5-Fluorouracil Ebewe

5-Fluorouracil Ebewe



EBEWE Pharma




Mega Lifesciences
Concise Prescribing Info
Adjuvant or palliative treatment of advanced colorectal cancer, advanced gastric cancer, advanced pancreatic cancer, advanced &/or metastatic breast cancer, advanced tumours of the head & neck area & advanced cervical cancer.
Dosage/Direction for Use
Initial therapy in daily use: 15 mg/kg or 600 mg/m2 IV infusion over 4 hr daily until onset of side effects or 12 mg/kg or 480 mg/m2 slow IV inj over 2-3 min on day 1, 2 & 3. Administer 6 mg/kg or 240 mg/m2 on day 5, 7 & 9 if no signs of toxicity are observable. Initial therapy in wkly use: 15 mg/kg or 600 mg/m2 slow IV once wkly. Maintenance therapy: 5-10 mg/kg or 200-400 mg/m2 IV once wkly. Max: 1 g daily. Patients w/ poor nutritional condition, after major surgical intervention, myelosuppression, severely impaired hepatic & renal function Reduce dose by ⅓-½.
Hypersensitivity. Myelosuppression, severe blood count alterations, serious infections, poor physical state, dihydropyrimidine dehydrogenase (DPD) deficiency. Concomitant use w/ brivudine, sorivudine & analogues; live vaccinations; poliomyelitis vaccines. Severe hepatic dysfunctions. Pregnancy & lactation.
Special Precautions
Avoid contact w/ skin & mucosae. Stomatitis/mucositis, diarrhoea & bleeding (particularly GI tract) may occur. Subsequent exams should be performed prior to & during therapy: daily inspection of oral cavity & pharynx in view of mucosal alterations, blood count including differential blood count & thrombocytes, retention & hepatic values. Closely monitor Quick's value in concurrent use w/ oral anticoagulants. Keep an interval of at least 4 wk in between intake of 5-FU & brivudine, sorivudine & analogues. Regularly examine for elevated phenytoin plasma level when used concomitantly w/ fluorouracil. Women of childbearing age & men should ensure effective contraception during treatment & up to 6 mth afterwards. May cause nausea & vomiting & lead to impaired ability to drive or operate machinery. Childn.
Adverse Reactions
Myelosuppression (leucopenia, neutropenia, thrombocytopenia), anaemia, epistaxis; immunosuppression w/ elevated infection rate; hyperuricaemia; ECG alterations typical for ischaemia; bronchospasm; potentially life-threatening mucositis (eg, stomatitis, pharyngitis, oesophagitis, proctitis), anorexia, watery diarrhoea, nausea & vomiting; alopecia, delayed wound healing, hand-&-foot syndrome associated w/ dysaesthesia & reddening, swelling, pain & desquamation of skin in palms & soles; exhaustion, general asthenia, fatigue, lack of impulse, fever. Febrile neutropenia, angina pectoris-like chest pain.
Drug Interactions
Toxicity may be increased w/ other cytostatics. Potentiated cutaneous toxicity of radiotherapies. Enhanced effect w/ Ca folinate. Drastic increase in plasma conc w/ nucleoside analogues eg, brivudine & sorivudine. Increased plasma level of phenytoin. Plasma level may be increased w/ cimetidine, metronidazole & interferons. Reduced granulocyte count w/ thiazide diuretic additionally to cyclophosphamide, methotrexate & fluorouracil. Decline in Quick's value w/ warfarin & fluorouracil alone &/or w/ levamisole. Hepatotoxic effects w/ levamisole. Aggravated risk of occurrence of thromboembolic events in combination treatment w/ cyclophosphamide, methotrexate & tamoxifen. Severe mucositis may occur w/ vinorelbine & fluorouracil/folinic acid. May yield elevated or false positive values in assay techniques for bilirubin & 5-hydroxyindole acetic acid. May elevate risk of infection after live vaccine.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BC02 - fluorouracil ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
5-Fluorouracil Ebewe infusion conc 50 mg/mL
10 mL x 1's;20 mL x 1's
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