In a double-blind, placebo-controlled, 3-month dose titration study, repaglinide or placebo doses for each patient were increased weekly from 0.25 mg (not an approved dose) through 0.5, 1, and 2 mg, to a maximum of 4 mg, until a fasting plasma glucose (FPG) level <160 mg/dL was achieved or the maximum dose reached. Also, exercise regularly and test for sugar in your blood or urine as directed. Hypoglycemia This medicine does not help patients who have insulin-dependent or type 1 diabetes. 2001 Nov 9;431(1):119-25. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Patients should administer Repaglinide Tablets before meals and be instructed to skip the dose of Repaglinide Tablets if a meal is skipped. Metabolites do not contribute to the glucose-lowering effect of repaglinide. 2005 Oct;97(4):249-56. doi: 10.1111/j.1742-7843.2005.pto_157.x. Repaglinide activity is dependent on the presence functioning cells and glucose. Federal government websites often end in .gov or .mil. There were reports in 2 of 250 patients (0.8%) treated with Repaglinide Tablets-thiazolidinedione therapy of episodes of edema with congestive heart failure. In a 104-week carcinogenicity study in mice at doses up to 500 mg/kg/day, no evidence of carcinogenicity was found in mice (which is approximately 187 times clinical exposure on a mg/m2 basis). Appropriate studies have not been performed on the relationship of age to the effects of repaglinide in the pediatric population. 2000 Apr;9(4):885-98. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Repaglinide Tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Co-administration of cimetidine with repaglinide did not significantly alter the absorption and disposition of repaglinide. Repaglinide: Belongs to the class of other blood glucose lowering drugs excluding insulins. The dose that achieved the targeted control or the maximum dose was continued to end of study. Nanoemulsion: for improved oral delivery of repaglinide. However, patients with severe renal function impairment should initiate Repaglinide Tablets therapy with the 0.5 mg dose and be carefully titrated [see Dosage and Administration (2.2)]. Approximately 90% of a single orally administered dose is eliminated in feces and 8% in urine. If you miss a dose of this medicine, take it as soon as possible. Weight Gain 2008;28(9):573-82. doi: 10.2165/00044011-200828090-00004. Because of the potential for hypoglycemia in breastfed infants, Repaglinide Tablets is not recommended for use when breastfeeding. Molecules. Repaglinide is the first of a new class of blood glucose lowering drugs called the 'meglitinides'. Approximately one month of therapy is required before a decrease in fasting blood glucose is seen. Like the sulphonylureas, repaglinide reduces blood glucose by stimulating insulin release f 2016 Jul;23(6):2026-34. doi: 10.3109/10717544.2015.1077290. Curr Med Chem. Inform patients that Repaglinide Tablets can cause hypoglycemia and instruct patients and their caregivers on self-management procedures including glucose monitoring and management of hypoglycemia. official website and that any information you provide is encrypted Repaglinide Tablets therapy resulted in dose-proportional glucose lowering over the full dose range. The aim of the present study was to develop modified nanoemulsions to improve the oral bioavailability and pharmacokinetics of a poor water-soluble drug, repaglinide (RPG). AUC over the therapeutic dose range included 69 to 1005 ng/mL*hr, but AUC exposure up to 5417 ng/mL*hr was reached in dose escalation studies without apparent adverse consequences. The risk or severity of hypoglycemia can be increased when Repaglinide is combined with Acetohexamide. Only 0.1% of the dose is cleared in the urine as parent compound. Repaglinide induces an early insulin response to meals decreasing postprandial blood glucose levels. 2001;61(11):1625-60. doi: 10.2165/00003495-200161110-00008. The drug is present in animal milk. Cardiovascular Events Drug-Drug Interactions Table 1: Adverse Reactions (%) occurring 2% in Repaglinide Tablets Treated Patients from Pool of 12 to 24 Week Placebo Controlled Trials*, *See trial descriptions in Clinical Trials (14). Repaglinide closes ATP-dependent potassium channels in the -cell membrane by binding at characterizable sites. Epub 2009 Sep 1. An official website of the United States government. No adverse effects on fertility were observed (which are over 60 times clinical exposure on a mg/m2 basis). The majority of these individuals (1228) received Repaglinide Tablets in one of five 1-year, active-controlled trials. Drug Saf. bioavailability; chitosan; nanoemulsion; pharmacokinetic; poloxamer 188; repaglinide. Eur J Pharmacol. In this study where pioglitazone dosage was kept constant, the combination therapy group showed dose-sparing effects with respect to repaglinide (see Figure 1 Legend). This medicine does not help patients who have insulin-dependent or type 1 diabetes. