Rosiglitazone and metformin (Oral)

Rosiglitazone and metformin combination is used to treat a type of diabetes called type 2 diabetes. It is used along with a proper diet and exercise to help control blood sugar levels.

Rosiglitazone helps your body use insulin more effectively. Metformin reduces how much sugar is absorbed from the stomach, lowers the release of stored sugar from the liver, and helps your body use sugar 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. You may need blood and urine tests to check for unwanted effects.

Call your doctor right away if you experience 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 having trouble breathing, feeling chest pain or discomfort, extreme tiredness or weakness, irregular breathing, an irregular heartbeat, or excessive swelling in the hands, wrists, ankles, or feet, contact your doctor immediately. These may indicate a heart problem or edema (fluid retention).

Inform your doctor or dentist that you are taking this medicine. Your doctor may recommend stopping this medicine before major surgery or diagnostic tests, especially those using a contrast dye.

In some cases, taking too much metformin can lead to a serious condition called lactic acidosis. The symptoms of lactic acidosis are severe and develop quickly. This condition usually happens when other serious health issues are present, such as a heart attack or kidney failure. Symptoms of lactic acidosis include: abdominal or stomach discomfort, decreased appetite, diarrhea, fast or shallow breathing, a general feeling of discomfort, muscle pain or cramping, and unusual sleepiness, tiredness, or weakness. If you experience more than one of these symptoms at the same time, seek emergency medical help immediately.

If you have abdominal or stomach pain, dark urine, loss of appetite, nausea or vomiting, unusual tiredness or weakness, or yellowing of the eyes or skin, contact your doctor right away. These may indicate a serious liver problem.

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

Certain women may be at an increased 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 chances of becoming pregnant. If you are a woman who can become pregnant, discuss birth control options with your doctor.

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

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

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

• 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 includes nonprescription medicines like aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members should learn how to prevent side effects or assist with side effects if they occur. Patients with diabetes may require special counseling regarding changes in dosing due to lifestyle adjustments, such as changes in exercise and diet. Counseling on contraception and pregnancy may also be needed due to potential complications in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for emergencies as you normally would. Make adjustments for changing time zones and try to maintain your usual meal times.
• In case of emergency—Be prepared for diabetes-related emergencies. It is advisable to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that indicates you have diabetes and lists all of your medicines.
• Symptoms of fluid retention—Know what to do if you begin to retain fluid. Fluid retention may worsen or lead to heart problems.

This medicine may cause hypoglycemia (low blood sugar). This is more likely when this medicine is taken with certain other medicines. Low blood sugar must be treated before it leads to unconsciousness. People can experience different symptoms of low blood sugar. It is important for you to learn which symptoms you typically have so you can treat it quickly. Discuss with your doctor the best way to treat low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough medicine or skip a dose, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated immediately. It is important for you to recognize your symptoms to treat it quickly. Talk to your doctor about the best way to manage high blood sugar.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. 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 inform your healthcare 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

There have not been any appropriate studies on how rosiglitazone and metformin combination affects children. Safety and effectiveness have not been established.

Geriatric

Studies so far have not shown any problems specific to older adults that would limit the usefulness of rosiglitazone and metformin combination in the elderly. However, older patients are more likely to have kidney problems related to age, which may require caution and a dose adjustment for those taking rosiglitazone and metformin combination.

Breast Feeding

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

Interactions with Medicines

While some medicines should never be used together, in other situations, two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or take other precautions. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acetrizoic Acid
• Diatrizoate
• Ethiodized Oil
• Iobenzamic Acid
• Iobitridol
• Iocarmic Acid
• Iocetamic Acid
• Iodamide
• Iodipamide
• Iodixanol
• Iodohippuric Acid
• Iodopyracet
• Iodoxamic Acid
• Ioglicic Acid
• Ioglycamic Acid
• Iohexol
• Iomeprol
• Iopamidol
• Iopanoic Acid
• Iopentol
• Iophendylate
• Iopronic Acid
• Ioseric Acid
• Iosimide
• Iotasul
• Iothalamate
• Iotrolan
• Iotroxic Acid
• Ioxaglate
• Ioxitalamic Acid
• Ipodate
• Metrizamide
• Metrizoic Acid
• Tyropanoate Sodium

