📋 Indications & Clinical Dosage
*Treatment of solid tumours including GI tract cancers and breast cancer, In combination with folinic acid in advanced colorectal cancer:*
BY IV INJ, IV INF, OR INTRA-ARTERIAL INF:
Adults: Initial: 12 mg/ kg/day (up to 800 mg/day) for 4 days, then 6 mg/kg on days 6, 8, 10 & 12. Maintenance: Either repeat initial dose every 30 day or after toxic signs subside, give 10-15 mg/kg/wk as a single dose (up to 1 gm/wk).
💊 Mode of Administration
Formulation may be given orally mixed in water, grape juice, or carbonated beverage. It is generally best to drink undiluted solution, then rinse the mouth. Coca-Cola has been recommended as the 'best chaser' for oral fluorouracil. IV: Irritant. Direct IVP injection (50 mg/ml solution needs no further dilution) or by IV Infusion. Toxicity may be reduced by giving the drug as a constant infusion. Bolus doses may be administered by slow IVP or IVP Bolus. Further dilution in D5W or NS at concentrations of 0.5-10 mg/ ml, are stable for 72 hours at 4C
⛔ Contraindications
Depressed bone marrow function, throm-bocytopenia, serious infection, major surgery.
⚠️ Precautions & Warnings
Impaired renal or liver function.
⚠️ Adverse Reactions / Side Effects
Alopecia, bone-marrow suppression, desquamative hand-foot syndrome (on prolonged
infusion), extravasation, hyperuricaemia, mucositis,
myleosuppression, nausea, oral mucositis, thromboembolism, tumourlysis syndrome, vomiting.
Rare: Cerebellar syndrome
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Positive evidence of risk: Avoid
Lactation / Breastfeeding:
Contraindicated. Discontinue breast-feeding.
🧪 Compatibility & Storage Stability
Compatibility: Stable in D5LR, D5W, NS.
Stability & Storage: Store at 15C-30C (59T-86F). Do not freeze. Protect from light. Retain in carton until time of use. Discard any unused portion.
📚 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.