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

nucare pharmaceuticals, inc. - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - pioglitazone 15 mg - pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see clinical studies (14)] . pioglitazone tablet exerts its antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.3)]. do not initiate in patients with nyha class iii or iv heart failure [see boxed warning] . do not use in patients with a history of a serious hypersensitivity reaction to pioglitazone tablets or any of its ingredients. pregnancy category c. there are no adeq

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

dispensing solutions, inc. - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - pioglitazone 15 mg - pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see clinical studies (14)] . pioglitazone tablet exerts its antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.3)]. do not initiate in patients with nyha class iii or iv heart failure [see boxed warning] . do not use in patients with a history of a serious hypersensitivity reaction to pioglitazone tablets or any of its ingredients. pregnancy category c. there are no adequate and well-controlled studies of pioglitazone hydrochloride in pregnant women. animal studies show increased rates of post-implantation loss, delayed development, reduced fetal weights, and delayed parturition at doses 10 to 40 times the maxim

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

macleods pharmaceuticals limited - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - pioglitazone 15 mg - pioglitazone and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and metformin is appropriate [see clinical studies (14)]. important limitations of use pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone and metformin hydrochloride tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.5)]. • initiation in patients with established nyha class iii or iv heart failure [see boxed warning]. • severe renal impairment (egfr below 30 ml/min/1.73 m2 ) [see warnings and precautions (5.2)]. • use in patients with known hypersensitivity to pioglitazone, metformin, or any other component of pioglitazone and metformin hydrochloride tablets. • metabolic acidosis, including diab

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

macleods pharmaceuticals limited - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - pioglitazone 15 mg - monotherapy and combination therapy pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see clinical studies (14)  ] . important limitations of use pioglitazone tablets, usp exerts its antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone tablets usp should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.3) ]. • initiation in patients with established new york heart association (nyha) class iii or iv heart failure [see boxed warning]. (4) • use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone hydrochloride.(4) risk summary limited data with pioglitazone hydrochloride in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or misca

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

mylan pharmaceuticals inc. - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - pioglitazone 15 mg - monotherapy and combination therapy pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see clinical studies (14)] . important limitations of use pioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as they would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.3)] . limited data with pioglitazone tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations]. in animal reproduction studies, no adverse developmental effects were observed when pioglitazone was administered to pregnant rats and rabbits during organog

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

aphena pharma solutions - tennessee, llc - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - pioglitazone 45 mg - monotherapy and combination therapy pioglitazone tablets, usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see clinical studies (14)] . important limitations of use pioglitazone tablets, usp exert its antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone tablets, usp should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.3)] . - initiation in patients with established nyha class iii or iv heart failure [see boxed warning]. - use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone tablets. teratogenic effects pregnancy category c. there are no adequate and well-controlled studies of pioglitazone in pregnant women. animal studies show increased rates of post-implantation

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

international laboratories, llc - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - pioglitazone 15 mg - monotherapy and combination therapy pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see clinical studies (14) ]. important limitations of use pioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.3) ]. •   initiation in patients with established nyha class iii or iv heart failure [see boxed warning]. •   use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone tablets. teratogenic effects pregnancy category c. there are no adequate and well-controlled studies of pioglitazone hydrochloride in pregnant women. animal studies show increased rates of post-implantation loss, delayed development,

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

acetris health, llc - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - pioglitazone 15 mg - monotherapy and combination therapy pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see clinical studies (14)] . important limitations of use pioglitazone tablets exert its antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.3)] . - initiation in patients with established nyha class iii or iv heart failure [see boxed warning]. - use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone tablets . risk summary limited data with pioglitazone in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly control

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

mylan institutional inc. - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - pioglitazone 15 mg - monotherapy and combination therapy pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see clinical studies (14)] . important limitations of use pioglitazone tablets exert its antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.3)] . - initiation in patients with established nyha class iii or iv heart failure [see boxed warning] . - use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone tablets. limited data with pioglitazone tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled di

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

zydus pharmaceuticals usa inc. - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - pioglitazone 15 mg - monotherapy and combination therapy pioglitazone tablets, usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see clinical studies (14)] . important limitations of use pioglitazone hydrochloride exerts its antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone hydrochloride should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.3)] . - initiation in patients with established nyha class iii or iv heart failure [see boxed warning]. - use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone hydrochloride. risk summary limited data with pioglitazone hydrochloride in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks t