Starlix (Nateglinide)

(nuh tay' gli nide)

Nateglinide is used alone or in combination with other medications to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) in people whose diabetes cannot be controlled by diet and exercise alone. Nateglinide belongs to a class of drugs called meglitinides. Nateglinide helps your body regulate the amount of glucose (sugar) in your blood. It decreases the amount of glucose by stimulating the pancreas to release insulin. Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Taking medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.

Nateglinide comes as a tablet to take by mouth. It is usually taken three times daily. Take nateglinide any time from 30 minutes before a meal to just before the meal. If you skip a meal, you need to skip the dose of nateglinide. If you add a meal, add a dose of nateglinide. Your doctor may gradually increase your dose, depending on your response to nateglinide. Monitor your blood glucose closely. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take nateglinide exactly as directed. Do not take more or less of it or take it more often than directed by the package label or prescribed by your doctor. Nateglinide controls diabetes but does not cure it. Continue to take nateglinide even if you feel well. Do not stop taking nateglinide without talking with your doctor.

Before taking nateglinide,
• tell your doctor and pharmacist if you are allergic to nateglinide or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially albuterol (Proventil, Ventolin); allergy or cold medications; aspirin and nonsteroidal anti-inflammatory drugs such as ibuprofen (Advil, Motrin) or naproxen (Aleve, Naprosyn); beta-blockers such as propranolol (Inderal); chloramphenicol (Chloromycetin); chlorpromazine (Thorazine); corticosteroids such as dexamethasone (Decadron), methylprednisolone (Medrol), or prednisone (Deltasone, Orasone); diuretics ('water pills'); epinephrine; estrogens; fluphenazine (Prolixin); isoniazid (Rifamate); medications that contain alcohol or sugar; mesoridazine (Serentil); niacin; oral contraceptives (birth control pills); perphenazine (Trilafon); phenelzine (Nardil); probenecid (Benemid); prochlorperazine (Compazine); promazine (Sparine); promethazine (Phenergan); terbutaline (Brethine, Bricanyl); thioridazine (Mellaril); thyroid medication; tranylcypromine (Parnate); trifluoperazine (Stelazine); triflupromazine (Vesprin); trimeprazine (Temaril); and vitamins or herbal products.
• tell your doctor if you have or have ever had liver or pituitary disease, adrenal insufficiency, diabetic ketoacidosis, neuropathy (disease of the nervous system), or if you have been told you have type 1 diabetes mellitus (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood) .
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking nateglinide, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking nateglinide.
• tell your doctor if you have fever, infection, injury, or illness with vomiting or diarrhea. These may affect your blood sugar level.

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.

Before you start taking nateglinide, ask your doctor what to do if you forget to take a dose. Write these directions down so you can refer to them later. As a general rule, if you have just begun to eat a meal, take the missed dose as soon as you remember it. However, if you have finished eating, or if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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 the these symptoms:

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

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

• headache
• nasal congestion
• runny nose
• joint aches
• back pain
• constipation
• cough
• flu-like symptoms

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.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.