DRUG NAME

Starlix ( Nateglinide/Starlix )

WARNINGS/PRECAUTIONS

Do not stop using this medicine without first checking with your doctor. Do not exceed the recommended dose without checking with your doctor. Follow the dietary plan provided by your doctor.

This medicine may cause hypoglycemia (low blood sugar). Signs of hypoglycemia include an increased heart rate, headache, sweating, tremor, increased hunger, changes in vision, nervousness, or tiredness. Discuss with your doctor how to handle hypoglycemic reactions.

Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine.

Using this medicine alone, with other medicines, or with alcohol, may lessen your ability to drive or to perform other potentially dangerous tasks. Before you have any medical or dental treatements, emergency care, or surgery, tell the doctor or dentist that you are using this medicine.

Before you begin taking any new medicine, either prescription or over-the-counter, check with your doctor or pharmacist. This medicine is not recommended for use during pregnancy. Insulin therapy may be necessary during pregnancy. Consult your doctor for more details. It is unknown if this medicine is excreted in breast milk. Do not breast-feed while taking this medicine.

MISSED DOSE

Since this drug is generally given only before meals, consult your doctor or pharmacist regarding advice on a missed dose.

DRUG CLASS AND MECHANISM

Starlix is an oral drug used to lower blood sugar (glucose) levels in type 2 diabetes. It is in a class of drugs called meglitinides which also includes repaglinide ( Prandin ). Approximately 90% of patients with diabetes have type 2 diabetes.

Type 2 diabetes usually occurs in adults and is associated with obesity and a strong family history of diabetes. Insulin is an important hormone that controls the blood level of glucose. Type 2 diabetics have an inability to control blood glucose levels. This is caused by reduced secretion of insulin from the pancreas after meals and resistance of the body's cells to the effect of insulin which is to stimulate the cells to remove glucose from the blood. This leads to high levels of blood glucose.

Starlix stimulates cells in the pancreas to produce insulin in a manner similar to the class of drugs called sulfonylureas, e.g., glyburide (Diabeta, Glynase and Micronase ) which also are used in type 2 diabetes. However, starlix appears to have a faster onset and a shorter duration of action than sulfonylureas. The benefit of this faster, shorter effect may be to prevent the rapid, transient rise in blood glucose that occurs in diabetics immediately following a meal.

POSSIBLE SIDE EFFECTS

Side effects that may occur while taking this medicine include dizziness, increased heartbeat, headache, sweating, tremor, increased hunger, changes in vision, nervousness, or tiredness. If they are severe or continue to occur, check with your doctor. An allergic reaction to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

DRUG USES

Starlix is used to control blood glucose levels in type 2 diabetes. It may be used with diet and exercise when diet and exercise alone are not successful in controlling blood glucose. It also may be used with metformin/Actoplus met, another drug that is used for controlling blood glucose in type 2 diabetes. Starlix is not recommended if blood glucose levels have not been controlled by a sulfonylurea since starlix and sulfonylureas have a similar mechanism of action. Therefore, if sulfonylureas are ineffective, it is likely that starlix also will be ineffective.

HOW TAKEN

Starlix may be prescribed at 60 or 120 mg three times daily. The dose is adjusted depending upon blood glucose and HbA1c levels. Starlix should be taken 30 minutes or less before a meal but should not be taken if a meal is skipped.

MORE INFORMATION

Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using this medicine. Certain conditions such as illness, stress, or emotional disturbances may change your insulin requirements. Follow your doctor's instructions carefully.

Carry an identification card at all times that says you are diabetic. Monitor your blood sugar levels regularly according to your doctor's directions. If your blood sugar level is often higher than it should be and you are taking this medicine according to directions, check with your doctor.

Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use.

Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when full. If using this medicine for an extended period of time, obtain more insulin before your supply runs out.

STORAGE

Starlix should be stored at room temperature, 15-30 degrees C(59-86 degrees F) in an air-tight container.

What is the shelf life of the pills?

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.