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)

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)

lupin pharmaceuticals, inc - perindopril erbumine (unii: 1964x464oj) (perindopril - unii:y5gmk36kgy) - perindopril erbumine 2 mg - stable coronary artery disease perindopril erbumine tablets are indicated in patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or non-fatal 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. hypertension 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. when using perindopril erbumine 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. available data are insufficient to determine whether perindopril erbumine tablets has a similar potential. (see warnings .) in considering use of

New Zealand - English - Medsafe (Medicines Safety Authority)

clinect nz pty limited - perindopril erbumine 2mg - tablet - 2 mg - active: perindopril erbumine 2mg excipient: lactose magnesium stearate - perindopril is indicated for: · the treatment of hypertension.

New Zealand - English - Medsafe (Medicines Safety Authority)

clinect nz pty limited - perindopril erbumine 4mg - tablet - 4 mg - active: perindopril erbumine 4mg excipient: lactose magnesium stearate - perindopril is indicated for: · the treatment of hypertension.

New Zealand - English - Medsafe (Medicines Safety Authority)

clinect nz pty limited - perindopril erbumine 8mg - tablet - 8 mg - active: perindopril erbumine 8mg excipient: lactose magnesium stearate - perindopril is indicated for: · the treatment of hypertension.

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

servier laboratories (aust) pty ltd - perindopril arginine, quantity: 10 mg; amlodipine besilate, quantity: 6.935 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; magnesium stearate; colloidal anhydrous silica - apx-perindopril arginine/ amlodipine is indicated as substitution therapy for the treatment of hypertension and/or stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine, given concurrently at the same dose level. treatment should not be initiated with this combination.

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

arrotex pharmaceuticals pty ltd - perindopril arginine, quantity: 10 mg; amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg) - tablet - excipient ingredients: microcrystalline cellulose; magnesium stearate; croscarmellose sodium; colloidal anhydrous silica - perindopril arginine and amlodipine combination tablet is indicated as substitution therapy for the treatment of hypertension and/or stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine, given concurrently at the same dose level. treatment should not be initiated with this combination.

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

arrotex pharmaceuticals pty ltd - perindopril arginine, quantity: 10 mg; amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg) - tablet - excipient ingredients: croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose - perindopril arginine and amlodipine combination tablet is indicated as substitution therapy for the treatment of hypertension and/or stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine, given concurrently at the same dose level. treatment should not be initiated with this combination.

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

arrotex pharmaceuticals pty ltd - perindopril erbumine, quantity: 8 mg - tablet, uncoated - excipient ingredients: lactose; magnesium stearate - treatment of hypertension. treatment of heart failure. in such patients it is recommended that perindopril be given with a diuretic and/or digoxin under close medical supervision. (the safety and efficacy of perindopril have not been demonstrated for new york heart association category iv patients). patients with established coronary artery disease (see clinical trials) who are stable on concomitant therapy and have no heart failure, to reduce the risk of nonfatal myocardial infarction or cardiac arrest.