Prandin

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

You may experience hypoglycemia (low blood sugar) while you are taking this medication. Your doctor will tell you what you should do if you develop hypoglycemia. He or she may tell you to check your blood sugar, eat or drink a food or beverage that contains sugar, such as hard candy or fruit juice, or get medical care. Follow these directions carefully if you have any of the following symptoms of hypoglycemia:

• shakiness
• dizziness or lightheadedness
• sweating
• nervousness or irritability
• sudden changes in behavior or mood
• headache
• numbness or tingling around the mouth
• weakness
• pale skin
• hunger
• clumsy or jerky movements

If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately.

• confusion
• seizures
• loss of consciousness

Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar):

• extreme thirst
• frequent urination
• extreme hunger
• weakness
• blurred vision

If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of these symptoms:

• dry mouth
• upset stomach and vomiting
• shortness of breath
• breath that smells fruity
• decreased consciousness

Repaglinide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nasal congestion
• joint aches
• back pain
• constipation
• diarrhea

Prandin

Hypoglycemia (low blood glucose) is the most frequent side effect and it occurs somewhat less frequently with repaglinide than with sulfonylureas such as glyburide and glipizide. Some symptoms of hypoglycemia include:

• hunger,
• nausea,
• tiredness,
• perspiration,
• headache,
• heart palpitations,
• numbness around the mouth,
• tingling in the fingers,
• tremors,
• muscle weakness,
• blurred vision,
• cold temperature,
• excessive yawning,
• irritability,
• confusion, or
• loss of consciousness.

Other common side effects include:

• headache,
• nausea,
• vomiting,
• diarrhea,
• constipation,
• stomach pain,
• back pain,
• upper respiratory infections, and
• chest pain.

Side effects that have been reported post-marketing inlcude:

• hair loss,
• pancreatitis,
• liver failure,
• severe skin reactions, and
• anemia.

What preparations of repaglinide are available?

Tablets: 0.5, 1, and 2 mg.

How should I keep repaglinide stored?

Tablets should be stored at room temperature, below 25 C (77 F).

Reviewed on 12/11/2014 References Reference: FDA Prescribing Information

Repaglinide is used alone or with other medications to control high blood sugar along with a proper diet and exercise program. It is used in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. It works by stimulating the body to produce more insulin. Insulin is a natural substance that allows the body to properly use sugar from the diet.

Before taking repaglinide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.Limit alcohol while taking this medication because it can increase the risk of developing low blood sugar.During times of stress, such as fever, infection, injury, or surgery, it may be more difficult to control your blood sugar. Consult your doctor because increased stress may require a change in your treatment plan, medications, or blood sugar testing.During pregnancy this medication should be used only when clearly needed. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy. Discuss the risks and benefits of different treatments (such as diet, exercise, and medications including insulin).It is not known whether this drug passes into breast milk and the effect on a nursing infant is unknown. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Common Side Effects of Repaglinide

Tell your doctor if any of the following side effects become severe or don't go away:

• Headache
• Constipation
• Diarrhea
• Nasal congestion
• Sinus pain or pressure
• Joint pain
• Back pain

Serious Side Effects of Repaglinide

Seek medical assistance right away if you experience any of the symptoms listed in the Warning section or any of the following serious side effects:

• Signs of an allergic reaction, which may include rash; hives; difficulty breathing; or swelling of the mouth, face, lips, or tongue
• Chest pain
• Seizures
• Yellowing of the eyes or skin (jaundice)
• Dark-colored urine
• Fever, chills, or a persistent sore throat
• Unusual bleeding or bruising

Severe hypoglycemic reactions with coma, seizure, or other neurological impairment may occur and constitute medical emergencies requiring immediate hospitalization. Hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring may continue until the physician is assured that the patient is out of danger. Patients should be closely monitored for a minimum of 24 to 48 hours, since hypoglycemia may recur after apparent clinical recovery. There is no evidence that PRANDIN is dialyzable using hemodialysis.

Your pharmacist can provide more information about repaglinide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Serious side effects have been reported with Prandin.  See the “Drug Precautions” section.

Common side effects include:

• headaches
• low blood sugar levels
• upper respiratory infections
• diarrhea
• constipation
• back pain
• muscle pain

This is not a complete list of Prandin side effects.  Ask your doctor or pharmacist for more information.

