Rosiglitazone (Oral)

Rosiglitazone is used to treat a type of diabetes called type 2 diabetes. It may be used by itself or with other medicines like metformin or sulfonylurea agents. Rosiglitazone is used along with a proper diet and exercise to help control blood sugar levels. It works by helping your body use insulin more effectively.

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

It is very important for your doctor to check your progress during regular visits to ensure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Call your doctor right away if you have chest pain or discomfort, nausea, pain or discomfort in the arms, jaw, back, or neck, shortness of breath, sweating, or vomiting. These may be signs of a heart attack.

If you are rapidly gaining weight or experiencing shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrists, ankles, or feet, contact your doctor immediately. These may be signs of a heart problem or edema (fluid retention).

If you have abdominal or stomach pain, dark urine, a loss of appetite, nausea or vomiting, unusual tiredness or weakness, or yellow eyes or skin, check with your doctor right away. These may be signs of a serious liver problem.

Contact your doctor immediately if you notice blurred vision, difficulty reading, or any other changes in your vision while taking this medicine. Your doctor may want you to see an ophthalmologist (eye doctor).

This medicine may increase the risk of bone fractures in women. Ask your doctor about ways to keep your bones strong to help prevent fractures.

Certain women may be at a higher risk for pregnancy while taking this medicine. If you have had problems with ovulation and irregular periods in the past, this medicine may cause you to ovulate. This could increase your chance of becoming pregnant. If you are a woman who can become pregnant, you should discuss birth control options with your doctor.

Ensure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

It is very important to carefully follow any instructions from your doctor about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your doctor.
• Other medicines—Do not take other medicines unless you have discussed them 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. Diabetic patients may also need special counseling about changes in diabetes medicine dosing due to lifestyle changes, such as changes in exercise and diet. Additionally, counseling on contraception and pregnancy may be necessary because of the complications that can arise in diabetic patients during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for emergencies as you normally would. Make allowances for changing time zones and try to keep your meal times close to your usual schedule.
• 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 states you have diabetes and lists all of your medicines.
• Symptoms of fluid retention—Know what to do if you start to retain fluid. Fluid retention may worsen or lead to heart problems.

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, or take rosiglitazone with another type of diabetes medicine. The 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 to 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 changes similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty thinking, drowsiness, excessive hunger, fast heartbeat, ongoing headache, 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 drinks, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergencies 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. Family members should also know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your 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, fruity breath odor, increased urination (both frequency and amount), ketones in the 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 call your doctor for instructions.

In deciding to use a medicine, you need to consider the risks of taking it against the benefits it will provide. This decision should be made with your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how rosiglitazone affects children. Its safety and effectiveness have not been established for this age group.

Geriatric

Studies done so far have not shown any specific problems in older adults that would limit the usefulness of rosiglitazone.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together even if an interaction might happen. If you take this medicine, it is very important for your healthcare professional to know if you are taking any of the following medicines. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or how often you take one or both of the medicines.

• Abiraterone Acetate
• Ceritinib
• Chloroquine
• Chlorothiazide
• Chlorthalidone
• Ciprofloxacin
• Delafloxacin
• Enoxacin
• Entacapone
• Furosemide
• Gatifloxacin
• Gemfibrozil
• Gemifloxacin
• Grepafloxacin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroxychloroquine
• Indapamide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Lanreotide
• Letermovir
• Levofloxacin
• Lomefloxacin
• Metolazone
• Moxifloxacin
• Norfloxacin
• Octreotide
• Ofloxacin
• Omaveloxolone
• Pasireotide
• Phenobarbital
• Pixantrone
• Polythiazide
• Primidone
• Somatrogon-ghla
• Sparfloxacin
• Thioctic Acid
• Triamterene
• Trovafloxacin

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

• Acebutolol
• Atenolol
• Betaxolol
• Bisoprolol
• Bitter Melon
• Carteolol
• Carvedilol
• Celiprolol
• Esmolol
• Fenofibrate
• Fenofibric Acid
• Fenugreek
• Glucomannan
• Guar Gum
• Labetalol
• Levobunolol
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Penbutolol
• Pindolol
• Practolol
• Propranolol
• Psyllium
• Rifampin
• Sotalol
• Timolol
• Trimethoprim

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Severe and acute angina or
• Diabetic ketoacidosis (ketones in the blood) or
• Acute heart attack or
• Severe heart failure or with symptoms or
• Type 1 diabetes — This medicine should not be used in patients with these conditions.

• Patients with kidney disease -- This drug should not be used with metformin in these patients.

• Diabetic macular edema (swelling of the back of the eye) or
• Edema (fluid retention or swelling) or
• History of heart attack or
• History of heart disease or
• Liver disease—Use with caution. It may worsen these conditions.

• Fever or
• Infection or
• Surgery or
• Trauma—Use with caution. These conditions may cause problems with blood sugar control.

• Fragile bones (especially in women)—Use with caution. This medicine may increase the risk for fractures.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects occur:

Less common

• Abdominal or stomach pain
• blurred vision
• chest pain or discomfort
• decrease in the amount of urine
• dry mouth
• 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
• rapid or unusual weight gain
• sweating
• swelling of the fingers, hands, feet, or lower legs
• trouble breathing
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Rare

• Anxiety
• chills
• cold sweats
• coma
• confusion
• dark urine
• depression
• dizziness
• fast heartbeat
• headache
• loss of appetite
• 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 the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• itching or skin rash
• light-colored stools
• redness of the skin
• 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 gets used to the medicine. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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
• lightheadedness
• pain or tenderness around the eyes and cheekbones

Other side effects not listed may also happen 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.

In the U.S.

• Avandia

Chemical Class: Thiazolidinedione

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Ask your doctor if you have any questions.

This medicine may be taken with or without food.

Carefully follow the special diet your doctor gave you. This is the most important part of controlling your diabetes and will help the medicine work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

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: Adults—At first, 4 milligrams (mg) per day, taken as a single dose or divided into two doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 8 mg per day. 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.