Nateglinide is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. nateglinide is not for treating type 1 diabetes.

Other diabetes medicines are sometimes used in combination with nateglinide if needed.

Nateglinide may also be used for purposes not listed in this medication guide.

You should not use nateglinide if you have diabetic ketoacidosis (call your doctor for treatment).

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Nateglinide is usually taken 3 times daily, within 1 to 30 minutes before a meal. If you skip a meal, do not take your dose of nateglinide. 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.

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.

Nateglinide 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:

Initial dose: 60 to 120 mg orally 3 times a day before meals
Maintenance dose: 60 to 120 mg orally 3 times a day before meals

Comments:
-For patients who are near HbA1c goal when therapy is initiated, initial dose should be 60 mg orally 3 times.
-Patients should take this drug 1 to 30 minutes before a meal; if a meal is skipped, the dose scheduled to be given with that meal should be skipped to avoid hypoglycemia.
-This drug should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

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

You should not use nateglinide if you are allergic to it, or if you have:

• diabetic ketoacidosis (call your doctor for treatment).

Tell your doctor if you have ever had:

• liver disease; or

• gout.

Follow your doctor's instructions about using nateglinide 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 this medicine.

Nateglinide 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. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. Calorie reduction, weight loss, and exercise will help to control your diabetes. It is important to eat a healthful diet. Alcohol may cause a decrease in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are taking nateglinide.

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: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Nateglinide may cause serious side effects. Call your doctor at once if you have:

• seizure (convulsions); or

• jaundice (yellowing of the skin or eyes).

Common side effects of nateglinide may include:

• runny or stuffy nose, sneezing, cough, cold or flu symptoms;

• diarrhea;

• back pain;

• dizziness; or

• joint pain or stiffness.

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.

Nateglinide may not work as well when you use other medicines at the same time. 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. Not all possible interactions are listed here. Tell your doctor about all medicines you start or stop using.

Keep all appointments with your doctor and the laboratory. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to nateglinide. Your doctor will also tell you how to check your response to this medication by measuring your blood or urine sugar levels at home. Follow these instructions carefully.

Keep yourself and your clothes clean. Wash cuts, scrapes, and other wounds quickly, and do not let them get infected.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.