Dosing and uses of Starlix (nateglinide)
Adult dosage forms and strengths
tablet
- 60mg
- 120mg
Type 2 DM Monotherapy, or With Metformin
120 mg PO q8hr; 60 mg PO q8hr if patient near goal HbA1C
Take dose 1-30 minutes before meaL
Pediatric dosage forms and strengths
Safety & efficacy not established
Starlix (nateglinide) adverse (side) effects
1-10%
Increased uric acid (10%)
Dizziness (4%)
Arthropathy (3%)
Flu-like syndrome
Weight gain
Hypoglycemia (2%)
Frequency not defined
Diarrhea
Nausea
Warnings
Contraindications
Documented hypersensitivity
Diabetic ketoacidosis, type I Dm
Cautions
Patients with risk of severe hypoglycemia: elderly, malnourished, adrenal or pituitary insufficiency, hepatic insufficiency
Patients with stress due to infection, fever, trauma, or surgery
Not to be used in combination with an insulin secretagogue (eg, glyburide)
Not to be used as substitute for metformin monnotherapy but as adjunctive
Pregnancy and lactation
Pregnancy category: C
Lactation: unsafe
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Starlix (nateglinide)
Mechanism of action
Increases insulin secretion via binding K+ channels on beta islet cells. Reduces postprandial hyperglycemia. Amount of insulin released is dependent upon existing glucose levels.
Half-Life
1.2-3 hr
Duration
4 hr
Onset
Initial effect: 15 min
Max effect: 1-2 hr
Excretion
Urine:83%
Feces: 10%
Distribution
10 L
Other Information
Peak Plasma Time: < 1hr
Bioavailability: 72-75%
Protein Bound: 97-99%
Metabolism: by hepatic cytochrome P450 CYP2C9 (70%) & CYP3A4 (30%)
Metabolites: major metabolite M1 (20% potency of parent drug), & many other metabolites
