Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
CAPECITABINE (UNII: 6804DJ8Z9U) (CAPECITABINE - UNII:6804DJ8Z9U)
Amneal Pharmaceuticals LLC
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. - trea
Capecitabine tablets, USP, 150 mg, are supplied as light peach, oblong, film-coated, biconvex, unscored tablets, debossed with ‘AN’ on one side and ‘843’ on the other side. They are available as follows: Bottles of 60: NDC 65162-843-06 Capecitabine tablets, USP, 500 mg, are supplied as peach, oblong, film-coated, biconvex, unscored tablets, debossed with ‘AN’ on one side and ‘844’ on the other side They are available as follows: Bottles of 60: NDC 65162-844-06 Bottles of 120: NDC 65162-844-16 Bottles of 500: NDC 65162-844-50 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED. Capecitabine tablets, USP are a hazardous drug. Follow applicable special handling and disposal procedures.1
Abbreviated New Drug Application
CAPECITABINE- CAPECITABINE TABLET AMNEAL PHARMACEUTICALS LLC ---------- 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 (2.1-2.7) (12/2022) Contraindications (4) (12/2022) Warnings and Precautions (5.1-5.12) (12/2022) INDICATIONS AND USAGE Capecitabine tablets are 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 progression on prior Læs hele dokumentet