Pranstad 1

Rx

Indications

• Repaglinide is indicated in adults with type 2 diabetes mellitus whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.
• Repaglinide is also indicated in combination with metformin in adults with type 2 diabetes mellitus who are not satisfactorily controlled on metformin alone.
• Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.

Dosage

• Repaglinide is given preprandially and is titrated individually to optimise glycaemic control.
  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 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 medicinal product, 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 studies have been conducted in patients above 75 years of age.
• Renal impairment: Repaglinide is not affected by renal disorders. Caution is advised when titrating these patients.
• No clinical studies have been conducted in patients with hepatic insufficiency.
• 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. In this case, the dosage of metformin should be maintained and repaglinide administered concomitantly. The starting dose of repaglinide is 0.5 mg, taken before main meals; titration is according to blood glucose response as for monotherapy.
• The safety and efficacy of repaglinide in children below 18 years have not been established.

Usage

• Pranstad 1 is administered orally, given within 15 minutes of each meal but may be given as early as 30 minutes prior to each meal up to immediately preceding each meal.

• Hypersensitivity to repaglinide or to any of the excipients.
• Diabetes mellitus type 1, C-peptide negative.
• Diabetic ketoacidosis, with or without coma.
• Severe hepatic function disorder.
• Concomitant use of gemfibrozil.

Common

• Hypoglycaemia,
• Abdominal pain, diarrhoea.

• 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.
• Repaglinide is capable of producing hypoglycaemia.
• Combination treatment with metformin is associated with an increased risk of hypoglycaemia.
• The use of repaglinide might be associated with an increased incidence of acute coronary syndrome (e.g. myocardial infarction).
• Repaglinide should be used with caution or be avoided in patients receiving medicinal products which influence repaglinide metabolism. If concomitant use is necessary, careful monitoring of blood glucose and close clinical monitoring should be performed.
• Repaglinide should be avoided during pregnancy and in breast-feeding women.
• Patients should be advised to take precautions to avoid hypoglycemia whilst driving. This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycemia or have frequent episodes of hypoglycemia. The advisability of driving should be considered in these circumstances.