País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
CAPECITABINE (UNII: 6804DJ8Z9U) (CAPECITABINE - UNII:6804DJ8Z9U)
Mylan Pharmaceuticals Inc.
CAPECITABINE
CAPECITABINE 150 mg
ORAL
PRESCRIPTION DRUG
Capecitabine tablets are contraindicated in patients with severe renal impairment (creatinine clearance below 30 mL/min [Cockroft and Gault]) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)] . Capecitabine tablets are contraindicated in patients with known hypersensitivity to capecitabine or to any of its components. Capecitabine tablets are contraindicated in patients who have a known hypersensitivity to 5-fluorouracil. Based on findings in animal reproduction studies and its mechanism of action,capecitabine tablets can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . Limited available human data are not sufficient to inform the drug-associated risk during pregnancy. In animal reproduction studies, administration of capecitabine to pregnant animals during the period of organogenesis caused embryo lethality and teratogenicity in mice and embryo lethality in monkeys at 0.2 and 0.6 times the exposure (AUC) in patients receiving the recommended
Capecitabine Tablets, USP are available containing 150 mg or 500 mg of capecitabine, USP. The 150 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 511 on the other side. They are available as follows: NDC 0378-2511-91 bottles of 60 tablets The 500 mg tablets are white, film-coated, oval, unscored tablets debossed with M512 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-2512-78 bottles of 120 tablets Storage and Handling: Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] KEEP TIGHTLY CLOSED. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Capecitabine tablets are a cytotoxic drug. Follow applicable special handling and disposal procedures.1 Any unused product should be disposed of in accordance with local requirements, or drug take back programs.
Abbreviated New Drug Application
CAPECITABINE- CAPECITABINE TABLET, FILM COATED MYLAN PHARMACEUTICALS 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: CAPECITABINE TABLETS-WARFARIN INTERACTION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ PATIENTS RECEIVING CONCOMITANT CAPECITABINE TABLETS 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. • • INDICATIONS AND USAGE Capecitabine tablets are a nucleoside metabolic inhibitor with antineoplastic activity indicated for: • • • DOSAGE AND ADMINISTRATION • • • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • OCCURRENCE: WITHIN SEVERAL DAYS AND UP TO SEVERAL MONTHS AFTER INITIATING CAPECITABINE TABLETS THERAPY; MAY ALSO BE SEEN WITHIN 1 MONTH AFTER STOPPING CAPECITABINE TABLETS PREDISPOSING FACTORS: AGE > 60 AND DIAGNOSIS OF CANCER 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 Take capecitabine tablets with water within 30 min after a meal (2.1) Monotherapy: 1250 mg/m twice daily orally for 2 weeks followed by a one week rest period in 3-week cycles (2.2) 2 Adjuvant treatment is recommended for a total of 6 months (8 cycles) (2.2) In combination with docetaxel, the recom Llegiu el document complet