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

aurobindo pharma limited - perindopril erbumine (unii: 1964x464oj) (perindoprilat - unii:2uv6znq92k) - perindopril erbumine 2 mg - perindopril erbumine tablets are indicated for the treatment of patients with essential hypertension. perindopril erbumine tablets may be used alone or given with other classes of antihypertensives, especially thiazide diuretics. perindopril erbumine tablets are indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. perindopril erbumine tablets can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive or lipid-lowering therapy. perindopril erbumine tablets are contraindicated in patients known to be hypersensitive (including angioedema) to this product or to any other ace inhibitor. perindopril erbumine tablets are also contraindicated in patients with hereditary or idiopathic angioedema. do not co-administer aliskiren with perindopril erbumine tablets in patients with diabetes. [see drug interactions (7.8) ] perindopril erbumine tablets are contraindicated in combination with neprilysin inhibitor (e.g., sacubitril). do not administer perindopril erbumine tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see warnings and precautions (5.1) ]. pregnancy category d [see boxed warning and warnings and precautions (5.4)] .  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. resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. when pregnancy is detected, discontinue perindopril erbumine as soon as possible. these adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. 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. appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. 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. if oligohydramnios is observed, discontinue perindopril erbumine, unless it is considered lifesaving for the mother. 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 perindopril erbumine for hypotension, oliguria, and hyperkalemia [see use in specific populations (8.4) ] . radioactivity was detectable in fetuses after administration of 14 c-perindopril to pregnant rats. milk of lactating rats contained radioactivity following administration of 14 c-perindopril. it is not known whether perindopril is secreted in human milk. because many drugs are secreted in human milk, caution should be exercised when perindopril erbumine is given to nursing mothers. neonates with a history of in utero exposure to perindopril erbumine:   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. perindopril, which crosses the placenta, can theoretically be removed from the neonatal circulation by these means, but limited experience has not shown that such removal is central to the treatment of these infants. safety and effectiveness of perindopril erbumine in pediatric patients have not been established. the mean blood pressure effect of perindopril was somewhat smaller in patients over 60 than in younger patients, although the difference was not significant. plasma concentrations of both perindopril and perindoprilat were increased in elderly patients compared to concentrations in younger patients. no adverse effects were clearly increased in older patients with the exception of dizziness and possibly rash. start at a low dose and titrate slowly as needed. monitor for dizziness because of potential for falls. experience with perindopril erbumine in elderly patients at daily doses exceeding 8 mg is limited. dosage adjustment may be necessary in renally impaired patients [see dosage and administration (2.3) and clinical pharmacology (12.3)] . the bioavailability of perindoprilat is increased in patients with impaired hepatic function [see clinical pharmacology (12.3)] .

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

lannett company, inc. - perindopril erbumine (unii: 1964x464oj) (perindoprilat - unii:2uv6znq92k) - perindopril erbumine 4 mg - perindopril erbumine tablets are indicated for the treatment of patients with essential hypertension. perindopril erbumine tablets may be used alone or given with other classes of antihypertensives, especially thiazide diuretics. perindopril erbumine tablets are indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. perindopril erbumine tablets can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive or lipid-lowering therapy. perindopril erbumine tablets are contraindicated in patients known to be hypersensitive (including angioedema) to this product or to any other ace inhibitor. perindopril erbumine tablets are also contraindicated in patients with hereditary or idiopathic angioedema. do not co-administer aliskiren with perindopril erbumine in patients with diabetes [see drug interactions (7.8)]. pregnancy category d  [see boxed warning and warn

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

west-ward pharmaceuticals corp. - perindopril erbumine (unii: 1964x464oj) (perindoprilat - unii:2uv6znq92k) - perindopril erbumine 2 mg - perindopril erbumine is indicated for the treatment of patients with essential hypertension. perindopril erbumine may be used alone or given with other classes of antihypertensives, especially thiazide diuretics. perindopril erbumine is indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. perindopril erbumine can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive or lipid-lowering therapy. perindopril erbumine is contraindicated in patients known to be hypersensitive (including angioedema) to this product or to any other ace inhibitor. perindopril erbumine is also contraindicated in patients with hereditary or idiopathic angioedema. do not co-administer aliskiren with perindopril erbumine in patients with diabetes [see drug interactions (7.8) ]. perindopril erbumine is contraindicated in combination with neprilysin inhibitor (e.g., sacubitril).

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

xoma (us) llc - perindopril erbumine (unii: 1964x464oj) (perindoprilat - unii:2uv6znq92k) - perindopril erbumine 2 mg - aceon is indicated for the treatment of patients with essential hypertension. aceon may be used alone or given with other classes of antihypertensives, especially thiazide diuretics. aceon is indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. aceon can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive or lipid-lowering therapy. aceon® (perindopril erbumine) is contraindicated in patients known to be hypersensitive (including angioedema) to this product or to any other ace inhibitor. aceon is also contraindicated in patients with hereditary or idiopathic angioedema. do not co-administer aliskiren with aceon in patients with diabetes [see drug interactions (7.8)] . pregnancy category d [see boxed warning and warnings and precautions (5.4) ]. use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregna

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

marlex pharmaceuticals inc - perindopril erbumine (unii: 1964x464oj) (perindoprilat - unii:2uv6znq92k) - perindopril erbumine 4 mg - perindopril erbumine tablets are indicated for the treatment of patients with essential hypertension. perindopril erbumine tablets may be used alone or given with other classes of antihypertensives, especially thiazide diuretics. perindopril erbumine tablets are indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. perindopril erbumine tablets can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive or lipid-lowering therapy. perindopril erbumine tablets are contraindicated in patients known to be hypersensitive (including angioedema) to this product or to any other ace inhibitor. perindopril erbumine tablets are also contraindicated in patients with hereditary or idiopathic angioedema. do not co-administer aliskiren with perindopril erbumine in patients with diabetes [see drug interactions ( 7.8 )] . pregnancy category d  [see boxed warning and

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

marina biotech - perindopril arginine (unii: tft5im1kgb) (perindoprilat - unii:2uv6znq92k), amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - perindopril arginine 3.5 mg - prestalia contains perindopril arginine, an angiotensin converting enzyme inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, and is indicated for the treatment of hypertension, to lower blood pressure. prestalia may be used in patients whose blood pressure is not adequately controlled on monotherapy. prestalia may be used as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. 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 amlodipine and the ace inhibitor class to which perindopril principally belongs. there are no controlled trials demonstrating risk reduction with prestalia. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithr

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

aurobindo pharma limited - perindopril erbumine (unii: 1964x464oj) (perindoprilat - unii:2uv6znq92k) -

Ireland - English - HPRA (Health Products Regulatory Authority)

imed healthcare ltd. - perindopril arginine - film coated tablet - 5 milligram - ace inhibitors, plain

Ireland - English - HPRA (Health Products Regulatory Authority)

imed healthcare ltd. - perindopril arginine - film coated tablet - 10 milligram - ace inhibitors, plain

Ireland - English - HPRA (Health Products Regulatory Authority)

tad pharma gmbh - perindopril arginine; amlodipine - tablet - perindopril and amlodipine