Gluconorm repaglinide product monograph page 5 of 41 of serious cv events including death was 4. Repaglinide is an oral medication used in addition to diet and exercise for blood sugar control in type 2 diabetes mellitus. Coadministration of repaglinide and tecovirimat may cause mild to moderate hypoglycemia. Highlights of prescribing information these highlights do not. Draft guidance on repaglinide this draft guidance, once finalized, will represent the food and drug administration s fdas current thinking on this. It has been suggested that the concomitant use of repaglinide with clopidogrel may inhibit.
When repaglinide was given with food, the mean t max was not changed, but the mean c max and auc area under the timeplasma concentration curve were decreased 20% and 12. In addition each tablet contains the following inactive ingredients. The metabolism of clopidogrel to its active metabolite can be impaired by genetic variations in cyp2c19 see boxed warning. In patients with diabetic ketoacidosis, with or without coma. Tell each of your health care providers about all medicines you use now and any medicine you. The magnitude of interaction could be higher at the recommended repaglinide dose see drug interactions 7. For a complete listing, see the dosage forms, composition and packaging section of the product monograph. The bioequivalence and the effects of food on the pharmacokinetics of the repaglinidemetformin fdc have been investigated in randomized, singleblind, crossover trials in healthy volunteers. Repaglinide tablets dosage was titrated for 4 to 8 weeks, followed by a 3month maintenance period. Renvela in patients with dysphagia, swallowing disorders, severe gi motility disorders including severe constipation, or major gi tract surgery have not been established.
Type 2 diabetes is a disease in which your pancreas does not make enough insulin to control the sugar in your blood or where your body does not respond normally to the insulin it produces. Prandin 2 mg tablets patient information leaflet pil emc. Repaglinide is eliminated from the blood stream with a halflife of approximately 1 hour. These highlights do not include all the information needed. Repaglinide is widely prescribed to reduce postprandial hyperglycemia and elevated glycated hemoglobin hba1c levels associated with type 2 diabetes, and clopidogrel is a thienopyridine antiplatelet agent and widely used in cardiovascular and cerebrovascular diseases. It belongs to the meglitinide class of shortacting insulin secretagogues, which act by binding to cells of the pancreas to stimulate insulin release. This includes prescription and overthecounter medicines, vitamins, and herbal products.
The peak plasma concentration is reached within an hour of the dose, and a response begins within 30 minutes. Research design and methods enrolled patients n 150 had received treatment with diet and exercise in the previous 3 months with hba1c 7 and. Highlights of prescribing information exjade initial. Postmarketing cases of metforminassociated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Precautions and warnings with repaglinide to be aware of include potential drug interactions, the risk of low blood sugar, and the danger of taking the drug when pregnant. An interaction between exjade and other cyp2c8 substrates cannot be excluded. Repaglinide, usp is a white to offwhite solid with molecular formula c 27 h 36 n 2 o 4 and a molecular weight of 452. The mechanism of action of repaglinide involves promoting insulin release from. Prandin 2 mg tablets patient information leaflet pil. Highlights of prescribing information macrovascular outcomes.
In clinical trials, repaglinide was more effective than a placebo at reducing blood glucose concentrations. It is available as tablets for oral administration. A combination therapy regimen of repaglinide tablets and pioglitazone n123 was compared to repaglinide tablets alone n61 and pioglitazone alone n62 in a 24week trial that enrolled 246 patients previously treated with sulfonylurea or metformin monotherapy hba 1c 7. Highlights of prescribing information patients who. You can help by reporting any side effects you may get. Repaglinidemetformin fixeddose combination to improve. Tell your doctor if you are pregnant or plan on getting pregnant. Prandin repaglinide side effects, images, uses, dosage. Repaglinide is used alone or with other medications to control high blood sugar along with a proper diet and exercise program. The use of other oral blood glucoselowering agent or insulin should be considered. There was an increase in mean repaglinide c max and auc 1.
