Glucovance Dosage/Direction for Use

FOR USE IN ADULTS ONLY.
Initial treatment: As first-line therapy: The initial dose is one tablet of metformin + glibenclamide (Glucovance) 250 mg/1.25 mg once a day. One tablet of metformin + glibenclamide (Glucovance) 250 mg/1.25 mg twice a day may be used if HbA1c > 9% or FPG > 2 g/L.
Metformin + glibenclamide (Glucovance) 500 mg/5 mg and metformin + glibenclamide (Glucovance) 1 gram/5 mg must not be used as initial therapy due to an increased risk of hypoglycemia.
As second-line therapy: The initial dose is one tablet of metformin + glibenclamide (Glucovance) 500 mg/2.5 mg or metformin + glibenclamide (Glucovance) 500 mg/5 mg once a day. In order to avoid hypoglycemia, the initial dose must not exceed the daily doses of glibenclamide (or equivalent dose of another sulfonylurea) or metformin already being taken.
As replacement for previous combination therapy with metformin and a sulfonylurea: The recommended initial dose must not exceed the daily dose of glibenclamide (or equivalent dose of another sulfonylurea) and metformin already being taken.
Titration: A gradual increase in the dosage may aid gastrointestinal tolerance and prevent the onset of hypoglycemia.
As first-line therapy: Dosage increase is recommended in increments of one tablet of metformin + glibenclamide (Glucovance) 250 mg/1.25 mg per day every 2 weeks or longer according to glycemia results up to the minimum effective dose to achieve adequate control of blood glucose.
As second-line therapy: Dosage increase is recommended in increments of no more than metformin + glibenclamide (Glucovance) 500 mg/5 mg per day every 2 weeks or longer according to glycemia results up to the minimum effective dose to achieve adequate control of blood glucose.
As replacement for previous combination therapy with metformin and a sulfonylurea: Dosage increase is recommended in increments of no more than metformin + glibenclamide (Glucovance) 500 mg/5 mg per day every 2 weeks or longer according to glycemia results up to the minimum effective dose to achieve adequate control of blood glucose. Patients must be monitored closely for signs and symptoms of hypoglycemia.
Maximum Dose: The maximum recommended dose is 2000 mg metformin hydrochloride/20 mg glibenclamide per day.
Elderly: Patients aged 65 years and older: Starting and maintenance doses of glibenclamide must be carefully adjusted to reduce the risk of hypoglycemia. Treatment should be started with the lowest available dose and increased gradually if necessary. It is recommended that these patients are not titrated to the maximum dose of metformin + glibenclamide (Glucovance) to avoid the risk of hypoglycemia. Regular assessment of renal function is necessary (see Precautions).
Debilitated and malnourished patients: It is recommended that these patients are not titrated to the maximum dose of metformin + glibenclamide (Glucovance) to avoid the risk of hypoglycemia.
Children: Neither safety nor efficacy has been established in children.
Patients with renal impairment: Metformin + glibenclamide (Glucovance) may be used in patients with moderate renal impairment, stage 3 (creatinine clearance [CrCl] between 30 and 59 mL/min or estimated glomerular filtration rate [eGFR] between 30 and 59 mL/min/1.73m²) only in the absence of other conditions that may increase the risk of lactic acidosis and with the following dose adjustments: Patients with CrCl between 30 and 59 mL/min or eGFR between 45 and 59 mL/min/1.73 m²: The maximum dose of metformin is 1000 mg daily. The renal function should be closely monitored every 3 - 6 months.
Patients with CrCl between 30 and 59 mL/min or eGFR between 30 and 44 mL/min/1.73m²: It is not recommended to initiate metformin + glibenclamide (Glucovance) but metformin + glibenclamide (Glucovance) can be maintained in patients already treated, provided that the maximum daily dose of metformin is not higher than 1000 mg. The renal function should be closely monitored every 3 months.
If CrCl or eGFR fall below 30 mL/min or below 30 mL/min/1.73m² respectively, metformin + glibenclamide (Glucovance) must be discontinued immediately.
Use with insulin: No clinical data are available on the concomitant use of metformin + glibenclamide (Glucovance) with insulin therapy.
Administration: The tablets should be taken with meals: Once a day, in the morning (breakfast) if the dosage is one tablet per day.
Twice a day, in the morning (breakfast) and evening (dinner) if the dosage is two or four tablets per day.
Three times a day, in the morning (breakfast), noon (lunch) and evening (dinner), if the dosage is three, five or six tablets per day.
The dosage regimen should be adjusted according to the individual eating habits. However, any intake must be followed by a meal with a sufficiently high carbohydrate content to prevent hypoglycemia. Patients should avoid alcohol when taking metformin + glibenclamide (Glucovance).
When metformin + glibenclamide (Glucovance) is co-administered with colesevelam, it is recommended that metformin + glibenclamide (Glucovance) should be administered at least 4 hours prior to colesevelam in order to minimize the risk of reduced absorption.
Missed dose: Patients must not take a double dose to make up for a forgotten dose. The next dose should be taken at the usual time.