CAPECITABINE tablet film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

KAISER FOUNDATION HOSPITALS

INN (Kansainvälinen yleisnimi):

CAPECITABINE

Koostumus:

CAPECITABINE 500 mg

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

CAPECITABINE- CAPECITABINE TABLET, FILM COATED
KAISER FOUNDATION HOSPITALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CAPECITABINE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR CAPECITABINE TABLETS.
CAPECITABINE TABLETS, USP FILM COATED FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: CAPECITABINE TABLETS-WARFARIN INTERACTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
PATIENTS RECEIVING CONCOMITANT CAPECITABINE TABLETS 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
Contraindications (4.1) 02/2015
Warnings and Precautions (5.1, 5.2, 5.5, and 5.7) 10/2014
Warnings and Precautions (5.4) 02/2015
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
OCCURRENCE: WITHIN SEVERAL DAYS AND UP TO SEVERAL MONTHS AFTER
INITIATING CAPECITABINE THERAPY; MAY
ALSO BE SEEN WITHIN ONE MONTH AFTER STOPPING CAPECITABINE TABLETS.
PREDISPOSING FACTORS: AGE > 60 AND DIAGNOSIS OF CANCER.
ADJUVANT COLON CANCER (1.1)
o
Patients with Dukes’ C colon cancer
METASTATIC COLORECTAL CANCER (1.1)
o
First-line as monotherapy when treatment with fluoropyrimidine therapy
alone is preferred
METASTATIC BREAST CANCER (1.2)
o
o
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