Utoral Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Fluorouracil

Indications/Uses

Palliative treatment of carcinoma of the colon, rectum, breast, stomach & pancreas not amenable to surgery or irradiation. Adjunct to surgery for the treatment of various solid tumors.

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Dosage/Direction for Use

IV inj 12 mg/kg to a max of 0.8-1 g daily for 3-4 days. If there is no evidence of toxicity, this may be followed after 1 day by 6 mg/kg on alternative days for 3 or 4 further doses. Alternative schedule: 15 mg/kg IV once a wk throughout the course. Course may be repeated after 4-6 wk or maintenance doses of 5-15 mg/kg daily up to a max of 1 g wkly. IV infusion 15 mg/kg daily. Max: 1 g infused in 500 mL of 0.9% NaCl or 5% glucose inj over 4 hr repeated on successive days until toxicity occurs or a total of 12-15 g has been given. Intra-arterial infusion 5-7.5 mg/kg daily (regional perfusion).

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Overdosage

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Contraindications

Hypersensitivity. Patients on tegafur, gemestat, otastat K therapy, poor nutritional state, depressed bone marrow function, potentially serious infections & non-malignant tumor. Pregnancy & lactation.

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Warnings

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Special Precautions

Dihydropyrimidine dehydrogenase deficiency. Severe hepatic impairment. Monitor hepatic function tests. Patients w/ severe surgical pus &/or a history of heart disease. Observe for severe enteritis & dehydration. Discontinue if severe abdominal pain or diarrhea occurs.

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Use In Pregnancy & Lactation

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Adverse Reactions

Malaise, dizziness; anorexia, nausea, vomiting, change of taste, severe enteritis; CHF, cardiac infarction, angina, pain, ECG abnormalities, chest pain; pancytopenia, leukopenia, neutropenia, anemia, thrombocytopenia; proteinuria; stomatitis, systemic malaise, alopecia.

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Drug Interactions

Methotrexate, metronidazole, tegafur, leucovorin, allopurinol & cimetidine can affect the availability of fluorouracil.

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Caution For Usage

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Storage

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Description

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Action

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MIMS Class

Cytotoxic Chemotherapy

ATC Classification

L01BC02 - fluorouracil ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.

Regulatory Classification

Presentation/Packing

Form

Utoral inj 50 mg/mL

Packing/Price

(vial) 10 mL x 10 × 1's

Utoral

fluorouracil

Manufacturer:

Korea United Pharma

Distributor:

Qualimed