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cardinal health - glipizide (unii: x7wdt95n5c) (glipizide - unii:x7wdt95n5c) - glipizide 5 mg - 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:

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

mylan pharmaceuticals inc. - glipizide (unii: x7wdt95n5c) (glipizide - unii:x7wdt95n5c) - glipizide 5 mg - 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:

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

physicians total care, inc. - glipizide (unii: x7wdt95n5c) (glipizide - unii:x7wdt95n5c) - glipizide 5 mg - glipizide tablets are indicated as an adjunct to diet for the control of hyperglycemia and its associated symptomatology in patients with non-insulin-dependent diabetes mellitus (niddm; type ii), formerly known as maturity-onset diabetes, after an adequate trial of dietary therapy has proved unsatisfactory. in initiating treatment for non-insulin-dependent diabetes, diet should be emphasized as the primary form of treatment. caloric restriction and weight loss are essential in the obese diabetic patient. proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. the importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified, and corrective measures taken where possible. if this treatment program fails to reduce symptoms and/or blood glucose, the use of an oral sulfonylurea or insulin should be considered. use of glipizide must be viewed by both the physician and patient as a treatment in addition t

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

legacy pharmaceutical packaging, llc - glipizide (unii: x7wdt95n5c) (glipizide - unii:x7wdt95n5c) - glipizide 5 mg - glipizide tablets 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.

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nucare pharmaceuticals,inc. - glipizide (unii: x7wdt95n5c) (glipizide - unii:x7wdt95n5c) - glipizide 10 mg - 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.

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clinical solutions wholesale, llc - glipizide (unii: x7wdt95n5c) (glipizide - unii:x7wdt95n5c) - glipizide 5 mg - glipizide tablets 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.

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lake erie medical dba quality care products llc - glipizide (unii: x7wdt95n5c) (glipizide - unii:x7wdt95n5c) - glipizide 10 mg - glipizide tablets 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)

pd-rx pharmaceuticals, inc. - 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 to 10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20 to 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 to 4% and 15 to 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 to 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)].

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denton pharma, inc. dba northwind pharmaceuticals - 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 i

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

nucare pharmaceuticals, inc. - 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 contraindicated in patients with: - known hypersensitivity to glipizide or any excipients in the tablets. known hypersensitivity to glipizide or any excipients in the tablets. - type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. this condition should be treated with insulin. type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. this condition should be treated with insulin.