Nateglinide

2 DOSAGE AND ADMINISTRATION The recommended dose of nateglinide is 120 mg orally three times daily before meals. The recommended dose of nateglinide is 60 mg orally three times daily before meals in patients who are near glycemic goal when treatment is initiated.

Instruct patients to take nateglinide 1 to 30 minutes before meals. 1)] . Recommended dose is 120 mg three times daily (2) In patients who are near glycemic goal when treatment is initiated, 60 mg three times daily may be administered.

(2) Administer 1 to 30 minutes before meals (2) If a meal is skipped, skip the scheduled dose to reduce the risk of hypoglycemia. 1)

1)] Common adverse reactions associated with nateglinide (3% or greater incidence) were upper respiratory tract infection, back pain, flu symptoms, dizziness, arthropathy, diarrhea. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, approximately 2,600 patients with type 2 diabetes mellitus were treated with nateglinide. Of these, approximately 1,335 patients were treated for 6 months or longer and approximately 190 patients for one year or longer.

Table 1 shows the most common adverse reactions associated with nateglinide. 4 Hypoglycemia Episodes of severe hypoglycemia (plasma glucose less than 36 mg/dL) were reported in two patients treated with nateglinide. 1)] . Weight Gain Patients treated with nateglinide had statistically significant mean increases in weight compared to placebo.

6 kg, respectively.

Laboratory Test Increases in Uric Acid:

There were increases in mean uric acid levels for patients treated with nateglinide alone, nateglinide in combination with metformin, metformin alone, and glyburide alone. 19 mg/dL. 2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of nateglinide.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity Reactions:

Rash, itching, and urticaria Hepatobiliary Disorders: Jaundice, cholestatic hepatitis, and elevated liver enzymes

5 WARNINGS AND PRECAUTIONS Hypoglycemia: Nateglinide may cause hypoglycemia. Administer before meals to reduce the risk of hypoglycemia. Skip the scheduled dose of nateglinide if a meal is skipped to reduce the risk of hypoglycemia. 1) Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with nateglinide.

1)] . Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. , driving or operating other machinery). Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual.

, beta-blockers) [see Drug Interactions (7)] , or in patients who experience recurrent hypoglycemia. , macronutrient content), changes in level of physical activity, changes to coadministered medication [see Drug Interactions (7)] , and concomitant use with other antidiabetic agents.

3)] . Patients should take nateglinide before meals and be instructed to skip the dose of nateglinide if a meal is skipped [see Dosage and Administration (2)] . Patients and caregivers must be educated to recognize and manage hypoglycemia.

Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.

2 Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with nateglinide.

4 CONTRAINDICATIONS Nateglinide tablets are contraindicated in patients with a history of hypersensitivity to nateglinide or its inactive ingredients. History of hypersensitivity to nateglinide or its inactive ingredients (4)