Metaglip for Type 2 Diabetes - Metaglip Patient Information

Brand Name: Metaglip

Generic Name: Glipizide and Metformin Hydrochloride

Metaglip, glipizide and metformin, full prescribing information

Why is Metaglip Prescribed?

Metaglip is an oral medication used to control blood sugar levels in people with type 2 (non-insulin-dependent) diabetes. It contains two drugs commonly used to lower blood sugar, glipizide and metformin. Metaglip replaces the need to take these two drugs separately. It is prescribed when diet and exercise alone do not control blood sugar levels, or when treatment with another antidiabetic medication does not work.

Blood sugar levels are ordinarily controlled by the body's natural supply of insulin, which helps sugar move out of the bloodstream and into the cells to be used for energy. People who have type 2 diabetes do not make enough insulin or do not respond normally to the insulin their bodies make, causing a buildup of unused sugar in the bloodstream. Metaglip helps remedy this problem in two ways: by causing your body to release more insulin and by helping your body use insulin more effectively.

Most Important Fact about Metaglip

Metaglip 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:

• Symptoms of lactic acidosis may include:
  Dizziness, extreme weakness or tiredness, light-headedness, low blood pressure, low body temperature, slow or irregular heartbeat, rapid breathing or trouble breathing, sleepiness, unexpected or unusual stomach discomfort, unusual muscle pain

How Should You Take Metaglip?

Do not take more or less of Metaglip than directed by your doctor. Metaglip should be taken in divided doses with meals to reduce the possibility of nausea or diarrhea, especially during the first few weeks of therapy.

• If you miss a dose...
  Take the forgotten dose as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular schedule. Never take two doses at once.
• Storage instructions...
  Store at room temperature.

What Side Effects may Occur?

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 using Metaglip.

• Side effects may include:
  Abdominal pain, diarrhea, dizziness, headache, high blood pressure, hypoglycemia (low blood sugar), muscle pain, upper respiratory infection

Why Should Metaglip Not Be Prescribed?

Metaglip 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 Metaglip if you need to take medicine for congestive heart failure.

Do not take Metaglip if you have ever had an allergic reaction to glipizide or metformin.

Do not take Metaglip 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).

Special Warnings about Metaglip

Some studies suggest that the glipizide component of Metaglip may lead to more heart problems than treatment with diet alone, or diet plus insulin. In a long-term trial of a similar drug, researchers noted an increase in heart-related deaths (though the overall mortality rate remained unchanged). If you have a heart condition or you're at risk for heart disease, you should discuss this potential danger with your doctor.

Because Metaglip can cause hypoglycemia (low blood sugar), it's very important to follow your doctor's instructions carefully. Low blood sugar is more likely to happen if you're older, weak, or undernourished, or if you have kidney, liver, adrenal, or pituitary gland problems. Your risk also increases if you miss meals or fail to eat after doing strenuous exercise. Combining Metaglip with other diabetes medications can also cause blood sugar to drop. Symptoms of a mild case include cold sweats, dizziness, shakiness, a light-headed feeling, and hunger. Check with your doctor immediately if you notice any of these warning signs, since severe low blood sugar can occasionally lead to seizures or coma.

Before you start therapy with Metaglip, and at least once a year thereafter, your doctor will do a complete assessment of your kidney function. If you develop kidney problems while on Metaglip, your doctor will discontinue Metaglip. If you are an older person, you will need to have your kidney function monitored more frequently, and your doctor may want to start you at a lower dosage.

You should temporarily stop taking Metaglip 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 Metaglip. Once you have resumed normal food and fluid intake, your doctor will tell you when you can start drug therapy again.

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

Because poor liver function could increase the risk of lactic acidosis, your doctor may decide to check your liver function before prescribing Metaglip and periodically thereafter. If you develop liver problems, your doctor may stop treatment with Metaglip.

Metaglip occasionally causes a mild deficiency of vitamin B12. Your doctor will check for this with yearly blood tests and may prescribe a supplement if necessary.

You should stop taking Metaglip 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.

While taking Metaglip, you should check your blood or urine periodically for abnormal sugar levels. If you notice sudden changes after you've been stabilized for a while, tell your doctor immediately. It could be a sign you're developing lactic acidosis or ketoacidosis.

