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Prandin

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Prandin

Prandin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Prandin (repaglinide) is used together with diet and exercise to treat type 2 (non-insulin dependent) diabetes. Other diabetes medicines are sometimes used in combination with Prandin. It is an oral diabetes medicine in the meglitinide class. Common side effects include weight gain, diarrhea, and joint pain.

The usual starting dose of Prandin ranges from 0.5 mg to 2 mg taken with each meal. Dosing adjustments are determined by blood glucose response. Hyperglycemia (high blood sugar) may result if you take Prandin with drugs that raise blood sugar, such as: isoniazid, diuretics (water pills), steroids, phenothiazines, thyroid medicine, birth control pills and other hormones, seizure medicines, and diet pills, or medicines to treat asthma, colds or allergies. Hypoglycemia (low blood sugar) may result if you take Prandin with drugs that lower blood sugar, such as: probenecid, blood thinners, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, sulfa drugs, monoamine oxidase inhibitors (MAOIs), or beta-blockers. It may also interact with cyclosporine, St. John's wort, antibiotics, antifungal medications, barbiturates, heart or blood pressure medications, HIV/AIDS medicines, rifamycins, or seizure medication. Tell your doctor all medications you are taking. During pregnancy Prandin should be used only when prescribed. Your doctor may change your diabetes treatment during your pregnancy. It is not known whether this drug passes into breast milk and the effect on a nursing infant is unknown. Breast-feeding while using this drug is not recommended.

Our Prandin (repaglinide) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Prandin in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have a serious side effect such as:

  • seizure (convulsions);
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness; or
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • runny or stuffy nose, sneezing, cough, cold or flu symptoms;
  • diarrhea, nausea;
  • back pain, headache;
  • dizziness;
  • blurred vision;
  • joint pain; or
  • temporary hair loss.

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 Prandin (Repaglinide) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Prandin Overview - Patient Information: Side Effects

SIDE EFFECTS: Weight gain, diarrhea, and joint pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Repaglinide can cause low blood sugar (hypoglycemia) especially if you are taking other medicines for diabetes. Consuming large quantities of alcohol, not getting enough calories from food, or doing unusually heavy exercise may also lead to low blood sugar. Symptoms may include chills, cold sweat, dizziness, drowsiness, shaking, fast heartbeat, weakness, headache, fainting, tingling of the hands or feet, or hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, raise your blood sugar quickly by eating a quick source of sugar such as table sugar, honey, candy, or drinking a glass of fruit juice or non-diet soda. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your doctor may need to adjust your diabetes medication(s).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Prandin (Repaglinide)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Prandin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Hypoglycemia

See PRECAUTIONS and OVERDOSAGE sections. PRANDIN has been administered to 2931 individuals during clinical trials. Approximately 1500 of these individuals with type 2 diabetes have been treated for at least 3 months, 1000 for at least 6 months, and 800 for at least 1 year. The majority of these individuals (1228) received PRANDIN in one of five 1-year, active-controlled trials. The comparator drugs in these 1-year trials were oral sulfonylurea drugs (SU) including glyburide and glipizide. Over one year, 13% of PRANDIN patients were discontinued due to adverse events, as were 14% of SU patients. The most common adverse events leading to withdrawal were hyperglycemia, hypoglycemia, and related symptoms (see PRECAUTIONS). Mild or moderate hypoglycemia occurred in 16% of PRANDIN patients, 20% of glyburide patients, and 19% of glipizide patients.

The table below lists common adverse events for PRANDIN patients compared to both placebo (in trials 12 to 24 weeks duration) and to glyburide and glipizide in one year trials. The adverse event profile of PRANDIN was generally comparable to that for sulfonylurea drugs (SU).

