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

pd-rx pharmaceuticals, inc. - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - 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 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)] . - 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 hydrochloride 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 poo

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

carilion materials management - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - pioglitazone 30 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 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) 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 their ingredients. pregnancy category c. there are no adequate and well-controlled studi

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

takeda pharmaceuticals australia pty ltd - alogliptin benzoate, quantity: 17 mg (equivalent: alogliptin, qty 12.5 mg); pioglitazone hydrochloride, quantity: 33.06 mg (equivalent: pioglitazone, qty 30 mg) - tablet, film coated - excipient ingredients: hypromellose; croscarmellose sodium; titanium dioxide; macrogol 8000; hyprolose; purified talc; iron oxide yellow; lactose monohydrate; magnesium stearate; microcrystalline cellulose; mannitol; iron oxide red; butan-1-ol; shellac; carnauba wax; ethanol absolute; glyceryl monooleate - oseni is indicated to improve glycaemic control in adult patients (> or = 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control and treatment with both alogliptin and pioglitazone is appropriate,- when treatment with metformin or pioglitazone alone does not provide adequate control; or,- in combination with metformin when dual therapy does not provide adequate control.,oseni can also be used to replace separate tablets of alogliptin and pioglitazone in patients already being treated with this combination.

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

takeda pharmaceuticals australia pty ltd - alogliptin benzoate, quantity: 17 mg (equivalent: alogliptin, qty 12.5 mg); pioglitazone hydrochloride, quantity: 33.06 mg (equivalent: pioglitazone, qty 30 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; hypromellose; microcrystalline cellulose; mannitol; magnesium stearate; iron oxide red; lactose monohydrate; titanium dioxide; iron oxide yellow; macrogol 8000; hyprolose; purified talc; butan-1-ol; shellac; carnauba wax; ethanol absolute; glyceryl monooleate - oseni is indicated to improve glycaemic control in adult patients (> or = 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control and treatment with both alogliptin and pioglitazone is appropriate,- when treatment with metformin or pioglitazone alone does not provide adequate control; or,- in combination with metformin when dual therapy does not provide adequate control.,oseni can also be used to replace separate tablets of alogliptin and pioglitazone in patients already being treated with this combination.

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

takeda pharmaceuticals australia pty ltd - alogliptin benzoate, quantity: 34 mg (equivalent: alogliptin, qty 25 mg); pioglitazone hydrochloride, quantity: 33.06 mg (equivalent: pioglitazone, qty 30 mg) - tablet, film coated - excipient ingredients: titanium dioxide; mannitol; hypromellose; lactose monohydrate; hyprolose; macrogol 8000; croscarmellose sodium; magnesium stearate; iron oxide yellow; purified talc; microcrystalline cellulose; iron oxide red; shellac; ethanol absolute; iron oxide black; 1-butanol - oseni is indicated to improve glycaemic control in adult patients (> or = 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control and treatment with both alogliptin and pioglitazone is appropriate,- when treatment with metformin or pioglitazone alone does not provide adequate control; or,- in combination with metformin when dual therapy does not provide adequate control.,oseni can also be used to replace separate tablets of alogliptin and pioglitazone in patients already being treated with this combination.

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

cambridge therapeutics technologies, llc - 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]. - •renal impairment (e.g., serum creatinine levels ≥1.5 mg/dl [males], ≥1.4 mg/dl [females], or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia [see warnings and precautions (5.2, 5.10)].

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)

aphena pharma solutions - tennessee, llc - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - 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

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

nucare pharmaceuticals,inc. - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - 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

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

arrotex pharmaceuticals pty ltd - pioglitazone hydrochloride, quantity: 33.069 mg (equivalent: pioglitazone, qty 30 mg) - tablet, uncoated - excipient ingredients: lactose monohydrate; hyprolose; magnesium stearate; carmellose calcium - treatment of type 2 diabetes mellitus inadequately controlled by diet and exercise:,as monotherapy,as dual therapy to improve glycaemic control,- in combination with metformin or sulfonylurea,- in combination with insulin,as triple therapy to improve glycaemic control,- in combination with metformin and sulfonylurea