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Fertility of male and female rats was unaffected by repaglinide administration at doses up to 80 mg/kg body weight/day (females) and 300 mg/kg body weight/day (males) buy prilosec 20 mg online; over 40 times clinical exposure on a mg/m2 basis discount prilosec 10mg without a prescription. Repaglinide was not teratogenic in rats or rabbits at doses 40 times (rats) and approximately 0. Because animal reproduction studies are not always predictive of human response, Prandin should be used during pregnancy only if it is clearly needed. Because recent information suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities, many experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible. 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 shortening, thickening, and bending of the humerus during the postnatal period. Relevant human exposure has not occurred to date and therefore the safety of Prandin administration throughout pregnancy or lactation cannot be established. 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 Nonteratogenic effects above) could be induced in control pups nursed by treated dams, although this occurred to a lesser degree than those pups treated in utero. Although it is not known whether repaglinide is excreted in human milk some oral agents are known to be excreted by this route. Because the potential for hypoglycemia in nursing infants may exist, and because of the effects on nursing animals, a decision should be made as to whether Prandin should be discontinued in nursing mothers, or if mothers should discontinue nursing. If Prandin is discontinued and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered. No studies have been performed in pediatric patients. In repaglinide clinical studies of 24 weeks or greater duration, 415 patients were over 65 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 other than the expected age-related increase in cardiovascular events observed for Prandin and comparator drugs. There was no increase in frequency or severity of hypoglycemia in older subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals to Prandin therapy cannot be ruled out. Prandin has been administered to 2931 individuals during clinical trials. Approximately 1500 of these individuals with type 2 diabetes have been treated for at least 3 months, 1000 for at least 6 months, and 800 for at least 1 year. The majority of these individuals (1228) received Prandin in one of five 1-year, active-controlled trials. The comparator drugs in these 1-year trials were oral sulfonylurea drugs (SU) including glyburide and glipizide. Over one year, 13% of Prandin patients were discontinued due to adverse events, as were 14% of SU patients. The most common adverse events leading to withdrawal were hyperglycemia, hypoglycemia, and related symptoms (see PRECAUTIONS ). Mild or moderate hypoglycemia occurred in 16% of Prandin patients, 20% of glyburide patients, and 19% of glipizide patients. The table below lists common adverse events for Prandin patients compared to both placebo (in trials 12 to 24 weeks duration) and to glyburide and glipizide in one year trials. The adverse event profile of Prandin was generally comparable to that for sulfonylurea drugs (SU). Commonly Reported Adverse Events (% of Patients)*Placebo controlled studiesActive controlled studiesIn one-year trials comparing Prandin to sulfonylurea drugs, the incidence of angina was comparable (1. The incidence of other selected cardiovascular events (hypertension, abnormal EKG, myocardial infarction, arrhythmias, and palpitations) was ?-T 1% and not different between Prandin and the comparator drugs. The incidence of total serious cardiovascular adverse events, including ischemia, was higher for repaglinide (4%) than for sulfonylurea drugs (3%) in controlled comparator clinical trials. In 1-year controlled trials, Prandin treatment was not associated with excess mortality when compared to the rates observed with other oral hypoglycemic agent therapies. Summary of Serious Cardiovascular Events (% of total patients with events) in Trials Comparing Prandin to SulfonylureasCardiac Ischemic EventsSeven controlled clinical trials included Prandin combination therapy with NPH-insulin (n=431), insulin formulations alone (n=388) or other combinations (sulfonylurea plus NPH-insulin or Prandin plus metformin) (n=120). There were six serious adverse events of myocardial ischemia in patients treated with Prandin plus NPH-insulin from two studies, and one event in patients using insulin formulations alone from another study. Prandin? is a registered trademark of Novo Nordisk A/S. Manufactured in Germany for? 2003-2008 Novo Nordisk A/S The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice.

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