NOVONORM TABLET 1 mg

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

TABLET

**Posology and method of administration** **Posology** Repaglinide is given preprandially and is titrated individually to optimise glycaemic control. In addition to self-monitoring by the patient of blood and/or urinary glucose, the patient’s blood glucose should 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. Periodic monitoring is necessary to detect inadequate lowering of blood glucose at the recommended maximum dose level (i.e. primary failure) and to detect loss of adequate blood glucose-lowering response after an initial period of effectiveness (i.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. The recommended starting dose is 0.5 mg. One to two weeks should elapse between titration steps (as determined by blood glucose response). If patients are transferred from another oral hypoglycaemic agent, the recommended starting dose is 1 mg. _Maintenance_ 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 trials have been conducted in patients > 75 years of age. _Renal impairment_ Repaglinide is not affected by renal disorders. 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. Patients with impaired liver function may be exposed to higher concentrations of repaglinide and its associated metabolites than would patients with normal liver function receiving usual doses. Therefore, repaglinide should not be used in patients with severe hepatic function disorder (see _Contraindications_) and should be used cautiously in patients with impaired liver function. Longer intervals between dose adjustments should be utilized to allow full assessment of response (see _Pharmacokinetic properties_– _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _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 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. The dosage of metformin should be maintained and repaglinide administered concomitantly. The starting dose of repaglinide is 0.5 mg. Titration is according to blood glucose response. _Paediatric population_ The safety and efficacy of repaglinide in children below 18 years have not been established. No data are available. **Method of administration** Doses are taken orally usually within 15 minutes of the meal but time may vary from immediately preceding the meal to as long as 30 minutes before the meal (i.e. preprandially 2, 3, or 4 meals a day). Patients who skip a meal (or add an extra meal) should be instructed to skip (or add) a dose for that meal. In the case of concomitant use, refer to sections _Special warnings and precautions for use_ and _Interaction with other medicinal products and other forms of interaction_ to assess dosage – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.