Starlix (nateglinide)

Starlix (nateglinide) 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 treat type 2 diabetes.

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

Important information

You should not use Starlix 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. 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:

• type 1 diabetes; or
• if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

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

• liver disease; or
• gout.

It is not known whether Starlix will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Nateglinide can pass into breast milk and may harm a nursing baby. You should not breast-feed while using Starlix.

How should I take Starlix?

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 30 minutes before eating a meal. Follow your doctor’s instructions. If you skip a meal, do not take your dose of Starlix. Wait until your next meal.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor’s office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your dose of Starlix or your dosing schedule without your doctor’s advice.

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.

Starlix dosing information

Usual Adult Dose for Diabetes Type 2:

120 mg orally three times daily before meals.
-or-
60 mg three times daily before meals (patients who are near goal HbA1c).

What happens if I miss a dose?

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 extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

What should I avoid while taking Starlix?

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

Starlix side effects

Get emergency medical help if you have any of these 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, nausea;
• 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.

What other drugs will affect Starlix?

Many other medicines that can increase or decrease the effects of Starlix on lowering your blood sugar. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

 

Side Effects

Note: This page contains side effects data for the generic drug nateglinide. It is possible that some of the dosage forms included below may not apply to the brand name Starlix.

It is possible that some side effects of Starlix may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to nateglinide: oral tablet

As well as its needed effects, nateglinide (the active ingredient contained in Starlix) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking nateglinide, check with your doctor immediately:

Less common

• Convulsions (seizures)
• unconsciousness

If any of the following side effects occur while taking nateglinide, check with your doctor or nurse as soon as possible:

Less common

• Low blood sugar, including anxious feeling, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, difficulty in thinking, drowsiness, excessive hunger, fast heartbeat, headache, nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness

Incidence not known-occurred during clinical practice

• Hives or welts
• itching
• redness of skin
• skin rash

Some nateglinide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common

• Cough
• runny or stuffy nose
• sore throat

Less common

• Abdominal or stomach pain
• back pain
• chills
• dizziness
• pain in joints or muscles
• sneezing
• swelling in joints

For Healthcare Professionals

Applies to nateglinide: oral tablet

General

Nateglinide (the active ingredient contained in Starlix) is generally well tolerated with the incidence of adverse effects similar to placebo. Upper respiratory tract infections, dizziness, flu symptoms, arthropathy, and accidental trauma were reported slightly more frequently than placebo in clinical trials.

Musculoskeletal

Musculoskeletal side effects have included back pain (4.0%) and arthropathy (3.3%).

Respiratory

Respiratory side effects have included upper respiratory infection (10.5%), bronchitis (2.7%), and coughing (2.4%).

Endocrine

There were increases in mean uric acid levels for patients treated with nateglinide (the active ingredient contained in Starlix) alone, nateglinide in combination with metformin, metformin alone, and glyburide alone. The respective differences from placebo were 0.29 mg/dL, 0.28 mg/dL, 0.28 mg/dL.

Endocrine side effects have included hypoglycemia (2.4%) and increases in uric acid.

Hypersensitivity

Hypersensitivity side effects have included rare cases of rash, itching and urticaria in postmarketing experience.

Hepatic

Hepatic side effects have included post-marketing reports of jaundice, cholestatic hepatitis, and elevated liver enzymes.

Starlix® (nateglinide) should be taken 1 to 30 minutes prior to meals.

 

Dosage:

Monotherapy and Combination with Metformin or a Thiazolidinedione

The recommended starting and maintenance dose of Starlix, alone or in combination with metformin or a thiazolidinedione, is 120 mg three times daily before meals.

The 60-mg dose of Starlix, either alone or in combination with metformin or a thiazolidinedione, may be used in patients who are near goal HbA1C when treatment is initiated.

Dosage in Geriatric Patients

No special dose adjustments are usually necessary. However, greater sensitivity of some individuals to Starlix therapy cannot be ruled out.

Dosage in Renal and Hepatic Impairment

No dosage adjustment is necessary in patients with mild-to-severe renal insufficiency or in patients with mild hepatic insufficiency. Dosing of patients with moderate-to-severe hepatic dysfunction has not been studied. Therefore, Starlix should be used with caution in patients with moderate-to-severe liver disease (see PRECAUTIONS, Hepatic Impairment).

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