Starlix

Contraindications

Documented hypersensitivity

Diabetic ketoacidosis, type I DM

Cautions

Patients with risk of severe hypoglycemia: elderly, malnourished, adrenal or pituitary insufficiency, hepatic insufficiency

Patients with stress due to infection, fever, trauma, or surgery

Not to be used in combination with an insulin secretagogue (eg, glyburide)

Not to be used as substitute for metformin monnotherapy but as adjunctive

The recommended dose of nateglinide alone or in combination with metformin or thiazolidinediones is 120 mg three times daily with meals. The 60 mg dose is used for patients who are close to their goal HbA1c when treatment is started. Nateglinide should be taken 30 minutes or less before a meal but should not be taken if a meal is skipped.

Tablet: 60 and 120 mg.

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

Nateglinide is the generic form of the brand-name drug Starlix.

It's used to help lower blood sugar in people who have type 2 diabetes.

If you have type 2 diabetes, your body doesn't make or use the hormone insulin normally, so it can't control the amount of sugar, or glucose, in the blood.

Nateglinide is used alone or with other medicines to treat people whose diabetes can't be controlled by diet and exercise alone.

The medication belongs to a class of drugs known as meglitinides. It helps the body regulate the amount of sugar in the blood by encouraging the pancreas to release insulin.

Taking nateglinide, along with adopting a healthy lifestyle, can decrease your risk of developing the serious or life-threatening complications of type 2 diabetes.

These may include cardiovascular diseases, such as heart attack, stroke, and problems related to blood circulation; nerve damage; kidney disease; or eye conditions.

Nateglinide was approved by the Food and Drug Administration in 2000 for manufacture by Novartis.

Nateglinide Warnings

Nateglinide shouldn't be used in people with type 1 diabetes (the body doesn't produce any insulin) or diabetic ketoacidosis (a dangerous condition that can occur if high blood sugar is untreated).

Before taking this medicine, tell your doctor if you have or have ever had:

• Liver disease
• Kidney disease
• Pituitary disease
• Neuropathy
• Adrenal problems
• Gout

Tell your healthcare providers that you're taking nateglinide before having any type of surgery, including a dental procedure.

This drug may cause changes in your blood sugar.

You should know the symptoms of high and low blood sugar episodes and be prepared to treat them.

Talk to your physician if you experience an illness, fever, injury, or unusual stress, because these events can affect your blood-sugar levels and how much nateglinide you need.

Nateglinide helps control diabetes but does not cure it. Continue to take it even if you feel well, and don't stop taking it without talking with your doctor.

Your doctor will probably want to check your glucose levels often while you are taking nateglinide.

Always wear a diabetic ID bracelet to be sure you get proper treatment in case of an emergency.

Pregnancy and Nateglinide

Nateglinide should not be used during pregnancy.

It's an FDA Pregnancy Category C drug, which means harm to an unborn baby can't be ruled out.

Tell your doctor if you're pregnant or plan to become pregnant before taking nateglinide.

You shouldn't breastfeed while taking nateglinide. The drug can pass into breast milk and may harm a breastfeeding baby.

If you take too much Starlix, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

You should not use nateglinide if you are allergic to it, or if you have:

• diabetic ketoacidosis (call your doctor for treatment).

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

• liver disease; or

• gout.

Follow your doctor's instructions about using this medicine if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy.

It is not known whether nateglinide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Nateglinide is not approved for use by anyone younger than 18 years old.

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of nateglinide. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Contraindications

• Known hypersensitivity to nateglinide or any ingredient in the formulation.1

• Type 1 (insulin-dependent) diabetes mellitus or diabetic ketoacidosis.1

Warnings/Precautions

General Precautions

Potential for hypoglycemia.1 3 4 Malnourished or geriatric patients and patients with adrenal or pituitary insufficiency may be particularly susceptible.1 Strenuous exercise, alcohol ingestion, insufficient caloric intake acutely or chronically, or use in combination with other antidiabetic agents may increase risk.1 Hypoglycemia may be difficult to recognize in patients with autonomic neuropathy or in those receiving β-adrenergic blocking agents.1

Possible loss of glycemic control during periods of stress (e.g., fever, trauma, infection, surgery).1 Temporary discontinuance of nateglinide and administration of insulin may be required.1

Efficacy of nateglinide may decrease over time.1

Specific Populations

Category C.1

Distributed into milk in rats; use not recommended.1

Safety and efficacy not established.1

No substantial differences in safety, efficacy, or pharmacokinetics relative to younger adults, but increased sensitivity cannot be ruled out.1

Use with caution in patients with moderate to severe hepatic impairment.1

Common Adverse Effects

Upper respiratory tract infection, back pain, flu symptoms, dizziness, arthropathy, diarrhea, accidental trauma, bronchitis, cough, hypoglycemia.1

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.

• If you have an allergy to nateglinide or any other part of Starlix (nateglinide).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Acidic blood problem or type 1 diabetes.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Starlix with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Usual Adult Dose for Diabetes Type 2:

Initial dose: 120 mg orally 3 times a day before meals
Maintenance dose: 60 to 120 mg orally 3 times a day before meals

Comments:
-For patients who are near goal HbA1c when therapy is initiated, therapy should be initiated at 60 mg orally 3 times.
-May be used as monotherapy, or in combination with metformin or a thiazolidinedione.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.