Please note

Due to the recent spike in Covid-19 cases, we are no longer able to entertain walk-in visits to our headquarters or any of our facilities.

Glumin XR 750mg sustained-release tablets

Ferron Par Pharmaceuticals

Ingredients in every sustained-release tablet

Metformin HCL 750 mg

Each package contains

4 blisters of 15 sustained-release tablets

Dosage form

sustained-release tablet

Dosage formTablet; coated; sustained-release

Flavour

None

W.H.O. classification

A10B
A10B

A.T.C. Level 1

Anatomical Main group

A - Alimentary tract and metabolism
A10B

A.T.C. Level 2

Therapeutic subgroup

A10 - Drugs Used in Diabetes
A10B

A.T.C. Level 3

Pharmacological subgroup

A10B - Blood Glucose Lowering Drugs; excl. Insulins

Available in

Indonesia

Warnings

Alcohol

NOT RECOMMENDEDThis item should not be used with alcohol.

Machinery

CAUTIONThis item may not be safe for use while operating heavy machinery. Use with caution and after consultation with your doctor.

Pregnancy

NOT RECOMMENDEDThis item is not safe for use during pregnancy.

Lactation

NOT RECOMMENDEDThis item is not safe for use during lactation.

Indication

As mono– or combined therapy
with sulphonylurea in patients with Non-insulin-dependent diabetes mellitus (type-2 diabetes) especially if overweight and whose blood glucose level cannot be controlled by diet alone.
As an adjuvant therapy
in insulin-dependent diabetic patients with hardly controlled symptoms.

Dosage

0 TO 17 YEARS OLD
Metformin XR is not recommended for use in pediatric patients.

17 TO 65 YEARS OLD
Recommended dosing schedule:
In general, clinically significant responses are not seen at doses below 1500 mg per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms. The usual starting dose of metformin XR is 750 mg (or 500 mg by using another tablet strength) is one tablet once daily with the evening meal. Dosage increases should be made in increments of 750 mg weekly, up to a maximum of 1500 mg once daily, with the evening meal. The daily dose of metformin XR may be increased up to a maximum of 2000 mg by switching to another tablet strength (metformin XR 500 mg).

If glycemic control is not achieved on metformin XR 2000 mg once daily, a trial of metformin XR 1000 mg twice daily should be considered. It is suggest that patients receiving metformin treatment may be safely switched to metformin XR once daily at the same total daily dose, up to 2000 mg once daily. Following a switch from metformin to metformin XR, glycemic control should be closely monitored and dosage adjustments made accordingly. For patients treated with metformin at doses higher than 2000 mg, switching to Glumin XR is no recommended.

Concomitant metformin XR and insulin therapy:
The current insulin dose should be continued upon initiation of metformin XR therapy. Metformin XR therapy should be initiated at 750 mg (or 500 mg by using another tablet strength) once daily in patients on insulin therapy. For patients not responding adequately, the dose of metformin XR should be increased by 750 mg (or 500 mg) after approximately 1 week and by 750 mg (or 500 mg) every week, thereafter, until adequate glycemic control is achieved. The maximum recommended daily dose is 2000 mg for metformin XR. It is recommended that the insulin dose be decreased by 10% - 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dl in patients receiving concomitant insulin and metformin XR. Further adjustment should be individualized based on glucose-lowering response.

65 YEARS OLD AND ABOVE
The initial and maintenance dosing of metformin XR should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of metformin XR. Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly.

ADMINISTRATION
Metformin XR should generally be given once daily with the evening meals. Patients should be informed that metformin XR must be swallowed whole and not crushed and chewed.

TRANSFER FROM OTHER ANTIDIABETIC THERAPY:
When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to metformin XR, no transition period generally is necessary. When transferring patients from chlorpropamide, care should be exercised during the first 2 weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.

CONCOMITANT METFORMIN XR AND ORAL SULFONYLUREA
If patients have not responded to 4 weeks of the maximum dose of metformin XR monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing metformin XR at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. With concomitant metformin XR and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant metformin XR and sulfonylurea therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken. If patients have not satisfactorily responded to 1 to 3 months of concomitant therapy with the maximum dose of metformin XR and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without metformin XR.