Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
CAPECITABINE (UNII: 6804DJ8Z9U) (CAPECITABINE - UNII:6804DJ8Z9U)
Teva Pharmaceuticals USA, Inc.
CAPECITABINE
CAPECITABINE 150 mg
ORAL
PRESCRIPTION DRUG
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.
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 0093-7473-06). 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 0093-7474-89). 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
Abbreviated New Drug Application
CAPECITABINE- CAPECITABINE TABLET, FILM COATED TEVA PHARMACEUTICALS USA, INC. ---------- 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: 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 combination with docetaxel after disease progres Olvassa el a teljes dokumentumot