Commonly Reported Adverse Events (% of Patients)*

EVENT PRANDIN
N = 352
PLACEBO
N = 108
PRANDI N
N = 1228
SU
N = 498
Placebo controlled studies Active controlled studies
Metabolic
Hypoglycemia 31** 7 16 20
Respiratory
URI 16 8 10 10
Sinusitis 6 2 3 4
Rhinitis 3 3 7 8
Bronchitis 2 1 6 7
Gastrointestinal
Nausea 5 5 3 2
Diarrhea 5 2 4 6
Constipation 3 2 2 3
Vomiting 3 3 2 1
Dyspepsia 2 2 4 2
Musculoskeletal
Arthralgia 6 3 3 4
Back Pain 5 4 6 7
Other
Headache 11 10 9 8
Paresthesia 3 3 2 1
Chest pain 3 1 2 1
Urinary tract infection 2 1 3 3
Tooth disorder 2 0 < 1 < 1
Allergy 2 0 1 < 1
*: Events ≥ 2% for the PRANDIN group in the placebo-controlled studies and ≥ events in the placebo group
**: See trial description in CLINICAL PHARMACOLOGY, Clinical Trials

Cardiovascular Events

In one-year trials comparing PRANDIN to sulfonylurea drugs, the incidence of angina was comparable (1.8%) for both treatments, with an incidence of chest pain of 1.8% for PRANDIN and 1.0% for sulfonylureas. The incidence of other selected cardiovascular events (hypertension, abnormal EKG, myocardial infarction, arrhythmias, and palpitations) was ≤ 1% and not different between PRANDIN and the comparator drugs.

The incidence of total serious cardiovascular adverse events, including ischemia, was higher for repaglinide (4%) than for sulfonylurea drugs (3%) in controlled comparator clinical trials. In 1 year controlled trials, PRANDIN treatment was not associated with excess mortality when compared to the rates observed with other oral hypoglycemic agent therapies.

Summary of Serious Cardiovascular Events (% of total patients with events) in Trials Comparing PRANDIN to Sulfonylureas

  PRANDIN SU*
Total Exposed 1228 498
Serious CV Events 4% 3%
Cardiac Ischemic Events 2% 2%
Deaths due to CV Events 0.50% 0.40%
*: glyburide and glipizide

Seven controlled clinical trials included PRANDIN combination therapy with NPH-insulin (n=431), insulin formulations alone (n=388) or other combinations (sulfonylurea plus NPH-insulin or PRANDIN plus metformin) (n=120). There were six serious adverse events of myocardial ischemia in patients treated with PRANDIN plus NPH-insulin from two studies, and one event in patients using insulin formulations alone from another study.

Infrequent Adverse Events ( < 1% of Patients)

Less common adverse clinical or laboratory events observed in clinical trials included elevated liver enzymes, thrombocytopenia, leukopenia, and anaphylactoid reactions.

Although no causal relationship with repaglinide has been established, postmarketing experience includes reports of the following rare adverse events: alopecia, hemolytic anemia, pancreatitis, Stevens-Johnson Syndrome, and severe hepatic dysfunction including jaundice and hepatitis.

Combination Therapy with Thiazolidinediones

During 24-week treatment clinical trials of PRANDIN-rosiglitazone or PRANDIN-pioglitazone combination therapy (a total of 250 patients in combination therapy), hypoglycemia (blood glucose < 50 mg/dL) occurred in 7% of combination therapy patients in comparison to 7% for PRANDIN monotherapy, and 2% for thiazolidinedione monotherapy.

Peripheral edema was reported in 12 out of 250 PRANDIN-thiazolidinedione combination therapy patients and 3 out of 124 thiazolidinedione monotherapy patients, with no cases reported in these trials for PRANDIN monotherapy. When corrected for dropout rates of the treatment groups, the percentage of patients having events of peripheral edema per 24 weeks of treatment were 5% for PRANDIN-thiazolidinedione combination therapy, and 4% for thiazolidinedione monotherapy. There were reports in 2 of 250 patients (0.8%) treated with PRANDINthiazolidinedione therapy of episodes of edema with congestive heart failure. Both patients had a prior history of coronary artery disease and recovered after treatment with diuretic agents. No comparable cases in the monotherapy treatment groups were reported.

Mean change in weight from baseline was +4.9 kg for PRANDIN-thiazolidinedione therapy. There were no patients on PRANDIN-thiazolidinedione combination therapy who had elevations of liver transaminases (defined as 3 times the upper limit of normal levels).

Read the entire FDA prescribing information for Prandin (Repaglinide) »

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Prandin - User Reviews

Prandin User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Prandin sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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