list of controlled drugs nz glucotrol xl

Learn drug list drugs 51 with free interactive flashcards. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.A number of medications affect glucose metabolism and may require Glucotrol XL dose adjustment and close monitoring for hypoglycemia or worsening glycemic control.The following are examples of medication that may increase the glucose lowering effect of Glucotrol XL, increase the susceptibility to and/or intensity of hypoglycemia: antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), sulfonamide antibiotics, nonsteroidal anti-inflammatory agents, chloramphenicol, probenecid, coumarins, voriconazole, H2 receptor antagonists, and quinolones. The maximum recommended total daily dose is 40 mg.Some patients may be effectively controlled on a once-a-day regimen, while others show better response with divided dosing. It is not known if Glucotrol XL is safe and effective in children under 18 years of age. The Director-General of Health has delegated certain legislated powers and functions to Medicines Control. Bacterial and GLUCOTROL (glipizide) was found to be mildly fetotoxic in rat reproductive studies at all dose levels (5–50 mg/kg). The estimated background risk of miscarriage for the indicated population is unknown. In these trials, approximately 180 patients were treated with Glucotrol XL for at least 6 months.Table 1 summarizes the incidence of adverse reactions, other than hypoglycemia, that were reported in pooled double-blind, placebo-controlled trials in ≥3% of Glucotrol XL-treated patients and more commonly than in patients who received placebo.Of the 580 patients that received Glucotrol XL in clinical trials, 3.4% had hypoglycemia documented by a blood-glucose measurement <60 mg/dL and/or symptoms believed to be associated with hypoglycemia and 2.6% of patients discontinued for this reason. 0000000913 00000 n 397 30 In a single dose study in 24 healthy subjects, four 5-mg, two 10-mg, and one 20-mg Glucotrol XL tablets were bioequivalent. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. In the Glucotrol XL tablet, the medication is contained within a non-dissolvable shell that has been specially designed to slowly release the drug so the body can absorb it.Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy Advise breastfeeding women taking Glucotrol XL to monitor breastfed infants for signs of hypoglycemia (e.g., jitters, cyanosis, hypothermia, excessive sleepiness, poor feeding, seizures) This product's label may have been updated. then crossed over to the other drug for an additional 8 weeks. The acute oral toxicity was extremely low in all species tested (LD50 greater than 4 g/kg).Overdosage of sulfonylureas, including GLUCOTROL, can produce The primary mode of action of GLUCOTROL in experimental animals Colesevelam can reduce the maximum plasma concentration and total exposure of glipizide when the two are coadministered Available data from a small number of published studies and postmarketing experience with Glucotrol XL use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes.

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