New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - indometacin sodium trihydrate 1.061mg equivalent to indomethacin 1 mg - powder for injection - 1 mg - active: indometacin sodium trihydrate 1.061mg equivalent to indomethacin 1 mg - indomethacin is indicated for the closure of patent ductus arteriosus in premature babies. clear-cut clinical evidence of a haemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray. indomethacin should only be used in a hospital under supervision of a specialist neonatologist.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - indometacin sodium trihydrate 1.061mg equivalent to indomethacin 1 mg - powder for injection - 1 mg - active: indometacin sodium trihydrate 1.061mg equivalent to indomethacin 1 mg - indomethacin is indicated for the closure of patent ductus arteriosus in premature babies. clear-cut clinical evidence of a haemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray. indomethacin should only be used in a hospital under supervision of a specialist neonatologist.

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

medtas pty ltd - indometacin sodium trihydrate, quantity: 1.061 mg (equivalent: indometacin, qty 1 mg) - injection, powder for - excipient ingredients: - indomethacin ch is indicated for the closure of patent ductus arteriosus in premature babies. clear-cut clinical evidence of a haemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray. this product should only be used in a hospital under supervision of a specialist neonatologist.

United States - English - 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

United States - English - 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

United States - English - 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

United States - English - 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

United States - English - 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

United States - English - 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 ).

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

stat rx usa llc - 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: - 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 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 , an