What brand names are available for rosiglitazone/metformin?
Is rosiglitazone/metformin available as a generic drug?
Do I need a prescription for rosiglitazone/metformin?
What are the side effects of rosiglitazone/metformin?
The most common side effects include
Taking Avandamet with food may help lessen some of
these side effects. Other commonly reported side effects include
Rare but serious side effects include new or
Metformin can cause a rare but serious condition known as lactic acidosis, a
build-up of acid in the blood. Lactic acidosis can cause death and requires
immediate treatment. Symptoms of lactic acidosis include
Patients suspected of have signs or symptoms of
lactic acidosis must seek emergency medical help.
What is the dosage for rosiglitazone/metformin?
The dosage of Avandamet should be individualized based on patient
response and tolerability. It is generally given in divided doses with meals.
For patients inadequately controlled on diet and exercise
- Generally, the recommended starting dose of Avandamet is 2/500 mg
administered once or twice daily.
- A starting dose of 2/500 mg twice daily may be considered for patients with
HbA1c >11% or fasting plasma glucose (FPG) >270 mg//dL.
- If patients are not adequately controlled after 4 weeks of treatment the
dosage may be increased in increments of 2/500 mg as necessary.
- The maximum daily dose of Avandamet is 8/2,000 mg.
For patients inadequately controlled on rosiglitazone or metformin
- The selection of the dose of Avandamet must be based on the patient’s current
doses of rosiglitazone and/or metformin.
- To switch to Avandamet for patients currently treated with metformin
- The usual starting dose of Avandamet is 4 mg rosiglitazone and base the
metformin dose on the current dose of metformin.
- To switch to Avandamet for patients currently treated with rosiglitazone
- The usual starting dose of Avandamet is 1,000 mg metformin and the
corresponding dose of rosiglitazone that the patient is taking.
The safety and efficacy of Avandamet has not been established in pediatric
patients. Therefore, use of Avandamet in this patient population is not
Metformin-containing drugs may be safely used in patients with mild to moderate renal impairment. Renal function should be assessed before starting treatment and at least yearly.
Metformin should not be used by patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m2 and starting metformin in patients with an eGFR between 30-45 mL/minute/1.73 m2 is not recommended.
Metformin should be stopped at the time of or before administering iodinated contrast in patients with an eGFR between 30 and 60 mL/minute/1.73 m2; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Kidney function should be evaluated 48 hours after receiving contrast and metformin may be restarted if kidney function is stable.
Which drugs or supplements interact with rosiglitazone/metformin?
Rosiglitazone is extensively metabolized or broken down by a group of liver
enzymes known as CYP2C8. Gemfibrozil (Lopid), a known inhibitor of CYP2C8 may
increase blood levels of rosiglitazone and consequently increase the risk of
side effects. Concomitant use of agents that also inhibit CYP2C8 requires a
reduction in the dose of rosiglitazone.
Rifampin (Rimactane or Rifadin), a known inducer of CYP2C8, increases the
breakdown of rosiglitazone. Therefore, concomitant use of agents that induce
CYP2C8 may decrease the effectiveness of rosiglitazone.
Drugs which cause blood glucose levels to increase may diminish the
effectiveness of Avandamet therapy. These drugs include
Is rosiglitazone/metformin safe to take if I’m pregnant or breastfeeding?
- Avandamet has not been adequately evaluated in
pregnant women. Due
to the lack of conclusive safety data, Avandamet should be used in pregnancy
only if the potential benefit justifies the potential risk to the fetus.
Avandamet is classified as FDA pregnancy risk category C.
- It is not known if Avandamet is excreted in breast milk. Due
to the lack of safety data, Avandamet is not recommended for use in
What else should I know about rosiglitazone/metformin?
What preparations of rosiglitazone/metformin are available?
Oral tablets containing Avandamet: 2/500, 4/500, 2/1,000, and
How should I keep rosiglitazone/metformin stored?
- Tablets should be stored at room temperature, between 15 C and 30 C (59
F and 86 F).
- Tablets should be dispensed and stored in an air-tight,
Medically Reviewed on 9/4/2019
FDA Prescribing Information