Rosiglitazone and glimepiride (Oral)

Rosiglitazone and glimepiride combination is used to treat a type of diabetes mellitus known as 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. Glimepiride encourages the pancreas to release insulin, which helps your body convert food into energy.

This medicine is only available 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 quickly gaining weight or having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or severe swelling of the hands, wrists, ankles, or feet, check with your doctor right away. 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.

Check with your doctor right away if you experience blurred vision, difficulty in reading, or any other change in vision while taking this medicine. Your doctor may want you to have your eyes checked by 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 ovulating and had 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.

This medicine may make your skin more sensitive to sunlight. Use sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Make sure 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 they have been discussed with your doctor. This 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. Additionally, diabetic patients may need special counseling about diabetes medicine dosing changes that might occur due to lifestyle changes, such as changes in exercise and diet. Counseling on contraception and pregnancy may also be needed because of the risks that can arise in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you normally would. Adjust for changing time zones and try to keep your meal times as close as possible to your usual schedule.
• In case of emergency—There may be times 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 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 can cause hypoglycemia (low blood sugar). Low blood sugar can also happen if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat due to nausea or vomiting. The symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people experience different symptoms of low blood sugar. It is important for you to learn which symptoms of low blood sugar you usually have so 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, continuing 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 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. 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, fruit-like 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 and your doctor need to weigh the risks of taking the medicine against the benefits it may provide. Consider the following points for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions 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 over-the-counter products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to determine how age affects the use of rosiglitazone and glimepiride combination in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not identified any specific issues in older adults that would limit the usefulness of rosiglitazone and glimepiride combination. However, older patients may be more likely to have age-related kidney problems, which may require careful monitoring and dose adjustments.

Breast Feeding

There are not enough 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 during breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if interactions could happen. In these cases, your doctor might adjust the dose or take other precautions. It's very important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions are significant and may not include all possible interactions.

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, your doctor may adjust the dose or how often you take one or both medicines.

• Abiraterone Acetate
• Alogliptin
• Aspirin
• Bexagliflozin
• Capecitabine
• Ceritinib
• Chloroquine
• Chlorothiazide
• Chlorthalidone
• Ciprofloxacin
• Delafloxacin
• Desmopressin
• Disopyramide
• Dulaglutide
• Enoxacin
• Entacapone
• Fluconazole
• 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
• Isoniazid
• Ivacaftor
• Lanreotide
• Letermovir
• Levofloxacin
• Levoketoconazole
• Liraglutide
• Lixisenatide
• Lomefloxacin
• Mavacamten
• Metformin
• Methotrexate
• Metolazone
• Metreleptin
• Miconazole
• Moxifloxacin
• Norfloxacin
• Octreotide
• Ofloxacin
• Omaveloxolone
• Pasireotide
• Phenobarbital
• Pioglitazone
• Pixantrone
• Polythiazide
• Porfimer
• Pramlintide
• Primidone
• Semaglutide
• Sitagliptin
• Somatrogon-ghla
• Sotagliflozin
• Sparfloxacin
• Sparsentan
• Thioctic Acid
• Triamterene
• Trovafloxacin
• Voriconazole

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

• Acebutolol
• Aminolevulinic Acid
• 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
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Psyllium
• Rasagiline
• Rifampin
• Safinamide
• Saxagliptin
• Selegiline
• Sotalol
• Timolol
• Tirzepatide
• Tranylcypromine
• Trimethoprim

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as certain foods, or alcohol and tobacco, because interactions may occur. The following interactions are significant and may not include all possible interactions.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may adjust the dose or give you specific instructions about using food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

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

• Adrenal gland problem (underactive) or
• Glucose 6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem), history of or
• Kidney problems or
• Pituitary gland problem (underactive) or
• Poorly nourished condition or
• Weakened physical condition—Use with caution. May worsen side effects.

• Allergy to sulfa drugs, history of or
• Severe and acute angina or
• Diabetic ketoacidosis (ketones in the blood) or
• Acute heart attack or
• Severe heart failure or with symptoms or
• Active liver disease or
• Type 1 diabetes—Should not be used in these conditions.

• 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. May worsen these conditions.

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

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

Along with its required effects, a 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 immediately if any of the following side effects occur:

More common

• Body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• fever
• headache
• injury
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

Less common

• Anxiety
• blurred vision
• chest pain or discomfort
• cold sweats
• coma
• confusion
• cool, pale skin
• decreased urine output
• depression
• dilated neck veins
• dizziness
• extreme fatigue
• fast heartbeat
• increased hunger
• irregular breathing
• irregular heartbeat
• nausea
• nightmares
• seizures
• shakiness
• slurred speech
• swelling of the face, fingers, feet, or lower legs
• tightness in the chest
• troubled breathing with exertion
• unusual bleeding or bruising
• weight gain

Incidence not known

• Abdominal or stomach pain or tenderness
• agitation
• back, leg, or stomach pains
• bleeding gums
• bloody, black, or tarry stools
• blue lips and fingernails
• coughing that sometimes produces a pink frothy sputum
• dark urine
• decreased appetite
• difficult, fast, or noisy breathing
• fluid-filled skin blisters
• general body swelling
• hostility
• increased sweating
• increased thirst
• irritability
• itching or skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• loss of appetite
• muscle pain or cramps
• muscle twitching
• nosebleeds
• pain or discomfort in the arms, jaw, back, or neck
• redness of the skin
• seizures
• sensitivity to the sun
• skin thinness
• sores, ulcers, or white spots on the lips or in the mouth
• stupor
• sweating
• swollen glands
• vomiting
• 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:

Less common

• Lack or loss of strength

Rare

• Burning, stinging, itching, or redness of the skin not present before treatment

Incidence not known

• Diarrhea

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.

In the U.S.

• Avandaryl

Chemical Class: 2nd Generation Sulfonylurea

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 should be taken with the first meal of the day.

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.

If you are also taking colesevelam (Welchol®), take Avandaryl® at least 4 hours before taking colesevelam.

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 already taking glimepiride or rosiglitazone alone: Adults—At first, rosiglitazone 4 milligrams (mg) plus glimepiride 1 mg or rosiglitazone 4 mg plus glimepiride 2 mg once a day, as directed by your doctor. Your doctor may adjust your dose as needed. However, the dose is usually not more than rosiglitazone 8 mg plus glimepiride 4 mg per day. Children—Use and dose must be determined by your doctor. For patients switching from a combination of glimepiride and rosiglitazone as separate tablets: Adults—The dose is the same as the dose you are already taking. Your doctor may adjust your dose as needed. However, the dose is usually not more than rosiglitazone 8 mg plus glimepiride 4 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.