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PHARMAURACIL

FLUOROURACIL · by PHARMEDIC

ANTINEOPLASTICS Antimetabolite PHARMEDIC

Composition

Inj 250 mg/500 mg:250 mg/500 mg 5-fluorouracil as its sodium salt in 5 ml/10 ml water for inj; vial.

Indications & 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).

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

Compatibility

Stable in D5LR, D5W, NS.

Stability

Store at 15C-30C (59T-86F). Do not freeze. Protect from light. Retain in carton until time of use. Discard any unused portion.

Contraindications

Depressed bone marrow function, throm-bocytopenia, serious infection, major surgery.

Precautions

Impaired renal or liver function.

Pregnancy

Positive evidence of risk: Avoid

Lactation

Contraindicated. Discontinue breast-feeding.

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