Ripalid

/ Padagis Israel Agencies Ltd

Usually initial dose is 0.5 mg, 30 min. before each main meal, with a glass of water. Dose may be increased up to 16 mg a day according to patient needs.
Please refer to the license holder for further details.

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.  

Hypersensitivity to Active Substance or any of Its Excipients. Patients wth type 1 diabetes. Patients with diabetic ketoacidosis. Severe liver disease. Concomitant use with gemfibrozil. Pregnant or breastfeeding

General
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 metformin
Combination treatment with metformin is associated with an increased risk of hypoglycaemia.
Acute coronary syndrome
The use of repaglinide might be associated with an increased incidence of acute coronary syndrome (e.g. myocardial infarction).

Common: Hypoglycaemia, Abdominal pain, diarrhoea.
See prescribing information for full details.

In vitro data indicate that repaglinide is metabolised predominantly by CYP2C8, but also by CYP3A4. Consequently metabolism, and by that clearance of repaglinide, may be altered by substances which influence these cytochrome P-450 enzymes via inhibition or induction. Special care should be taken when inhibitors of both CYP2C8 and 3A4 are coadministered simultaneously with repaglinide.
Based on in vitro data, repaglinide appears to be a substrate for active hepatic uptake (organic anion transporting protein OATP1B1). Substances that inhibit OATP1B1 may likewise have the potential to increase plasma concentrations of repaglinide, as has been shown for ciclosporin.
The following substances may enhance and/or prolong the hypoglycaemic effect of repaglinide: Gemfibrozil, clarithromycin, itraconazole, ketokonazole, trimethoprim, ciclosporin, deferasirox, clopidogrel, other antidiabetic substances, monoamine oxidase inhibitors (MAOI), non selective beta blocking substances, angiotensin converting enzyme (ACE)-inhibitors, salicylates, NSAIDs, octreotide, alcohol, and anabolic steroids.
β-blocking medicinal products may mask the symptoms of hypoglycaemia
The following substances may reduce the hypoglycaemic effect of repaglinide: Oral contraceptives, rifampicin, barbiturates, carbamazepine, thiazides, corticosteroids, danazol, thyroid hormones and sympathomimetics. When these medications are administered to or withdrawn from a patient receiving repaglinide, the patient should be observed closely for changes in glycaemic control. When repaglinide is used together with other medicinal products that are mainly secreted by the bile, like repaglinide, any potential interaction should be considered.
See prescribing information for full details.

Pregnancy: There are no studies of repaglinide in pregnant women. Repaglinide should be avoided during pregnancy.
Lactation: There are no studies in breast-feeding women. Repaglinide should not be used in breast-feeding women.