Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - enalapril maleate, quantity: 10 mg - tablet, uncoated - excipient ingredients: pregelatinised maize starch; maize starch; iron oxide red; iron oxide yellow; sodium bicarbonate; lactose monohydrate; magnesium stearate - auspril tablets are indicated in the treatment of: hypertension: all grades of essential hypertension renovascular hypertension. congestive heart failure: all degrees of symptomatic heart failure. in such patients, it is recommended that auspril be administered together with a diuretic. left ventricular dysfunction: all degrees of left ventricular dysfunction where the left ventricular ejection fraction is less than 35%, irrespective of the presence or severity of obvious symptoms of heart failure.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - enalapril maleate, quantity: 20 mg - tablet, uncoated - excipient ingredients: maize starch; pregelatinised maize starch; sodium bicarbonate; iron oxide red; lactose monohydrate; magnesium stearate - auspril tablets are indicated in the treatment of: hypertension: all grades of essential hypertension renovascular hypertension. congestive heart failure: all degrees of symptomatic heart failure. in such patients, it is recommended that auspril be administered together with a diuretic. left ventricular dysfunction: all degrees of left ventricular dysfunction where the left ventricular ejection fraction is less than 35%, irrespective of the presence or severity of obvious symptoms of heart failure.

United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - enalapril maleate (unii: 9o25354epj) (enalaprilat anhydrous - unii:q508q118jm) - enalapril maleate oral solution is indicated for the treatment of hypertension, to lower blood pressure in adults and children older than one month [see pediatric use (8.4) and clinical studies (14)]. lowering blood pressure reduces 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 including this drug. 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 one 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. enalapril maleate oral solution is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. the blood pressure lowering effects of enalapril maleate oral solution and thiazides are approximately additive. enalapril maleate oral solution is indicated for the treatment of symptomatic heart failure, usually in combination with diuretics and digitalis. in these patients, enalapril maleate oral solution increases survival and decreases the frequency of hospitalization. in clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate oral solution decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure. enalapril maleate oral solution is contraindicated in patients with: - a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme (ace) inhibitor. [see warnings and precautions (5.2)] -  hereditary or idiopathic angioedema. [see warnings and precautions (5.2)] do not co-administer aliskiren with enalapril maleate oral solution in patients with diabetes [see drug interactions (7.2)] . enalapril maleate oral solution is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer enalapril maleate oral solution within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see warnings and precautions (5.2)] . risk summary enalapril maleate 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 enalapril maleate 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. adverse reactions in the fetus or in neonates with a history of in utero exposure to enalapril maleate. use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, oligohydramnios, fetal lung hypoplasia, 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 oligohydraminos may not appear until after the fetus has sustained irreversible injury. closely observe infants with histories of in utero exposure to enalapril maleate for hypotension, oliguria, and hyperkalemia. if oliguria or hypotension occurs in neonates with a history of in utero exposure to enalapril maleate, 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 enalapril and enalaprilat have been detected in human breast milk. because of the potential for severe adverse reactions in the breastfed infant, including hypotension, hyperkalemia and renal impairment, advise women not to breastfeed during treatment with enalapril maleate. neonates with a history of in utero exposure to enalapril maleate 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. enalapril, which crosses the placenta, has been removed from neonatal circulation by peritoneal dialysis with some clinical benefit, and theoretically may be removed by exchange transfusion, although there is no experience with the latter procedure. pediatric patients with hypertension enalapril maleate is not recommended in neonates (i.e., infants 1 month of age or less), preterm infants who have not reached a corrected post-conceptual age of 44 weeks, and in pediatric patients with glomerular filtration rate <30 ml/min/1.73 m2 [see nonclinical toxicology (13.2)] . enalapril lowers blood pressure in hypertensive pediatric patients age 6 years to 16 years. use of enalapril in these age groups is supported by evidence from adequate and well-controlled studies of enalapril in pediatric and adult patients as well as by published literature in pediatric patients [see clinical pharmacology (12.3) and dosage and administration (2.1)] . clinical efficacy studies of enalapril in pediatric patients with hypertension did not enroll patients less than 6 years of age. in a previous clinical study in pediatric patients between 2 months and 6 years of age, a higher weight-based dose was required to match exposure in children aged 6 to 16 years [see clinical pharmacology (12.3)] . it is unknown whether post-natal use of ace inhibitors such as enalapril before maturation of renal function is complete has long-term deleterious effects on the kidney. in humans, nephrogenesis is thought to be complete around birth; however maturation of other aspects of kidney function (such as glomerular filtration and tubular function) may continue until approximately 2 years of age [see nonclinical toxicology (13.2)] . pediatric patients with heart failure or asymptomatic left ventricular dysfunction safety and effectiveness of enalapril have not been established in pediatric patients with heart failure or asymptomatic left ventricular dysfunction. this drug is known to be substantially excreted by the kidney, and the risk of adverse 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, and it may be useful to monitor renal function. ace inhibitors, including enalapril maleate, as monotherapy have an effect on blood pressure that is less in black patients than in non-blacks. use a lower initial dose of enalapril maleate in patients undergoing hemodialysis and in patients whose egfr is ≤ 30 ml/min [see dosage and administration (2.1) and clinical pharmacology (12.3)] .

