Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.
Nateglinide should be taken within 1 to 30 minutes before meals (usually breakfast, lunch and dinner).
The dosage of nateglinide should be determined by the physician according to the patient’s requirements.
The recommended starting dose is 60 mg three times daily before meals, particularly in patients who are near goal HbA1c. This may be increased to 120 mg three times daily.
Dose adjustments should be based on periodic glycosylated haemoglobin (HbA1c) measurements. Since the primary therapeutic effect of Starlix is to reduce mealtime glucose (a contributor to HbA1c), the therapeutic response to Starlix may also be monitored with 1-2 hour post-meal glucose.
The recommended maximum daily dose is 180 mg three times daily to be taken before the three main meals.
The clinical experience in patients over 75 years of age is limited.
No dose adjustment is necessary in patients with mild to moderate renal impairment. Although there is a 49% decrease in Cmax of nateglinide in dialysis patients, the systemic availability and half-life in diabetic subjects with moderate to severe renal insufficiency (creatinine clearance 15-50 ml/min) was comparable between renal subjects requiring haemodialysis and healthy subjects. Although safety was not compromised in this population dose adjustment may be required in view of low Cmax.
No dose adjustment is necessary for patients with mild to moderate hepatic impairment. As patients with severe liver disease were not studied, nateglinide is contraindicated in this group.
There are no data available on the use of nateglinide in patients under 18 years of age, and therefore its use in this age group is not recommended.
In debilitated or malnourished patients the initial and maintenance dosage should be conservative and careful titration is required to avoid hypoglycaemic reactions.
In a clinical study in patients, Starlix was administered in increasing doses up to 720 mg a day for 7 days and was well tolerated. There is no experience of an overdose of Starlix in clinical trials. However, an overdose may result in an exaggerated glucose-lowering effect, with the development of hypoglycaemic symptoms. Hypoglycaemic symptoms without loss of consciousness or neurological findings should be treated with oral glucose and adjustments in dosage and/or meal patterns. Severe hypoglycaemic reactions with coma, seizure or other neurological symptoms should be treated with intravenous glucose. As nateglinide is highly protein-bound, dialysis is not an efficient means of removing it from the blood.
3 years.
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