Glucophage/Glucophage Forte/Glucophage XR

Glucophage/Glucophage Forte/Glucophage XR Dosage/Direction for Use

metformin

Manufacturer:

Merck

Distributor:

Zuellig
Full Prescribing Info
Dosage/Direction for Use
Glucophage/Glucophage Forte: Unless otherwise prescribed, the dosage and administration is as follows: Adults: Monotherapy or in combination with other oral antidiabetic agents: The usual starting dose is one tablet of metformin (Glucophage) 500 mg or one tablet of metformin (Glucophage Forte) 850 mg, 2 or 3 times daily given during or after meals. Metformin (Glucophage) must be taken daily without interruption, except if specifically indicated by the doctor. If the patient has forgotten to take metformin (Glucophage), the next dose should be taken at the usual time. Do not double the dose of metformin (Glucophage). If the patient has taken more metformin (Glucophage) tablets than indicated, the doctor or pharmacist must be consulted immediately.
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.
In patients receiving a high metformin dose (2 to 3 grams per day), it is possible to replace two metformin (Glucophage) 500 mg tablets with one metformin (Glucophage) 1 gram tablet.
The maximum recommended dose of metformin hydrochloride is 3 grams daily, taken as 3 divided doses.
If transfer from another oral antidiabetic is intended, discontinue the other agent and initiate metformin at the dose indicated previously.
Monotherapy in the indication prediabetes: The usual dose is 1000 to 1700 mg metformin hydrochloride per day divided in two doses given during or after meals. It is recommended to regularly monitor the glycemic status as well as the risk factors to evaluate whether treatment is still needed.
Combination with insulin: Metformin and insulin may be used in combination therapy to achieve better blood glucose control. Unless otherwise prescribed, metformin is given at the usual starting dose of one tablet of metformin (Glucophage) 500 mg or metformin (Glucophage Forte) 850 mg 2 or 3 times daily, while insulin dosage is adjusted on the basis of blood glucose measurements.
Children from 10 years of age and adolescents: Monotherapy or in combination with insulin: Metformin (Glucophage) can be used in children from 10 years of age and adolescents as monotherapy or in combination with insulin.
The usual starting dose is one tablet of metformin (Glucophage) 500 mg or one tablet of metformin (Glucophage Forte) 850 mg once daily, given during or after meals.
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 of metformin hydrochloride is 2 grams daily, taken as 2 or 3 divided doses.
Patients with renal impairment: Metformin 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 (see Contraindications) and with the following dose adjustments: The starting dose is 500mg or 850mg metformin hydrochloride daily. The maximum daily dose is 1000mg. The renal function should be closely monitored: Every 3-6 months in patients with CrCl between 45 and 59 mL/min or eGFR between 45 and 59 mL/min/1.73 m2; Every 3 months in patients with CrCl between 30 and 44 mL/min or eGFR between 30 and 44 mL/min/1.73 m2.
If CrCl or eGFR fall below 30 mL/min or 30 mL/min/1.73m2 respectively, metformin must be discontinued immediately.
Elderly: Due to the potential for decreased renal function in elderly subjects, it is recommended that the metformin dosage be adjusted based on renal function. Regular assessment of renal function is necessary (see Precautions).
Combination with iodinated contrast materials: Iodinated contrast materials may be administered intravenously in metformin-treated patients with creatinine clearance equal or greater than 45 mL/min or eGFR equal or greater than 45 mL/min/1.73 m2 without discontinuation of metformin before the test (see Contraindications).
Patients receiving intravenous iodinated contrast materials with a CrCl below 45 mL/min or eGFR <45 mL/min/1.73 m2 or receiving intra-arterial iodinated contrast materials with a CrCl below 60 mL/min or eGFR of <60 mL/min/1.73 m2 should stop taking metformin 48 hours before the test. Renal function should be re-assessed 48 hours after contrast material administration and metformin should only be restarted if it has not deteriorated further.
Glucophage XR: The dosage of metformin (Glucophage XR) is determined by the doctor on an individual basis according to the results of laboratory blood glucose measurement. The tablets are swallowed whole, without chewing and must be taken daily without interruption with the evening meal (once daily dosage). Metformin (Glucophage XR) should always be taken with food. This will avoid the patient having gastrointestinal discomfort (see Adverse Reactions). Patients who have stopped the treatment must contact their doctor. In case the patient has forgotten to take metformin (Glucophage XR), the next dose should be taken at the usual time. Do not double the dose of metformin (Glucophage XR) unless otherwise prescribed by the doctor. If the patient has taken more metformin (Glucophage XR) than indicated, the doctor or pharmacist should be consulted immediately.
