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Drugs reference index «Avandia»

Avandia
Avandia
Avandia


Avandia

Generic Name: rosiglitazone (Oral route)

roe-zi-GLI-ta-zone

Oral routeTablet
  • Congestive Heart Failure and Myocardial Ischemia
    • Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients. After initiation of rosiglitazone maleate, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of rosiglitazone maleate must be considered.
    • Rosiglitazone maleate is not recommended in patients with symptomatic heart failure. Initiation of rosiglitazone maleate in patients with established NYHA Class III or IV heart failure is contraindicated.
    • A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patient), most of which compared rosiglitazone maleate to placebo, showed rosiglitazone maleate to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 total patients), comparing rosiglitazone maleate to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive .

May cause or worsen congestive heart failure, is not recommended in patients with symptomatic heart failure, and is contraindicated in patients with established NYHA Class III or IV heart failure. Monitor patients for signs and symptoms of heart failure after initiation or dose increases and if heart failure occurs, consider dose reducing or discontinuing rosiglitazone maleate and manage according to current standards of care. Overall, the available data on the risk of myocardial ischemia is inconclusive .

Commonly used brand name(s):

In the U.S.

  • Avandia

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antidiabetic

Chemical Class: Thiazolidinedione

Uses For Avandia

Rosiglitazone is used to treat high blood sugar levels that are caused by a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. Normally, after you eat, your pancreas releases insulin to help your body store excess sugar for later use. This process occurs during normal digestion of food. In type 2 diabetes, your body does not work properly to store excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future. Proper diet is the first step in managing type 2 diabetes, but often medicines are needed to help your body. Rosiglitazone helps your body use the insulin better and it reduces the amount of insulin in your body. It may be used alone or with another type of diabetes medicine, such as metformin, a sulfonylurea, or a sulfonylurea plus metformin .

This medicine is available only with your doctor's prescription.

Before Using Avandia

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rosiglitazone in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of rosiglitazone in the elderly .

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Bitter Melon
  • Fenugreek
  • Gemfibrozil
  • Glucomannan
  • Guar Gum
  • Psyllium
  • Rifampin
  • St John's Wort
  • Trimethoprim

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diabetic ketoacidosis (ketones in the blood) or
  • Lactic acidosis (lactic acid in the blood) or
  • Metabolic acidosis (extra acids in the blood) or
  • Type 1 diabetes—Patients with any of these conditions should not use this medicine .
  • Diabetic macular edema (swelling of the back of the eye) or
  • Edema or
  • Jaundice or
  • Liver disease—Rosiglitazone may make these conditions worse .
  • Fragile bones (especially women)—Use with caution. This medicine may increase the risk of fractures .
  • Heart disease or
  • Heart surgery in the past or
  • History of heart attacks or
  • Other heart problems—This medicine may increase the risk of heart attacks and make these conditions worse
  • Heart failure, severe —This medicine should not be used in patients with this condition .

Proper Use of Avandia

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 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 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 metformin:
        • Adults—At first, the dose is 4 milligrams (mg) once a day or 2 mg twice a day. Any changes in dose will be determined by your doctor .
        • Children—Use and dose must be determined by your doctor.
      • Rosiglitazone with a sulfonylurea:
        • Adults—4 milligrams (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.
      • Rosiglitazone with sulfonylurea plus metformin:
        • Adults—4 milligrams (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 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.

Precautions While Using Avandia

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects .

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.

Seek medical attention immediately if you experience chest pain or discomfort; nausea; pain or discomfort in arms, jaw, back or neck; shortness of breath; sweating; or vomiting. These may be symptoms of a heart attack.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor) .

If you are rapidly gaining weight, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

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

Make sure your doctor knows if you are using insulin or nitrate medicines (e.g., Isordil®, Imdur®, or Sorbitrate®) before you start taking this medicine. Using any of them together with this medicine may increase your risk of having serious side effects .

It is very important to carefully follow 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 occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, cannot eat because of nausea or vomiting, take certain medicines, or take rosiglitazone with another type of diabetes medicine. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

Symptoms of low blood sugar include anxiety; 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 (frequency and amount); ketones in urine; loss of appetite; sleepiness; 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.

It is important to tell your healthcare professional that you are taking this medicine if you are going to have any medical procedures or surgical procedures.

Avandia Side Effects

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 immediately 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
  • pale skin
  • shortness of breath
  • sweating
  • swelling of fingers, hands, feet, or lower legs
  • trouble breathing
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • weight gain, rapid or unusual
Rare
  • Anxiety
  • chills
  • cold sweats
  • coma
  • confusion
  • dark urine
  • depression
  • dizziness
  • fast heartbeat
  • headache
  • loss of appetite
  • nervousness
  • nightmares
  • seizures
  • shakiness
  • slurred speech
Incidence not known
  • Blue lips and fingernails
  • changes in vision
  • coughing that sometimes produces a pink frothy sputum
  • hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • itching
  • light-colored stools
  • redness of skin
  • skin rash
  • wheezing
  • yellow eyes or skin

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Ear congestion
  • fever
  • general feeling of discomfort or illness
  • hoarseness or other voice changes
  • injury
  • joint pain
  • muscle aches and pains
  • runny or stuffy nose
  • shivering
  • sneezing
  • sore throat
  • trouble sleeping
Less common
  • Back pain
  • cough
  • diarrhea
  • light-headedness
  • pain or tenderness around the eyes and cheekbones

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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  • Avandia Prescribing Information (FDA)
  • Avandia Consumer Overview
  • Avandia Detailed Consumer Information (PDR)
  • Avandia MedFacts Consumer Leaflet (Wolters Kluwer)
  • Rosiglitazone Prescribing Information (FDA)

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