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Prandimet

Last reviewed on RxList: 11/29/2016
Prandimet Side Effects Center

Last reviewed on RxList 4/21/2016

PrandiMet (repaglinide and metformin HCl) is a combination of oral diabetes medications that help control blood sugar levels and is used together with diet and exercise to treat type 2 (non-insulin dependent) diabetes. Common side effects of PrandiMet include nausea, diarrhea, and upset stomach as your body adjusts to the metformin. Other side effects of PrandiMet include:

The dosage of is individualized based on the patient's current regimen, effectiveness and tolerability. PrandiMet can be administered 2 to 3 times a day up to a maximum daily dose of 10 mg repaglinide/2500 mg metformin HCl. PrandiMet may interact with beta-blockers, any heart or blood pressure medications, cimetidine, ranitidine, cyclosporine, delavirdine, digoxin, fluconazole, ketoconazole, morphine, nicardipine, nifedipine, procainamide, quinidine, quinine, rifampin, tolbutamide, trimethoprim, vancomycin, ketoconazole, diuretics, or nonsteroidal anti-inflammatory drugs (NSAIDs). Tell your doctor all medications and supplements you use. During pregnancy, PrandiMet should be used only when prescribed. Insulin treatment may be preferred during pregnancy. Discuss the risks and benefits with your doctor. This medication passes into breast milk and may have undesirable effects on a nursing infant. Breastfeeding while using PrandiMet is not recommended.

Our PrandiMet (repaglinide and metformin HCl) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Prandimet Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Hypoglycemia, or low blood sugar, is the most common side effect of metformin and repaglinide. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets with you in case you have low blood sugar.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Less serious side effects may include:

  • headache;
  • nausea, diarrhea; or
  • runny or stuffy nose, sneezing, cough, or cold symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Prandimet (Repaglinide and Metformin HCl Tablets)

Prandimet Professional Information

SIDE EFFECTS

Most Frequently Observed Adverse Reactions

Repaglinide

In clinical trials of repaglinide, hypoglycemia is the most common adverse reaction (> 5%) leading to withdrawal of patients treated with repaglinide.

Metformin HCl

Gastrointestinal reactions (e.g., diarrhea, nausea, vomiting) are the most common adverse reactions (> 5%) with metformin HCl treatment and are more frequent at higher metformin HCl doses.

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
N (%)
Metformin HCl monotherapy
N (%)
Repaglinide monotherapy
N (%)
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].

Postmarketing Experience

Repaglinide

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 entire FDA prescribing information for Prandimet (Repaglinide and Metformin HCl Tablets)

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