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

mylan pharmaceuticals inc. - repaglinide (unii: 668z8c33lu) (repaglinide - unii:668z8c33lu) - repaglinide 0.5 mg - repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitation of use: repaglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. repaglinide tablets are contraindicated in patients with: there are no adequate and well-controlled studies in pregnant women. it is unknown whether repaglinide tablets can cause fetal harm when administered to a pregnant woman. repaglinide tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. repaglinide was not teratogenic in rats or rabbits at doses 40 times (rats) and approximately 0.8 times (rabbit) clinical exposure (on a mg/m2 basis) throughout pregnancy. offspring of rat dams exposed to repaglinide at 15 times clinical exposure on a mg/m2 basis during days 17 to 22 of gestation and during lactation developed nonteratogenic skeletal deformities consisting of shor

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

golden state medical supply, inc. - repaglinide (unii: 668z8c33lu) (repaglinide - unii:668z8c33lu) - repaglinide 0.5 mg - repaglinide tablets, usp (repaglinide) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitation of use: repaglinide tablets, usp (repaglinide) should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. repaglinide tablets is contraindicated in patients with: - concomitant use of gemfibrozil [see drug interactions (7.1)] - known hypersensitivity to repaglinide or any inactive ingredients risk summary limited available data from case reports and case series with repaglinide tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy ( see clinical considerations ). teratogenicity was not observed in rats and rabbits administered repaglinide during organogenesis

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

breckenridge pharmaceutical, inc. - repaglinide (unii: 668z8c33lu) (repaglinide - unii:668z8c33lu) - repaglinide 0.5 mg - repaglinide tablets, usp (repaglinide) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitation of use: repaglinide tablets, usp (repaglinide) should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. repaglinide tablets is contraindicated in patients with: - concomitant use of gemfibrozil [see drug interactions (7.1)] - known hypersensitivity to repaglinide or any inactive ingredients risk summary limited available data from case reports and case series with repaglinide tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations ). teratogenicity was not observed in rats and rabbits administered repaglinide during organogenesis at approximately 60 and 1 times the maximum daily

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

rising health, llc - repaglinide (unii: 668z8c33lu) (repaglinide - unii:668z8c33lu) - repaglinide 0.5 mg - repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitation of use: repaglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. repaglinide tablets are contraindicated in patients with: - concomitant use of gemfibrozil [see drug interactions (7)] - known hypersensitivity to repaglinide or any inactive ingredients risk summary limited available data from case reports and case series with repaglinide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . teratogenicity was not observed in rats and rabbits administered repaglinide during organogenesis at approximately 60 and 1 times the maximum daily clinical dose, based on bod

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

aurobindo pharma limited - repaglinide (unii: 668z8c33lu) (repaglinide - unii:668z8c33lu) - repaglinide 0.5 mg - repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitation of use: repaglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. repaglinide tablets are contraindicated in patients with: - concomitant use of gemfibrozil [see drug interactions (7)] - known hypersensitivity to repaglinide or any inactive ingredients risk summary limited available data from case reports and case series with repaglinide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . teratogenicity was not observed in rats and rabbits administered repaglinide during organogenesis at approximately 60 and 1 times the maximum daily clinical dose, based on body surfac

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

american health packaging - repaglinide (unii: 668z8c33lu) (repaglinide - unii:668z8c33lu) - repaglinide 1 mg - repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitation of use: repaglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. repaglinide tablets are contraindicated in patients with: - concomitant use of gemfibrozil [see drug interactions (7.1)] - known hypersensitivity to repaglinide or any inactive ingredients pregnancy category c. there are no adequate and well-controlled studies in pregnant women. it is unknown whether repaglinide tablets can cause fetal harm when administered to a pregnant woman. repaglinide tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. repaglinide was not teratogenic in rats or rabbits at doses 40 times (rats) and approximately 0.8 times (rabbit) clinical exposure (on a mg/m 2 basis) throughout pregnancy. offspring of rat dams expos

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

sun pharmaceutical industries, inc. - repaglinide (unii: 668z8c33lu) (repaglinide - unii:668z8c33lu) - repaglinide 1 mg - repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitation of use: repaglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. repaglinide tablets are contraindicated in patients with: risk summary limited available data from case reports and case series with repaglinide tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations ). teratogenicity was not observed in rats and rabbits administered repaglinide during organogenesis at approximately 60 and 1 times the maximum daily clinical dose, based on body surface area. no adverse developmental effects were observed in offspring of rats administered repaglinide during late gestation and lactatio

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

padagis us llc - repaglinide (unii: 668z8c33lu) (repaglinide - unii:668z8c33lu) - repaglinide 0.5 mg - repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitation of use: repaglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. repaglinide tablets are contraindicated in patients with: risk summary limited available data from case reports and case series with repaglinide tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . teratogenicity was not observed in rats and rabbits administered repaglinide during organogenesis at approximately 60 and 1 times the maximum daily clinical dose, based on body surface area. no adverse developmental effects were observed in offspring of rats administered repaglinide during late gestation and lactatio

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - repaglinide - diabetes mellitus, type 2 - drugs used in diabetes - repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (niddm)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. repaglinide is also indicated in combination with metformin in type-2-diabetes patients who are not satisfactorily controlled on metformin alone.treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - repaglinide - diabetes mellitus, type 2 - drugs used in diabetes - repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (niddm)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.