Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - glyburide (unii: sx6k58tvwc) (glyburide - unii:sx6k58tvwc) - glyburide tablets, usp (micronized) are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glyburide tablets (micronized) 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.

Jungtinės Valstijos - anglų - 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)].

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - glimepiride (unii: 6ky687524k) (glimepiride - unii:6ky687524k) - glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see clinical studies ( 14.1) ]. limitations of use glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. glimepiride tablets are contraindicated in patients with a history of a hypersensitivity reaction to:  - glimepiride or any of the product’s ingredients [see warnings and precautions ( 5.2) ]. - sulfonamide derivatives: patients who have developed an allergic reaction to sulfonamide derivatives may develop an allergic reaction to glimepiride. do not use glimepiride in patients who have a history of an allergic reaction to sulfonamide derivatives.   risk summary available data from a small number of published studies and postmarketing experience with glimepiride use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. however, sulfonylureas (including glimepiride) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. therefore, glimepiride 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 (see data) , there were no effects on embryo-fetal development following administration of glimepiride to pregnant rats and rabbits at oral doses approximately 4,000 times and 60 times the maximum human dose based on body surface area, respectively. however, fetotoxicity was observed in rats and rabbits at doses 50 times and 0.1 times the maximum human dose, respectively.   the estimated background risk of major birth defects is 6% to 10% in women with pregestational diabetes with a hba1c >7% and has been reported to be as high as 20% to 25% in women with a 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, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, still birth, 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, glimepiride tablets should be discontinued at least two weeks before expected delivery (see fetal/neonatal adverse reactions ).   data   animal data   in animal studies, there was no increase in congenital anomalies, but an increase in fetal deaths occurred in rats and rabbits at glimepiride doses 50 times (rats) and 0.1 times (rabbits) the maximum recommended human dose (based on body surface area). this fetotoxicity was observed only at doses inducing maternal hypoglycemia and is believed to be directly related to the pharmacologic (hypoglycemic) action of glimepiride, as has been similarly noted with other sulfonylureas. risk summary   breastfed infants of lactating women using glimepiride tablets should be monitored for symptoms of hypoglycemia (see clinical considerations) . it is not known whether glimepiride is excreted in human milk and there are no data on the effects of glimepiride on milk production. glimepiride is present in rat milk [see data] . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for glimepiride and any potential adverse effects on the breastfed child from glimepiride 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). data   during prenatal and postnatal studies in rats, significant concentrations of glimepiride were present in breast milk and the serum of the pups. offspring of rats exposed to high levels of glimepiride during pregnancy and lactation developed skeletal deformities consisting of shortening, thickening, and bending of the humerus during the postnatal period. these skeletal deformations were determined to be the result of nursing from mothers exposed to glimepiride. the pharmacokinetics, efficacy and safety of glimepiride have been evaluated in pediatric patients with type 2 diabetes as described below. glimepiride tablets are not recommended in pediatric patients because of its adverse effects on body weight and hypoglycemia.   the pharmacokinetics of a 1 mg single dose of glimepiride was evaluated in 30 patients with type 2 diabetes (male = 7; female = 23) between ages 10 and 17 years. the mean (± sd) auc (0-last) (339±203 ng•hr/ml), c max (102±48 ng/ml) and t 1/2 (3.1±1.7 hours) for glimepiride were comparable to historical data from adults (auc (0-last) 315±96 ng•hr/ml, c max 103±34 ng/ml and t 1/2 5.3±4.1 hours). the safety and efficacy of glimepiride in pediatric patients was evaluated in a single-blind, 24-week trial that randomized 272 patients (8 to 17 years of age) with type 2 diabetes to glimepiride (n=135) or metformin (n=137). both treatment-naïve patients (those treated with only diet and exercise for at least 2 weeks prior to randomization) and previously treated patients (those previously treated or currently treated with other oral antidiabetic medications for at least 3 months) were eligible to participate. patients who were receiving oral antidiabetic agents at the time of study entry discontinued these medications before randomization without a washout period. glimepiride was initiated at 1 mg, and then titrated up to 2, 4 or 8 mg (mean last dose 4 mg) through week 12, targeting a self-monitored fasting fingerstick blood glucose < 126 mg/dl. metformin was initiated at 500 mg twice daily and titrated at week 12 up to 1000 mg twice daily (mean last dose 1365 mg). after 24 weeks, the overall mean treatment difference in hba 1c between glimepiride and metformin was 0.2%, favoring metformin (95% confidence interval -0.3% to +0.6%).  based on these results, the trial did not meet its primary objective of showing a similar reduction in hba 1c with glimepiride compared to metformin. the profile of adverse reactions in pediatric patients treated with glimepiride was similar to that observed in adults [see adverse reactions ( 6) ].   hypoglycemic events documented by blood glucose values <36 mg/dl were observed in 4% of pediatric patients treated with glimepiride and in 1% of pediatric patients treated with metformin. one patient in each treatment group experienced a severe hypoglycemic episode (severity was determined by the investigator based on observed signs and symptoms). in clinical trials of glimepiride, 1053 of 3491 patients (30%) were >65 years of age. no overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. there were no significant differences in glimepiride pharmacokinetics between patients with type 2 diabetes ≤65 years (n=49) and those >65 years (n=42) [see clinical pharmacology ( 12.3) ].   glimepiride is substantially excreted by the kidney. elderly patients are more likely to have renal impairment. in addition, hypoglycemia may be difficult to recognize in the elderly [see dosage and administration ( 2.1) and warnings and precautions ( 5.1) ]. use caution when initiating glimepiride and increasing the dose of glimepiride tablets in this patient population. to minimize the risk of hypoglycemia, the recommended starting dose of glimepiride tablets are 1 mg daily for all patients with type 2 diabetes and renal impairment [see dosage and administration ( 2.1) and warnings and precautions ( 5.1) ].   a multiple-dose titration study was conducted in 16 patients with type 2 diabetes and renal impairment using doses ranging from 1 mg to 8 mg daily for 3 months. baseline creatinine clearance ranged from 10 to 60 ml/min. the pharmacokinetics of glimepiride tablets were evaluated in the multiple-dose titration study and the results were consistent with those observed in patients enrolled in a single-dose study. in both studies, the relative total clearance of glimepiride increased when kidney function was impaired. both studies also demonstrated that the elimination of the two major metabolites was reduced in patients with renal impairment [see clinical pharmacology ( 12.3) ].

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

denton pharma, inc. dba northwind pharmaceuticals - 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.

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - 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.

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

repharm pharmaceuticals - 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:

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

nucare 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.

Malaizija - anglų - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

imeks pharma sdn. bhd. - acyclovir -

Malaizija - anglų - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

imeks pharma sdn. bhd. - acyclovir -

Malaizija - anglų - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

imeks pharma sdn. bhd. - acyclovir -