Uses
Diabetes Mellitus
Used as monotherapy as an adjunct to diet and exercise for the management of type 2 (noninsulin-dependent) diabetes mellitus in patients whose hyperglycemia cannot be controlled by diet and exercise alone and who have not been treated chronically with other oral antidiabetic agents.
May be used in combination with metformin as an adjunct to diet and exercise for the management of type 2 diabetes mellitus in patients who do not achieve adequate glycemic control with metformin monotherapy. Should be added to, not substituted for, metformin therapy in such patients.
Should not be added to or substituted for other insulin secretagogues (e.g., sulfonylureas) in patients not controlled adequately with such drugs.
Not indicated for type 1 diabetes mellitus or ketoacidosis.
Dosage and Administration
Administration
Oral Administration
Administer 3 times daily 1–30 minutes before meals to reduce the risk of hypoglycemia.
If a meal is skipped, the dose of nateglinide should be omitted.
Dosage
Adults
Diabetes Mellitus
Oral
120 mg 3 times daily before meals. For patients who are near their goal glycosylated hemoglobin (HbA1c) when nateglinide therapy is initiated, 60 mg 3 times daily before meals.
Special Populations
Dosage in Hepatic Impairment
No dosage adjustment necessary in patients with mild impairment. Use with caution in patients with moderate or severe impairment.
Dosage in Renal Impairment
No dosage adjustment necessary.
Geriatric Patients
No dosage adjustment necessary.
Cautions
Contraindications
Warnings/Precautions
General Precautions
Hypoglycemia
Potential for hypoglycemia. Malnourished or geriatric patients and patients with adrenal or pituitary insufficiency may be particularly susceptible. Strenuous exercise, alcohol ingestion, insufficient caloric intake acutely or chronically, or use in combination with other antidiabetic agents may increase risk. Hypoglycemia may be difficult to recognize in patients with autonomic neuropathy or in those receiving β-adrenergic blocking agents.
Loss of Glycemic Control
Possible loss of glycemic control during periods of stress (e.g., fever, trauma, infection, surgery). Temporary discontinuance of nateglinide and administration of insulin may be required.
Efficacy of nateglinide may decrease over time.
Specific Populations
Pregnancy
Category C.
Lactation
Distributed into milk in rats; use not recommended.
Pediatric Use
Safety and efficacy not established.
Geriatric Use
No substantial differences in safety, efficacy, or pharmacokinetics relative to younger adults, but increased sensitivity cannot be ruled out.
Hepatic Impairment
Use with caution in patients with moderate to severe hepatic impairment.
Common Adverse Effects
Upper respiratory tract infection, back pain, flu symptoms, dizziness, arthropathy, diarrhea, accidental trauma, bronchitis, cough, hypoglycemia.
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