Singapur - angličtina - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - dapagliflozin propanediol 12.30mg eqv dapagliflozin - tablet, film coated - 10mg - dapagliflozin propanediol 12.30mg eqv dapagliflozin 10mg

Singapur - angličtina - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - dapagliflozin propanediol 6.15mg eqv dapagliflozin - tablet, film coated - 5mg - dapagliflozin propanediol 6.15mg eqv dapagliflozin 5mg

Singapur - angličtina - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - irbesartan - tablet, film coated - 150.00 mg - irbesartan 150.00 mg

Singapur - angličtina - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - irbesartan - tablet, film coated - 300.00 mg - irbesartan 300.00 mg

Malta - angličtina - Medicines Authority

medochemie limited 1-10 constantinoupleos street, 3011 limassol, cyprus - enalapril maleate - tablet - enalapril maleate 20 mg - agents acting on the renin-angiotensin system

Malta - angličtina - Medicines Authority

medochemie limited 1-10 constantinoupleos street, 3011 limassol, cyprus - enalapril maleate - tablet - enalapril maleate 5 mg - agents acting on the renin-angiotensin system

Spojené štáty - angličtina - NLM (National Library of Medicine)

physicians total care, inc. - candesartan cilexetil (unii: r85m2x0d68) (candesartan - unii:s8q36md2xx) - candesartan cilexetil 4 mg - atacand is indicated for the treatment of hypertension in adults and children 1 to < 17 years of age. it may be used alone or in combination with other antihypertensive agents. atacand is indicated for the treatment of heart failure (nyha class ii-iv) in adults with left ventricular systolic dysfunction (ejection fraction ≤ 40%) to reduce cardiovascular death and to reduce heart failure hospitalizations [see clinical studies (14.2)] . atacand also has an added effect on these outcomes when used with an ace inhibitor. atacand is contraindicated in patients who are hypersensitive to any component of this product. pregnancy categories c (first trimester) and d (second and third trimesters) [see warnings and precautions (5.1)]. the effect of atacand on labor and delivery in humans is unknown [see warnings and precautions (5.1)]. it is not known whether candesartan is excreted in human milk, but candesartan has been shown to be present in rat milk. because of the potential for adverse effects on the nursing

Spojené štáty - angličtina - NLM (National Library of Medicine)

lxo us inc. - aliskiren hemifumarate (unii: c8a0p8g029) (aliskiren - unii:502fwn4q32) - aliskiren 150 mg - tekturna is indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age and older to lower blood pressure. 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. there are no controlled trials demonstrating risk reduction with tekturna. 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 have also 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 (e.g., 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. do not use tekturna with arbs or aceis in patients with diabetes [see warnings and precautions ( 5.2) and clinical studies ( 14.3)]. tekturna is contraindicated in patients with known hypersensitivity to any of the components [see warnings and precautions ( 5.3)]. tekturna is contraindicated in pediatric patients less than 2 years of age because of the risk of high aliskiren exposures identified in juvenile animals due to immaturity of transporters and metabolic enzymes [see use in specific populations ( 8.4)]. risk summary tekturna 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 [see clinical considerations] . 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 tekturna as soon as possible. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major malformations and miscarriage in clinically recognized pregnancies is 2-4%, and 15-20%, 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 use of drugs that act on 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, oligohydramnios, 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. in patients taking tekturna during pregnancy, perform serial ultrasound examinations to assess the intra- amniotic environment. fetal testing may be appropriate, based on the week of gestation. 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 tekturna for hypotension, oliguria, and hyperkalemia. if oliguria or hypotension occur in neonates with a history of in utero exposure to aliskiren, 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. data animal data in developmental toxicity studies, pregnant rats and rabbits received oral aliskiren hemifumarate during organogenesis at doses up to 20 and 7 times the maximum recommended human dose (mrhd) based on body surface area (mg/m 2 ), respectively, in rats and rabbits. (actual animal doses were up to 600 mg/kg/day in rats and up to 100 mg/kg/day in rabbits.) no teratogenicity was observed; however, fetal birth weight was decreased in rabbits at doses 3.2 times the mrhd based on body surface area (mg/m 2 ). aliskiren was present in placentas, amniotic fluid and fetuses of pregnant rabbits. risk summary there is no information regarding the presence of aliskiren in human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential for serious adverse reactions, including hypotension, hyperkalemia and renal impairment in nursing infants, advise a nursing woman that breastfeeding is not recommended during treatment with tekturna. tekturna is contraindicated in patients less than 2 years of age [see contraindications ( 4)]. tekturna is indicated for treatment of hypertension in pediatric patients 6 years of age and older weighing 50 kg or more. the safety and effectiveness of aliskiren have been established in pediatric patients 6 years of age and older weighing 20 kg or more, but tekturna is not approved in patients 6 years of age and older weighing 20 kg to less than 50 kg because of the lack of an appropriate dosage form. use of tekturna in pediatric patients 6 years and older is supported by evidence from a pharmacokinetic trial and two randomized, double-blind clinical trials in pediatric patients with hypertension 6 years to 17 years of age weighing 20 kg or more [see clinical pharmacology ( 12.3), clinical studies ( 14.4 ) ] . the safety and effectiveness of tekturna have not been established in pediatric patients younger than 6 years of age and patients less than 20 kg. avoid use in patients 2 years to less than 6 years and patients weighing less than 20 kg due to the limited information about aliskiren metabolism and exposures in this age group. no data are available in pediatric patients weighing less than 20 kg or in pediatric patients with a glomerular filtration rate <30 ml/min/1.73 m 2 . juvenile animal toxicity data toxicology studies in juvenile animals the approximate human age equivalent of children less than 2 years of age identified 85- to 385-fold increased systemic exposure to aliskiren compared to adult rats. the increased aliskiren exposure in juvenile rats was attributed to immaturity in aliskiren drug transporters and metabolizing enzymes. increased aliskiren exposures were associated with premature deaths. although a definitive pathology-based cause of death could not be ascertained, the premature deaths were attributed to the immaturity in aliskiren metabolism. the nonclinical findings suggest a distinct age-dependent relationship between dose and exposure. neonates with a history of in utero exposure to tekturna 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. of the total number of patients receiving aliskiren in clinical studies, 1,275 (19%) were 65 years or older and 231 (3.4%) were 75 years or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. safety and effectiveness of tekturna in patients with severe renal impairment [creatinine clearance (crcl) less than 30 ml/min] have not been established as these patients were excluded in efficacy trials [see clinical studies ( 14)].

