CAPECITABINE tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Mylan Pharmaceuticals Inc.

INN (Nama Antarabangsa):

CAPECITABINE

Komposisi:

CAPECITABINE 150 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Capecitabine tablets are contraindicated in patients with severe renal impairment (creatinine clearance below 30 mL/min [Cockroft and Gault]) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)] . Capecitabine tablets are contraindicated in patients with known hypersensitivity to capecitabine or to any of its components. Capecitabine tablets are contraindicated in patients who have a known hypersensitivity to 5-fluorouracil. Based on findings in animal reproduction studies and its mechanism of action,capecitabine tablets can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . Limited available human data are not sufficient to inform the drug-associated risk during pregnancy. In animal reproduction studies, administration of capecitabine to pregnant animals during the period of organogenesis caused embryo lethality and teratogenicity in mice and embryo lethality in monkeys at 0.2 and 0.6 times the exposure (AUC) in patients receiving the recommended

Ringkasan produk:

Capecitabine Tablets, USP are available containing 150 mg or 500 mg of capecitabine, USP. The 150 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 511 on the other side. They are available as follows: NDC 0378-2511-91 bottles of 60 tablets The 500 mg tablets are white, film-coated, oval, unscored tablets debossed with M512 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-2512-78 bottles of 120 tablets Storage and Handling:   Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] KEEP TIGHTLY CLOSED. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Capecitabine tablets are a cytotoxic drug. Follow applicable special handling and disposal procedures.1 Any unused product should be disposed of in accordance with local requirements, or drug take back programs.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

CAPECITABINE- CAPECITABINE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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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, 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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INDICATIONS AND USAGE
Capecitabine tablets 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 TABLETS THERAPY; MAY ALSO BE SEEN WITHIN 1 MONTH AFTER
STOPPING
CAPECITABINE TABLETS
PREDISPOSING FACTORS: AGE > 60 AND DIAGNOSIS OF CANCER
ADJUVANT COLON CANCER (1.1)
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Patients with Dukes’ C colon cancer
METASTATIC COLORECTAL CANCER (1.1)
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First-line as monotherapy when treatment with fluoropyrimidine therapy
alone is preferred
METASTATIC BREAST CANCER (1.2)
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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 (2.1)
Monotherapy: 1250 mg/m twice daily orally for 2 weeks followed by a
one week rest period in 3-week
cycles (2.2)
2
Adjuvant treatment is recommended for a total of 6 months (8 cycles)
(2.2)
In combination with docetaxel, the recom