Possible Food and Drug Interactions when Taking Metaglip

If Metaglip 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 Metaglip with the following:

Amiloride

Antibiotics known as sulfonamides, including sulfamethoxazole

Antidepressants known as MAO inhibitors, including phenelzine and tranylcypromine

Antifungal drugs that are taken orally, such as fluconazole and miconazole

Anti-inflammatories that contain salicylates, such as aspirin, diflunisal, and mesalamine

Beta-blocking blood pressure medicines such as atenolol, metoprolol, and propranolol

Calcium channel blockers (heart medications) such as nifedipine and verapamil

Chloramphenicol

Cimetidine

Decongestant, airway-opening drugs such as albuterol and pseudoephedrine

Digoxin

Estrogens

Furosemide

Isoniazid, a drug used for tuberculosis

Morphine

Niacin

Nifedipine

Nonsteroidal anti-inflammatory drugs such as ibuprofen and naproxen

Oral contraceptives

Phenytoin

Probenecid

Procainamide

Quinidine

Quinine

Ranitidine

Steroids such as prednisone

Thyroid hormones such as levothyroxine

Tranquilizers such as chlorpromazine

Triamterene

Trimethoprim

Vancomycin

Warfarin sodium

Water pills (diuretics) such as hydrochlorothiazide

Do not drink too much alcohol, since excessive alcohol consumption can cause low blood sugar and increase the risk of developing lactic acidosis.

Special Information if You Are Pregnant or Breastfeeding

If you are pregnant or plan to become pregnant, tell your doctor immediately. Metaglip has not been adequately studied in pregnant women and should not be taken during pregnancy unless the potential benefit outweighs the potential risk. Since studies suggest the importance of maintaining normal blood sugar levels during pregnancy, your doctor may prescribe insulin injections instead.

It is not known whether Metaglip appears in human breast milk. Therefore, you should discuss with your doctor whether to discontinue the medication or to stop breastfeeding. If the medication is discontinued and if diet alone does not control blood sugar levels, your doctor may prescribe insulin injections.

Recommended Dosage for Metaglip

ADULTS

Your doctor will start therapy at a low dose and increase it until your blood sugar levels are under control.

For patients not previously treated with diabetes medications

The recommended starting dose is 2.5 milligrams of glipizide with 250 milligrams of metformin once a day. If your fasting blood sugar levels are particularly high, you doctor may have you take 2.5 milligrams of glipizide with 500 milligrams of metformin twice a day.

The daily dosage can be increased by one tablet every 2 weeks until blood sugar levels are controlled. The maximum daily dose is 10 milligrams of glipizide with 2,000 milligrams of metformin.

For patients previously treated with glipizide (or a similar drug) or metformin

The recommended starting dose of Metaglip is either 2.5 or 5 milligrams of glipizide with 500 milligrams of metformin twice a day. If this regimen doesn't control your blood sugar, the daily dose can be increased by increments of up to 5 milligrams (glipizide)/500 milligrams (metformin). The maximum daily dose is 20 milligrams of glipizide with 2,000 milligrams of metformin.

For patients on combination therapy taking separate doses of glipizide and metformin

The maximum daily dose should not exceed your current doses of glipizide and metformin. The usual daily starting dose is either 2.5 or 5 milligrams of glipizide with 500 milligrams of metformin. If this regimen doesn't control your blood sugar, the daily dose can be increased by increments of up to 5 milligrams (glipizide)/500 milligrams (metformin). The maximum daily dose is 20 milligrams of glipizide with 2,000 milligrams of metformin.

CHILDREN

Children should not take Metaglip, since the safety and effectiveness of the drug have not been studied in this group.

Overdosage

An overdose of Metaglip can cause an attack of low blood sugar requiring immediate treatment. If you experience any of the symptoms listed in "Special warnings about Metaglip," see a doctor immediately.

An excessive dose of Metaglip can also trigger lactic acidosis. If you begin to notice the warning signs listed in "Most important fact about Metaglip," seek emergency treatment.

Last Updated: 07/09

Metaglip, glipizide and metformin, full prescribing information

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