📋 Indications & Clinical Dosage
*Stage III colon cancer, adjuvant following surgery (monotherapy):*
Adult: 1.25 g/m2 twice daily for 14 days, subsequent courses repeated after a 7-day interval, usually for 6 months, adjust dose according to tolerability.
*Stage III colon cancer, adjuvant following surgery (combination therapy):*
Adult: 0.8-1 g/m2 twice daily for 14 days, subsequent courses repeated after a 7-day interval, usually for 6 months, adjust dose according to tolerability.
*Metastatic colorectal cancer (monotherapy):*
Adult: 1.25 g/m2 twice daily for 14 days, subsequent courses repeated after a 7-day interval, adjust dose according to tolerability.
*Metastatic colorectal cancer (combination therapy):*
Adult: 0.8-1 g/m2 twice daily for 14 days, subsequent courses repeated after a 7-day interval, adjust dose according to tolerability.
*Advanced gastric cancer (first-line treatment in combination with a platinum based regimen):*
Adult: 0.8-1 g/m2 twice daily for 14 days, subsequent courses repeated after a 7-day interval, alternatively 625 mg/m2 twice daily given continuously, adjust dose according to tolerability.
*Locally advanced or metastatic breast cancer (second-line treatment as monotherapy), Locally advanced ormetastatic breast cancer (second-line treatment, in combination with docetaxel):*
Adult: 1.25 g/m2 twice daily for 14 days, subsequent courses repeated after a 7-day interval, adjust dose according to tolerability.
⛔ Contraindications
Severe renal or hepatic impairment, hypersensitivity to fluoropyrimidines or fluorouracil. Dihydropy-rimidine dehydrogenase deficiency, severe leucopenia, neutropenia or thrombocytopenia
⚠️ Precautions & Warnings
Mild to moderate hepatic impairment. Moderate renal impairment; reduce initial dose, history of cardiac disease, hypocalcaemia, hypercaldaemia, nervous system disease, diabetes, stomatitis, elderly. Monitor for symptoms of hand-foot syndrome; interrupt treatment if significant. Monitor plasma-calcium concentration. Monitor for eye disorders (including keratitis and corneal disorders).
🔄 Drug Interactions
Coumarin anticoagulants, phenytoin, folinicacid, antacids, allopurinol, interferon alfa-2a.
⚠️ Adverse Reactions / Side Effects
Alopecia,bone-marrow suppression, hyperuricaemia, thrombocytopenia, hyperbilirubinemia, fatigue, anorexia, diarrhoea, fever, eye disorder, constipation, abdominal pain, erythema, stimattis, dermatitis, paresthesias, nausea, oral mucositis, thromboembolism, tumourlysis syndrome, vomiting
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Contraindicated
Lactation / Breastfeeding:
Contraindicated. Discontinue breast-feeding.
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.