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Iressa

[gefitinib tablets]

In patients receiving a potent CYP3A4 inducer such as rifampicin or phenytoin, a dose increase to 500 mg daily should be considered in the absence of severe adverse drug reaction, and clinical response and adverse events should be carefully monitored (see CLINICAL PHARMACOLOGY-Pharmacokinetics- Drug-Drug Interactions and PRECAUTIONS-Drug Interactions sections). No dosage adjustment is required on the basis of patient age, body weight, gender, ethnicity, or renal function; or in patients with moderate to severe hepatic impairment due to liver metastases (see CLINICAL PHARMACOLOGY-Pharmacokinetics-Special Populations section).

HOW SUPPLIED

IRESSA tablets are supplied as round, biconvex, brown film- coated tablets intagliated with "IRESSA 250" on one side and plain on the other side, each containing 250 mg of gefitinib. Bottles of 30 Tablets (NDC 0310-0482- 30) Storage Store at controlled room temperature 20-25° C (68-77° F) [see USP]. All trademarks are the property of the AstraZeneca group (c) AstraZeneca 2003

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