressure is not controlled with Leruze 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.
Pediatric Patients 6 Years of Age and Older with Hypertension
For pediatric patients with glomerular filtration rate >30 mL/min/1.73 m2, 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.
Leruze is not recommended in pediatric patients <6 years or in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m2.
Heart Failure
The recommended starting dose for Leruze, when used with diuretics and (usually) digitalis as adjunctive therapy 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. The appearance of hypotension after the initial dose of Leruze does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
Acute Myocardial Infarction
In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, give Leruze 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 (100-120 mmHg) during the first 3 days after the infarct. 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 Leruze.
Dose in Patients with Renal Impairment
No dose adjustment of Leruze is required in patients with creatinine clearance >30 mL/min. In patients with creatinine clearance 10-30 mL/min, reduce the initial dose of Leruze 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.
Initiation of Leruze in patients on diuretics may result in excessive reduction of blood pressure. The possibility of hypotensive effects with Leruze can be minimized by either decreasing or discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with Leruze. If this is not possible, reduce the starting dose of Leruze.
Leruze 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.
Antidiabetics
Concomitant administration of Leruze and antidiabetic medicines (insulins, oral hypoglycemic agents) may cause an increased blood-glucose-lowering effect with risk of hypoglycemia.
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 Leruze, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Leruze and NSAID therapy.
The antihypertensive effect of ACE inhibitors, including Leruze, 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.
The VA NEPHRON trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 mL/min), randomized them to Leruze 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 Leruze 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 Leruze and other agents that affect the RAS.
Do not co-administer aliskiren with Leruze in patients with diabetes. Avoid use of aliskiren with Leruze in patients with renal impairment (GFR < 60 mL/min).
Lithium
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.
Gold
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 Leruze.
Mtor Inhibitors
Patients taking concomitant mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema.
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
In clinical trials in patients with hypertension treated with Leruze, 5.7% of patients on Leruze discontinued with adverse reactions.
The following adverse reactions (events 2% greater on Leruze than on placebo) were observed with Leruze alone: headache (by 3.8%), dizziness (by 3.5%), and cough (by 2.5%).
Heart Failure
In patients with systolic heart failure treated with Leruze for up to four years, 11% discontinued therapy with adverse reactions. In controlled studies in patients with heart failure, therapy was discontinued in 8.1% of patients treated with Leruze for 12 weeks, compared to 7.7% of patients treated with placebo for 12 weeks.
The following adverse reactions (events 2% greater on Leruze than on placebo) were observed with Leruze: hypotension (by 3.8%), and chest pain (by 2.1%).
In the two-dose ATLAS trial in heart failure patients, withdrawals due to adverse reactions were not different between the low and high dose groups, either in total number of discontinuation (17-18%) or in rare specific reactions (< 1%). 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 treated with Leruze had a higher incidence of hypotension (by 5.3%) and renal dysfunction (by 1.3%) compared with patients not taking Leruze.
Other clinical adverse reactions occurring in 1% or higher of patients with hypertension or heart failure treated with Leruze in controlled clinical trials and do not appear in other sections of labeling are listed below:
Body as a whole: Fatigue, asthenia, orthostatic effects.
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 Leruze-treated patients with hypertension and heart failure, respectively.
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 Leruze alone. Increases were more common in patients receiving concomitant diuretics and in patients with renal artery stenosis. Reversible minor increases in blood urea nitrogen and serum creatinine were observed in 11.6% of patients with heart failure on concomitant diuretic therapy. Frequently, these abnormalities resolved when the dosage of the diuretic was decreased.
Patients with acute myocardial infarction in the GISSI-3 trial treated with Leruze had a higher (2.4% versus 1.1% in placebo) incidence of renal dysfunction 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).
Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.4 g% and 1.3 vol%, respectively) occurred frequently in patients treated with Leruze but were rarely of clinical importance in patients without some other cause of anemia. In clinical trials, less than 0.1% of patients discontinued therapy due to anemia.
Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of Leruze that are not included in other sections of labeling. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Other Reactions Include
Metabolism and Nutrition Disorders
Hyponatremia, cases of hypoglycemia in diabetic patients on oral antidiabetic agents or insulin.
Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation have been reported in patients taking cisapride with other drugs that inhibit cytochrome P450 3A4. Some of these events have been fatal. Concomitant oral or intravenous administration of the following drugs with cisapride may lead to elevated cisapride blood levels and is contraindicated. Antibiotics:
Oral or IV erythromycin, clarithromycin (Biaxin), troleandomycin (TAO). Antidepressants: Nefazodone (Serzone). Antifungals:
Oral or IV fluconazole (Diflucan), itraconazole (Sporanox), oral ketoconazole (Nizoral). Protease Inhibitors: Indinavir (Crixivan), ritonavir (Norvir).Leruze is Also Contraindicated for Patients With: History of prolonged electrocardiographic QT intervals or known family history of congenital long QT syndrome; renal failure; history of ventricular arrhythmias, ischemic heart disease, and congestive heart failure; clinically significant bradycardia; uncorrected electrolyte disorders (hypokalemia, hypomagnesemia); respiratory failure; and concomitant medications known to prolong the QT interval and increase the risk of arrhythmia, such as certain antiarrhythmics, certain antipsychotics, certain antidepressants, astemizole, bepridil, sparfloxacin, and terodiline. The preceding lists of drugs are not comprehensive. Leruze should not be used in patients with uncorrected hypokalemia or hypomagnesemia or who might experience rapid reduction of plasma potassium such as those administered potassium-wasting diuretics and/or insulin in acute settings. Leruze should not be used in patients in whom an increase in gastrointestinal motility could be harmful, e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation. Leruze is contraindicated in patients with known sensitivity or intolerance to the drug.
DailyMed. "HYDROCHLOROTHIAZIDE; LISINOPRIL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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