Monotherapy and combination with other oral antidiabetic agents: Unless otherwise prescribed, usual starting dose is one tablet metformin (Glucophage XR) 500 mg or one tablet metformin (Glucophage XR) 750 mg once daily with the evening meal. Metformin (Glucophage XR) 1 gram is intended as a maintenance therapy for patients treated with either 1 gram or 2 grams of metformin hydrochloride and should be taken 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 of metformin (Glucophage XR) 500 mg is four (4) tablets daily. The recommended dose of metformin (Glucophage XR) 750 mg is 2 tablets once daily. If glycemic control is not achieved on 2 tablets of metformin (Glucophage XR) 750 mg once daily, metformin (Glucophage XR) 750 mg may be increased to a maximum dose of 3 tablets daily. The maximum recommended dose of metformin (Glucophage XR) 1 gram is two (2) tablets daily.
Dosage increase is recommended in increments of 500 mg every 10 to 15 days, up to 2 grams once daily. If glycemic control is not achieved on 3 tablets of metformin (Glucophage XR) 750 mg or 2 grams metformin hydrochloride (Glucophage XR) extended release once daily, patients may be switched to metformin hydrochloride (Glucophage) immediate-release to a maximum dose of 3 grams daily. In patients already treated with metformin immediate-release, a starting dose of metformin extended release equivalent to the daily dose of the metformin immediate-release is recommended. In patients treated with metformin immediate-release at a dose above 2 grams daily, switching to metformin hydrochloride extended release is not recommended.
If transfer from another oral antidiabetic agent is intended, discontinue the other agent and initiate metformin (Glucophage XR) at the dose indicated previously. Titration should begin with metformin (Glucophage XR) 500 mg before switching to metformin (Glucophage XR) 1 gram as indicated previously.
Combination with insulin: Metformin can never replace insulin in Type 1 diabetes but concomitant administration with insulin makes it possible to reduce the insulin doses and obtain more stable blood glucose levels. In case metformin (Glucophage XR) is used in combination with insulin, the usual starting dose is one tablet of metformin (Glucophage XR) 500 mg or 750 mg once daily, while insulin dosage is adjusted on the basis of blood glucose measurements. After titration, switch to metformin (Glucophage XR) 1 gram should be considered.
Monotherapy in the indication prediabetes: The usual dose is 1000mg to 1500mg metformin hydrochloride once daily during or after meals. It is recommended to regularly monitor the glycemic status as well as the risk factors to evaluate whether treatment is still needed.
Patients with renal impairment: Metformin 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 (see Contraindications) and with the following dose adjustments: The starting dose is 500 mg or 850 mg metformin hydrochloride daily. The maximum daily dose is 1000 mg. The renal function should be closely monitored: Every 3 - 6 months in patients with CrCl between 45 and 59 mL/min or eGFR between 45 and 59 mL/min/1.73m2; Every 3 months in patients with CrCl between 30 and 44 mL/min or eGFR between 30 and 44 mL/min/1.73m2 If CrCl or eGFR fall below 30 mL/min or 30 mL/min/1.73m2 respectively, metformin must be discontinued immediately.
Elderly: Due to the potential for decreased renal function in elderly subjects, it is recommended that the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary (see Precautions).
Children: Metformin (Glucophage XR) is not recommended for use in children.
Combination with iodinated contrast materials: Iodinated contrast materials may be administered intravenously in metformin-treated patients with CrCl equal or greater than 45 mL/min or eGFR equal or greater than 45 mL/min/1.73m2 without discontinuation of metformin before the test (see also Contraindications).
Patients receiving intravenous iodinated contrast materials with CrCl below 45 mL/min or eGFR below 45 mL/min/1.73m2 or receiving intra-arterial iodinated contrast materials with CrCl below 60 mL/min or eGFR below 60 mL/min/1.73m2 should stop taking metformin 48 hours before the test. Renal function should be re-assessed 48 hours after contrast material administration and metformin should only be restarted if it has not deteriorated further.
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