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

• Abiraterone Acetate
• Acetazolamide
• Alogliptin
• Aspirin
• Bexagliflozin
• Bictegravir
• Brinzolamide
• Bupropion
• Capmatinib
• Ceritinib
• Chloroquine
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Cimetidine
• Ciprofloxacin
• Dasabuvir
• Delafloxacin
• Dichlorphenamide
• Dofetilide
• Dolutegravir
• Dorzolamide
• Enoxacin
• Entacapone
• Fedratinib
• Fexinidazole
• Furosemide
• Gatifloxacin
• Gemfibrozil
• Gemifloxacin
• Glimepiride
• Glipizide
• Glyburide
• Grepafloxacin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroxychloroquine
• Indapamide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Iopromide
• Ioversol
• Isavuconazole
• Lanreotide
• Letermovir
• Levofloxacin
• Levoketoconazole
• Liraglutide
• Lomefloxacin
• Methazolamide
• Metolazone
• Moxifloxacin
• Nateglinide
• Norfloxacin
• Octreotide
• Ofloxacin
• Omaveloxolone
• Ombitasvir
• Paritaprevir
• Pasireotide
• Phenobarbital
• Pioglitazone
• Pixantrone
• Polythiazide
• Pramlintide
• Primidone
• Ranolazine
• Repaglinide
• Semaglutide
• Sitagliptin
• Somatrogon-ghla
• Sotagliflozin
• Sparfloxacin
• Tafenoquine
• Thioctic Acid
• Tolazamide
• Tolbutamide
• Topiramate
• Triamterene
• Trovafloxacin
• Vandetanib
• Zonisamide

Using this medicine with any of the following medicines may increase the 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 take one or both of the medicines.

• Acebutolol
• Atenolol
• Betaxolol
• Bisoprolol
• Bitter Melon
• Carteolol
• Carvedilol
• Celiprolol
• Colesevelam
• Esmolol
• Fenofibrate
• Fenofibric Acid
• Fenugreek
• Glucomannan
• Guar Gum
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Methylene Blue
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Ozanimod
• Patiromer
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Psyllium
• Rasagiline
• Rifampin
• Safinamide
• Selegiline
• Sotalol
• Timolol
• Tirzepatide
• Tranylcypromine
• Trimethoprim
• Verapamil

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating or with certain types of food, as interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions have been chosen based on their potential significance and may not include all possible interactions.

Other Medical Problems

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

• Adrenal gland problem (underactive) or
• Alcohol abuse, history of or
• Severe dehydration or
• Pituitary gland problem (underactive) or
• Poorly nourished condition or
• Sepsis (severe infection) or
• Weakened physical condition—Use with caution. May cause side effects to worsen.

• Anemia (low red blood cells) or
• Diabetic macular edema (swelling in the back of the eye) or
• Edema (fluid retention or swelling) or
• History of heart attack or
• History of heart disease or
• Vitamin B12 deficiency—Use with caution. May make these conditions worse.

• Severe and acute angina or
• Diabetic ketoacidosis (high ketones in the blood) or
• Acute heart attack or
• Severe heart failure or with symptoms or
• Severe kidney disease or
• Liver disease or
• Metabolic acidosis (acid in the blood) or
• Type 1 diabetes—Should not be used in patients with these conditions.

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

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

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

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

More common

• Pale skin
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Anxiety
• blurred vision
• chest pain or discomfort
• chills
• cold sweats
• coma
• confusion
• cool, pale skin
• depression
• dilated neck veins
• dizziness
• extreme fatigue
• fast heartbeat
• headache
• increased hunger
• irregular breathing
• irregular heartbeat
• nausea
• nightmares
• seizures
• shakiness
• slurred speech
• swelling of the face, fingers, feet, or lower legs
• weight gain

Rare

• Abdominal or stomach discomfort
• decreased appetite
• diarrhea
• fast, shallow breathing
• general feeling of discomfort
• muscle pain or cramping
• sleepiness

Incidence not known

• Change in vision
• dark urine
• decreased urine output
• hives or welts, itching, or skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• pain or discomfort in the arms, jaw, back, or neck
• redness of the skin
• stomach pain
• sweating
• vomiting

Some side effects may happen 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 how 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

• Body aches or pain
• cough, fever, sneezing, or sore throat
• difficulty with breathing
• ear congestion
• loss of voice
• pain or tenderness around the eyes and cheekbones
• stuffy or runny nose

Less common

• Back pain
• cold or flu-like symptoms
• difficulty with moving
• pain in the joints

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 can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Avandamet

Available Dosage Forms:

• Tablet

Therapeutic Class: Hypoglycemic

Chemical Class: Metformin

Use 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 should be taken with meals to help reduce the unwanted stomach effects that may occur during the first few weeks.

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: For patients inadequately controlled on diet and exercise: Adults—At first, rosiglitazone 2 milligrams (mg) plus metformin 500 mg once or two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than rosiglitazone 8 mg plus metformin 2000 mg per day, divided into two doses. Children—Use and dose must be determined by your doctor. For patients on metformin therapy: Adults—rosiglitazone 4 milligrams (mg) per day plus the dose of metformin already being taken, divided into two doses. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor. For patients on rosiglitazone therapy: Adults—metformin 1000 milligrams (mg) per day plus the dose of rosiglitazone already being taken, divided into two doses. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor. For patients previously treated with rosiglitazone and metformin: Adults—The dose is the same as the dose you are already taking. Your doctor may adjust your dose as needed. 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.