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Avandamet Dosage

Generic name: rosiglitazone maleate and metformin hydrochloride
Dosage form: tablet, film coated

This dosage information does not include all the information needed to use Avandamet safely and effectively. See full prescribing information for Avandamet.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

​Prior to prescribing AVANDAMET, refer to Indications and Usage (1) for appropriate patient selection. Only prescribers enrolled in the AVANDIA-Rosiglitazone Medicines Access Program can prescribe AVANDAMET [see Warnings and Precautions (5.4)].

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 (5.5)].

If therapy with a combination tablet containing rosiglitazone and metformin is considered appropriate for a patient with type 2 diabetes mellitus, 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 (5.1)].

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 (5.7) and Clinical Pharmacology (12.3)].

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.

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