Starlix
Starlix Information
Brand Name: Starlix
Generic Name: Nateglinide
Starlix Indications
Starlix (nateglinide) is indicated as monotherapy to lower blood glucose in patients with Type 2 diabetes (non-insulin dependent diabetes mellitus, NIDDM) whose hyperglycemia cannot be adequately controlled by diet and physical exercise and who have not been chronically treated with other anti-diabetic agents.
Starlix is also indicated for use in combination with metformin. In patients whose hyperglycemia is inadequately controlled with metformin, Starlix may be added to, but not substituted for, metformin.
Patients whose hyperglycemia is not adequately controlled with glyburide or other insulin secretagogues should not be switched to Starlix, nor should Starlix be added to their treatment regimen.
Starlix Ingredients and Composition
How Does Starlix Work?
Mechanism of Action
Nateglinide, the active ingredient in Starlix, is an amino-acid derivative that lowers blood glucose levels by stimulating insulin secretion from the pancreas. This action is dependent upon functioning beta-cells in the pancreatic islets. Nateglinide interacts with the ATP-sensitive potassium (K+ ATP ) channel on pancreatic beta-cells. The subsequent depolarization of the beta cell opens the calcium channel, producing calcium influx and insulin secretion. The extent of insulin release is glucose dependent and diminishes at low glucose levels. Nateglinide is highly tissue selective with low affinity for heart and skeletal muscle.
How To Take Starlix and Starlix Dosage and Administration
Starlix (nateglinide) should be taken 1 to 30 minutes prior to meals.
Monotherapy and Combination with Metformin
The recommended starting and maintenance dose of Starlix, alone or in combination with metformin, is 120 mg three times daily before meals.
The 60-mg dose of Starlix, either alone or in combination with metformin, may be used in patients who are near goal HbA 1C 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
If you suspect a Starlix Overdose
In a clinical study in patients with Type 2 diabetes, Starlix (nateglinide) was administered in increasing doses up to 720 mg a day for 7 days and there were no clinically significant adverse events reported. There have been no instances of Starlix overdose in clinical trials. However, an overdose may result in an exaggerated glucose-lowering effect with the development of hypoglycemic symptoms. Hypoglycemic symptoms without loss of consciousness or neurological findings should be treated with oral glucose and adjustments in dosage and/or meal patterns. Severe hypoglycemic reactions with coma, seizure, or other neurological symptoms should be treated with intravenous glucose. As nateglinide is highly protein bound, dialysis is not an efficient means of removing it from the blood.
Starlix Pill Identification / ID and Appearance
60 mg Starlix (nateglinide) tablets
Pink, round, beveled edge tablet with "STARLIX" debossed on one side and "60" on the other.
- Bottles of 100 ............................... NDC 0078-0351-05
- Bottles of 500 ............................... NDC 0078-0351-08
120 mg Starlix (nateglinide) tablets
Yellow, ovaloid tablet with "STARLIX" debossed on one side and "120" on the other.
- Bottles of 100 ............................... NDC 0078-0352-05
- Bottles of 500 ............................... NDC 0078-0352-08
Starlix Side Effects
Contraindications to Starlix
Starlix (nateglinide) is contraindicated in patients with:
- Known hypersensitivity to the drug or its inactive ingredients.
- Type 1 diabetes.
- Diabetic ketoacidosis. This condition should be treated with insulin.
Starlix Clinical Trials and Studies
Storing Starlix
Store Starlix at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F).
Additional Patient Information for Starlix
Patients should be informed of the potential risks and benefits of Starlix and of alternative modes of therapy. The risks and management of hypoglycemia should be explained. Patients should be instructed to take Starlix 1 to 30 minutes before ingesting a meal, but to skip their scheduled dose if they skip the meal so that the risk of hypoglycemia will be reduced. Drug interactions should be discussed with patients. Patients should be informed of potential drug-drug interactions with Starlix.
