Verified by DRAP 🩺 ANTINEOPLASTICS 🏷️ Antimetabolites
👨‍⚕️ Clinically Reviewed by: PakistaniBano Medical Editorial Board (Pharm.D Panel)
📅 Reviewed: November 2026 • 🔍 Authority: DRAP / WHO ATC
📦 Formulations, Pack Sizes & Retail Prices Currency: Rs.
Dosage Form Reg. No Pack Size Trade Price (TP) Maximum Retail Price (MRP)
Tab 500 mg 027375 10 Rs.1754.00 Rs.2064.00

📋 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.
DRAP Registration Number: 072593

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