Glucophage/Glucophage Forte/Glucophage XR

Glucophage/Glucophage Forte/Glucophage XR Special Precautions

metformin

Manufacturer:

Merck

Distributor:

Zuellig
Full Prescribing Info
Special Precautions
Glucophage 500 mg/Glucophage Forte: Renal function: As metformin is excreted by the kidney, it is recommended that creatinine clearance or GFR be determined before initiating treatment and regularly thereafter: at least annually in patients with normal renal function; at least every 3 to 6 months in patients with CrCl between 45 and 59 mL/min or eGFR between 45 and 59 mL/min/1.73m2 and in elderly subjects; at least every 3 months in patients with CrCl between 30 and 44 mL/min or eGFR between 30 and 44 mL/min/1.73m2.
In case creatinine clearance or eGFR is <30 mL/min/1.73m2 respectively, metformin is contraindicated (see Contraindications).
Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution is recommended in situations where renal function may become acutely impaired, for example due to dehydration (severe or prolonged diarrhea or vomiting), or when initiating drugs which can acutely impair renal function (such as antihypertensives, diuretics and NSAIDs). In the acute conditions listed, metformin must be immediately and temporarily discontinued. In these cases, it is also recommended to check renal function before initiating treatment with metformin.
Cardiac function: Patients with heart failure are more at risk of hypoxia and renal insufficiency. In patients with stable chronic heart failure, metformin may be used with a regular monitoring of cardiac and renal function.
For patients with acute and unstable heart failure, metformin is contraindicated (see Contraindications).
Children from 10 years of age and adolescents: The diagnosis of type 2 diabetes mellitus must be confirmed before treatment with metformin is initiated.
No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially pre-pubescent children, is recommended.
Only 15 subjects aged between 10 and 12 years were included in the controlled clinical studies conducted in children and adolescents. Although metformin efficacy and safety in children below 12 did not differ from efficacy and safety in older children, particular caution is recommended when prescribing to children aged between 10 and 12 years.
Other precautions: It is recommended that all patients continue their diet with a regular distribution of carbohydrate intake during the day and that overweight patients continue their energy-restricted diet.
It is recommended that the usual laboratory tests for diabetes monitoring be performed regularly.
Metformin alone never causes hypoglycemia, although caution is advised when it is used in combination with insulin, sulphonylureas or meglitinides.
Glucophage 1 gram: Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter: at least annually in patients with normal renal function, at least every 3 to 6 months in patients with CrCl between 45 and 59 mL/min or eGFR between 45 and 59 mL/min/1.73m2 and in elderly subjects, at least every 3 months in patients with CrCl between 30 and 44 mL/min or eGFR between 30 and 44 mL/min/1.73m2. In case CrCl is below 30 mL/min or eGFR is below 30 mL/min/1.73m2 respectively, metformin is contraindicated (see Contraindications).
Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become acutely impaired, for example due to dehydration (severe or prolonged diarrhea or vomiting), or when initiating drugs which can acutely impair renal function (such as antihypertensive therapy or diuretic therapy and NSAIDs). In the acute conditions listed, metformin must be immediately and temporarily discontinued. In these cases, it is also recommended to check renal function before initiating treatment with metformin.
Children from 10 years of age and adolescents: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated.
No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially pre-pubescent children, is recommended.
Only 15 subjects aged between 10 and 12 years were included in the controlled clinical studies conducted in children and adolescents. Although metformin efficacy and safety in children below 12 did not differ from efficacy and safety in older children, particular caution is recommended when prescribing to children aged between 10 and 12 years.
Other precautions: It is recommended that all patients should continue their diet with a regular distribution of carbohydrate intake during the day and that overweight patients should continue their energy-restricted diet.
It is recommended that the usual laboratory tests for diabetes monitoring should be performed regularly.
Metformin alone does not cause hypoglycemia, but caution is advised when it is used in combination with insulin or other oral antidiabetics (e.g. sulfonylureas or meglitinides).
Glucophage XR: Renal function: As metformin is excreted mainly by the kidney, it is recommended that CrCl (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) or eGFR should be determined before initiating treatment and regularly thereafter: At least annually in patients with normal renal function, at least every 3 to 6 months in patients with CrCl between 45 and 59 mL/min or eGFR between 45 and 59 mL/min/1.73m2 and in elderly subjects, at least every 3 months in patients with CrCl between 30 and 44 mL/min or eGFR between 30 and 44 mL/min/1.73m2. In case CrCl is below 30 mL/min or eGFR is below 30 mL/min/1.73m2 respectively, metformin is contraindicated (see Contraindications).
Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become acutely impaired, for example due to dehydration (severe or prolonged diarrhea or vomiting), or when initiating drugs which can acutely impair renal function (such as antihypertensives, and NSAIDs). In the acute conditions listed, metformin must be immediately and temporarily discontinued. In these cases, it is also recommended to check renal function before initiating treatment with metformin.
Cardiac function: Patients with heart failure are more at risk of hypoxia and renal insufficiency. In patients with stable chronic heart failure, metformin may be used with a regular monitoring of cardiac and renal function.
For patients with acute and unstable heart failure, metformin is contraindicated (see Contraindications).
Other Precautions: It is recommended that all patients should continue their diet with a regular distribution of carbohydrate intake during the day and that overweight patients continue their energy-restricted diet.
It is recommended that the usual laboratory tests for diabetes monitoring should be performed regularly.
Metformin alone never causes hypoglycemia, although caution is advised when it is used in combinations with sulphonylureas or meglitinides.
Effect on the ability to drive and to use machines: Metformin monotherapy does not cause hypoglycemia and therefore has no effect on the ability to drive or to use machines. However, patients should be alerted to the risk of hypoglycemia when metformin is used in combination with other antidiabetic agents (sulfonylureas, insulin, glinides or other hypoglycemic agents). It is important to be aware of the onset of hypoglycemia. Symptoms of hypoglycemia include weakness, dizziness, increased sweating, fast heartbeat, vision disorders or difficulty in concentration. When a patient starts to feel these symptoms, he should not drive or use machines.
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