CAPECITABINE tablet film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

CAPECITABINE (UNII: 6804DJ8Z9U) (CAPECITABINE - UNII:6804DJ8Z9U)

Tillgänglig från:

AvKARE, Inc.

INN (International namn):

CAPECITABINE

Sammansättning:

CAPECITABINE 150 mg

Receptbelagda typ:

PRESCRIPTION DRUG

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

CAPECITABINE - CAPECITABINE TABLET, FILM COATED
AVKARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CAPECITABINE TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CAPECITABINE TABLETS
USP.
CAPECITABINE TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: CAPECITABINE-WARFARIN INTERACTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
PATIENTS RECEIVING CONCOMITANT CAPECITABINE AND ORAL
COUMARIN-DERIVATIVE ANTICOAGULANTS SUCH AS
WARFARIN AND PHENPROCOUMON SHOULD HAVE THEIR ANTICOAGULANT RESPONSE
(INR OR PROTHROMBIN TIME)
MONITORED FREQUENTLY IN ORDER TO ADJUST THE ANTICOAGULANT DOSE
ACCORDINGLY. ALTERED COAGULATION
PARAMETERS AND/OR BLEEDING, INCLUDING DEATH, HAVE BEEN REPORTED DURING
CONCOMITANT USE.
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RECENT MAJOR CHANGES
Dosage and Administration (2) 10/2014
Warnings and Precautions (5.1, 5.2, 5.5, and 5.7) 10/2014
INDICATIONS AND USAGE
Capecitabine Tablets USP are a nucleoside metabolic inhibitor with
antineoplastic activity indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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OCCURRENCE: WITHIN SEVERAL DAYS AND UP TO SEVERAL MONTHS AFTER
INITIATING CAPECITABINE THERAPY; MAY
ALSO BE SEEN WITHIN 1 MONTH AFTER STOPPING CAPECITABINE
PREDISPOSING FACTORS: AGE> 60 AND DIAGNOSIS OF CANCER
ADJUVANT COLON CANCER (1.1)
Patients with Dukes' C colon cancer
METASTATIC COLORECTAL CANCER (1.1)
First-line as monotherapy when treatment with fluoropyrimidine therapy
alone is preferred
METASTATIC BREAST CANCER (1.2)
In combination with docetaxel after failure of prior
anthracycline-containing therapy
As monotherapy in patients resistant to both paclitaxel and an
anthracycline-containing regimen
Take capecitabine tablets with water within 30 min after a meal (2)
Monotherapy: 1250 mg/m twice daily orally for 2 weeks followed by a
one week rest period in 3-week cycles (2.1)
2
Adjuvant treatment is recommended for a total o