Starlix

DRUG DESCRIPTION

Starlix® (nateglinide) is an oral antidiabetic agent used in the management of Type 2 diabetes mellitus [also known as non-insulin dependent diabetes mellitus (NIDDM) or adult-onset diabetes]. Starlix, (-)-N-[(trans-4isopropylcyclohexane)carbonyl]-D-phenylalanine, is structurally unrelated to the oral sulfonylurea insulin secretagogues.

The structural formula is as shown

Starlix® (nateglinide)  Structural Formula Illustration

Nateglinide is a white powder with a molecular weight of 317.43. It is freely soluble in methanol, ethanol, and chloroform, soluble in ether, sparingly soluble in acetonitrile and octanol, and practically insoluble in water. Starlix biconvex tablets contain 60 mg, or 120 mg, of nateglinide for oral administration.

Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, iron oxides (red or yellow), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide.

What are the possible side effects of nateglinide (Starlix)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • seizure (convulsions); or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • runny or stuffy nose, sneezing, cough, cold or flu symptoms;
  • diarrhea, nausea;
  • back pain;
  • dizziness; or
  • ...

Read All Potential Side Effects and See Pictures of Starlix »

What are the precautions when taking nateglinide (Starlix)?

Before taking nateglinide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, gout.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase the risk of developing low blood sugar.

During...

Read All Potential Precautions of Starlix »


Starlix Consumer (continued)

SIDE EFFECTS: Weight gain may occur. If this effect persists or worsens, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Nateglinide can cause low blood sugar (hypoglycemia) especially if you are taking other medicines for diabetes. Consuming large quantities of alcohol, not getting enough calories from food, or doing unusually heavy exercise may also lead to low blood sugar. Symptoms may include chills, cold sweat, dizziness, drowsiness, shaking, fast heartbeat, weakness, headache, fainting, tingling of the hands or feet, or hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, raise your blood sugar quickly by eating a quick source of sugar such as table sugar, honey, candy, or drinking a glass of fruit juice or non-diet soda. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your doctor may need to adjust your diabetes medication(s).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking nateglinide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, gout.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase the risk of developing low blood sugar.

During times of stress, such as fever, infection, injury, or surgery, it may be more difficult to control your blood sugar. Consult your doctor because increased stress may require a change in your treatment plan, medications, or blood sugar testing.

During pregnancy, this medication should be used only when clearly needed. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy. Discuss the risks and benefits of different treatments (such as diet, exercise, and medications including insulin).

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Starlix Patient Information Including Side Effects

Brand Names: Starlix

Generic Name: nateglinide (oral) (Pronunciation: na ta GLYE nide)

  • What is nateglinide (Starlix)?
  • What are the possible side effects of nateglinide (Starlix)?
  • What is the most important information I should know about nateglinide (Starlix)?
  • What should I discuss with my doctor before taking nateglinide (Starlix)?
  • How should I take nateglinide (Starlix)?
  • What happens if I miss a dose (Starlix)?
  • What happens if I overdose (Starlix)?
  • What should I avoid while taking nateglinide (Starlix)?
  • What other drugs will affect nateglinide (Starlix)?
  • Where can I get more information?

What is nateglinide (Starlix)?

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

Nateglinide is used together with diet and exercise to treat type 2 (non-insulin dependent) diabetes. Other diabetes medicines are sometimes used in combination with nateglinide if needed.

Nateglinide may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of nateglinide (Starlix)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • seizure (convulsions); or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • runny or stuffy nose, sneezing, cough, cold or flu symptoms;
  • diarrhea, nausea;
  • back pain;
  • dizziness; or
  • joint pain or stiffness.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about nateglinide (Starlix)?

Do not use this medication if you are allergic to nateglinide, if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Take care not to let your blood sugar get too low, causing hypoglycemia. You may have hypoglycemia if you skip a meal, exercise too long, drink alcohol, or are under stress.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them. Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. Severe hypoglycemia may cause loss of consciousness, seizures, or death. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

If your blood sugar gets too high (hyperglycemia), you may feel very thirsty or hungry. You may also urinate more than usual. Call your doctor right away if you have any symptoms of hyperglycemia.

Nateglinide 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.

It is important to take nateglinide regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

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