CAPECITABINE tablet, film coated

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

NORTHSTAR RXLLC

INN (Isem Internazzjonali):

CAPECITABINE

Kompożizzjoni:

CAPECITABINE 150 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

- Capecitabine tablets, USP are indicated as a single agent for adjuvant treatment in patients with Dukes' C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. Capecitabine was non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS). Physicians should consider results of combination chemotherapy trials, which have shown improvement in DFS and OS, when prescribing single-agent capecitabine in the adjuvant treatment of Dukes' C colon cancer. - Capecitabine tablets, USP are indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated with capecitabine monotherapy. Use of capecitabine tablets, USP instead of 5-FU/LV in combinations has not been adequately studied to assure sa

Sommarju tal-prodott:

150 mg Color: Light peach Engraving: 150 on one side, plain on the other 150 mg tablets are packaged in bottles of 60 (NDC 16714-467-01) individually packaged in a carton. 500 mg Color: Peach Engraving: 500 on one side, plain on the other 500 mg tablets are packaged in bottles of 120 (NDC 16714-468-01) individually packaged in a carton. Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED. Capecitabine tablets, USP are 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.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

CAPECITABINE- CAPECITABINE TABLET, FILM COATED
NORTHSTAR RXLLC
----------
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 -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.
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
INDICATIONS AND USAGE
Capecitabine is a nucleoside metabolic inhibitor with antineoplastic
activity indicated for:
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
DOSAGE AND ADMINISTRATION
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)
Adjuvant treatment is recommended for a total of 6 months (8 cycles) (
2.2)
In combination with docetaxel, the recommended dose of capecitabine
tablet is 1250 mg/m
twice
daily for 2 weeks followed by a 7-day rest period, combined with
docetaxel at 75 mg/m
as a 1-hour IV
infusion eve