Trazec

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 Trazec is to reduce mealtime glucose, (a contributor to HbA1c), the therapeutic response to Trazec 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. Specific patient groups Elderly The clinical experience in patients over 75 years of age is limited. Children and adolescents 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.

Patients with hepatic impairment 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. Medicinal product no longer authorised3 Patients with renal impairment 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. Others In debilitated or malnourished patients the initial and maintenance dosage should be conservative and careful titration is required to avoid hypoglycaemic reactions.

Based on the experience with nateglinide and with other hypoglycaemic agents, the following adverse reactions have been seen. Frequencies are defined as: common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000).

Hypoglycaemia As with other antidiabetic agents, symptoms suggestive of hypoglycaemia have been observed after administration of nateglinide. These symptoms included sweating, trembling, dizziness, increased appetite, palpitations, nausea, fatigue, and weakness.

These were generally mild in nature and easily handled by intake of carbohydrates when necessary. 1% with placebo.

Immune system disorders Rare:

Hypersensitivity reactions such as rash, itching and urticaria.

Metabolism and nutrition disorders Common:

Symptoms suggestive of hypoglycaemia.

Gatrointestinal disorders Common:

Abdominal pain, diarrhoea, dyspepsia, nausea.

Uncommon:

Vomiting.

Hepatobiliary disorders Rare:

Elevations in liver enzymes. Other events Other adverse events observed in clinical studies were of a similar incidence in Trazec-treated and placebo-treated patients. Post-marketing data revealed very rare cases of erythema multiforme.

General Nateglinide should not be used in monotherapy. Like other insulin secretagogues, nateglinide is capable of producing hypoglycaemia. 8). Elderly, malnourished patients and those with adrenal or pituitary insufficiency or severe renal impairment are more susceptible to the glucose- lowering effect of these treatments.

The risk of hypoglycaemia in type 2 diabetic patients may be increased by strenuous physical exercise, or ingestion of alcohol. 5%). Combination with metformin is associated with an increased risk of hypoglycaemia compared to monotherapy.

Hypoglycaemia may be difficult to recognise in subjects receiving beta blockers. When a patient stabilised on any oral hypoglycaemic agent is exposed to stress such as fever, trauma, infection or surgery, a loss of glycaemic control may occur.

At such times, it may be necessary to discontinue oral hypoglycaemic treatment and replace it with insulin on a temporary basis. Trazec contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, of the Lapp lactase deficiency or of glucose-galactose malabsorption should not take this medicine.

Specific patient groups Nateglinide should be used with caution in patients with moderate hepatic impairment. No clinical studies have been conducted in patients with severe hepatic impairment or children and adolescents. Treatment is therefore not recommended in these patient groups.

Medicinal product no longer authorised4

6) • Severe hepatic impairment