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - enalapril maleate (unii: 9o25354epj) (enalaprilat anhydrous - unii:q508q118jm) - enalapril maleate is indicated for the treatment of hypertension. enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. the blood pressure lowering effects of enalapril maleate and thiazides are approximately additive. enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. in these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see clinical pharmacology, heart failure, mortality trials for details and limitations of survival trials). in clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see clinical pharmacology, heart failure, mortality trials for details and limitations of survival trials). in using enalapril maleate 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 enalapril maleate does not have a similar risk (see warnings, neutropenia/agranulocytosis ). in considering use of enalapril maleate, 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, it should be noted that black patients receiving ace inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see warnings, head and neck angioedema ). enalapril maleate is 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. do not coadminister aliskiren with enalapril maleate in patients with diabetes (see precautions, drug interactions ). enalapril maleate is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer enalapril maleate within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see warnings, head and neck angioedema ).

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - enalapril maleate (unii: 9o25354epj) (enalaprilat anhydrous - unii:q508q118jm) - enalapril maleate is indicated for the treatment of hypertension. enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. the blood pressure lowering effects of enalapril maleate and thiazides are approximately additive. enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. in these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see clinical pharmacology, heart failure, mortality trials for details and limitations of survival trials). in clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see clinical pharmacology, heart failure, mortality trials for details and limitations of survival trials). in using enalapril maleate 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 enalapril maleate does not have a similar risk (see warnings, neutropenia/agranulocytosis ). in considering use of enalapril maleate, 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, it should be noted that black patients receiving ace inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see warnings, head and neck angioedema ). enalapril maleate is 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. do not coadminister aliskiren with enalapril maleate in patients with diabetes (see precautions, drug interactions ). enalapril maleate is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer enalapril maleate within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see warnings, head and neck angioedema ).

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - enalapril maleate (unii: 9o25354epj) (enalaprilat anhydrous - unii:q508q118jm) - enalapril maleate tablets, usp are indicated for the treatment of hypertension. enalapril maleate tablets, usp are effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. the blood pressure lowering effects of enalapril maleate and thiazides are approximately additive. enalapril maleate tablets, usp are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. in these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see clinical pharmacology, heart failure, mortality trials for details and limitations of survival trials). in clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate tablets, usp decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see clinical pharmacology, heart failure, mortality trials  for details and limitations of survival trials). in using enalapril maleate, 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 enalapril maleate does not have a similar risk (see warnings, neutropenia/agranulocytosis ). in considering use of enalapril maleate, 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, it should be noted that black patients receiving ace inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see warnings, head and neck angioedema ). enalapril maleate tablets, usp 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. do not coadminister aliskiren with enalapril maleate in patients with diabetes (see precautions, drug interactions ). enalapril maleate tablets, usp are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer enalapril maleate tablets usp within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see warnings , head and neck angioedema ).

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - enalapril maleate (unii: 9o25354epj) (enalaprilat anhydrous - unii:q508q118jm) - enalapril maleate tablets are indicated for the treatment of hypertension. enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazidetype diuretics. the blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive. enalapril maleate tablets are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. in these patients enalapril maleate tablets improve symptoms, increase survival, and decrease the frequency of hospitalization (see clinical pharmacology, heart failure, mortality trials for details and limitations of survival trials). in clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate tablets decrease the rate of development of overt heart failure and decrease the incidence of hospitalization for heart failure (see clinical pharmacology, heart failure, mortality trials for details and limitations of survival trials). in using enalapril maleate 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 enalapril maleate tablets do not have a similar risk (see warnings, neutropenia/agranulocytosis ). in considering use of enalapril maleate 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, it should be noted that black patients receiving ace inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see warnings, head and neck angioedema ). enalapril maleate 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. do not coadminister aliskiren with enalapril maleate tablets in patients with diabetes (see precautions, drug interactions ). enalapril maleate tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer enalapril maleate tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see warnings, head and neck angioedema ).

United States - English - NLM (National Library of Medicine)

blenheim pharmacal, inc. - enalapril maleate (unii: 9o25354epj) (enalaprilat anhydrous - unii:q508q118jm) - enalapril maleate is indicated for the treatment of hypertension. enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. the blood pressure lowering effects of enalapril maleate and thiazides are approximately additive. enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. in these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see clinical pharmacology, heart failure, mortality trials for details and limitations of survival trials). in clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see clinical pharmacology, heart failure, mortality trials for details and

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - enalapril maleate (unii: 9o25354epj) (enalaprilat anhydrous - unii:q508q118jm) - enalapril maleate is indicated for the treatment of hypertension. enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. the blood pressure lowering effects of enalapril maleate and thiazides are approximately additive. enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. in these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see clinical pharmacology, heart failure, mortality trials for details and limitations of survival trials). in clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see clinical pharmacology, heart failure, mortality trials for details and

United States - English - NLM (National Library of Medicine)

doh central pharmacy - enalapril maleate (unii: 9o25354epj) (enalaprilat anhydrous - unii:q508q118jm) - enalapril maleate is indicated for the treatment of hypertension. enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. the blood pressure lowering effects of enalapril maleate and thiazides are approximately additive. enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. in these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see clinical pharmacology, heart failure, mortality trials for details and limitations of survival trials). in clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see clinical pharmacology, heart failure, mortality trials for details and limitations of survival trials