REPAGLINIDE 1 MG - search results

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

repaglinide tablet

american health packaging - repaglinide (unii: 668z8c33lu) (repaglinide - unii:668z8c33lu) - 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 surface area. no adverse developmental effects were observed in offspring of rats administered repaglinide during late gestation and lactation at approximately 4 times the maximum daily clinical dose (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 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, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth and macrosomia related morbidity. data animal data repaglinide was not teratogenic in rats or rabbits at doses 60 times (rats) and approximately 1 times (rabbit) clinical exposure (on a mg/m 2 basis) when administered during the period of organogenesis. offspring of rat dams exposed to repaglinide at ≥22 times clinical exposure on a mg/m 2 basis during days 17 to 22 of gestation and during lactation were less viable and developed skeletal deformations consisting of shortening, thickening, and bending of the humerus during the postnatal period. this effect was not seen at doses up to 4 times clinical exposure (on a mg/m 2 basis). risk summary there are no data on the presence of repaglinide in human milk, the effects on the breastfeeding infant, or the effects on milk production. the drug is present in animal milk. when a drug is present in animal milk, it is likely that the drug will be present in human milk (see data) . because of the potential for hypoglycemia in breastfed infants, repaglinide is not recommended for use when breastfeeding. data in rat reproduction studies, measurable levels of repaglinide were detected in the breast milk of the dams and lowered blood glucose levels were observed in the pups. cross fostering studies indicated that skeletal changes [see use in specific populations (8.1)] could be induced in control pups nursed by treated dams, although this occurred to a lesser degree than those pups treated in utero . safety and effectiveness have not been established in pediatric patients. in clinical studies of 24 weeks or greater duration, 415 patients were over 65 years of age and no patients were greater than 75 years of age. in one-year, active-controlled trials, no differences were seen in effectiveness or adverse events between these subjects and those less than 65. there was no increase in frequency or severity of hypoglycemia in older subjects, but greater sensitivity of some older individuals to repaglinide therapy cannot be ruled out. pharmacokinetic studies of repaglinide were conducted in patients with mild to moderate renal function impairment (crcl = 40 to 80 ml/min), and severe renal function impairment (crcl = 20 to 40 ml/min). initial dose adjustment is not required in patients with mild to moderate renal dysfunction. however, patients with severe renal function impairment should initiate repaglinide therapy with the 0.5 mg dose and be carefully titrated [see dosage and administration (2.2)] . studies were not conducted in patients with creatinine clearances below 20 ml/min or patients with renal failure requiring hemodialysis. a single-dose study was conducted 12 patients with chronic liver disease. patients with moderate to severe impairment of liver function had higher and more prolonged serum concentrations. therefore, repaglinide should be used cautiously in patients with impaired liver function. longer intervals between dose adjustments may be needed to allow full assessment of response.

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

repaglinide tablet

mylan institutional inc. - repaglinide (unii: 668z8c33lu) (repaglinide - unii:668z8c33lu) - repaglinide 0.5 mg