Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

aurobindo pharma limited - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 75 mg - indomethacin extended-release capsules are indicated for: - moderate to severe rheumatoid arthritis including acute flares of chronic disease - moderate to severe ankylosing spondylitis - moderate to severe osteoarthritis - acute painful shoulder (bursitis and/or tendinitis) indomethacin extended-release capsules are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see warnings and precautions (5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1) ] risk summary use of nsaids, including indomethacin extended-release capsules, can cause premature closure of the fetal ductus arteriosus and

Сједињене Америчке Државе - Енглески - 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)] .

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

american health packaging - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 75 mg - indomethacin extended-release capsules are indicated for: - moderate to severe rheumatoid arthritis including acute flares of chronic disease - moderate to severe ankylosing spondylitis - moderate to severe osteoarthritis - acute painful shoulder (bursitis and/or tendinitis) indomethacin extended-release capsules are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see warnings and precautions ( 5.7, 5.9)] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions ( 5.7, 5.8)] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions ( 5.1)] risk summary use of nsaids, including indomethacin extended-release capsules, can cause premature clos

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

jubilant cadista pharmaceuticals inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 75 mg - indomethacin extended-release capsules are indicated for: - moderate to severe rheumatoid arthritis including acute flares of chronic disease moderate to severe rheumatoid arthritis including acute flares of chronic disease - moderate to severe ankylosing spondylitis moderate to severe ankylosing spondylitis - moderate to severe osteoarthritis moderate to severe osteoarthritis - acute painful shoulder (bursitis and/or tendinitis) acute painful shoulder (bursitis and/or tendinitis) indomethacin extended-release is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see warnings and precautions ( 5.7, 5.9) ] known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see warnings and precautions ( 5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

jubilant cadista pharmaceuticals inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 25 mg - indomethacin capsules are indicated for: - moderate to severe rheumatoid arthritis including acute flares of chronic disease. moderate to severe rheumatoid arthritis including acute flares of chronic disease. - moderate to severe ankylosing spondylitis. moderate to severe ankylosing spondylitis. - moderate to severe osteoarthritis. moderate to severe osteoarthritis. - acute painful shoulder (bursitis and/or tendinitis). acute painful shoulder (bursitis and/or tendinitis). - acute gouty arthritis. acute gouty arthritis. indomethacin capsules are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see warnings and precautions (5.7, 5.9)] known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see warnings and precautions (5.7, 5.9)] - history of asthma, urticaria, or other allergic-type react

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

eon labs, inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 75 mg - indomethacin extended-release capsules are indicated for: indomethacin extended-release is contraindicated in the following patients: risk summary use of nsaids, including indomethacin extended-release, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including indomethacin extended-release, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of indomethacin extended-release in pregnant women. data from observational studies regarding potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in the general u.s. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. in animal reproduction studies retarded fetal ossification was observed with administration of indomethacin to mice and ra

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 25 mg - indomethacin capsules are indicated for: - moderate to severe rheumatoid arthritis including acute flares of chronic disease - moderate to severe ankylosing spondylitis - moderate to severe osteoarthritis - acute painful shoulder (bursitis and/or tendinitis) - acute gouty arthritis indomethacin capsules are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see warnings and precautions ( 5.7, 5.9)] . - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions ( 5.7, 5.8)] . - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 25 mg - indomethacin capsules are indicated for: indomethacin capsules are contraindicated in the following patients: use of nsaids, including indomethacin capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including indomethacin capsules, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of indomethacin capsules in pregnant women. data from observational studies regarding potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in the general u.s. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations, and 15 to 20% for pregnancy loss. in animal reproduction studies, retarded fetal ossification was observed with administration of indomethacin to mice and rats during organogenesis at doses 0.1 and 0.2 times, respective

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 25 mg - indomethacin capsules are indicated for: - moderate to severe rheumatoid arthritis including acute flares of chronic disease. - moderate to severe ankylosing spondylitis. - moderate to severe osteoarthritis. - acute painful shoulder (bursitis and/or tendinitis). - acute gouty arthritis. indomethacin capsules are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [ see warnings and precautions (5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [ see warnings and precautions (5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [ see warnings and precautions (5.1) ] use of nsaids, including indomethacin capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal d

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

medvantx, inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 50 mg - carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). indomethacin capsules have been found effective in active stages of the following: indomethacin is contraindicated in patients with known hypersensitivity to indomethacin or the excipients (see description ). indomethacin should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic/anaphylactoid reactions to nsaids have been reported in such patients (see warnings, anaphylactic/anaphylactoid reactions , and precautions, preexisting asthma ). indomethacin is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (cabg) surgery (see warnings ).