GLUCOVANCE TABLET 500 MG/5 MG [SIN12322P]

Product Info

GLUCOVANCE TABLET 500 MG/5 MG

[SIN12322P]

INDICATIONS AND USAGE
GLUCOVANCE 250 mg/1.25 mg is indicated as initial therapy, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone.
GLUCOVANCE 500 mg/2.5 mg, 500 mg/5 mg and 1000/5mg is indicated as second-line therapy when diet, exercise, and initial treatment with a sulfonylurea or metformin do not result in adequate glycemic control in patients with type 2 diabetes.

DOSAGE AND ADMINISTRATION
General Considerations
Oral route. For use in adults only.
Dosage of GLUCOVANCE must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of 2000 mg metformin/20 mg glibenclamide. The tablets should be taken with meals. Any intake must be followed by a meal with a sufficiently high carbohydrate content to prevent the onset of hypoglycaemic episodes.

With initial treatment and during dose titration, appropriate blood glucose monitoring should be used to determine the therapeutic response GLUCOVANCE and to identify the minimum effective dose for the patient. Thereafter, HbA_1c should be measured at intervals of approximately 3 months to assess the effectiveness of therapy.

GLUCOVANCE as Initial Therapy
The starting dose of GLUCOVANCE is 250 mg/1.25 mg once a day with a meal. In patients with baseline HbA_1c > 9% or an FPG > 200 mg/dl, a starting dose of GLUCOVANCE 250 mg/1.25 mg twice daily with the morning and evening meals may be used. Dosage increases should be made in increments of 250 mg/1.25 mg per day every two weeks up to the minimum effective dose necessary to achieve adequate control of blood glucose.

GLUCOVANCE 500 mg/5 mg and Glucovance 1000mg/5mg should not be used as initial therapy due to an increased risk of hypoglycemia.

GLUCOVANCE Use in Previously Treated Patients (Second-Line Therapy)
The starting dose of GLUCOVANCE is 500 mg/2.5 mg or 500 mg/5 mg twice daily with the morning and evening meals. In order to avoid hypoglycemia, the starting dose of GLUCOVANCE should not exceed the daily doses of glibenclamide or metformin already being taken. The daily dose should be titrated in increments of no more than 500 mg/5 mg up to the minimum effective dose to achieve adequate control of blood glucose or to a maximum dose of 2000 mg/20 mg per day.

For patients previously treated with combination therapy of glibenclamide (or another sulfonylurea) plus metformin, if switched to GLUCOVANCE, the starting dose should not exceed the daily dose of glibenclamide (or equivalent dose of another sulfonylurea) and metformin already being taken. Patients should be monitored closely for signs and symptoms of hypoglycemia following such a switch and the dose of GLUCOVANCE should be titrated as described above to achieve adequate control of blood glucose.

For patients already treated with Glucovance, two tablets of Glucovance 500 mg/2.5 mg can be replaced by one tablet of Glucovance 1000 mg/5 mg.

When GLUCOVANCE is co-administered with a colesevelam, it is recommended that GLUCOVANCE should be administered at least 4 hours prior to the bile acid sequestrant in order to minimize the risk of reduced absorption (see ‘Drug Interactions’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Specific Patient Populations
GLUCOVANCE is not recommended for use during pregnancy or for use in children.

Elderly patients:
GLUCOVANCE should not be used in patients with advanced age.
The initial and maintenance dosing of GLUCOVANCE should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment requires a careful assessment of renal function. (See WARNINGS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.)

CONTRAINDICATIONS

• Known hypersensitivity to metformin hydrochloride, glibenclamide or other sulphonylurea and sulphonamide or to any of the excipients

• Type I diabetes (insulin-dependent diabetes), diabetic pre-coma

• Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)

• Renal disease or renal dysfunction (creatinine clearance < 60 mL/min) which may also result from conditions such as dehydration, severe infection and cardiovascular collapse (shock)

• Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock

• Acute or chronic diseases which may cause tissue hypoxia such as cardiac or respiratory failure, recent myocardial infarction, shock

• Hepatic insufficiency, acute alcohol intoxication, alcoholism

• Porphyria

• Lactation

• In association with miconazole

GLUCOVANCE must be discontinued 48 hours prior to elective major surgical interventions and may not be reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal.