Prandimet
- Generic Name: repaglinide and metformin hcl tablets
- Brand Name: Prandimet
Prandimet (Repaglinide and Metformin HCl Tablets) side effects drug center
Prandimet Side Effects Center
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:
- weight gain
- joint pain
- headache
- runny or stuffy nose
- sneezing
- cough, or
- cold symptoms
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.
Prandimet Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- severe hypoglycemia--extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure; or
- lactic acidosis--unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.
Common side effects may include:
- low blood sugar;
- headache;
- nausea, vomiting; or
- diarrhea.
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)
&Copy; Prandimet Patient Information is supplied by Cerner Multum, Inc. and Prandimet Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.