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

amneal pharma australia pty ltd - candesartan cilexetil, quantity: 32 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; macrogol 8000; hyprolose; carmellose calcium; magnesium stearate; maize starch; iron oxide red - treatment of hypertension.,treatment of patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction <=40percent) as add-on therapy to ace inhibitors or when ace inhibitors are not tolerated.

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

amneal pharma australia pty ltd - candesartan cilexetil, quantity: 16 mg - tablet, uncoated - excipient ingredients: macrogol 8000; lactose monohydrate; carmellose calcium; magnesium stearate; hyprolose; maize starch; iron oxide red - treatment of hypertension.,treatment of patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction <=40percent) as add-on therapy to ace inhibitors or when ace inhibitors are not tolerated.

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

amneal pharma australia pty ltd - candesartan cilexetil, quantity: 8 mg - tablet, uncoated - excipient ingredients: hyprolose; lactose monohydrate; maize starch; carmellose calcium; macrogol 8000; magnesium stearate; iron oxide red - treatment of hypertension.,treatment of patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction <=40percent) as add-on therapy to ace inhibitors or when ace inhibitors are not tolerated.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

carilion materials management - candesartan cilexetil (unii: r85m2x0d68) (candesartan - unii:s8q36md2xx) - candesartan cilexetil 16 mg - candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and children 1 to <17 years of age, to lower blood pressure. lowering blood pressure reduces 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 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 (j

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

amneal pharma australia pty ltd - candesartan cilexetil -

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

amneal pharma australia pty ltd - candesartan cilexetil -

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

amneal pharma australia pty ltd - candesartan cilexetil -

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

amneal pharma australia pty ltd - candesartan cilexetil -

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - candesartan cilexetil (unii: r85m2x0d68) (candesartan - unii:s8q36md2xx) - candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to < 17 years of age, to lower blood pressure. lowering blood pressure reduces 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 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 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. candesartan cilexetil tablets may be used alone or in combination with other antihypertensive agents. candesartan cilexetil tablets are 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)] . candesartan cilexetil tablets also have an added effect on these outcomes when used with an ace inhibitor [see drug interactions (7.4)] . candesartan cilexetil tablets are contraindicated in patients who are hypersensitive to candesartan. do not co-administer aliskiren with candesartan cilexetil tablets in patients with diabetes [see drug interactions (7.4)] . candesartan cilexetil tablets 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 candesartan cilexetil tablets 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 birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 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. pregnant women with chronic heart failure are at increased risk for preterm birth. stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. heart failure may worsen with pregnancy and may lead to maternal death. closely monitor pregnant patients for destabilization of their heart failure. 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, 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. if oligohydramnios is observed, consider alternative drug treatment. closely observe infants with histories of in utero exposure to candesartan for hypotension, oliguria, hyperkalemia or other symptoms of renal impairment [see use in specific populations (8.4)] . in neonates with a history of in utero exposure to candesartan, if oliguria or hypotension occurs, support blood pressure and renal perfusion. exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. oral doses ≥ 10 mg of candesartan cilexetil/kg/day administered to pregnant rats during late gestation and continued through lactation were associated with reduced survival and an increased incidence of hydronephrosis in the offspring. the 10-mg/kg/day dose in rats is approximately 2.8 times the maximum recommended daily human dose (mrhd) of 32 mg on a mg/m2 basis (comparison assumes human body weight of 50 kg). candesartan cilexetil is toxic to rabbits. when given to pregnant rabbits at an oral dose of 3 mg/kg/day (approximately 1.7 times the mrhd on a mg/m2 basis), candesartan cilexetil caused maternal toxicity (decreased body weight and death) but, in surviving dams, had no adverse effects on fetal survival, fetal weight, or external, visceral, or skeletal development. no maternal toxicity or adverse effects on fetal development were observed when oral doses up to 1000 mg of candesartan cilexetil/kg/day (approximately 138 times the mrhd on a mg/m2 basis) were administered to pregnant mice. 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 serious adverse reactions in breastfed infants, advise a nursing woman that breastfeeding is not recommended during treatment with candesartan cilexetil tablets [see warnings and precautions (5.2)] . the antihypertensive effects of candesartan cilexetil tablets were evaluated in hypertensive children 1 to < 17 years of age in randomized, double-blind clinical studies [see clinical studies (14.1)] . the pharmacokinetics of candesartan cilexetil tablets have been evaluated in pediatric patients 1 to < 17 years of age [see clinical pharmacology (12.3)] . children < 1 year of age must not receive candesartan cilexetil tablets for hypertension [see warnings and precautions (5.2)] .

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

bryant ranch prepack - candesartan cilexetil (unii: r85m2x0d68) (candesartan - unii:s8q36md2xx) - candesartan cilexetil is indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, to lower blood pressure. lowering blood pressure reduces 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 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 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. candesartan cilexetil may be used alone or in combination with other antihypertensive agents. candesartan cilexetil 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)] . candesartan cilexetil also has an added effect on these outcomes when used with an ace inhibitor [see drug interactions (7.4)] . candesartan cilexetil is contraindicated in patients who are hypersensitive to candesartan. do not co-administer aliskiren with candesartan cilexetil in patients with diabetes [see drug interactions (7.4)] . risk summary candesartan cilexetil 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 candesartan cilexetil 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 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. pregnant women with chronic heart failure are at increased risk for preterm birth. stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. heart failure may worsen with pregnancy and may lead to maternal death. closely monitor pregnant patients for destabilization of their heart failure. 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, 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. if oligohydramnios is observed, consider alternative drug treatment. closely observe infants with histories of in utero exposure to candesartan cilexetil for hypotension, oliguria, hyperkalemia or other symptoms of renal impairment [see use in specific populations (8.4)] . in neonates with a history of in utero exposure to candesartan cilexetil, if oliguria or hypotension occurs, support blood pressure and renal perfusion. exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. animal data oral doses ≥10 mg of candesartan cilexetil/kg/day administered to pregnant rats during late gestation and continued through lactation were associated with reduced survival and an increased incidence of hydronephrosis in the offspring. the 10-mg/kg/day dose in rats is approximately 2.8 times the maximum recommended daily human dose (mrhd) of 32 mg on a mg/m2 basis (comparison assumes human body weight of 50 kg). candesartan cilexetil is toxic to rabbits. when given to pregnant rabbits at an oral dose of 3 mg/kg/day (approximately 1.7 times the mrhd on a mg/m2 basis), candesartan cilexetil caused maternal toxicity (decreased body weight and death) but, in surviving dams, had no adverse effects on fetal survival, fetal weight, or external, visceral, or skeletal development. no maternal toxicity or adverse effects on fetal development were observed when oral doses up to 1000 mg of candesartan cilexetil/kg/day (approximately 138 times the mrhd on a mg/m2 basis) were administered to pregnant mice. 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 serious adverse reactions in breastfed infants, advise a nursing woman that breastfeeding is not recommended during treatment with candesartan cilexetil [see warnings and precautions (5.2)] . the antihypertensive effects of candesartan cilexetil were evaluated in hypertensive children 1 to < 17 years of age in randomized, double-blind clinical studies [see clinical studies (14.1)] . the pharmacokinetics of candesartan cilexetil have been evaluated in pediatric patients 1 to < 17 years of age [see clinical pharmacology (12.3)] . children < 1 year of age must not receive candesartan cilexetil for hypertension [see warnings and precautions (5.2)].