Rosiglitazone
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- We do not rely simply on drug package inserts and manufacturer claims.
- Our information about drug and safety, off-label uses, side effects and interactions is based on the best available clinical evidence -- the same information used by hospital pharmacists
Avandia, Avandaryl (as a combination product containing rosiglitazone and glimepiride), Avandamet (as a combination product containing rosiglitazone and metformin)
Important warning
Rosiglitazone may cause fluid retention (a condition where the body keeps excess fluid) that may lead to or worsen congestive
heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body). Before you start
to take rosiglitazone, tell your doctor if you have or have ever had congestive heart failure, especially if your heart failure
is so severe that you must limit your activity and are only comfortable when you are at rest or you must remain in a chair
or bed. Also tell your doctor if you were born with a heart defect, and if you have or have ever had swelling of the arms,
hands, feet, ankles, or lower legs; heart disease, high blood pressure; coronary artery disease (narrowing of the blood vessels
that lead to the heart); a heart attack; an irregular heartbeat; or high cholesterol or fats in the blood. Your doctor may
tell you not to take rosiglitazone or may monitor you carefully during your treatment.
If you develop congestive heart failure or other heart problems, you may experience certain symptoms. Tell your doctor immediately
if you have any of the following symptoms, especially when you first start taking rosiglitazone or after your dose is increased:
large weight gain in a short period of time; shortness of breath; swelling of the arms, hands, feet, ankles, or lower legs;
swelling or pain in the stomach; waking up short of breath during the night; the need to sleep with extra pillows in order
to breathe while lying down; frequent dry cough; or increased tiredness.
Some studies have shown that rosiglitazone may increase the risk of angina (chest pain), heart attack, and other problems
that are caused by decreased blood flow to the heart. Other studies have not proven or ruled out that rosiglitazone increases
this risk. Until more information is available, it is important that you talk to your doctor about this possible risk. Tell
your doctor or get emergency medical care immediately if you experience any of the following symptoms: shortness of breath,
pain in the jaw or arm, or chest pain or pressure .
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment
with rosiglitazone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist
if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/cder) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of taking rosiglitazone.
Rosiglitazone is used along with a diet and exercise program and sometimes with one or more other medications to treat type
2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in
the blood). Rosiglitazone is in a class of medications called thiazolidinediones. It works by increasing the body's sensitivity
to insulin, a natural substance that helps control blood sugar levels. Rosiglitazone is not used to treat type 1 diabetes
(condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or
diabetic ketoacidosis (a serious condition that may occur if high blood sugar is not treated).
Rosiglitazone comes as a tablet to take by mouth. It is usually taken once or twice daily with or without meals. Take rosiglitazone
at about the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist
to explain any part you do not understand. Take rosiglitazone exactly as directed. Do not take more or less of it or take
it more often than prescribed by your doctor.
Your doctor may increase your dose of rosiglitazone after 8-12 weeks, based on your body's response to the medication.
Rosiglitazone helps control type 2 diabetes but does not cure it. It may take 2 weeks for your blood sugar to decrease, and
2-3 months or longer for you to feel the full benefit of rosiglitazone. Continue to take rosiglitazone even if you feel well.
Do not stop taking rosiglitazone without talking to your doctor.
This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to
do if you have these symptoms.
You may experience hypoglycemia (low blood sugar) if you are taking this medication in combination with other medications
used to treat diabetes. Your doctor will tell you what you should do if you develop hypoglycemia. He or she may tell you to
check your blood sugar, eat or drink a food or beverage that contains sugar, such as hard candy or fruit juice, or get medical
care. Follow these directions carefully if you have any of the following symptoms of hypoglycemia:
- shakiness
- dizziness or lightheadedness
- sweating
- nervousness or irritability
- sudden changes in behavior or mood
- headache
- numbness or tingling around the mouth
- weakness
- pale skin
- hunger
- clumsy or jerky movements
If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend
time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately.
