Starlix is an oral diabetes medicine that helps control blood sugar levels. This medicine helps your body respond better to insulin produced by your pancreas.

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

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

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

Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Starlix 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.

Before taking this medicine

You should not use Starlix if you are allergic to nateglinide, or if you have ever had:

• diabetic ketoacidosis (call your doctor for treatment).

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

• liver disease; or

• gout.

Follow your doctor's instructions about using Starlix 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 nateglinide.

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

Take Starlix exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Starlix 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 Starlix. 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.

Starlix 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: 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 goal HbA1c when therapy is initiated, therapy should be initiated at 60 mg orally 3 times.
-May be used as monotherapy, or in combination with metformin or a thiazolidinedione.

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

You should not use Starlix if you are allergic to nateglinide, or if you have ever had:

• diabetic ketoacidosis (call your doctor for treatment).

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

• liver disease; or

• gout.

Follow your doctor's instructions about using Starlix 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 nateglinide.

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

Take the missed dose as soon as you remember, but only if you are getting ready to eat a meal. Skip the missed dose if it is almost time for your next scheduled dose. 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).

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

Call your doctor at once if you have:

• seizure (convulsions); or

• jaundice (yellowing of the skin or eyes).

Common Starlix side effects 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.

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