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The physician's instructions as to dosage and diet should be strictly observed. The patient should not discontinue treatment without consulting the physician.
Initial therapy: Treatment with Gliquidone (GLURENORM) is usually initiated with ½ tablet (15 mg) at breakfast. If this proves inadequate, the dose should be gradually increased, upon the physician's instruction. It should be noted that total daily doses over 4 tablets (120 mg) do not usually produce further improvement in control.
GLURENORM tablets should be taken at the beginning of the meal. After intake of the GLURENORM tablet, the meal should not be skipped.
If treatment with ½ a tablet at breakfast proves inadequate, the dose should be gradually increased, upon the physician's instructions. When not more than two tablets (60 mg) are prescribed, the daily dose of GLURENORM may be taken as a single dose at breakfast.
When higher daily doses are required, better control can be achieved, however, with a twice or three-time daily dosage. In that case, the highest dosage should be taken at breakfast. Total daily doses over 4 tablets (120 mg) do not usually produce further improvement in glycaemic control. Therefore, the maximum recommended daily dose is 4 tablets (120 mg).
Dosing in patients with renal impairment: Based on pharmacokinetic data only about 5% of the metabolites of administered GLURENORM is excreted via the kidneys. In a clinical study with diabetic patients suffering from stage 1 to 4 of renal impairment - compared to those without renal impairment - a daily GLURENORM dose of 40 - 50 mg on average had very similar effects on blood glucose profiles, no accumulation or hypoglycaemic symptoms were observed. Thus, no dose adjustment in patients with renal impairment is required.
Dosing in patients with hepatic impairment: Daily GLURENORM doses higher than 75 mg require careful medical control. Since 95% of administered GLURENORM is metabolized by the liver and excreted by the biliary system, GLURENORM should not be given in patients with moderate and severe hepatic impairment (see Contraindications).
In two clinical studies with diabetic patients suffering from different grades of liver impairment (including active liver cirrhosis with portal hypertension) GLURENORM did not cause further deterioration of liver function, the number of side effects was low and no marked hypoglycaemic reactions were observed.
Paediatric and adolescents population: GLURENORM is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Transfer: (From other oral antidiabetic agents with similar mode of action).
The patient's current state of diabetic control will determine the initial dosage. When changing over from other antidiabetic agents it should be noted that the effect of 1 Gliquidone (GLURENORM) tablet (30 mg) is approximately equivalent to 1000 mg tolbutamide.
The initial dose is usually ½ to 1 tablet. The dosage should be increased only on medical advice.
When not more than two tablets (60 mg) are prescribed, the daily dose of GLURENORM may be taken as a single dose at breakfast.
Better control can be achieved, however, with a twice or three times daily dossage.
Gliquidone (GLURENORM) tablets should be taken at the beginning of the meal.
