120 mg PO q8hr; 60 mg PO q8hr if patient near goal HbA1CPatients with risk of severe hypoglycemia: elderly, malnourished, adrenal or pituitary insufficiency, hepatic insufficiencyPatients with stress due to infection, fever, trauma, or surgeryNot to be used in combination with an insulin secretagogue (eg, glyburide)Not to be used as substitute for metformin monnotherapy but as adjunctiveA: Generally acceptable. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia Patients should take Starlix before meals and be instructed to skip the dose of Starlix if a meal is skipped There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Starlix.The following serious adverse reaction is also described elsewhere in the labeling: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 Starlix. Please confirm that you would like to log out of Medscape. x��=�n�����e����d�} � _��-��d�p� K����2�������e�d���fk�>��Hɺ�z������㓻��~������������������v}�t��������r��׏w���������������>�.6u5����>0��bӴ����yxaZ�x�m>�>|Po>�~����{��_6����g�����ͳ�O6���~�����������n6���U4�NV�T����p��@6�G0��O�n����yk�O�˃[�������[������޻�2}횽Cx�|ώ�ne�����d��%Á�\��U+�n~ |o�R�ؘ���÷�n�A�� Î�08�����qRr�! 4 0 obj However, greater sensitivity of some older individuals to Starlix therapy cannot be ruled out.No dosage adjustment is recommended in patients with mild to severe renal impairment No dose adjustment is recommended for patients with mild hepatic impairment. HealthyPlace.com Staff Writer. Patients previously treated with antidiabetic medications were required to discontinue that medication for at least 2 months before randomization.At Week 24, treatment with Starlix before meals resulted in statistically significant reductions in mean HbA1C and mean fasting plasma glucose (FPG) compared to placebo (see Table 5). Contact the applicable plan If you log out, you will be required to enter your username and password the next time you visit. Breast-feeding. Inhibition of CYP3A4 metabolic reactions was not detected in in vitro experiments.In vitro displacement studies with highly protein-bound drugs such as furosemide, propranolol, captopril, nicardipine, pravastatin, glyburide, warfarin, phenytoin, acetylsalicylic acid, tolbutamide, and metformin showed no influence on the extent of nateglinide protein binding. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made as to whether Starlix should be discontinued in nursing mothers, or if mothers should discontinue nursing.The safety and effectiveness of Starlix have not been established in pediatric patients.436 patients 65 years and older, and 80 patients 75 years and older were exposed to Starlix in clinical studies. Brand Name: Starlix Generic Name: nateglinide tablets Contents: Description Clinical Pharmacology Clinical Studies Indications and Usage Contraindications Precautions Adverse Reactions Overdosage Dosage and Administration How Supplied. There is no data on pharmacokinetics of Starlix in patients with moderate-to-severe hepatic impairment.No clinically significant differences in nateglinide pharmacokinetics were observed between men and women.Results of a population pharmacokinetic analysis including subjects of Caucasian, Black, and other ethnic origins suggest that race has little influence on the pharmacokinetics of nateglinide.Age does not influence the pharmacokinetic properties of nateglinide.Starlix is a potential inhibitor of the CYP2C9 isoenzyme in vivo as indicated by its ability to inhibit the in vitro metabolism of tolbutamide. 1 0 obj

Instruct patients that skip meals to skip their dose of Starlix [see Dosage and Administration (2)].Inform patients that Starlix can cause hypoglycemia and instruct patients and their caregivers on self-management procedures including glucose monitoring and management of hypoglycemia.