Glucophage/Glucophage XR Dosage/Direction for Use

Glucophage: Oral route.
Adults with normal renal function (GFR ≥ 90mL/min): Monotherapy and combination with other oral antidiabetic agents: The usual starting dose is one tablet of Glucophage 500 mg or 850 mg 2 or 3 times daily, given during or after meals.
After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability.
In patients receiving a high metformin dose (2 to 3 grams per day), it is possible to replace two Glucophage 500 mg, film-coated tablets with one Glucophage 1000 mg, film-coated tablet.
The maximum recommended dose of metformin is 3 g daily, taken as 3 divided doses.
If transfer from another oral antidiabetic agent is intended: discontinue the other agent and initiate metformin at the dose indicated previously.
Combination with insulin: Metformin and insulin may be used in combination therapy to achieve better blood glucose control. Metformin is given at the usual starting dose of one tablet of Glucophage 500 mg or 850 mg, film-coated tablet, 2-3 times daily, while insulin dosage is adjusted on the basis of blood glucose measurements.
Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary (see Precautions).
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. (See Table 2.)

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Paediatric population: Monotherapy and combination with insulin: Glucophage film-coated tablets can be used in children from 10 years of age and adolescents.
The usual starting dose is one tablet of 500mg twice daily, given during meals or after meals.
After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose of metformin is 2 g daily, taken as 2 or 3 divided doses.
Glucophage XR: Adults with normal renal function (GFR ≥ 90 mL/min): 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 Glucophage 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 gastro-intestinal 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 glycaemic 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 re-evaluate 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: Glucophage XR 500 mg: The usual starting dose of Glucophage XR 500 mg is one tablet once daily with the evening meal.
Glucophage XR tablets 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 glycaemic control is not achieved on Glucophage XR 2000 mg once daily, Glucophage XR 1000 mg twice daily should be considered, with both doses being given with food. If glycaemic 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 Glucophage 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 Glucophage XR is not recommended.
Glucophage XR 750 mg: Glucophage XR 750 mg is intended for patients who are already treated with metformin tablets (extended or immediate release). The dose of Glucophage XR 750 mg 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 Glucophage XR 750mg is 2 tablets once daily. If glycaemic control is not achieved on Glucophage XR 1500 mg once daily, the dose may be increased to a maximum dose of 2000 mg once daily. If glycaemic control is not achieved on Glucophage XR 2000 mg once daily, Glucophage XR 1000 mg twice daily should be considered, with both doses being given with food. If glycaemic control is still not achieved, patients may be switched to standard metformin tablets to a maximum dose of 3000 mg daily.
Glucophage XR 1000 mg: Glucophage XR 1000 mg 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 Glucophage XR should be equivalent to the current daily dose of metformin hydrochloride.
Glucophage XR 1000 mg should be taken once daily with the evening meal at a maximum recommended dose of 2 tablets per day. If glycaemic control is not achieved on Glucophage XR 2000 mg once daily, Glucophage XR 1000 mg twice daily should be considered, with both doses being given with food. If glycaemic control is still not achieved, patients may be switched to standard metformin tablets to a maximum dose of 3000 mg daily.
Combining Glucophage XR dosage strengths: The combined use of different strengths of Glucophage XR 500, Glucophage XR 750 or Glucophage XR 1000 is not recommended. Only one strength (Glucophage XR 500, Glucophage XR 750 or Glucophage XR 1000) should be used at a time in order to avoid accidentally exceeding the recommended upper daily dose limit of 2000mg.
Transfer from another oral antidiabetic agent: If transfer from another oral antidiabetic agent is intended, discontinue the other agent and initiate Glucophage XR 500 mg at the dose indicated previously, before switching to Glucophage XR 750mg or Glucophage XR 1000 mg.
Combination with insulin: Metformin and insulin may be used in combination therapy to achieve better blood glucose control. The usual starting dose of Glucophage XR is 500mg 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 subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary (see Precautions).
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 (see Pharmacology: Pharmacodynamics under Actions) and metformin initiation is therefore not recommended in these patients (see Precautions).
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. (See Table 3.)

Click on icon to see table/diagram/image

Paediatric population: In the absence of available data, Glucophage XR should not be used in children.