Glucophage XR

Metformin comes as a liquid, tablet, and extended-release tablet to take by mouth. You should try to take the medicine around the same time each day with food.

Typical Adult Dose for Type 2 Diabetes

Immediate-release tablets: 500 milligrams (mg) twice a day, or 850 mg once a day. This dose may be gradually increased by 500 mg a week or 850 mg every two weeks. The maximum daily dose of metformin is 2,550 mg divided into three smaller doses.

Extended-release tablets: 500 mg or 1,000 mg daily with an evening meal. The dose can be increased by 500 mg a week to a maximum of 2,000 mg. If you take Fortamet or Glumetza (modified release formulations of metformin), you may be given different dosing instructions.

You should swallow the extended-release tablet whole. Do not split, crush, or chew it.

Typical Child Dose for Type 2 Diabetes

Children between 10-16 years old: 500 mg twice a day. The dose can be increased by 500 mg a week to a maximum of 2,000 mg in divided doses.

Children older than 17 years old: 500 mg of extended-release tablets daily up to a maximum of 2,000 mg daily.

Metformin Overdose

Symptoms of an overdose may include the following:

• Diarrhea
• Vomiting
• Abdominal pain
• Rapid heartbeat
• Drowsiness

If you suspect an overdose, you should contact a poison control center or emergency room immediately. You can get in touch with a poison control center at (800) 222-1222.

Missed Dose of Metformin

If you miss a dose of metformin, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue on your regular medication schedule. Don't take extra medicine to make up for a missed dose.

Glucophage XR is part of the drug class:

• Biguanides

Follow dietary (food) recommendations made by your doctor and dietitian which should include a healthy diet. Skipping meals should be avoided as this can cause problems maintaining blood sugar control. There are no specific foods to avoid while using Glucophage XR.

If you take too much Glucophage XR, call your local Poison Control Center or seek emergency medical attention right away.

• Store Glucophage XR at 20° to 25° C (68° to 77° F).
• Keep this and all medicines out of the reach of children.

In the U.S.

• Fortamet
• Glucophage
• Glucophage XR
• Glumetza
• Riomet

Available Dosage Forms:

• Tablet
• Tablet, Extended Release
• Solution

Therapeutic Class: Hypoglycemic

Chemical Class: Metformin

This section provides information on the proper use of a number of products that contain metformin. It may not be specific to Glucophage XR. Please read with care.

This medicine usually comes with a patient information insert. Read the information carefully and make sure you understand it before taking this medicine. If you have any questions, ask your doctor.

Carefully follow the special meal plan your doctor gave you. This is a very important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Metformin should be taken with meals to help reduce stomach or bowel side effects that may occur during the first few weeks of treatment.

Swallow the tablet or extended-release tablet whole with a full glass of water. Do not crush, break, or chew it.

While taking the extended-release tablet, part of the tablet may pass into your stool after your body has absorbed the medicine. This is normal and nothing to worry about.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

You may notice improvement in your blood glucose control in 1 to 2 weeks, but the full effect of blood glucose control may take up to 2 to 3 months. Ask your doctor if you have any questions about this.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For type 2 diabetes:
  • For oral dosage form (extended-release tablets):
    • Adults—
      • Metformin alone (Fortamet®): At first, 1000 milligrams (mg) once a day taken with the evening meal. Your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 2500 mg per day.
      • Metformin alone (Glucophage® XR): At first, 500 mg once daily with the evening meal. Your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 2000 mg per day.
      • Metformin alone (Glumetza®): At first, 500 mg once a day taken with the evening meal. Then, your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 2000 mg per day.
      • Metformin with a sulfonylurea: Your doctor will determine the dose of each medicine.
      • Metformin with insulin: At first, 500 mg once a day. Then, your doctor may increase your dose by 500 mg every week if needed until your blood sugar is controlled. However, the dose is usually not more than 2500 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (solution):
    • Adults—
      • Metformin alone: At first, 5 milliliters (mL) two times a day, or 8.5 mL once a day with meals. Your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 25.5 mL per day.
      • Metformin with a sulfonylurea: Your doctor will determine the dose of each medicine.
      • Metformin with insulin: At first, 5 mL once a day. Your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 25 mL per day.
    • Children 10 to 16 years of age—At first, 5 mL two times a day with meals. Your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 20 mL per day.
    • Children younger than 10 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—
      • Metformin alone: At first, 500 milligrams (mg) two times a day taken with the morning and evening meals, or 850 mg a day taken with the morning meal. Your doctor may increase your dose if needed until your blood sugar is controlled. Later, your doctor may want you to take 500 or 850 mg two to three times a day with meals. However, the dose is usually not more than 2550 mg per day.
      • Metformin with a sulfonylurea: Your doctor will determine the dose of each medicine.
      • Metformin with insulin: At first, 500 mg a day. Your doctor may increase your dose by 500 mg every week if needed until your blood sugar is controlled. However, the dose is usually not more than 2500 mg per day.
    • Children 10 to 16 years of age—At first, 500 mg two times a day taken with the morning and evening meals. Your doctor may increase your dose if needed until your blood sugar is controlled. However, the dose is usually not more than 2000 mg per day.
    • Children younger than 10 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
• Check your blood sugar as you have been told by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor.
• Follow the diet and workout plan that your doctor told you about.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• You may see something that looks like the tablet in your stool. This is normal and not a cause for concern. If you have questions, talk with your doctor.
• If you are 65 or older, use Glucophage XR with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

GLUCOPHAGE® (metformin hydrochloride) Tablets and GLUCOPHAGE® XR (metformin hydrochloride) Extended-Release Tablets are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:

Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 • HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.

GLUCOPHAGE tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg and 850 mg tablets contains hypromellose and the coating for the 1000 mg tablet contains hypromellose and polyethylene glycol.

Glucophage XR contains 500 mg or 750 mg of metformin hydrochloride as the active ingredient.

Glucophage XR 500 mg tablets contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose, microcrystalline cellulose, and magnesium stearate.

Glucophage XR 750 mg tablets contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose, and magnesium stearate.

System Components and Performance–Glucophage XR comprises a dual hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymer to form an "inner" phase, which is then incorporated as discrete particles into an "external" phase of a second polymer. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass.