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Most Frequently Observed Adverse Reactions
In clinical trials of repaglinide, hypoglycemia is the most common adverse reaction (> 5%) leading to withdrawal of patients treated with repaglinide.
Clinical Trial Experience
Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Patients with Inadequate Glycemic Control on Metformin HCl Monotherapy
Table 1 summarizes the most common adverse reactions occurring in a 6-month randomized study of repaglinide added to metformin HCl in patients with type 2 diabetes inadequately controlled on metformin HCl alone.
Table 1: Repaglinide added to metformin HCl in patients with type 2 diabetes inadequately controlled on metformin HCl alone. Adverse reaction
reported (regardless of Investigator Assessment of Causality) in ≥10% of
patients receiving combination therapy*
|Coadministered repaglinide and metformin HCl
|Metformin HCl monotherapy
|No. of Patients Exposed||27||27||28|
|Gastrointestinal System Disorder||9 (33)||13 (48)||10 (36)|
|Diarrhea||5 (19)||8 (30)||2 (7)|
|Nausea||4 (15)||2 (7)||1 (4)|
|Symptomatic Hypoglycemia **||9 (33)||0 (0)||3 (11)|
|Headache||6 (22)||4 (15)||3 (11)|
|Upper Respiratory Tract Infection||3 (11)||3 (11)||3 (11)|
|*Intent to treat population
** There were no cases of severe hypoglycemia (hypoglycemia requiring the assistance of another person)
Cardiovascular Events in repaglinide monotherapy trials
In one-year trials comparing repaglinide to sulfonylurea drugs, the incidence of angina was 1.8% for both treatments, with an incidence of chest pain of 1.8% for repaglinide and 1.0% for sulfonylureas. The incidence of other selected cardiovascular events (hypertension, abnormal electrocardiogram, myocardial infarction, arrhythmias, and palpitations) was ≤ 1% and not different between repaglinide and the comparator drugs.
The incidence of total serious cardiovascular adverse events, including ischemia, was higher for repaglinide (51/1228 or 4%) than for sulfonylurea drugs (13/498 or 3%) in controlled clinical trials. In 1-year controlled trials, repaglinide treatment was not associated with excess mortality when compared to the rates observed with other oral hypoglycemic agent therapies such as glyburide and glipizide.
Seven controlled clinical trials included repaglinide combination therapy with NPH-insulin (n=431), insulin formulations alone (n=388) or other combinations (sulfonylurea plus NPH-insulin or repaglinide plus metformin HCl) (n=120). There were six serious adverse events of myocardial ischemia in patients treated with repaglinide plus NPH-insulin (1.4%) from two studies, and one event in patients using insulin formulations alone from another study (0.3%) [see WARNINGS AND PRECAUTIONS].
The following additional adverse reactions have been identified during postapproval use of repaglinide. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or a causal relationship to drug exposure.
Postmarketing experience with repaglinide includes infrequent reports of the following adverse events; alopecia, hemolytic anemia, pancreatitis, Stevens-Johnson Syndrome, and severe hepatic dysfunction including jaundice and hepatitis.
Read the Prandimet (repaglinide and metformin hcl tablets) Side Effects Center for a complete guide to possible side effects
Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin) that are eliminated by renal tubular secretion theoretically have the potential for interaction with metformin by competing for common renal tubular transport systems. Careful patient monitoring and dose adjustment of PrandiMet and/or the interfering drug is recommended in patients who are taking cationic medications that are excreted via the proximal renal tubular secretory system [see CLINICAL PHARMACOLOGY].
CYP2C8 and CYP3A4 Inhibitors/Inducers
Repaglinide is metabolized by CYP2C8 and to a lesser extent by CYP3A4. Drugs that inhibit 2C8 (gemfibrozil, trimethoprim, deferasirox), inhibit 3A4 (itraconazole, ketaconazole), or induce CYP2C8/3A4 (rifampin) may alter the pharmacokinetics and pharmacodynamics of repaglinide. In vivo data from a study that evaluated the coadministration of gemfibrozil and repaglinide in healthy subjects showed a significant increase in repaglinide blood levels. Administration of PrandiMet and gemfibrozil to the same patient is not recommended [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
Read the Prandimet Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 5/7/2012
Additional Prandimet Information
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