Avandia

[Rosiglitazone maleate]

Overdosage & Contraindications
CONTRAINDICATIONS

AVANDIA is contraindicated in patients with known hypersensitivity to this product or any of its components.

OVERDOSAGE

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Limited data are available with regard to overdosage in humans. In clinical studies in volunteers, AVANDIA has been administered at single oral doses of up to 20 mg and was well-tolerated. In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient's clinical status.

HOW SUPPLIED

Tablets: Each pentagonal film-coated TILTAB tablet contains rosiglitazone as the maleate as follows: 2 mg– pink, debossed with SB on one side and 2 on the other; 4 mg– orange, debossed with SB on one side and 4 on the other; 8 mg– red-brown, debossed with SB on one side and 8 on
the other.
2 mg bottles of 30: NDC 0029-3158-13
2 mg bottles of 60: NDC 0029-3158-18
2 mg bottles of 100: NDC 0029-3158-20
2 mg bottles of 500: NDC 0029-3158-25
2 mg SUP 100s: NDC 0029-3158-21

4 mg bottles of 30: NDC 0029-3159-13
4 mg bottles of 60: NDC 0029-3159-18
4 mg bottles of 100: NDC 0029-3159-20
4 mg bottles of 500: NDC 0029-3159-25
4 mg SUP 100s: NDC 0029-3159-21

8 mg bottles of 30: NDC 0029-3160-13
8 mg bottles of 100: NDC 0029-3160-20
8 mg bottles of 500: NDC 0029-3160-25
8 mg SUP 100s: NDC 0029-3160-21

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

AVANDIA and TILTAB are registered trademarks of GlaxoSmithKline.
DATE OF ISSUANCE MAR. 2003
©2003, GlaxoSmithKline
All rights reserved.

GlaxoSmithKline
Research Triangle Park, NC 27709