GLUCIENT XR EXTENDED-RELEASE TABLET 750MG [SIN16095P]

Product Info

GLUCIENT XR EXTENDED-RELEASE TABLET 750MG

[SIN16095P]

Indications:
Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycemic control. GLUCIENT XR may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

Recommended Dosage:
Adult with normal renal function (GFR ≥90 ml/minute)

Reduction in the risk or delay of the onset of type 2 diabetes

• Metformin should only be considered where intensive lifestyle modifications are not feasible.

• The therapy should be initiated with one tablet GLUCIENT XR 500 mg once daily with the evening meal.

• After 10 to 15 days dose adjustment on the basis of blood glucose measurements is recommended. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose is 2000 mg once daily with the evening meal.

• It is recommended to regularly monitor (every 3–6 months) the glycemic status (OGTT and/or FPG and/or HbA1c value) as well as the risk factors to evaluate whether treatment needs to be continued, modified or discontinued.

• A decision to reevaluate therapy is also required if the patient subsequently implements improvements to diet and/or exercise, or if changes to the medical condition will allow increased lifestyle interventions to be possible.

Monotherapy and combination with other oral antidiabetic agents in type 2 diabetes mellitus:
GLUCIENT XR 500

• The usual starting dose of GLUCIENT XR 500 is one tablet once daily with the evening meal.

• GLUCIENT XR must be swallowed whole and never crushed or chewed.

• After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements.

• To improve gastrointestinal tolerability, dosage increase is recommended in increments of 500 mg every 10 to 15 days, up to 2000 mg once daily with the evening meal. If glycemic control is not achieved on GLUCIENT XR 2000 mg once daily, GLUCIENT XR 1000 mg twice daily should be considered, with both doses being given with food. If glycemic control is still not achieved, patients may be switched to standard metformin tablets to a maximum dose of 3000 mg daily.

• In patients already treated with metformin tablets, the starting dose of GLUCIENT XR should be equivalent to the daily dose of metformin immediate-release tablets. In patients treated with metformin at a dose above 2000 mg daily, switching to GLUCIENT XR is not recommended.

GLUCIENT XR 750

• GLUCIENT XR 750 is intended for patients who are already treated with metformin tablets (extended- or immediate-release). The dose of GLUCIENT XR 750 should be equivalent to the daily dose of metformin tablets (extended- or immediate-release), up to a maximum dose of 1500 mg given with the evening meal.

• After 10 to 15 days dose adjustment on the basis of blood glucose measurements is recommended. A slow increase of dose may improve gastrointestinal tolerability. The recommended dose of GLUCIENT XR 750 is 2 tablets once daily. If glycemic control is not achieved on GLUCIENT XR 1500 mg once daily, the dose may be increased to a maximum dose of 2000 mg once daily. If glycemic control is not achieved on GLUCIENT XR 2000 mg once daily, GLUCIENT XR 1000 mg twice daily should be considered, with both doses being given with food. If glycemic control is still not achieved, patients may be switched to standard metformin tablets to a maximum dose of 3000 mg daily.

GLUCIENT XR 1000

• GLUCIENT XR 1000 is intended as a maintenance therapy for patients treated with either 1000 mg or 2000 mg of metformin hydrochloride. On switch, the daily dose of GLUCIENT XR should be equivalent to the current daily dose of metformin hydrochloride.

• GLUCIENT XR 1000 should be taken once daily with the evening meal at a maximum recommended dose of 2 tablets per day. If glycemic control is not achieved on GLUCIENT XR 2000 mg once daily, GLUCIENT XR 1000 mg twice daily should be considered, with both doses being given with food. If glycemic control is still not achieved, patients may be switched to standard metformin tablets to a maximum dose of 3000 mg daily.

Combining GLUCIENT XR dosage strengths
The combined use of different strengths of GLUCIENT XR 500, GLUCIENT XR 750 or GLUCIENT XR 1000 is not recommended. Only one strength (GLUCIENT XR 500, GLUCIENT XR 750 or GLUCIENT XR 1000) should be used at a time in order to avoid accidentally exceeding the recommended upper daily dose limit of 2000 mg.

Transfer from another oral antidiabetic agent
If transfer from another oral antidiabetic agent is intended, discontinue the other agent and initiate GLUCIENT XR 500 at the dose indicated above, before switching to GLUCIENT XR 750 or GLUCIENT XR 1000.

Combination with insulin
Metformin and insulin may be used in combination therapy to achieve better blood glucose control. The usual starting dose of GLUCIENT XR is 500 mg once daily, while insulin dosage is adjusted on the basis of blood glucose measurements.

Elderly
Due to the potential for decreased renal function in elderly patients, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Benefit in the reduction of risk or delay of the onset of type 2 diabetes mellitus has not been established in patients 75 years and older and metformin initiation is therefore not recommended in these patients (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patient with renal impairment
A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. In patients at an increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3–6 months.

Pediatric population
In the absence of available data, GLUCIENT XR should not be used in children.

Contraindications:

• Hypersensitivity to metformin hydrochloride or to any of the excipients.

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

• Diabetic precoma.

• Severe renal failure (GFR <30 ml/minute).

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

• Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock.

• Hepatic insufficiency, acute alcohol intoxication, alcoholism.