Sanfuracil

Sanfuracil

fluorouracil

Manufacturer:

Sanbe
Full Prescribing Info
Contents
Fluorouracil.
Description
Each mL contains: Fluorouracil 50 mg.
Action
Pharmacology: Fluorouracil is a potent antimetabolite used in cancer chemotherapy. It blocks the formation of thymine, and therefore, inhibits the synthesis of DNA, and to a lesser extent RNA.
Since DNA and RNA are essential for cell division and growth, thymine deficiency caused by Fluorouracil leads to unbalanced growth and death of the cell.
These effects are most marked on rapidly growing cells such as cancer cells and cells of the hematopoietic and gastrointestinal systems.
Indications/Uses
SANFURACIL is indicated for palliative treatment of carcinoma of the colon, rectum, breast, stomach and pancreas in patients who are considered incurable by surgery or other means.
Dosage/Direction for Use
SANFURACIL injection is for i.v. use only, and no dilution is required. Actual body weight is used for dosage calculation, except in obese patients and in the presence of abnormal fluid retention (oedema, ascites), the estimated lean body mass is used.
Usual dosage: 12 mg/kg i.v. once daily for 4 successive days. The maximum daily dose is 800 mg. If no toxicity is observed, 6 mg/kg are given on days 6, 8, 10 and 12 (no therapy is given on days 5, 7, 9 and 11). Therapy is discontinued at the end of day 12, even if no toxicity is observed.
Poor risk patients or those with inadequate nutritional state: 6 mg/kg/day for 3 days. If no toxicity is observed, 3 mg/kg are given on days 5, 7 and 9 (no therapy on days 4, 6 and 8). The maximum daily dose is 400 mg. The above sequence of injections constitutes a "course of therapy".
Maintenance Therapy: In instances where toxicity not been a problem, it is recommended that continue therapy using either of the following schedules: Repeat dosage of first course every 30 days after the last day of the previous course.
When toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dosage of 10 to 15 mg/kg/week as a single dose. Do not exceed 1 g per week.
The amount of the drug to be used may vary from 9 to 45 courses of treatment during periods which ranged from 12 to 60 months.
Contraindications
SANFURACIL is contraindicated in patients with a poor nutritional state, depressed bone marrow function, potentially serious infections, or known hypersensitivity to this drug.
Special Precautions
Since SANFURACIL is a highly toxic drug with a narrow margin of safety, it should be given only by or under the careful supervision of a qualified physician who is experienced in cancer chemotherapy.
The daily dose of SANFURACIL should not exceed 800 mg.
Because of the possibility of severe toxic reactions, it is recommended that patients be hospitalized during the initial course of therapy.
SANFURACIL should be used with extreme caution in poor risk patients with a history of high dosage irradiation, previous use of alkylating agents, or who have a widespread involvement of bone marrow by metastatic tumors or impaired hepatic or renal function.
SANFURACIL, should not be used during pregnancy, especially in the first trimester, unless the potential benefits are considered to outweigh hazards on foetal development.
The toxicity of SANFURACIL increases with any therapy which increases the stress of the patients, interferes with nutrition, or depresses bone marrow function.
Severe hematological toxicity, gastrointestinal haemorrhage, and even death may result from SANFURACIL use despite careful patients selection and dosage adjustment.
Therapy should be discontinued promptly whenever one of the following signs of toxicity appears: Stomatitis or esophagopharyngitis; Leucopenia (WBC under 3500), or a rapidly falling white blood count; Thrombocytopenia (under 100,000); Haemorrhage from any site; Gastrointestinal ulceration and bleeding; Severe diarrhea; Intractable vomiting.
Adverse Reactions
Gastrointestinal disturbances (stomatitis, esophagopharyngitis, diarrhea, anorexia, nausea, and vomiting), are commonly seen during therapy.
Leucopenia usually follows every course of adequate therapy. The lowest WBC counts usually occur between the 9th and 14th days after the first course of treatment and the count returns to the normal range by the 30th day.
Alopecia may occur; it is a transient effect.
Dermatitis, most oftenly seen as a pruritic maculopapular rash, usually appears on the extremities and less frequently on the trunk. It is reversible and responsive to symptomatic treatment. Dry skin, fissuring, and occasionally photosensitivity have also been observed.
Also noted were photophobia, lacrimation, epistaxis, euphoria, acute cerebellar syndrome (which may persist after discontinuation of treatment), nail changes (including loss of nails), and myocardial ischaemia.
Storage
Store below 30°C, protect from light. Do not cool and freeze. If a precipitate occurs due to exposure to low temperatures, resolubilize by heating to 60°C with vigorous shaking; allow to cool to body temperature before using.
ATC Classification
L01BC02 - fluorouracil ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Presentation/Packing
Inj (vial) 50 mg/mL x 5 mL x 1's, 10 mL x 1's.
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