In the U.S.—

In Canada—

• Antidiabetic agent

Rosiglitazone (ROS-e-glit-a-zone) is used to treat a certain type of diabetes mellitus (sugar diabetes) called type 2 diabetes. It may be used alone or with another type of diabetes medicine, such as metformin, insulin or a sulfonylurea.

This medicine is available only with your doctor's prescription, in the following dosage form:

Oral
• Tablets (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For rosiglitazone, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to rosiglitazone. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Rosiglitazone has not been studied in pregnant women. However, it is easier during pregnancy to control your blood sugar by using injections of insulin, rather than by taking rosiglitazone. Close control of your blood sugar can reduce the chance of your baby gaining too much weight, having birth defects, or having high blood sugar before birth. Be sure to tell your doctor if you plan to become pregnant or you think you are pregnant.

Breast-feeding—It is not known whether rosiglitazone passes into the breast milk of humans. However, rosiglitazone is not recommended during breast-feeding.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of rosiglitazone in children with use in other age groups.

Older adults—This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

• Diabetic ketoacidosis (ketones in the blood) or,

• Type 1 diabetes–Insulin is needed to control these conditions or,
• Heart disease or
• Jaundice or
• Liver disease–Rosiglitazone may make these conditions worse or,

• Edema- May increase the side effects of rosiglitazone.

Follow carefully the special meal plan your doctor gave you. This is the most 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.

Rosiglitazone may be taken with or without food.

Dosing—

The dose of rosiglitazone will be different for different patients. Follow your doctor's orders or the directions on the label. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For type 2 diabetes:
    • Rosiglitazone alone:
      • Adults—At first, the dose is 4 milligrams (mg) once a day or 2 mg twice a day. After 8 to 12 weeks, the dose may be increased to 8 mg once a day or 4 mg twice a day
      • Children—Use and dose must be determined by your doctor.
    • Rosiglitazone with insulin:
      • Adults—4 milligrams (mg) once a day. Your doctor may adjust your dose as needed
      • Children—Use and dose must be determined by your doctor.
    • Rosiglitazone with metformin:
      • Adults—At first, the dose is 4 mg once a day or 2 mg twice a day. After 8 to 12 weeks, the dose may be increased to 8 mg once a day or 4 mg twice a day.
      • Children—Use and dose must be determined by your doctor.
    • Rosiglitazone with a sulfonylurea:
      • Adults—4 mg once a day or 2 mg twice a day. Any changes in the dose will be determined by your doctor.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

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

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

If you experience abdominal or stomach pain, dark urine, loss of appetite, nausea or vomiting, unusual tiredness or weakness, or yellow eyes or skin, check with your doctor immediately. These may be symptoms of liver problems.

If you are rapidly gaining weight, shortness of breath, or have excessive swelling of hands, wrist, ankles, or feet. These may be symptoms of heart problems or your body keeping too much water.

Rosiglitazone may increase the chance of a premenopausal women with type 2 diabetes getting pregnant. Reliable birth control is recommended. Talk to your health care professional about choices, risks, and benefits.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

It is very important to follow carefully any instructions from your health care team about

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines during the time you are taking rosiglitazone unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, diabetic patients may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
• In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
• This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occurif you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.
• Symptoms of low blood sugar includeanxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.
• If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination should include the (frequency and amount); ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur

• Less common
  • Abdominal or stomach pain;  blurred vision;  chest pain or discomfort;  decrease in amount of urine;  dry mouth;  fatigue;  flushed, dry skin;  fruit-like breath odor;  increased hunger ;  increased thirst;  increased urination;  irregular heartbeat;  nausea;  noisy, rattling breathing;  pain in the shoulders, arms, jaw or neck;  shortness of breath;  sweating;  swelling of fingers, hands, feet, or lower legs;  troubled breathing;  unexplained weight loss;  weight gain, rapid or unusual;  vomiting  
  
  

• Rare
  • Anxiety;  chills;  cold sweats;  coma;  confusion ;  cool pale skin;  dark urine ;  depression;  dizziness ;  fast heartbeat;  headache ;  loss of appetite;  nervousness ;  nightmares;  seizures;  shakiness;  slurred speech;  unusual tiredness or weakness 
  
  

• Frequency not determined
  • Blue lips and fingernails;  coughing that sometimes produces a pink frothy sputum;  hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs ;  itching;  light-colored stools;  redness of skin;  skin rash;  wheezing;  yellow eyes or skin 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Fever;  injury;  runny or stuffy nose 
  
  

• Less common
  • Back pain;  diarrhea;  cough;  light-headedness;  pain or tenderness around eyes and cheekbones 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.