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|Starlix

NATEGLINIDE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Starlix

Category

• Antidiabetic agent

Description

Nateglinide (na-TEG-li-nide) is used to treat a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. With this type of diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly. Using nateglinide alone, or with metformin or a thiazolidinedione (other types of oral antidiabetic medicines), will help to lower blood sugar when it is too high and help restore the way you use food to make energy.

Many people can control type 2 diabetes with diet alone or with diet and exercise. Following a specially planned diet and exercising will always be important when you have diabetes, even when you are taking medicines. To work properly, the amount of nateglinide you take must be balanced against the amount and type of food you eat and the amount of exercise you do. If you change your diet, your exercise, or both, you will want to test your blood sugar to find out if it is too low. Your health care professional will teach you what to do if this happens.

Nateglinide does not help patients who have insulin-dependent or type 1 diabetes because they cannot produce insulin from their pancreas gland. Their blood glucose is best controlled by insulin injections.

Nateglinide does not help patients who have already been treated with other antidiabetic medicines for a long time.

Nateglinide may be used together with metformin or a thiazolidinedione, but should not take the place of these medicines.

Nateglinide is available only with your doctor"s prescription, in the following dosage form:

• Oral
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For nateglinide, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to nateglinide. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Nateglinide has not been studied in pregnant women. However, studies in animals have shown that nateglinide causes birth defects. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding— It is not known whether nateglinide passes into human breast milk. However, nateglinide is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of nateglinide in children with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, older patients may be more likely to develop low blood sugar.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking nateglinide, it is especially important that your health care professional know if you are taking any of the following:

• Beta-adrenergic blocking agents (acebutolol [e.g., Sectral], atenolol [e.g., Tenormin], betaxolol [e.g., Kerlone], bisoprolol [e.g., Zebeta], carteolol [e.g., Cartrol], labetalol [e.g., Trandate], metoprolol [e.g., Lopressor], nadolol [e.g., Corgard], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol [e.g., Visken], propranolol [e.g., Inderal], sotalol [e.g., Betapace], timolol [e.g., Blocadren])—These medicines can hide some of the symptoms of low blood sugar; because of this, a person with diabetes might not recognize that he or she has low blood sugar and might not take immediate steps to treat it

Other medical problems—The presence of other medical problems may affect the use of nateglinide. Make sure you tell your doctor if you have any other medical problems, especially:

• Adrenal gland or pituitary gland not producing enough hormones or
• Malnourishment (not getting enough nutrients in your diet) or
• Severe kidney problems—These conditions can make patients on nateglinide be more at risk for having low blood sugar.

• Alcohol use or
• Not eating enough or
• Strenuous physical exercise—May increase risk of low blood sugar

• Fever or
• Infection or
• Surgery or
• Trauma—Temporary loss of blood sugar control may occur in patients with these conditions. Insulin therapy may be needed.

• Ketones in the blood (diabetic ketoacidosis) or
• Type 1 (insulin-dependent) diabetes—Insulin is needed to control diabetes in patients with these conditions

• Liver disease, moderate to severe—Use of nateglinide in patients with this condition have not been studied. Caution should be used.

• Nervous system disorder (autonomic neuropathy)—Patients with this condition might not be able to detect the symptoms of low blood sugar and might not take immediate steps to treat it

Proper Use of This Medicine

Follow carefully the special meal plan that your doctor gave you. This is the most important part of controlling your condition and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

This medicine is usually taken between 1 and 30 minutes before a meal. If you skip the meal, also skip the scheduled dose of nateglinide.

Use this medicine as directed even if you feel well and do not notice any signs of high blood sugar. Remember that this medicine will not cure your diabetes, but it does help to control it. You must to continue to take it as directed if you expect to lower your blood sugar and keep it low. You may have to take an antidiabetic medicine for the rest of your life. If high blood sugar is not treated, it can cause serious problems, such as blood vessel disease, eye disease, heart failure, or kidney disease.

Dosing—The dose of nateglinide will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of nateglinide. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For type 2 diabetes:
    • Adults—60 to 120 mg three times a day taken between one and thirty minutes before meals.
    • Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take it before your next main meal. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Your doctor will want to check your progress at regular visits , especially during the first few weeks that you take this medicine.

It is very important to follow carefully any instructions from your health care team about :

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines during the time you are taking nateglinide unless they have been discussed with your doctor. This especially includes nonprescription medicines for appetite control, asthma, colds, cough, hay fever, pain relief, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency —There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

Nateglinide can cause low blood sugar (hypoglycemia). Low blood sugar also can occur if you use nateglinide with another antidiabetic medicine, delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out) . Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly .

Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, nondiet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur . Food or drink should not be forced because the patient could choke from not swallowing correctly.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination; ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions .

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 05/29/2001
Revised: 08/10/2004

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