Exjade is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. Repaglinide tablets dosage was titrated during the first 12. Paclitaxel injection, usp is a clear colorless to slightly yellow viscous solution. Repaglinide is almost completely metabolised by the liver and is cleared from the circulation within six hours.
Repaglinide induces an early insulin response to meals decreasing postprandial blood glucose. Glucovance glyburide and metformin hcl tablets contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes, glyburide and metformin hydrochloride. Prandin repaglinide oral uses, side effects, dosage. Macleods challenging frontiers in health care products. Repaglinide is a prescription drug that is licensed to lower blood sugar in people with type 2 diabetes. Prandin, innrepaglinide european medicines agency europa. In clinical trials, the incidence of serious cardiovascular treatment emergent adverse events was higher for repaglinide than for glyburide but lower than that for glipizide see adverse reactions and clinical trials. Abrupt discontinuation of any chronically administered betaadrenergic blocking agent, such as propranolol, can result in the exacerbation of angina and, in some cases, myocardial ischemia or myocardial infarction, ventricular arrhythmias, or severe hypertension, especially in patients with preexisting cardiac disease.
Prandin repaglinide dosing, indications, interactions. Labelingpackage insert label is not available on this site. You should not use repaglinide together with gemfibrozil lopid or nph insulin such as isophane insulin. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. See full prescribing information for repaglinide tablets. Repaglinide tablets, usp 1 mg 5199185401 repaglinide tablets, usp 2 mg 5199185501 risperidone oral solution, usp 1mg 5199171641 rivastigmine tartrate capsules, usp 1. The metabolism of clopidogrel can also be impaired by drugs that inhibit cyp2c19, such. This emedtv web page explains how the drug works to increase insulin production, lists potential side effects, and offers tips on taking it. This will allow quick identification of new safety information. Peripheral oedema, tachycardia were reported in a few patients following larger clinical trials investigating oral administration in osteoarthritis. Pdf to investigate the efficacy and safety of repaglinide alone and in combination.
See full prescribing information for complete boxed warning. Its used to treat people with type 2 diabetes who cant manage their condition by diet and exercise alone. Known hypersensitivity to repaglinide or any inactive ingredients 4warnings and precautions hypoglycemia. After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer. Feb 04, 2019 what is the most important information i should know about repaglinide prandin. Repaglinide prandin side effects, dosage, interactions. Edited boxed warning april 7, 2017 postmarketing cases of metforminassociated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Prior to taking it, talk to your healthcare provider about any medical conditions you. Fda revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function. Labeling package insert label is not available on this site. Draft guidance on repaglinide food and drug administration.
Draft guidance on repaglinide this draft guidance, once finalized, will represent the food and drug administration s fdas current thinking on this topic. Glyburide is an oral antihyperglycemic drug of the sulfonylurea class. The content on this site is presented in a summary fashion, and is intended to be used for educational and entertainment purposes only. Repaglinide is an oral diabetes medicine that helps control blood sugar levels by causing the pancreas to produce insulin repaglinide is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. The survey package insert test paint aimed to examine the availability and comprehensibility of the information contained on five package inserts and five model versions for the same drugs. Wait at least 1 week to assess response after each dose adjustment. Highlights of prescribing information macrovascular. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. In clinical trials with repaglinide tablets, hypoglycemia is the most commonly observed adverse reaction. Repaglinide and metformin hydrochloride tablets, for oral use. Highlights of prescribing information patients who have known. See package insert for full prescribing information.
