NovoNorm

Posology Repaglinide is given preprandially and is titrated individually to optimise glycaemic control. In addition to the usual self-monitoring by the patient of blood and/or urinary glucose, the patient’s blood glucose must be monitored periodically by the physician to determine the minimum effective dose for the patient.

Glycosylated haemoglobin levels are also of value in monitoring the patient’s response to therapy. e. e. secondary failure). Short-term administration of repaglinide may be sufficient during periods of transient loss of control in type 2 diabetic patients usually controlled well on diet.

Initial dose The dosage should be determined by the physician, according to the patient’s requirements. 5 mg. One to two weeks should elapse between titration steps (as determined by blood glucose response). If patients are transferred from another oral hypoglycaemic medicinal product, the recommended starting dose is 1 mg.

Maintenance 3 The recommended maximum single dose is 4 mg taken with main meals. The total maximum daily dose should not exceed 16 mg. Special populations Elderly No clinical studies have been conducted in patients >75 years of age. 2).

Eight percent of one dose of repaglinide is excreted through the kidneys and total plasma clearance of the product is decreased in patients with renal impairment. As insulin sensitivity is increased in diabetic patients with renal impairment, caution is advised when titrating these patients.

Hepatic impairment No clinical studies have been conducted in patients with hepatic insufficiency. Debilitated or malnourished patients In debilitated or malnourished patients the initial and maintenance dosage should be conservative and careful dose titration is required to avoid hypoglycaemic reactions.

Patients receiving other oral hypoglycaemic medicinal products Patients can be transferred directly from other oral hypoglycaemic medicinal products to repaglinide. However, no exact dosage relationship exists between repaglinide and the other oral hypoglycaemic medicinal products.

The recommended maximum starting dose of patients transferred to repaglinide is 1 mg given before main meals. Repaglinide can be given in combination with metformin, when the blood glucose is insufficiently controlled with metformin alone.

e. hypoglycaemia. The occurrence of such reactions depends on individual factors, such as dietary habits, dosage, exercise and stress. Tabulated list of adverse reactions Based on the experience with repaglinide and with other hypoglycaemic medicinal products the following adverse reactions have been seen: Frequencies are defined as: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).

g. anaphylactic reaction), or immunological reactions such as vasculitis. Refraction disorders Changes in blood glucose levels have been known to result in transient visual disturbances, especially at the commencement of treatment. Such disturbances have only been reported in very few cases after initiation of repaglinide treatment.

No such cases have led to discontinuation of repaglinide treatment in clinical trials. Abnormal hepatic function, increased liver enzymes Isolated cases of increased liver enzymes have been reported during treatment with repaglinide.

Most cases were mild and transient, and very few patients discontinued treatment due to increased liver enzymes. In very rare cases, severe hepatic dysfunction has been reported. Hypersensitivity Hypersensitivity reactions of the skin may occur as erythema, itching, rashes and urticaria.

There is no reason to suspect cross-allergenicity with sulphonylurea due to the difference in chemical structure. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

4 General Repaglinide should only be prescribed if poor blood glucose control and symptoms of diabetes persist despite adequate attempts at dieting, exercise and weight reduction. When a patient stabilised on any oral hypoglycaemic medicinal product 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 repaglinide and treat with insulin on a temporary basis. Hypoglycaemia Repaglinide, like other insulin secretagogues, is capable of producing hypoglycaemia. Combination with insulin secretagogues The blood glucose-lowering effect of oral hypoglycaemic medicinal products decreases in many patients over time.

This may be due to progression of the severity of the diabetes or to diminished responsiveness to the medicinal product. This phenomenon is known as secondary failure, to distinguish it from primary failure, where the medicinal product is ineffective in an individual patient when first given.

Adjustment of dose and adherence to diet and exercise should be assessed before classifying a patient as a secondary failure. Repaglinide acts through a distinct binding site with a short action on the β-cells. Use of repaglinide in case of secondary failure to insulin secretagogues has not been investigated in clinical trials.

Trials investigating the combination with other insulin secretagogues have not been performed. Combination with Neutral Protamine Hagedorn (NPH) insulin or thiazolidinediones Trials of combination therapy with NPH insulin or thiazolidinediones have been performed.

However, the benefit risk profile remains to be established when comparing to other combination therapies. Combination with metformin Combination treatment with metformin is associated with an increased risk of hypoglycaemia. g. 1. 5).

If concomitant use is necessary, careful monitoring of blood glucose and close clinical monitoring should be performed.

1. • Diabetes mellitus type 1, C-peptide negative. • Diabetic ketoacidosis, with or without coma. • Severe hepatic function disorder. 5).