Spojené štáty - angličtina - NLM (National Library of Medicine)

cardinal health 107, llc - empagliflozin (unii: hdc1r2m35u) (empagliflozin - unii:hdc1r2m35u) - empagliflozin 10 mg - jardiance is indicated: limitations of use risk summary based on animal data showing adverse renal effects, jardiance is not recommended during the second and third trimesters of pregnancy. the limited available data with jardiance in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations] . in animal studies, adverse renal changes were observed in rats when empagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. doses approximately 13-times the maximum clinical dose caused renal pelvic and tubule dilatations that were reversible [see data] . the estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20% to 25% in women with hba1c >10. the estimat

Spojené štáty - angličtina - NLM (National Library of Medicine)

amneal pharmaceuticals llc - benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - benazepril hydrochloride 5 mg - benazepril hcl tablets are indicated for the treatment of hypertension, to lower blood pressure. 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 the class to which this drug principally belongs.  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 mm hg 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. it may be used alone or in combination with thiazide diuretics. benazepril hcl tablets are contraindicated in patients: - who are hypersensitive to benazepril or to any other ace inhibitor - with a history of angioedema with or without previous ace inhibitor treatment benazepril hcl is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer benazepril hcl within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see warnings and precautions (5.2)]. do not co-administer aliskiren with angiotensin receptor blockers, ace inhibitors; including benazepril hcl tablets in patients with diabetes [see drug interactions (7.4)]. risk summary benazepril hcl 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 benazepril hcl as soon as possible. the estimated background risk of major birth defects and miscarriage for the indicated population are unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 benazepril hcl for hypotension, oliguria, and hyperkalemia. if oliguria or hypotension occur in neonates with a history of in utero exposure to benazepril hcl, 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. minimal amounts of unchanged benazepril and of benazeprilat are excreted into the breast milk of lactating women treated with benazepril. a newborn child ingesting entirely breast milk would receive less than 0.1% of the mg/kg maternal dose of benazepril and benazeprilat. the antihypertensive effects of benazepril hcl have been evaluated in a double-blind study in pediatric patients 7 to 16 years of age [see clinical pharmacology (12.3)]. the pharmacokinetics of benazepril hcl have been evaluated in pediatric patients 6 to 16 years of age [see clinical pharmacology (12.3)]. infants below the age of 1 year should not be given benazepril hcl because of the risk of effects on kidney development. safety and effectiveness of benazepril hcl have not been established in pediatric patients less than 6 years of age or in children with glomerular filtration rate < 30 ml/min/1.73 m² [see dosage and administration (2.1) and clinical pharmacology (12.3)]. of the total number of patients who received benazepril in u.s. clinical studies of benazepril hcl, 18% were 65 or older while 2% were 75 or older. no overall differences in effectiveness or safety were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. benazepril and benazeprilat are substantially excreted by the kidney. 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 [see dosage and administration (2.2)] . ace inhibitors, including benazepril hcl, as monotherapy, have an effect on blood pressure that is less in black patients than in non-blacks.  dose adjustment of benazepril hcl is required in patients undergoing hemodialysis or whose creatinine clearance is ≤ 30 ml/min. no dose adjustment of benazepril hcl is required in patients with creatinine clearance > 30 ml/min [see dosage and administration (2.2) and clinical pharmacology (12.3)].