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

 

Absorption

Bioavailability

Approximately 56% (absolute).1 5 14 61 71

Peak plasma drug concentrations attained within approximately 1 hour.1 10 14 56 59 60 61 62 64 65 68 71 100 107

Onset

Peak serum insulin concentrations achieved in approximately 1.5 hours.113 Maximum glycemic effect within 3–3.5 hours.2 61 79 Most of the hypoglycemic effect occurs within 1–3 weeks.1 5 11 14 61 65 71 80 113

Duration

Plasma insulin concentrations remain elevated for 4 hours after each meal in patients with type 2 diabetes mellitus;10 return toward premeal concentrations between meals and at bedtime.1 2 5 11 14 61 64 71

Food

Food may delay and reduce the extent of GI absorption.1 5 14 59 61 71 Administration with a high-fat meal slightly reduces peak plasma concentration and AUC but not time to peak concentration;60 61 64 reduction not clinically important.14 59

Special Populations

Greater systemic exposure (as determined by peak plasma concentrations and AUCs) to repaglinide in patients with hepatic impairment.1 5 14 61 71 105

Increases in plasma concentrations and AUC of repaglinide in patients with severe renal impairment (Clcr 20–40 mL/minute).1 5 59 60 61 64 71 104 Such alterations not found in patients with mild to moderate renal impairment.1 5 71 104

No pharmacokinetic differences (peak plasma concentration, AUC) observed in geriatric individuals (≥65 years of age) compared with healthy younger individuals.1 5 14 101

Distribution

Extent

Distributes into erythrocytes.107

Distributes into milk in rats; not known whether distributed into human milk.1 14

Plasma Protein Binding

>98%.1 5 14 61 64 71 104

Elimination

Metabolism

Rapidly metabolized by CYP3A4 to inactive metabolites.1 5 14 59 62 64 65 67 71 80 81 99 100 101 104 105 107

Elimination Route

Extensively metabolized in liver and excreted into bile and feces (90%) as metabolites.1 3 5 14 40 56 59 60 61 64 68 71 73 80 99 104 106 107

Small amount excreted in urine (8%) principally as metabolites.1 5 14 56 59 60 61 64 65 68 80 99 104 106 107

Does not appear to be removed by hemodialysis.1 104

Half-life

About 1 hour.1 3 5 14 59 61 62 64 65 68 101 107

Special Populations

In patients with hepatic impairment, elimination of unbound repaglinide reduced compared with that in healthy individuals.14 71 105

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Anxiety
• blurred vision
• chills
• cold sweats
• coma
• confusion
• cool, pale skin
• depression
• dizziness
• fast heartbeat
• headache
• increased hunger
• nausea
• nightmares
• seizures
• shakiness
• slurred speech
• unusual tiredness or weakness

Less common

• Bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• frequent urge to urinate
• lower back or side pain

Incidence not known

• Back, leg, or stomach pains
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• clay-colored stools
• constipation
• cough
• darkened urine
• diarrhea
• difficulty with breathing
• fever
• general body swelling
• general tiredness and weakness
• indigestion
• itching or rash
• joint or muscle pain
• light-colored stools
• loss of appetite
• nosebleeds
• pains in the side, or abdomen, possibly radiating to the back
• pale skin
• red skin lesions, often with a purple center
• red, irritated eyes
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• unpleasant breath odor
• upper right abdominal or stomach pain
• vomiting
• vomiting of blood
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Body aches or pain
• difficulty with moving
• ear congestion
• loss of voice
• muscle stiffness
• pain in the joints
• pain or tenderness around the eyes and cheekbones
• sneezing
• sore throat
• stuffy or runny nose
• tightness of the chest

Less common

• Acid or sour stomach
• belching
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• cough producing mucus
• heartburn
• indigestion
• weight gain

Incidence not known

• Hair loss or thinning of the hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

• It is used to lower blood sugar in patients with high blood sugar (diabetes).

You should not use Prandin if you are allergic to repaglinide, or if you have:

• severe liver disease;

• diabetic ketoacidosis (call your doctor for treatment with insulin); or

• if you also take gemfibrozil.

To make sure Prandin is safe for you, tell your doctor if you have:

• liver disease; or

• if you also take metformin or other diabetes medicines.

Follow your doctor's instructions about using Prandin if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester.

