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

northwind pharmaceuticals, llc - glipizide (unii: x7wdt95n5c) (glipizide - unii:x7wdt95n5c) - glipizide xl is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glipizide xl is not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. glipizide is contraindicated in patients with: - known hypersensitivity to glipizide or any of the product's ingredients. - hypersensitivity to sulfonamide derivatives. risk summary available data from a small number of published studies and postmarketing experience with glipizide xl use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. however, sulfonylureas (including glipizide) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. therefore, glipizide xl should be discontinued at least two weeks before expected delivery (see clinical considerations). poorly controlled diabetes in pregnancy is also associated with risks to the mother and fetus (see clinical considerations). in animal studies, there were no effects on embryofetal development following administration of glipizide to pregnant rats and rabbits during organogenesis at doses 833 times and 8 times the human dose based on body surface area, respectively. however, increased pup mortality was observed in rats administered glipizide from gestation day 15 throughout lactation at doses 2 times the maximum human dose based on body surface area (see data) . the estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20–25% in women with hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly-controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, miscarriage, preterm delivery, stillbirth, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. fetal/neonatal adverse reactions neonates of women with gestational diabetes who are treated with sulfonylureas during pregnancy may be at increased risk for neonatal intensive care admission and may develop respiratory distress, hypoglycemia, birth injury, and be large for gestational age. prolonged severe hypoglycemia, lasting 4–10 days, has been reported in neonates born to mothers receiving a sulfonylurea at the time of delivery and has been reported with the use of agents with a prolonged half-life. observe newborns for symptoms of hypoglycemia and respiratory distress and manage accordingly. dose adjustments during pregnancy and the postpartum period due to reports of prolonged severe hypoglycemia in neonates born to mothers receiving a sulfonylurea at the time of delivery, glipizide xl should be discontinued at least two weeks before expected delivery (see fetal/neonatal adverse reactions) . data animal data in teratology studies in rats and rabbits, pregnant animals received daily oral doses of glipizide during the period of organogenesis at doses up to 2000 mg/kg/day and 10 mg/kg/day (approximately 833 and 8 times the human dose based on body surface area), respectively. there were no adverse effects on embryo-fetal development at any of the doses tested. in a peri- and postnatal study in pregnant rats, there was a reduced number of pups born alive following administration of glipizide from gestation day 15 throughout lactation through weaning at doses ≥5 mg/kg/day (about 2 times the recommended maximum human dose based on body surface area). risk summary breastfed infants of lactating women using glipizide xl should be monitored for symptoms of hypoglycemia (see clinical considerations) . although glipizide was undetectable in human milk in one small clinical lactation study; this result is not conclusive because of the limitations of the assay used in the study. there are no data on the effects of glipizide on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for glipizide xl and any potential adverse effects on the breastfed child from glipizide xl or from the underlying maternal condition. clinical considerations monitoring for adverse reactions monitor breastfed infants for signs of hypoglycemia (e.g., jitters, cyanosis, apnea, hypothermia, excessive sleepiness, poor feeding, seizures). safety and effectiveness in children have not been established. there were no overall differences in effectiveness or safety between younger and older patients, but greater sensitivity of some individuals cannot be ruled out. elderly patients are particularly susceptible to the hypoglycemic action of anti-diabetic agents. hypoglycemia may be difficult to recognize in these patients. therefore, dosing should be conservative to avoid hypoglycemia [see dosage and administration (2.1), warnings and precautions (5.1) and clinical pharmacology (12.3)] . there is no information regarding the effects of hepatic impairment on the disposition of glipizide. however, since glipizide is highly protein bound and hepatic biotransformation is the predominant route of elimination, the pharmacokinetics and/or pharmacodynamics of glipizide may be altered in patients with hepatic impairment. if hypoglycemia occurs in such patients, it may be prolonged and appropriate management should be instituted [see dosage and administration (2.1), warnings and precautions (5.1) and clinical pharmacology (12.3)] .

