CAPECITABINE- capecitabine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Shilpa Medicare Limited

INN (International Name):

CAPECITABINE

Composition:

CAPECITABINE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- Capecitabine tablets 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 tablets 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 tablets in the adjuvant treatment of Dukes' C colon cancer. - Capecitabine tablets 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 tablets monotherapy. Use of capecitabine tablets instead of 5-FU/LV in combinations has not been adequately studied to

Product summary:

150 mg : Light pink coloured, capsule shaped, biconvex film coated tablet debossed with one side CAP and other side 150. 150 mg tablets are packaged in bottles of 60 (NDC 63759-3000-1). 500 mg : Dark pink coloured, capsule shaped, biconvex film coated tablet debossed with one side CAP and other side 500. 500 mg tablets are packaged in bottles of 120 (NDC 63759-3001-1). 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. Care should be exercised in the handling of capecitabine tablets USP. Capecitabine tablets USP should not be cut or crushed. Procedures for the proper handling and disposal of anticancer drugs should be considered. Any unused product should be disposed of in accordance with local requirements, or drug take back programs. Several guidelines on the subject have been published.1-4

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CAPECITABINE- CAPECITABINE TABLET, FILM COATED
SHILPA MEDICARE LIMITED
----------
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, FILM COATED 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
RECENT MAJOR CHANGES
Dosage and Administration (2.0) 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:
• 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)
Monotherapy: 1250 mg/m twice daily orally for 2 weeks followed by a
one week rest period in 3-week cycles (2.1)
Adjuvant treatment is recommend