Starlix® (nateglinide) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Starlix® (nateglinide) should be taken 1 to 30 minutes prior to meals.

Monotherapy and Combination with Metformin or a Thiazolidinedione

The recommended starting and maintenance dose of Starlix, alone or in combination with metformin or a thiazolidinedione, is 120 mg three times daily before meals.

The 60-mg dose of Starlix, either alone or in combination with metformin or a thiazolidinedione, may be used in patients who are near goal HbA1C 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 (see PRECAUTIONS, Hepatic Impairment).

Starlix® (nateglinide) tablets

60 mg

Pink, round, beveled edge tablet with “STARLIX” debossed on one side and “60” on the other.

Bottles of 100...............................NDC 0078-0351-05

120 mg

Yellow, ovaloid tablet with “STARLIX” debossed on one side and “120” on the other.

Bottles of 100...............................NDC 0078-0352-05

Storage

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F).

Dispense in a tight container, USP

REV: July 2008. Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. FDA revision date: 07/15/08

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