Rosiglitazone and glimepiride

Take rosiglitazone and glimepiride 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.

rosiglitazone and glimepiride 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.

rosiglitazone and glimepiride 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 rosiglitazone and glimepiride 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 rosiglitazone and glimepiride. 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 rosiglitazone and glimepiride, 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.

• Tell all of your health care providers that you take rosiglitazone and glimepiride. This includes your doctors, nurses, pharmacists, and dentists.
• Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
• Be careful if you have G6PD deficiency. Anemia may happen.
• Check your blood sugar as you have been told by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have an eye exam as you have been told by your doctor.
• Talk with your doctor before you drink alcohol.
• Follow the diet and workout plan that your doctor told you about.
• If you also take colesevelam, take it at least 4 hours after you take this medicine.
• This medicine may raise the chance of death from heart disease. Talk with your doctor.
• It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor.
• This medicine may raise the chance of broken bones. The chance may be higher in women. Broken bones were seen after people took rosiglitazone and glimepiride for 1 year. Most of the broken bones happened in the upper arm, hand, or foot. Talk with your doctor about how to keep your bones healthy or if you have any questions.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Do not give to a child. Talk with your doctor.
• There is a chance of pregnancy in women of childbearing age who have not been ovulating. If you want to avoid pregnancy, use birth control that you can trust while taking rosiglitazone and glimepiride.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

(roh si GLI ta zone & GLYE me pye ride)

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Avandaryl: 4 mg/1 mg: Rosiglitazone 4 mg and glimepiride 1 mg [DSC]

Avandaryl: 4 mg/2 mg: Rosiglitazone 4 mg and glimepiride 2 mg [DSC]

Avandaryl: 4 mg/4 mg: Rosiglitazone 4 mg and glimepiride 4 mg [DSC]

Avandaryl: 8 mg/2 mg: Rosiglitazone 8 mg and glimepiride 2 mg [DSC]

Avandaryl: 8 mg/4 mg: Rosiglitazone 8 mg and glimepiride 4 mg [DSC]

Rosiglitazone 4 mg and glimepiride 1 mg once daily; carefully titrate dose.

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.

Percentages below refer to combination Avandaryl. Also see individual agents.

1% to 10%:

Cardiovascular: Edema (3%), cardiac failure(≤3%), myocardial infarction (≤3%), hypertension (2% to 3%), cerebrovascular accident (≤2%)

Central nervous system: Headache (3% to 6%)

Endocrine & metabolic: Hypoglycemia (4% to 6%)

Neuromuscular & skeletal: Bone fracture (≤8%; incidence greater in females; usually upper limbs or distal lower limbs)

Respiratory: Nasopharyngitis (4% to 5%)

<1% (Limited to important or life-threatening): Cardiac failure, increased serum ALT, weight gain

Hemoglobin A1c (at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with therapy change [ADA 2017a]), fasting serum glucose

Liver enzymes (prior to initiation of therapy, then periodically thereafter); evaluate patients with ALT ≤2.5 times ULN at baseline or during therapy for cause of enzyme elevation. Patients with an elevation in ALT >3 times ULN should be rechecked as soon as possible. If the ALT levels remain >3 times ULN, therapy should be discontinued.

Blood pressure; signs and symptoms of fluid retention or heart failure, weight gain; signs and symptoms of hypoglycemia (fatigue, excessive hunger, profuse sweating, numbness of extremities); ophthalmic exams

Animal reproduction studies have not been conducted with this combination. See individual agents.