Classes
DEA Class; Rx
Common Brand Names; Starlix
- Antidiabetics, Meglitinides Derivatives
Description
Meglitinide oral hypoglycemic agent; stimulates insulin secretion
Rapid onset and short duration of action replicates physiological insulin profiles around meals
Used prior to meals for the treatment of type 2 diabetes mellitus in adults; not commonly used as monotherapy
Indications
Indicated for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise.
Not for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis
Contraindications
Documented hypersensitivity
Adverse Effects
Increased uric acid (10%)
Dizziness (4%)
Arthropathy (3%)
Flu-like syndrome
Weight gain
Hypoglycemia (2%)
Diarrhea
Nausea
Warnings
Not to be used in combination with an insulin secretagogue (eg, glyburide)
Not to be used as substitute for metformin monotherapy but as adjunctive
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with therapy
Pregnancy and Lactation
Available data from published literature and applicant’s pharmacovigilance in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes
There are no data on presence of nateglinide in human milk, effects on breastfeeding infant, or on milk production
Maximum Dosage
360 mg/day PO.
360 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Nateglinide
tablet
- 60mg
- 120mg
