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Avandamet (Rosiglitazone Maleate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

AVANDAMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both rosiglitazone and metformin is appropriate. [See Clinical Studies .]

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.
  • The use of AVANDAMET with nitrates is not recommended [see Warnings and Precautions].
  • 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 and Warnings and Precautions].

Patients Inadequately Controlled With 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 with diet and exercise alone, the recommended starting dose of AVANDAMET is 2mg/500mg administered once or twice daily. For patients with HbA1c >11% or fasting plasma glucose (FPG) >270mg/dL, a starting dose of 2mg/500mg twice daily may be considered. The dose of AVANDAMET may be increased in increments of 2mg/500mg per day given in divided doses if patients are not adequately controlled after 4weeks. The maximum dose of AVANDAMET is 8 mg/2,000 mg per day.

Patients Inadequately Controlled With 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.

For patients inadequately controlled on metformin monotherapy, the usual starting dose of AVANDAMET is 4mg rosiglitazone (total daily dose) plus the dose of metformin already being taken (see Table 1).

For patients inadequately controlled on rosiglitazone monotherapy, the usual starting dose of AVANDAMET is 1,000mg 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
Metformin*
1,000mg/day 2mg/500mg 1 tablet twice a day
2,000mg/day 2mg/1,000mg 1 tablet twice a day
Rosiglitazone
4mg/day 2mg/500mg 1 tablet twice a day
8mg/day 4mg/500mg 1 tablet twice a day

*For patients on doses of metformin between 1,000 and 2,000mg/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 4mg rosiglitazone and/or 500mg metformin.

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

Maximum Dose

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

DOSAGE FORMS AND STRENGTHS

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

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

HOW SUPPLIED/STORAGE AND HANDLING

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

2mg/500mg — pale pink, tablet, debossed with gsk on one side and 2/500 on the other.

4mg/500mg — orange, tablet, debossed with gsk on one side and 4/500 on the other.

2mg/1,000mg — yellow, tablet, debossed with gsk on one side and 2/1000 on the other.

4mg/1,000mg — pink, tablet, debossed with gsk on one side and 4/1000 on the other.

2mg/500mg bottles of 60: NDC 0007-3167-18

4mg/500mg bottles of 60: NDC 0007-3168-18

2mg/1,000mg bottles of 60: NDC 0007-3163-18

4mg/1,000mg bottles of 60: NDC 0007-3164-18

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

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