- confusion
- seizures
- loss of consciousness
Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar):
- extreme thirst
- frequent urination
- extreme hunger
- weakness
- blurred vision
If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call
your doctor immediately if you have any of these symptoms:
- dry mouth
- upset stomach and vomiting
- shortness of breath
- breath that smells fruity
- decreased consciousness
Rosiglitazone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- headache
- runny nose and other cold symptoms
- sore throat
- back pain
- painful or irregular menstrual periods
Some side effects can be serious. If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING
section, call your doctor immediately:
- loss of appetite
- nausea
- vomiting
- dark urine
- yellowing of the skin or eyes
- blurred vision
- vision loss
- difficulty seeing colors
- difficulty seeing in the dark
- pale skin
- dizziness
- swelling of the eyes, face, lips, tongue, or throat
- hoarseness
- difficulty swallowing or breathing
- hives
- itching
- fever
- blisters
Rosiglitazone may cause other side effects. Call your doctor if you experience any unusual problems while you are taking this
medication.
In clinical studies, more women who took rosiglitazone experienced fractures, especially of the hands, arms, feet, ankles,
and lower legs than women who did not take rosiglitazone. Men who took rosiglitazone did not have a greater risk of experiencing
fractures than men who did not take the medication. If you are a woman, talk to your doctor about the risk of taking this
medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA)
MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
Before taking rosiglitazone,
- tell your doctor and pharmacist if you are allergic to rosiglitazone or any other medications.
- tell your doctor if you are taking insulin or nitrates such as isosorbide dinitrate (Isordril, Sorbitrate), isosorbide mononitrate (Imdur, ISMO), or nitroglycerin (Nitro-BID, Nitro-Dur, Nitroquick, Nitrostat, others). Nitrates come as tablets, sublingual (under the tongue) tablets, sprays, patches, pastes, and ointments. Ask your doctor if you are not sure if any of your medications contain nitrates. Your doctor will probably tell you not to take rosiglitazone if you are taking these medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: gemfibrozil (Lopid), other medications for diabetes, montelukast (Singulair), and rifampin (Rifadin, Rimactane, in Rifamate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or diabetic eye disease such as macular edema (swelling of the back of the eye); or liver disease. Also tell your doctor if you have ever taken troglitazone (Rezulin, no longer available in the United States), especially if you stopped taking it because you experienced side effects.
- tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking rosiglitazone, call your doctor. Do not breastfeed while you are taking rosiglitazone.
- if you have not yet experienced menopause (change of life; end of monthly menstrual periods) you should know that rosiglitazone may increase the chance that you will become pregnant even if you do not have regular monthly periods or you have a condition that prevents you from ovulating (releasing an egg from the ovaries). Talk to your doctor about methods of birth control that will work for you.
- if you will be having surgery, including dental surgery, tell the doctor or dentist that you are taking rosiglitazone.
- ask your doctor what to do if you get sick, develop an infection or fever, experience unusual stress, or are injured. These conditions can affect your blood sugar and the amount of rosiglitazone you may need.
Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy
diet, exercise regularly, and lose weight if necessary. This will help to control your diabetes and help rosiglitazone work
more effectively
Take the missed dose as soon as you remember it. However, if it is time for the next dose, skip the missed dose and continue
your regular dosing schedule. Do not take a double dose to make up for a missed one.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature
and away from light, excess heat, and moisture (not in the bathroom). Throw away any medication that is outdated or no longer
needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing,
call local emergency services at 911.
Keep all appointments with your doctor, your eye doctor, and the laboratory. Your doctor will probably order regular eye examinations
and certain laboratory tests to check your body's response to rosiglitazone. Your blood sugar and glycosylated hemoglobin
should be checked regularly to determine your response to rosiglitazone. Your doctor may also tell you how to check your response
to rosiglitazone by measuring your blood or urine sugar levels at home. Follow these directions carefully.
You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines
you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list
with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with
you in case of emergencies.
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