REPAGLINIDE MEVON TABLETS 0.5 MG

PHARMATHEN S.A. (GREECE)🇸🇬 Health Sciences Authority

Approval Date: Nov 12, 2021
Approval ID: 250cffa41656c244
Company: PHARMATHEN S.A. (GREECE)
Type: Therapeutic

Approval Details

Approval Id: 250cffa41656c244
Drug Name: REPAGLINIDE MEVON TABLETS 0.5 MG
Product Name: REPAGLINIDE MEVON TABLETS 0.5 MG
Approval Number: SIN16376P
Approval Date: 2021-11-12
Registrant: NOVEM PHARMA PRIVATE LIMITED
Licence Holder: NOVEM PHARMA PRIVATE LIMITED
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET
Dosage: 4.2 Posology and method of administration 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. 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 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 >75 years of age. Renal impairment Repaglinide is primarily excreted via the bile and excretion is therefore 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 or 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 4.3 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 5.2 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 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. Paediatric population The safety and efficacy of repaglinide in children below 18 years have not been established. No data are available. Method of administration Repaglinide should be taken before main meals (i.e. preprandially). Doses are usually taken 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 with other active substances refer to sections 4.4 and 4.5 to assess the dosage – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Route Of Administration: ORAL
Indication Info: 4.1 Therapeutic 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.
Contraindications: 4.3 Contraindications <ul> <li>Hypersensitivity to repaglinide or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.</li> <li>Diabetes mellitus type 1, C-peptide negative</li> <li>Diabetic ketoacidosis, with or without coma</li> <li>Severe hepatic function disorder</li> <li>Concomitant use of gemfibrozil (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> </ul>
Atc Code: A10BX02
Atc Item Name: repaglinide
Pharma Manufacturer Name: NOVEM PHARMA PRIVATE LIMITED

Active Ingredients

Repaglinide

0.50 mg

Repaglinide

0.50 mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Nov 12, 2021

Approval ID

250cffa41656c244

Type

Therapeutic

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