LISINOPRIL tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

LISINOPRIL (UNII: E7199S1YWR) (LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD)

Beschikbaar vanaf:

REMEDYREPACK INC.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Lisinopril tablets, USP, are indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Lisinopril tablets, USP, may be administered alone or with other antihypertensive agents [see Clinical Studies (14.1)]. Lisinopril tablets, USP, are indicated to reduce signs and symptoms of systolic heart failure [see Clinical Studies (14.2)] . Lisinopril tablets, USP, are indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see Clinical Studies (14.3)]. Lisinopril is contraindicated in patients with: - a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme inhibitor - hereditary or idiopathic angioedema Do not co-administer aliskiren with lisinopril in patients with diabetes [see Drug Interactions (7.4)]. Risk Summary Lisinopril can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. When pregnancy is detected, discontinue lisinopril as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the general U.S. population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia and skeletal deformations, including skull hypoplasia, hypotension, and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to lisinopril for hypotension, oliguria, and hyperkalemia. If oliguria or hypotension occur in neonates with a history of in utero exposure to lisinopril, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and substituting for disordered renal function. Risk Summary No data are available regarding the presence of lisinopril in human milk or the effects of lisinopril on the breast fed infant or on milk production. Lisinopril is present in rat milk. Because of the potential for severe adverse reactions in the breastfed infant, advise women not to breastfeed during treatment with lisinopril. Milk of lactating rats contains radioactivity following administration of 14 C lisinopril. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ACE inhibitors, a decision should be made whether to discontinue nursing or discontinue Lisinopril, taking into account the importance of the drug to the mother. Antihypertensive effects and safety of lisinopril have been established in pediatric patients aged 6 to 16 years [see  Dosage and Administration (2.1) and Clinical Studies (14.1)] . No relevant differences between the adverse reaction profile for pediatric patients and adult patients were identified. Safety and effectiveness of lisinopril have not been established in pediatric patients under the age 6 or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73 m 2 [see Dosage and Administration (2.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1)]. Neonates with a history of in utero exposure to lisinopril If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. No dosage adjustment with lisinopril is necessary in elderly patients. In a clinical study of lisinopril in patients with myocardial infarctions (GISSI-3 Trial) 4,413 (47%) were 65 and over, while 1,656 (18%) were 75 and over. In this study, 4.8 % of patients aged 75 years and older discontinued lisinopril treatment because of renal dysfunction vs. 1.3% of patients younger than 75 years. No other differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. ACE inhibitors, including lisinopril, have an effect on blood pressure that is less in black patients than in non blacks. Dose adjustment of lisinopril is required in patients undergoing hemodialysis or whose creatinine clearance is ≤ 30 mL/min. No dose adjustment of lisinopril is required in patients with creatinine clearance > 30 mL/min [see  Dosage and Administration (2.4) and Clinical Pharmacology (12.3)] .

Product samenvatting:

2.5 mg Tablets: white to off-white, capsule-shaped tablets, imprinted with ‘H 144’ on one side and plain on the other side. NDC: 70518-1790-00 NDC: 70518-1790-01 PACKAGING: 1 in 1 POUCH PACKAGING: 100 in 1 BOX Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

LISINOPRIL- LISINOPRIL TABLET
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LISINOPRIL TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LISINOPRIL TABLETS
LISINOPRIL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1988
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE LISINOPRIL AS SOON AS
POSSIBLE. (5.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELOPING FETUS.
(5.1)
INDICATIONS AND USAGE
Lisinopril is an angiotensin converting enzyme (ACE) inhibitor
indicated for:
Treatment of hypertension in adults and pediatric patients 6 years of
age and older (1.1)
Adjunct therapy for heart failure (1.2)
Treatment of Acute Myocardial Infarction (1.3)
DOSAGE AND ADMINISTRATION
Hypertension: Initial adult dose is 10 mg once daily. Titrate up to 40
mg daily based on blood pressure response. Initiate patients on
diuretics at 5 mg once daily (2.1)
Pediatric patients with glomerular filtration rate > 30 mL/min/1.73 m
: Initial dose in patients 6 years of age and older is 0.07 mg
per kg (up to 5 mg total) once daily (2.1)
Heart Failure: Initiate with 5 mg once daily. Increase dose as
tolerated to 40 mg daily (2.2)
Acute Myocardial Infarction (MI): Give 5 mg within 24 hours of MI.
Followed by 5 mg after 24 hours, then 10 mg once daily (2.3)
Renal Impairment: For patients with creatinine clearance ≥ 10 mL/min
and ≤ 30 mL/min, halve usual initial dose. For patients with
creatinine clearance < 10 mL/min or on hemodialysis, the recommended
initial dose is 2.5 mg (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg, (3)
CONTRAINDICATIONS
Lisinopril is contraindicated in combination with a neprilysin
inhibitor (e.g., sacubitril). Do not administer lisinopril within 36
hours of
switching to or from sacubitril/valsartan, a neprilysin inhibitor
_[see Warnings and Precautions (5.2)] _.
WARNINGS AND PRECAUTIONS
Angi