Prandin is an oral diabetes medicine that helps control blood sugar levels by causing the pancreas to produce insulin.

Prandin is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Prandin is not for treating type 1 diabetes.

You should not use Prandin if you have type 1 diabetes, severe liver disease, or diabetic ketoacidosis.

You should not use Prandin together with gemfibrozil or NPH insulin (such as isophane insulin).

Prandin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Take Prandin exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Prandin is usually taken 2 to 4 times daily, within 30 minutes before eating a meal. Follow your doctor's instructions. If you skip a meal, do not take your dose of Prandin. Wait until your next meal.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Prandin is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store at room temperature away from moisture and heat.

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.

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

• severe liver disease; or

• diabetic ketoacidosis (call your doctor for treatment).

Many drugs can interact with repaglinide and some drugs should not be used at the same time. Your doctor may change your treatment plan if you also use:

• clopidogrel;

• cyclosporine;

• gemfibrozil; or

• NPH insulin (such as isophane insulin).

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

• liver disease; or

• if you also take metformin or other diabetes medicines.

Follow your doctor's instructions about using Prandin if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

You should not breastfeed while using repaglinide.

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

Take your dose as soon as you can, but only if you are getting ready to eat a meal. If you skip a meal, skip the missed dose and wait until your next meal.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A repaglinide overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

Get emergency medical help if you have signs of an allergic reaction to Prandin (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• pale or yellowed skin, dark colored urine, fever, confusion or weakness; or

• pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting.

Common Prandin side effects may include:

• low blood sugar;

• nausea, diarrhea;

• headache, back pain;

• joint pain; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

Many other medicines that can increase or decrease the effects of repaglinide on lowering your blood sugar. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.