Avandamet

[rosiglitazone maleate and metformin HCl]

Specific Patient Populations:

AVANDAMET is not recommended for use in pregnancy or for use in pediatric patients.

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. 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).

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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) (see PRECAUTIONS, Hepatic Effects and CLINICAL PHARMACOLOGY, Hepatic Impairment). Liver enzyme monitoring is recommended in all patients prior to initiation of therapy with AVANDAMET and periodically thereafter (see PRECAUTIONS, Hepatic Effects).

HOW SUPPLIED

Tablets: Each tablet contains rosiglitazone as the maleate and metformin hydrochloride as follows:
1 mg/ 500 mg - yellow, film-coated oval tablet, debossed with gsk on one side and 1/ 500 on the other.
2 mg/ 500 mg - pale pink, film-coated oval tablet, debossed with gsk on one side and 2/ 500 on the other.
4 mg/ 500 mg - orange, film-coated oval tablet, debossed with gsk on one side and 4/ 500 on the other.
2 mg/ 1,000 mg - yellow, film-coated oval tablet, debossed with gsk on one side and 2/ 1000 on the other.
4 mg/ 1,000 mg - pink, film-coated oval tablet, debossed with gsk on one side and 4/ 1000 on the other.
1 mg/ 500 mg bottles of 60: NDC 0007-3166-18
1 mg/ 500 mg bottles of 100: NDC 0007-3166-20
1 mg/ 500 mg SUP 100s: NDC 0007-3166-21
2 mg/ 500 mg bottles of 60: NDC 0007-3167-18
2 mg/ 500 mg bottles of 100: NDC 0007-3167-20
2 mg/ 500 mg SUP 100s: NDC 0007-3167-21
4 mg/ 500 mg bottles of 60: NDC 0007-3168-18
4 mg/ 500 mg bottles of 100: NDC 0007-3168-20
4 mg/ 500 mg SUP 100s: NDC 0007-3168-21
2 mg/ 1,000 mg bottles of 60: NDC 0007-3163-18
2 mg/ 1,000 mg bottles of 100: NDC 0007-3163-20
4 mg/ 1,000 mg bottles of 60: NDC 0007-3164-18
4 mg/ 1,000 mg bottles of 100: NDC 0007-3164-20
STORAGE Store at 25 C (77 F); excursions permitted to 15 to 30 C (59 to 86 F).
Dispense in a tight, light-resistant container.
GLUCOPHAGE is a registered trademark of Merck Santé S. A. S., an associate of Merck KGaA
of Darmstadt, Germany. Licensed to Bristol-Myers Squibb Company.
GlaxoSmithKline
Research Triangle Park, NC 27709
AVANDAMET is a registered trademark of GlaxoSmithKline.
2004, GlaxoSmithKline. All rights reserved.
February 2004 AT: L4 25

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