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

northwind pharmaceuticals, llc - glipizide (unii: x7wdt95n5c) (glipizide - unii:x7wdt95n5c) - glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glipizide extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. glipizide is contraindicated in patients with: - known hypersensitivity to glipizide or any of the product’s ingredients. - hypersensitivity to sulfonamide derivatives. risk summary available data from a small number of published studies and postmarketing experience with glipizide extended-release tablets use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. however, sulfonylureas (including glipizide) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. therefore, glipizide extended-release tablets should be discontinued at least two weeks before expected delivery ( see clinical considerations ). poorly controlled diabetes in pregnancy is also associated with risks to the mother and fetus ( see clinical considerations ). in animal studies, there were no effects on embryofetal development following administration of glipizide to pregnant rats and rabbits during organogenesis at doses 833 times and 8 times the human dose based on body surface area, respectively. however, increased pup mortality was observed in rats administered glipizide from gestation day 15 throughout lactation at doses 2 times the maximum human dose based on body surface area ( see data ). the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20-25% in women with hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.    clinical considerations     disease-associated maternal and/or embryo/fetal risk poorly-controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, miscarriage, preterm delivery, stillbirth, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. fetal/neonatal adverse reactions     neonates of women with gestational diabetes who are treated with sulfonylureas during pregnancy may be at increased risk for neonatal intensive care admission and may develop respiratory distress, hypoglycemia, birth injury, and be large for gestational age. prolonged severe hypoglycemia, lasting 4-10 days, has been reported in neonates born to mothers receiving a sulfonylurea at the time of delivery and has been reported with the use of agents with a prolonged half-life. observe newborns for symptoms of hypoglycemia and respiratory distress and manage accordingly.   dose adjustments during pregnancy and the postpartum period due to reports of prolonged severe hypoglycemia in neonates born to mothers receiving a sulfonylurea at the time of delivery, glipizide extended-release tablets should be discontinued at least two weeks before expected delivery ( see fetal/neonatal adverse reactions ). data   animal data in teratology studies in rats and rabbits, pregnant animals received daily oral doses of glipizide during the period of organogenesis at doses up to 2000 mg/kg/day and 10 mg/kg/day (approximately 833 and 8 times the human dose based on body surface area), respectively. there were no adverse effects on embryo-fetal development at any of the doses tested. in a peri-and postnatal study in pregnant rats, there was a reduced number of pups born alive following administration of glipizide from gestation day 15 throughout lactation through weaning at doses ≥5 mg/kg/day (about 2 times the recommended maximum human dose based on body surface area).     risk summary   breastfed infants of lactating women using glipizide extended-release tablets should be monitored for symptoms of hypoglycemia ( see clinical considerations ). although glipizide was undetectable in human milk in one small clinical lactation study; this result is not conclusive because of the limitations of the assay used in the study. there are no data on the effects of glipizide on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for glipizide extended-release tablets and any potential adverse effects on the breastfed child from glipizide extended-release tablets or from the underlying maternal condition. clinical considerations      monitoring for adverse reactions monitor breastfed infants for signs of hypoglycemia (e.g., jitters, cyanosis, apnea, hypothermia, excessive sleepiness, poor feeding, seizures). safety and effectiveness in children have not been established. there were no overall differences in effectiveness or safety between younger and older patients, but greater sensitivity of some individuals cannot be ruled out. elderly patients are particularly susceptible to the hypoglycemic action of anti-diabetic agents. hypoglycemia may be difficult to recognize in these patients. therefore, dosing should be conservative to avoid hypoglycemia [ see dosage and administration (2.1),warnings and precautions (5.1) and clinical pharmacology (12.3)]. there is no information regarding the effects of hepatic impairment on the disposition of glipizide. however, since glipizide is highly protein bound and hepatic biotransformation is the predominant route of elimination, the pharmacokinetics and/or pharmacodynamics of glipizide may be altered in patients with hepatic impairment. if hypoglycemia occurs in such patients, it may be prolonged and appropriate management should be instituted [ see dosage and administration (2.1),warnings and precautions (5.1) and clinical pharmacology (12.3)].

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

rpk pharmaceuticals, inc. - glyburide (unii: sx6k58tvwc) (glyburide - unii:sx6k58tvwc) - glyburide tablets, usp is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glyburide tablets are contraindicated in patients with:   - known hypersensitivity or allergy to the drug. - diabetic ketoacidosis, with or without coma. this condition should be treated with insulin. - type i diabetes mellitus. - concomitant administration of bosentan. special warning on increased risk of cardiovascular mortality the administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. this warning is based on the study conducted by the university group diabetes program (ugdp), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. the study involved 823 patients who were randomly assigned to one of fo

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

pharmaceutical associates, inc. - glyburide (unii: sx6k58tvwc) (glyburide - unii:sx6k58tvwc) - glyburide tablets usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glyburide tablets are contraindicated in patients with: - known hypersensitivity or allergy to the drug. - diabetic ketoacidosis, with or without coma. this condition should be treated with insulin. - type i diabetes mellitus. - concomitant administration of bosentan.

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

winthrop pharmaceuticals (pty) ltd - tablet - see ingredients - each tablet contains glimepiride 2,0 mg

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

denton pharma, inc. dba northwind pharmaceuticals - glyburide (unii: sx6k58tvwc) (glyburide - unii:sx6k58tvwc) - glyburide tablets usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glyburide tablets are contraindicated in patients with: - known hypersensitivity or allergy to the drug. - diabetic ketoacidosis, with or without coma. this condition should be treated with insulin. - type i diabetes mellitus. - concomitant administration of bosentan.

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

modavar pharmaceuticals llc - glyburide (unii: sx6k58tvwc) (glyburide - unii:sx6k58tvwc) - glyburide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glyburide tablets are contraindicated in patients with: 1. known hypersensitivity or allergy to the drug. 2. diabetic ketoacidosis, with or without coma. this condition should be treated with insulin. 3. type i diabetes mellitus. 4. concomitant administration of bosentan.

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

ani pharmaceuticals, inc. - glipizide (unii: x7wdt95n5c) (glipizide - unii:x7wdt95n5c) - glipizide tablets usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glipizide is contraindicated in patients with: 1. known hypersensitivity to the drug. 2. type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. this condition should be treated with insulin.

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

preferred pharmaceuticals inc.. - glipizide (unii: x7wdt95n5c) (glipizide - unii:x7wdt95n5c) - glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glipizide tablets are contraindicated in patients with:     1. known hypersensitivity to the drug.     2. type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. this condition should be treated with insulin.

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

preferred pharmaceuticals, inc. - glipizide (unii: x7wdt95n5c) (glipizide - unii:x7wdt95n5c) - glipizide tablets usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glipizide is contraindicated in patients with: 1. known hypersensitivity to the drug. 2. type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. this condition should be treated with insulin.