Aug 22, 2019 titrate initial dosage of repaglinide during combination therapy as with repaglinide monotherapy. If patients are transferred from another oral hypoglycaemic medicinal product. Prior to taking it, talk to your healthcare provider about any medical conditions you may have and medications you are taking. These highlights do not include all the information needed to. Technologies at 15417532000 or fda at 1800fda1088 or. Repaglinide is an antidiabetic drug in the class of medications known as meglitinides, and was invented in 1983. Prandin repaglinide is an oral blood glucoselowering drug of the. Arava leflunomide, tablets, for oral use prescribing. Lopid gemfibrozil tablets, usp description lopid gemfibrozil tablets, usp is a lipid regulating agent. Dec 01, 2018 repaglinide tablets in combination with metformin. If metforminassociated lactic acidosis is suspected, immediately discontinue janumet and.
Skip the scheduled dose of prandin if a meal is skipped to reduce the risk of hypoglycemia. Co administration with itraconazole and a single dose of 0. Pioglitazone, repaglinide, rosiglitazone, glimepiride, tolbutamide, troglitazone, glucosamine is likely safe in patients with wellcontrolled diabetes hba1c less than 6. It is not intended to be and should not be interpreted as medical advice or a diagnosis of any health or fitness problem, condition or disease. Caution should be exercised when renvela is used in patients with these gi disorders. These and other label changes are searchable in the drug safety labeling changes slc database, where. Repaglinide is the generic name of the brandname drug prandin. You should not use repaglinide if you have type 1 diabetes, severe liver disease, or diabetic ketoacidosis. In patients with known hypersensitivity to the drug or any of its components. Pdf the efficacy of repaglinide monotherapy and in combination. After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there were six 0.
Instruct patients to skip the scheduled repaglinide dose to reduce the risk of. This medicine is not for treating type 1 diabetes repaglinide may also be used for purposes not listed in this medication guide. Risk of hypoglycemia associated with repaglinide combined. Monitor blood glucose and monitor for hypoglycemic symptoms when administering tpoxx with repaglinide. Objective a randomized, parallelgroup, openlabel, multicenter 16week clinical trial compared efficacy and safety of repaglinide monotherapy and nateglinide monotherapy in type 2 diabetic patients previously treated with diet and exercise. Research design and methods enrolled patients n 150 had received treatment with diet and exercise in the. These patients should be monitored carefully while being treated with renvela. Double dose up to 4 mg with each meal until satisfactory glycemic control achieved.
Repaglinide tablets fda prescribing information, side. Repaglinide versus nateglinide monotherapy diabetes care. The clinically important adverse reactions observed in trials comparing plavix plus aspirin to placebo plus aspirin and trials comparing plavix alone to aspirin alone are discussed below. The patients dose should be doubled up to 4 mg with each meal until satisfactory glycemic control is. Many other medicines that can increase or decrease the effects of repaglinide on lowering your blood sugar. Prandin is an oral antidiabetic medicine containing repaglinide which helps your pancreas produce more insulin and thereby lower your blood sugar glucose. You will need to talk about the benefits and risks of using repaglinide while you are pregnant. Pdf inappropriate dosage instructions in package inserts. Specific package insert requirement for glucosamine cardiovascular. If you have any further questions, ask your doctor or pharmacist. Repaglinide tablets were studied in combination with metformin in 83 patients not satisfactorily controlled on exercise, diet, and metformin alone. Highlights of prescribing information exjade initial u. Inhibition of platelet aggregation by clopidogrel is achieved through an active metabolite. Consider repaglinide dose reduction and carefully monitor blood glucose levels when repaglinide is used concomitantly with exjade.
Plavix has been evaluated for safety in more than 54,000 patients, including over 21,000 patients treated for one year or more. Mild or moderate hypoglycemia occurred in 31% of repaglinide tablets treated patients and 7% of placebo treated patients see warnings and precautions 5. Repaglinide is an oral antihyperglycemic agent used for the treatment of noninsulindependent diabetes mellitus niddm. The fdas medwatch program safety labeling changes for boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made to the safety information.
416 463 1100 864 1095 1283 619 8 888 1158 786 17 816 1216 1283 142 33 1123 861 976 280 1455 774 707 1356 943 1330 1446 932 425 233 1021 606 403 665 543 367 1073