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Repaglinide Tablets Prescribing Information, [see Drug Interactions (7.1), Clinical Pharmacology (, Combination Therapy with Thiazolidinediones, Infrequent Adverse Events (<1% of Patients), Drugs That May Increase the Risk of Hypoglycemia, Drugs That May Decrease the Blood Glucose Lowering Effect of Repaglinide Tablets, Drugs That May Blunt Signs and Symptoms of Hypoglycemia, Disease-associated maternal and/or embryo/fetal risk, Table 7: Effect of Other Drugs on AUC and C, Repaglinide in Combination With Metformin, Table 8: Repaglinide in Combination with Metformin: Mean Change from Baseline after 4 to 5 Months of Treatment, Repaglinide in Combination With Pioglitazone, Figure 1: Repaglinide in Combination with Pioglitazone: HbA, Repaglinide in Combination With Rosiglitazone, Table 9: Repaglinide in Combination with Rosiglitazone: Mean Change from Baseline in a 24-Week Study. Table 7: Effect of Other Drugs on AUC and Cmax of Repaglinide, 1Unless indicated all drug interactions were observed with single dose of 0.25 mg repaglinide The typical initial dose in adults is 0.5 mg three times daily before meals, with a gradual increase to a maximum of 16 mg daily. As such, repaglinide is more effective at reducing postprandial blood glucose levels than fasting blood glucose levels and requires a longer duration of therapy (approximately one month) before decreases in fasting blood glucose are observed. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Repaglinide Tablets. Package insert / product label Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. It decreases the amount of glucose by stimulating the pancreas to release insulin. 2 mg tablets (peach, round, biconvex, uncoated tablets debossed with ML26 on one side and plain on other side), Repaglinide Tablets are contraindicated in patients with: PRANDIN (repaglinide) is an oral blood glucose-lowering drug of the meglitinide class used in the management of type 2 diabetes mellitus (also known as non-insulin dependent diabetes mellitus. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. In comparative studies with either sulphonylurea or metformin, repaglinide caused similar or improved control (i.e. Drugs that induce the CYP3A4 and/or 2C8 enzyme systems include rifampin, barbiturates, and carbamezapine, Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, nonsteroidal anti-inflammatory agents (NSAIDs), pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. Drug Deliv. In normal people, following a meal, the insulin secretion increases rapidly, reaching peak concentration in the blood within an hour. Drug class: Meglitinides. The implications of tailoring repaglinide treatment to meals were examined in a study where repaglinide was dosed either morning and evening, or with each main meal (i.e. Initial dose adjustment is not required in patients with mild to moderate renal dysfunction. The metabolism of Repaglinide can be decreased when combined with Abiraterone. The following serious adverse reaction is also described elsewhere in the labeling: For non-prescription products, read the label or package ingredients carefully. Limited available data from case reports and case series with Repaglinide Tablets use in pregnant women have not identified a drug-associated The influx of calcium ions stimulates calcium-dependent exocytosis of insulin granules. Disclaimer. Available for Android and iOS devices. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth and macrosomia related morbidity. PrandiMet Prandin Repaglinide Drug Class Repaglinide is part of the drug class: Other blood glucose lowering drugs, excl. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Repaglinide is available generically and under the brand name Prandin in tablets of 0.5, 1 and 2 mg. Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c>7 and has been reported to be as high as 20-25% in women with a HbA1c>10. Race As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Background Repaglinide is an oral antihyperglycemic agent used for the treatment of non-insulin-dependent diabetes mellitus (NIDDM). Vss = volume of distribution at steady state In contrast to sulfonylurea insulin secretatogogues, repaglinide has no effect on insulin release in the absence of glucose. In patients who skip meals, instruct patients to skip the scheduled dose of Repaglinide Tablets to reduce the risk of hypoglycemia. sharing sensitive information, make sure youre on a federal Known hypersensitivity to repaglinide or any inactive ingredients. U.S. Patent US20040102477, issued May 27, 2004. HbA1c, mean glucose levels) and the drug was well tolerated (e.g. Generic name: repaglinide [re-PAG-li-nide] Safety and effectiveness have not been established in pediatric patients. No comparable cases in the monotherapy treatment groups were reported. Bethesda, MD 20894, Web Policies Repaglinide dosage was titrated for 4 to 8 weeks, followed by a 3-month maintenance period. All glinides, including Repaglinide Tablets, can cause hypoglycemia [see Adverse Reactions (6.1)]. A., & Philips, W. T. (2003). Repaglinide stimulates insulin secretion. The ion channel mechanism is highly tissue selective with low affinity for heart and skeletal muscle. AUC was statistically correlated with caffeine clearance. Differences between the repaglinide-and placebo-treated groups were -61 mg/dL (FPG) and -104 mg/dL (PPG) (Table 4). In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended [see Warnings and Precautions (5.1)]. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Br J Clin Pharmacol. In a rat fertility study, repaglinide was administered to male and female rats at doses up to 300 and 80 mg/kg/day, respectively. This medicine does not help patients who have insulin-dependent or type 1 diabetes. A combination therapy regimen of repaglinide and pioglitazone (N=123) was compared to repaglinide alone (N=61) and pioglitazone alone (N=62) in a 24-week trial that enrolled 246 patients previously treated with sulfonylurea or metformin monotherapy (HbA 1c > 7.0%). [, FDA Approved Drug Products: PRANDIN (repaglinide) tablets [, Hu S, Wang S, Fanelli B, Bell PA, Dunning BE, Geisse S, Schmitz R, Boettcher BR: Pancreatic beta-cell K(ATP) channel activity and membrane-binding studies with nateglinide: A comparison with sulfonylureas and repaglinide. Store at 20 to 25 C (68 to 77 F); excursions permitted to 15 to 30C (59 to 86 F) [See USP Controlled Room Temperature]. Safety and efficacy have not been established. These data indicate that repaglinide did not accumulate in serum. Liver diseaseUse with caution. The average weight gain in patients treated with Repaglinide Tablets and not previously treated with sulfonylurea drugs was 3.3%. MeSH Repaglinide works by causing your pancreas to release more insulin into the blood stream. It is very important to follow carefully any instructions from your health care team about: In case of emergencyThere may be a time when you need emergency help for a problem caused by your diabetes. * Indicates data are from published literature. [, Wangler B, Beck C, Shiue CY, Schneider S, Schwanstecher C, Schwanstecher M, Feilen PJ, Alavi A, Rosch F, Schirrmacher R: Synthesis and in vitro evaluation of (S)-2-([11C]methoxy)-4-[3-methyl-1-(2-piperidine-1-yl-phenyl)-butyl-carbamoyl]-be nzoic acid ([11C]methoxy-repaglinide): a potential beta-cell imaging agent. Our datasets provide approved product information including: Access drug product information from over 10 global regions. In one-year, active-controlled trials, no differences were seen in effectiveness or adverse events between these subjects and those less than 65. Repaglinide may also be used for purposes not listed in this medication guide. Recent Pat Drug Deliv Formul. The therapeutic efficacy of Repaglinide can be increased when used in combination with Acebutolol. Repaglinide is completely metabolized by oxidative biotransformation and direct conjugation with glucuronic acid after either an IV or oral dose. Proper Use. No evidence of carcinogenicity was found in female rats. Your doctor may increase your dose as needed. Rapidly and completely absorbed following oral administration. Repaglinide is rapidly metabolized via oxidation and dealkylation by cytochrome P450 3A4 and 2C9 to form the major dicarboxylic acid derivative (M2). High glucose concentrations cause ATP-sensitive potassium channels to close resulting in membrane depolarization and opening of L-type calcium channels. 2000 Sep;24 Suppl 3:S38-44. Limitation of Use: Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. Drug Delivery, 23, 2026-2034. insulins, Predicted MS/MS Spectrum - 10V, Positive (Annotated), Predicted MS/MS Spectrum - 20V, Positive (Annotated), Predicted MS/MS Spectrum - 40V, Positive (Annotated), Predicted MS/MS Spectrum - 10V, Negative (Annotated), Predicted MS/MS Spectrum - 20V, Negative (Annotated), Predicted MS/MS Spectrum - 40V, Negative (Annotated), LC-MS/MS Spectrum - LC-ESI-QTOF , negative, splash10-0udi-0000900000-c0108433e6c3f3bf1c75, splash10-004i-0009000000-30aa31031f07d8ae52b8, splash10-002r-0908000000-b76282b9697187110f0a, LC-MS/MS Spectrum - LC-ESI-QTOF , positive, splash10-0udi-0000900000-2f6de321d96a7df0cde9, splash10-0udi-0140900000-4fef8b8042e88aa84955, splash10-001i-0290000000-4867f74dff429e78bb45, splash10-001i-0290000000-bdb018b622ca04e9d8b1, splash10-001i-0590000000-60f613e4ee0d364efcea, splash10-0f89-2791700000-333192fa8176a2febaa5, Solute carrier organic anion transporter family member 1B1. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use in Specific Populations (8.6, 8.7)]. The pharmacokinetic analysis confirmed that Cs-RPG-NEs were more efficient than uncoated ones for the oral delivery of RPG. Repaglinide is used together with diet and exercise to treat high blood sugar (glucose) levels in patients with type 2 diabetes. In a 104-week carcinogenicity study in rats at doses up to 120 mg/kg/day, which is approximately 90 times clinical exposure on a mg/m2 basis, the incidences of benign adenomas of the thyroid and liver were increased in male rats. The recommended dose range is 0.5 mg to 4 mg before meals, with a maximum daily dose of 16 mg. indicates increase Table 4: Repaglinide Tablets vs Placebo Easily compare up to 40 drugs with our drug interaction checker. 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. Save 2.20. FOIA Do not double doses. Using these medicines together may cause unwanted effects. If you believe you are experiencing an interaction, contact a healthcare provider immediately. Repaglinide, S(+)2-ethoxy-4(2((3-methyl-1-(2-(1-piperidinyl) phenyl)-butyl) amino)-2-oxoethyl) benzoic acid, is chemically unrelated to the oral sulfonylurea insulin secretagogues. Adverse Reactions ( 6.1 ) ] with mild to moderate renal dysfunction increases rapidly, peak! Dose is eliminated in feces and 8 % in urine ( 6.1 ]! Metabolized via oxidation and dealkylation by cytochrome P450 3A4 and 2C9 to form the dicarboxylic!, or cause death between these subjects and those less than 65 efficient than uncoated ones the... Hypoglycemia can cause hypoglycemia and instruct patients and their caregivers on self-management procedures including glucose monitoring and management hypoglycemia..., exercise regularly and test for sugar in your blood or urine as parent compound 431 ( 1:119-25! 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