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Avandamet

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Avandamet

INDICATIONS

AVANDAMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Important Limitations of Use

  • Due to its mechanism of action, rosiglitazone is active only in the presence of endogenous insulin. Therefore, AVANDAMET should not be used in patients with type 1 diabetes.
  • Coadministration of AVANDAMET with insulin is not recommended [see WARNINGS AND PRECAUTIONS].

DOSAGE AND ADMINISTRATION

The dosage of antidiabetic therapy with AVANDAMET should be individualized on the basis of effectiveness and tolerability. The risk-benefit of initiating monotherapy versus dual therapy with AVANDAMET should be considered.

Starting Dose

AVANDAMET is generally given in divided doses with meals.

All patients should start the rosiglitazone component of AVANDAMET at the lowest recommended dose. Further increases in the dose of rosiglitazone should be accompanied by careful monitoring for adverse events related to fluid retention [see BOXED WARNING, WARNINGS AND PRECAUTIONS].

Patients Inadequately Controlled on Diet and Exercise

If therapy with a combination tablet containing rosiglitazone and metformin is considered appropriate for a patient with type 2 diabetes mellitus inadequately controlled on diet and exercise alone, the recommended starting dose of AVANDAMET is 2 mg/500 mg administered once or twice daily. For patients with HbA1c >11% or fasting plasma glucose (FPG) >270 mg/dL, a starting dose of 2 mg/500 mg twice daily may be considered. The dose of AVANDAMET may be increased in increments of 2 mg/500 mg per day given in divided doses if patients are not adequately controlled after 4 weeks. The maximum dose of AVANDAMET is 8 mg/2,000 mg per day.

Patients Inadequately Controlled on Rosiglitazone or Metformin Monotherapy

If therapy with a combination tablet containing rosiglitazone and metformin is considered appropriate for a patient with type 2 diabetes mellitus inadequately controlled on rosiglitazone or metformin monotherapy, then the selection of the dose of AVANDAMET should 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 (total daily dose) plus the dose of metformin already being taken (see Table 1).

To switch to AVANDAMET for patients currently treated with rosiglitazone, the usual starting dose of AVANDAMET is 1,000 mg metformin (total daily dose) plus the dose of rosiglitazone already being taken (see Table 1).

When switching from combination therapy of rosiglitazone plus metformin as separate tablets, the usual starting dose of AVANDAMET is the dose of rosiglitazone and metformin already being taken.

Table 1: AVANDAMET Starting Dose for Patients Treated With Metformin and/or Rosiglitazone

PRIOR THERAPY Usual AVANDAMET Starting Dose
Total Daily Dose Tablet Strength Number of Tablets
Metformina
1,000 mg/day 2 mg/500 mg 1 tablet twice a day
2,000 mg/day 2 mg/1,000 mg 1 tablet twice a day
Rosiglitazone
4 mg/day 2 mg/500 mg 1 tablet twice a day
8 mg/day 4 mg/500 mg 1 tablet twice a day
aFor patients on doses of metformin between 1,000 and 2,000 mg/day, initiation of AVANDAMET requires individualization of therapy.

Dose Titration

AVANDAMET is generally given in divided doses with meals, with gradual dose escalation. This reduces gastrointestinal side effects (largely due to metformin) and permits determination of the minimum effective dose for the individual patient.

Sufficient time should be given to assess adequacy of therapeutic response. FPG should be used initially to determine the therapeutic response to AVANDAMET. If additional glycemic control is needed, the daily dose of AVANDAMET may be increased by increments of 4 mg rosiglitazone and/or 500 mg metformin.

After an increase in metformin dosage, dose titration is recommended if patients are not adequately controlled after 1 to 2 weeks. After an increase in rosiglitazone dosage, dose titration is recommended if patients are not adequately controlled after 8 to 12 weeks.

Maximum Dose

The maximum recommended total daily dose of AVANDAMET is 8 mg rosiglitazone (taken as 4 mg twice daily) and 2,000 mg metformin (taken as 1,000 mg twice daily).

Specific Patient Populations

Renal Impairment

Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of AVANDAMET. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly [see WARNINGS AND PRECAUTIONS].

Hepatic Impairment

Liver enzymes should be measured prior to initiating treatment with AVANDAMET. Therapy with AVANDAMET should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT >2.5X upper limit of normal at start of therapy). After initiation of AVANDAMET, liver enzymes should be monitored periodically per the clinical judgment of the healthcare professional [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].

Geriatric

The initial and maintenance dosing of AVANDAMET should be conservative in patients with advanced age, due to the potential for decreased renal function in this population.

Pediatric

Safety and effectiveness of AVANDAMET in pediatric patients have not been established. AVANDAMET and rosiglitazone are not recommended for use in pediatric patients.

Pregnancy

AVANDAMET is not recommended for use in pregnancy.

HOW SUPPLIED

Dosage Forms And Strengths

Each film-coated oval tablet contains rosiglitazone as the maleate and metformin hydrochloride as follows:

  • 2 mg/500 mg - pale pink, debossed with gsk on one side and 2/500 on the other
  • 4 mg/500 mg - orange, debossed with gsk on one side and 4/500 on the other
  • 2 mg/1,000 mg - yellow, debossed with gsk on one side and 2/1000 on the other
  • 4 mg/1,000 mg - pink, debossed with gsk on one side and 4/1000 on the other

Storage And Handling

Each film-coated oval tablet contains rosiglitazone as the maleate and metformin hydrochloride as follows:

2 mg/500 mg - pale pink, tablet, debossed with gsk on one side and 2/500 on the other.
4 mg/500 mg - orange, tablet, debossed with gsk on one side and 4/500 on the other.
2 mg/1,000 mg - yellow, tablet, debossed with gsk on one side and 2/1000 on the other.
4 mg/1,000 mg - pink, tablet, debossed with gsk on one side and 4/1000 on the other.

2 mg/500 mg bottles of 60: NDC 0173-0837-18
4 mg/500 mg bottles of 60: NDC 0173-0839-18
2 mg/1,000 mg bottles of 60: NDC 0173-0838-18
4 mg/1,000 mg bottles of 60: NDC 0173-0840-18

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Dispense in a tight, light-resistant container.

GlaxoSmithKline, Research Triangle Park, NC 27709. May 2014

Last reviewed on RxList: 5/28/2014
This monograph has been modified to include the generic and brand name in many instances.

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