Glucophage/Glucophage XR

Generic name: Metformin hydrochloride

What is Glucophage/Glucophage XR?

Glucophage and Glucophage XR are used to treat type 2 diabetes. Regular Glucophage tablets are taken two or three times daily. The extended-release form, Glucophage XR, is available for once-daily dosing.

What is the most important information I should know about Glucophage/Glucophage XR?

Glucophage/Glucophage XR could cause a very rare—but potentially fatal—side effect known as lactic acidosis. It is caused by a buildup of lactic acid in the blood. The problem is most likely to occur in people whose liver or kidneys are not working well, and in those who have multiple medical problems, take several medications, or have congestive heart failure. The risk also is higher if you are an older adult or drink alcohol. Lactic acidosis is a medical emergency that must be treated in a hospital. Notify your doctor immediately if you experience any of the following: dizziness, extreme weakness or tiredness, light-headedness, low body temperature, rapid breathing or trouble breathing, sleepiness, slow or irregular heartbeat, unexpected or unusual stomach discomfort, or unusual muscle pain.

You should not take Glucophage/Glucophage XR for 2 days before and after having an X-ray procedure (such as an angiogram) that uses an injectable dye. Also, if you are going to have surgery, except minor surgery, you should stop taking Glucophage/Glucophage XR. Once you have resumed normal food and fluid intake, your doctor will tell you when you can start drug therapy again.

If you are taking Glucophage/Glucophage XR, you should check your blood or urine periodically for abnormal sugar (glucose) levels.

Glucophage/Glucophage XR does not usually cause hypoglycemia (low blood sugar). However, it remains a possibility, especially in older, weak, and undernourished people and those with kidney, liver, adrenal, or pituitary gland problems. The risk of low blood sugar increases when Glucophage is combined with other diabetes medications. The risk is also boosted by missed meals, alcohol, and excessive exercise. To avoid low blood sugar, you should closely follow the diet and exercise plan suggested by your doctor.

If your blood sugar becomes unstable due to the stress of a fever, injury, infection, or surgery, your doctor may temporarily take you off Glucophage/Glucophage XR and ask you to take insulin instead.

You should stop taking Glucophage/Glucophage XR if you become seriously dehydrated, since this increases the likelihood of developing lactic acidosis. Tell your doctor if you lose a significant amount of fluid due to vomiting, diarrhea, fever, or some other condition.

The effectiveness of any oral antidiabetic, including Glucophage/Glucophage XR, may decrease with time. This may occur because of either a diminished responsiveness to the medication or a worsening of the diabetes.

Who should not take Glucophage/Glucophage XR?

Glucophage/Glucophage XR is processed primarily by the kidneys, and can build up to excessive levels in the body if the kidneys aren't working properly. It should be avoided if you have kidney disease or your kidney function has been impaired by a condition such as shock, blood poisoning, or a heart attack.

You should not use Glucophage/Glucophage XR if you need to take medicine for congestive heart failure.

Do not take Glucophage/Glucophage XR if you have ever had an allergic reaction to metformin.

Do not take Glucophage/Glucophage XR if you have metabolic or diabetic ketoacidosis (a life-threatening medical emergency caused by insufficient insulin and marked by excessive thirst, nausea, fatigue, pain below the breastbone, and fruity breath). Diabetic ketoacidosis should be treated with insulin.

What should I tell my doctor before I take the first dose of Glucophage/Glucophage XR?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with this drug. Also, talk to your doctor about your complete medical history, especially if you have kidney or liver problems.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Your doctor will tailor your dosage to your individual needs.

Glucophage

Adults: The usual starting dose is one 500-milligram tablet twice a day, taken with morning and evening meals. Your doctor may increase your daily dose by 500 milligrams at weekly intervals, based on your response up to a total of 2,000 milligrams. An alternative starting dose is one 850-milligram tablet a day, taken with the morning meal. Your doctor may increase this by 850 milligrams at 14-day intervals, to a maximum of 2,550 milligrams a day. The usual maintenance dose ranges from 1,500 to 2,550 milligrams daily. If you take more than 2,000 milligrams a day, your doctor may recommend that the medication be divided into three doses, taken with each meal.

Children 10 to 16 years old: The usual starting dose is one 500-milligram tablet twice a day with meals. The dosage may be increased by 500 milligrams at weekly intervals up to a maximum of 2,000 milligrams daily.

Glucophage XR

Adults: The usual starting dose is one 500-milligram tablet once daily with the evening meal. Your doctor may increase your dose by 500 milligrams at weekly intervals, up to a maximum dosage of 2,000 milligrams a day. If a single 2,000-milligram dose fails to control your blood sugar, you may be asked to take 1,000-milligram doses twice a day. If you need more than 2,000 milligrams a day, the doctor will switch you to regular Glucophage.

The safety and effectiveness of Glucohpage XR in children have not been established.

How should I take Glucophage/Glucophage XR?

Do not take more or less of this medication than directed by your doctor. The drug should be taken with food to reduce the possibility of nausea or diarrhea, especially during the first few weeks of therapy.

If taking Glucophage XR, be sure to swallow the tablet whole; do not crush it or chew it. The inactive ingredients in the tablet may occasionally appear in the stool. This is not a cause for concern.

What should I avoid while taking Glucophage/Glucophage XR?

Avoid drinking too much alcohol while taking this drug. Heavy drinking increases the danger of lactic acidosis and can also trigger an attack of low blood sugar.

What are possible food and drug interactions associated with Glucophage/Glucophage XR?

If Glucophage/Glucophage XR is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining this medication with the following: alcohol, amiloride, calcium channel blockers (heart medications) such as nifedipine and verapamil, cimetidine, decongestants or airway-opening drugs such as albuterol and pseudoephedrine, digoxin, estrogens, furosemide, glyburide, isoniazid, major tranquilizers such as chlorpromazine, morphine, niacin, nifedipine, oral contraceptives, phenytoin, procainamide, quinidine, quinine, ranitidine, steroids such as prednisone, thyroid hormones such as levothyroxine, triamterene, trimethoprim, vancomycin, and diuretics such as hydrochlorothiazide.

What are the possible side effects of Glucophage/Glucophage XR?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: abdominal discomfort, diarrhea, gas, headache, indigestion, nausea, vomiting, weakness

Can I receive Glucophage/Glucophage XR if I am pregnant or breastfeeding?

If you are pregnant or plan to become pregnant, tell your doctor immediately. Glucophage/Glucophage XR have not been studied during pregnancy. It is not known whether Glucophage/Glucophage XR appears in breast milk. Therefore, women should discuss with their doctors whether to discontinue the medication or to stop breastfeeding. If the medication is discontinued and if diet alone does not control glucose levels, then your doctor may consider insulin injections.

What should I do if I miss a dose of Glucophage/Glucophage XR?

Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take 2 doses at the same time.

How should I store Glucophage/Glucophage XR?

Store it at room temperature.