CAPECITABINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

CAPECITABINE

Composition:

CAPECITABINE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CAPECITABINE- CAPECITABINE TABLET
AMNEAL PHARMACEUTICALS LLC
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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