It is not known whether repaglinide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Prandin is not approved for use by anyone younger than 18 years old.

Usual Adult Dose for Diabetes Type 2:

Individualize therapy:
Dose preprandially 2, 3, or 4 times a day
-For patients not previously treated with antidiabetic agents or whose glycosylated hemoglobin (HbA1c) is less than 8%:
Initial dose: 0.5 mg orally with each meal
-For patients previously treated with antidiabetic agents or whose HbA1c is 8% or higher:
Initial dose: 1 or 2 mg orally with each meal

Dose Adjustments: Based upon blood glucose response, double the preprandial dose up to a maximum meal time dose of 4 mg until satisfactory glycemic response is achieved; allow at least 1 week to assess response after each dose adjustment.
Recommended Dose Range: 0.5 to 4 mg orally with each meal
Maximum Daily Dose: 16 mg per day

Comments:
-Fasting blood glucose concentrations are generally used to adjust doses, however, postprandial glucose levels may be used in patients whose pre-meal blood glucose levels are satisfactory but whose overall glycemic control (HbA1c) is inadequate.
-When hypoglycemia occurs in patients taking this drug in combination with a thiazolidinedione or metformin, the dose of this drug should be reduced.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Applies to repaglinide: oral tablet

General

The most frequently reported adverse reactions were changes in blood glucose levels; the occurrence of these reactions was dependent on individual factors such as dietary habits, dose, exercise, and stress.[Ref]

Metabolic

Very common (10% or more): Hypoglycemia (up to 31%)[Ref]

In 12 to 24 week clinical trials, hypoglycemia occurred in 31% of patients receiving this drug compared to 7% of placebo-treated patients. In 1 year trials, hypoglycemia occurred in 16% of patients receiving this drug compared to 19% and 20% of glipizide and glyburide patients, respectively.[Ref]

Cardiovascular

Cardiovascular events were evaluated in trials comparing this drug to sulfonylureas. Serious cardiovascular events including ischemia with this drug were higher at 4% than for sulfonylurea drugs (3%). No excess mortality was associated with this increase. Selected cardiovascular events including hypertension, abnormal EKG, MI, arrhythmias, and palpitations were observed at 1% or less and no more frequently with this drug than with comparator drugs.

Trials of this drug in combination with NPH insulin found 6 serious events of myocardial ischemia.[Ref]

Common (1% to 10%): Chest pain, angina, serious cardiovascular events including ischemia
Frequency not reported: Hypertension, abnormal EKG, MI, arrhythmias, palpitations[Ref]

Hypersensitivity

Common (1% to 10%): Allergy
Uncommon (0.1% to 1%): Allergic skin reactions such as rash, urticaria, and pruritus
Frequency not reported: Anaphylactoid reactions[Ref]

Anaphylactoid reactions were reported in less than 1% of patients. Allergic skin reactions such as rash, urticaria, and pruritus have been observed. There is no reason to suspect cross-allergenicity with sulfonylurea drugs due to the difference in chemical structure.[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, constipation, vomiting, dyspepsia, tooth disorder
Postmarketing reports: Pancreatitis[Ref]

Nervous system

Very common (10% or more): Headache (up to 11%)
Common (1% to 10%): Paresthesia[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain[Ref]

Respiratory

Very common (10% or more): Upper respiratory infection (up to 16%)
Common (1% to 10%): Sinusitis, rhinitis, bronchitis[Ref]

Hepatic

Postmarketing experience has included reports of severe hepatic dysfunction including jaundice and hepatitis.[Ref]

Frequency not reported: Elevated liver enzymes
Postmarketing reports: Severe hepatic dysfunction including jaundice and hepatitis[Ref]

Hematologic

Thrombocytopenia or leukopenia have been reported in less than 1% of patients.[Ref]

Frequency not reported: Thrombocytopenia, leukopenia
Postmarketing reports: Hemolytic anemia[Ref]

Ocular

Rare (less than 0.1%): Blurred vision
Very rare (less than 0.01%): Refraction disorder[Ref]

Refraction disorders have been known to result due to changes in blood glucose levels.[Ref]

Dermatologic

Postmarketing reports: Alopecia, Stevens-Johnson syndrome[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Some side effects of Prandin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

LactMed Record Number

238

Last Revision Date

20150310

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Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.