PrandiMet contains a combination of metformin and repaglinide. Metformin and repaglinide are both oral diabetes medicines that help control blood sugar levels. Repaglinide works by causing the pancreas to produce insulin. Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines.

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

PrandiMet is not for treating type 1 diabetes.

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

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

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking PrandiMet.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

Before taking this medicine

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

• severe kidney disease;

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

• if you also use gemfibrozil or NPH insulin (such as isophane insulin).

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking PrandiMet. Be sure your caregivers know ahead of time that you are using this medicine.

Tell your doctor if you have ever had:

• liver disease; or

• heart disease.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

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

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

You should not breastfeed while using PrandiMet.

Take PrandiMet 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. Use the medicine exactly as directed.

PrandiMet is usually taken 2 or 3 times daily, within 15 minutes before eating a meal. Follow your doctor's instructions. If you skip a meal, do not take the medicine. Wait until your next meal.

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.

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.

PrandiMet is only part of a complete 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, heat, and light. Keep the bottle tightly closed when not in use.

Your doctor may have you take extra vitamin B12 while you are taking metformin and repaglinide. Take only the amount your doctor has prescribed.

Usual Adult Dose for Diabetes Type 2:

Individualize based on current therapy, effectiveness, and tolerability

Initial dose:
Patients inadequately controlled on metformin monotherapy: repaglinide 1 mg/metformin 500 mg orally twice a day with meals
Patients inadequately controlled on meglitinide monotherapy: current meglitinide dose with metformin 500 mg orally twice a day with meals
Patients receiving individual components concomitantly: current or similar dose of individual components without exceeding current dose

Titrate gradually based on glycemic control and tolerability
Maximum single dose: repaglinide 4 mg/metformin 1000 mg
Maximum daily dose: repaglinide 10 mg/metformin 2500 mg

Comments:
-To be given 2 to 3 times a day within 15 minutes prior to meal; if a meal is skipped, a dose should not be given for that meal.
-Patients who have not been previously treated with a meglitinide should be started on the lowest dose of repaglinide to reduce the risk of hypoglycemia.
-Blood glucose monitoring should be performed to assess therapeutic response.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already being treated with a meglitinide and metformin or who have inadequate glycemic control on a meglitinide alone or metformin alone.

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

• severe kidney disease;

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

• if you also use gemfibrozil or NPH insulin (such as isophane insulin).

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking PrandiMet. Be sure your caregivers know ahead of time that you are using this medicine.

Tell your doctor if you have ever had:

• liver disease; or

• heart disease.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

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

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

You should not breastfeed while using PrandiMet.

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. An overdose can cause severe hypoglycemia or lactic acidosis.

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Get emergency medical help if you have signs of an allergic reaction to PrandiMet: 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 PrandiMet 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.

Many drugs can interact with metformin and repaglinide, making this medicine less effective or increasing your risk of lactic acidosis. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.