Capecitabine Tablets 500mg / High Quality

• Customization: Available
• Certified: GMP
• Dossier: Ctd
• Model NO.: Tablet
• Packing: Customization
• Package: 12 Tablets /Box
• Transport Package: Box
• Specification: 500mg
• Trademark: Sinolead
• Origin: China
• Production Capacity: 10, 000, 000

Product Description

Capecitabine Tablets 500mg

Composition:

Each film-coated tablet contains:

• Capecitabine 500mg

Description:

Capecitabine is an oral prodrug of 5-fluorouracil (5-FU), a pyrimidine analog that inhibits DNA synthesis, leading to cancer cell death. It is selectively activated in tumor tissues, enhancing its efficacy while reducing systemic toxicity.

Indications:

Capecitabine Tablets are indicated for the treatment of:

• Metastatic colorectal cancer (mCRC)
• Adjuvant therapy for stage III colon cancer
• Metastatic breast cancer, either as monotherapy or in combination with other agents (e.g., docetaxel)
• Gastric cancer (off-label in some regions)

Dosage & Administration:

Standard Dosage (Adults Only):

Colorectal and Breast Cancer:

• 1250 mg/m² twice daily for 14 days, followed by a 7-day rest period (21-day cycle)
• Continue treatment as prescribed by a healthcare provider

Combination Therapy (with Docetaxel for Breast Cancer):

• Capecitabine 1250 mg/m² twice daily for 14 days + Docetaxel 75 mg/m² IV on Day 1 of a 21-day cycle

Dose Adjustments:

• Elderly Patients: Consider lower starting doses due to increased toxicity risks
• Renal Impairment:
  • Moderate (CrCl 30-50 mL/min): Reduce dose by 25%
  • Severe (CrCl <30 mL/min): Contraindicated
• Hepatic Impairment: Use with caution in patients with liver dysfunction

Administration:

• Take orally within 30 minutes after a meal
• Swallow whole with water-do not crush, chew, or split
• Maintain consistent dosing times

Contraindications:

• Severe renal impairment (CrCl <30 mL/min)
• Hypersensitivity to Capecitabine, 5-FU, or any excipient
• Severe bone marrow suppression
• Pregnancy and breastfeeding (Category D-may cause fetal harm)

Precautions:

• Hand-Foot Syndrome (Palmar-Plantar Erythrodysesthesia): Monitor for redness, swelling, pain, or peeling of the palms and soles
• Cardiotoxicity: Use with caution in patients with a history of coronary artery disease
• Hematologic Toxicity: Monitor for neutropenia, thrombocytopenia, and anemia
• Diarrhea & Dehydration: Risk of severe diarrhea; rehydrate promptly
• Drug Interactions: Avoid warfarin (increased bleeding risk) and phenytoin (toxicity risk)

Adverse Reactions:

• Common: Fatigue, diarrhea, nausea, vomiting, stomatitis, hand-foot syndrome
• Serious: Bone marrow suppression, cardiotoxicity, liver dysfunction, severe skin reactions

Drug Interactions:

• Warfarin & Other Anticoagulants: Increases INR and bleeding risk-monitor INR closely
• Leucovorin: May enhance toxicity
• CYP2C9 Substrates (Phenytoin): Increased plasma levels-monitor closely

Overdose & Management:

• Symptoms: Nausea, vomiting, diarrhea, mucositis, gastrointestinal bleeding, bone marrow suppression
• Treatment: Supportive care, IV hydration, and symptom management (antidiarrheals, antiemetics)

Storage Conditions:

• Store below 25°C, in a dry place
• Keep in original packaging to protect from moisture