CAPECITABINE tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Golden State Medical Supply, Inc.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Capecitabine tablets are indicated for the: - adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. - perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. - treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. Capecitabine tablets are indicated for the: - treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated. - treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. Capecitabine tablets are indicated for the: - treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen.

Produktsammanfattning:

Capecitabine tablets, USP are available as follows: 150 mg: Peach to light peach, oblong, film-coated, biconvex, unscored tablets, debossed with 190 on one side and 77 on the other side. Available in bottles of 60 tablets (NDC 51407-639-60). 500 mg: Peach to light peach, oblong, film-coated, biconvex, unscored tablets debossed with 191 on one side and 77 on the other side. Available in bottles of 120 tablets (NDC 51407-640-12). Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP TIGHTLY CLOSED. Keep this and all medications out of the reach of children. Capecitabine is a hazardous drug. Follow applicable special handling and disposal procedures. 1

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

CAPECITABINE- CAPECITABINE TABLET, FILM COATED
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
CAPECITABINE TABLETS. 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: INCREASED RISK OF BLEEDING WITH CONCOMITANT USE OF VITAMIN K
ANTAGONISTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ALTERED COAGULATION PARAMETERS AND/OR BLEEDING, INCLUDING DEATH, HAVE
BEEN REPORTED
IN PATIENTS TAKING CAPECITABINE CONCOMITANTLY WITH ORAL VITAMIN K
ANTAGONISTS. ( 5.1,
7.2)
MONITOR INTERNATIONAL NORMALIZED RATIO (INR) MORE FREQUENTLY AND
ADJUST THE DOSE OF THE
VITAMIN K ANTAGONIST AS APPROPRIATE. ( 7.2)
RECENT MAJOR CHANGES
Boxed Warning (12/2022)
Indications and Usage, Colorectal Cancer ( 1.1) (12/2022)
Indications and Usage, Breast Cancer ( 1.2) (12/2022)
Indications and Usage, Gastric, Esophageal, or
Gastroesophageal Junction Cancer ( 1.3) (12/2022)
Indications and Usage, Pancreatic Cancer ( 1.4) (12/2022)
Dosage and Administration ( 2.1 to 2.7) (12/2022)
Contraindications ( 4) (12/2022)
Warnings and Precautions ( 5.1 to 5.12) (12/2022)
INDICATIONS AND USAGE
Capecitabine is a nucleoside metabolic inhibitor indicated for:
COLORECTAL CANCER
adjuvant treatment of patients with Stage III colon cancer as a single
agent or as a component of a
combination chemotherapy regimen. ( 1.1)
perioperative treatment of adults with locally advanced rectal cancer
as a component of
chemoradiotherapy. ( 1.1)
treatment of patients with unresectable or metastatic colorectal
cancer as a single agent or as a
component of a combination chemotherapy regimen. ( 1.1)
BREAST CANCER
treatment of patients with advanced or metastatic breast cancer as a
single agent if an anthracycline-
or taxane-containing chemotherapy is not indicated. ( 1.2)
treatment of patients with advanced or metastatic breast cancer in
combinatio