INTRODUCTION
5 FLUCEL 500MG INJECTION contains Fluorouracil, which belongs to a group of medicines called Nucleoside metabolic inhibitors. 5 FLUCEL 500MG INJECTION is used to treat cancer involving the breast, oesophagus, stomach, colon, rectum, pancreas, prostate, ovary, bladder, and head and neck cancer.
5 FLUCEL 500MG INJECTION should not be used in patients with serious infections (for example, Herpes zoster or chickenpox), non-malignant tumours, poor nutrition, weakened immunity due to long illness, damaged bone marrow due to other antineoplastics or radiotherapy, severe liver disease, or homozygotic or complete deficiency of dihydropyrimidine dehydrogenase (DPD) enzyme.
5 FLUCEL 500MG INJECTION should be used with caution in patients with decreased blood cells, oral ulcers, fever or haemorrhage at any site or weakness (due to decreased blood cells), kidney or liver problems like jaundice (yellowing of the skin) or heart problems like chest pain, reduced activity or deficiency of the enzyme DPD (dihydropyrimidine dehydrogenase), had high-dose radiation to pelvic, spine, ribs, metastatic tumours with involvement of bone marrow, severe bone marrow suppression include neutropenia, thrombocytopenia, and anaemia, viral, bacterial, fungal and/or parasitic infections, encephalopathy, gastrointestinal side effects like stomatitis, diarrhoea, bleeding from the G.I. tract or haemorrhage at any site, family history of partial or complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD), had recent major surgery.
5 FLUCEL 500MG INJECTION is generally not recommended for use in pregnant women unless recommended by your doctor. 5 FLUCEL 500MG INJECTION is not recommended for use in breastfeeding women as it may pass through the breast milk. 5 FLUCEL 500MG INJECTION is not recommended for use by children. 5 FLUCEL 500MG INJECTION should be used with caution in elderly patients aged 65 years or above.
The most common side effects of receiving 5 FLUCEL 500MG INJECTION are anaemia, neutropenia, leukopenia, loss of appetite, watery diarrhoea, nausea, vomiting, hair loss, general weakness etc. Contact your doctor if any of the symptoms worsen.
USES OF 5 FLUCEL 500MG INJECTION
Treats:
Breast cancer
Oesophageal cancer
Stomach cancer
Colon cancer
Rectum cancer
Pancreatic cancer
Prostate cancer
Ovary cancer
Bladder cancer
Head and neck cancer
HOW 5 FLUCEL 500MG INJECTION WORKS
5 FLUCEL 500MG INJECTION works by interfering with the synthesis of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) of cancer cells and affects the rapidly growing cells, leading to cell death.
DIRECTIONS FOR USE
5 FLUCEL 500MG INJECTION will be given to you only by a doctor or a nurse into a vein as an intravenous injection or infusion. Your physician will decide the correct dose and duration for you depending upon your age, body weight, and disease condition.
SIDE EFFECTS OF 5 FLUCEL 500MG INJECTION
COMMON
Ischemic ECG abnormalities
Neutropenia (a decrease in neutrophils)
Leukopenia (a decrease in white blood cells)
Anaemia (a decreased red blood cells)
Pancytopenia (decreased production of blood cells in the bone marrow)
High fever with a sharp decrease in white blood cells
Inflammation of the mouth and oesophagus
Pharyngitis
Inflammation of the rectum and anus
Anorexia
Watery stools, nausea, vomiting
Hair loss
Delayed wound healing
Nosebleed
Hand-foot syndrome (redness, tenderness, peeling of hands and soles)
General weakness, tiredness, malaise
Infections
Increased uric acid in the blood
Angina pectoris (severe chest pain)
UNCOMMON
Abnormal heart rhythm
Heart attack
Myocardial ischemia (decreased oxygen supply to the heart muscle)
Myocarditis (inflammation of the heart muscle)
Heart failure
Dilative cardiomyopathy
Cardiac shock
Low blood pressure
Sleepiness
Dehydration
Bacterial infections
Gastrointestinal ulcers, bleeding, and removal of the skin
Rhythmic movements of the eyes
Headache
Sensations of body imbalance and unsteadiness
Symptoms of Parkinson?s disease (Ex. tremors, rigidity, slow movements)
Pyramidal signs
Feeling sick
Inflammation of the skin
Skin alterations such as dry skin, fissures, loss of skin (erosion), redness, itchy maculopapular rash
Skin eruptions accompanying certain infectious diseases
Presence of red marks on the skin, itchy
Sensitivity to the sun light (photosensitivity)
Hyperpigmentation (darkening of the skin)
Hyperpigmentation or depigmentation in veins
Changes in the nails (Ex. blue colour pigmentation, hyperpigmentation, nail deformity, pain, thickening of the nail bed)
Inflammation of the tissue surrounding a fingernail (paronychia)
Inflammation of the nail matrix with pus formation or nail shedding
Disorder of sperm or egg (ovum) production
Liver cell damage
Tears secretion
Blurring of vision
Redness of the whites of the eye and below the eyelid
Change in eye movement
Optic neuritis
Diplopia (double vision)
Decrease in eyesight
Increased sensitivity to sunlight and dislike of sunlight or well-lit places
Chronic inflammation of the eyelid margins
Lower eyelid turns outwards
Blocked tear ducts
Mass of dead tissue separated from surrounding living tissue, like in a wound, a sore, or an inflammation
Euphoria
RARE
Decreased blood flow in the brain, intestine, and peripheral organs
Discoloration of the fingers and toes
Generalized allergic reaction
Swelling of veins caused due to blood clot
Severe, whole-body allergic reaction (anaphylaxis)
Development of a blood clot in arteries or veins
Vasodilation of blood vessels causing low blood pressure
Confusion
Elevated T4 (total thyroxin), and T3 (total triiodothyronine) levels
Stop receiving 5 FLUCEL 500MG INJECTION and contact your doctor immediately if you experience the following side effects:
Severe allergic reaction such as a sudden rash (hives), itching, swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing) or fainting
Blood or black stained stools
Mouth sore or ulcers
Numbness, tingling and tremor in the hands or feet
Confusion, feeling unsteady or coordination problems in arms and legs or altered mental status, difficulty in thinking or speech, problems with memory or vision
Symptoms of cardiotoxicity such as chest pain, shortness of breath, dizziness, or light-headedness
HOW TO MANAGE SIDE EFFECTS
Headache:
Rest and relax. Drink plenty of fluids such as water and electrolytes. Apply a pain-relieving balm on the head if necessary. Contact your doctor if the symptom does not improve.
Nausea and vomiting:
Take the medicine with or just after a meal. Stick to simple meals. Avoid eating oily or spicy foods.
Diarrhoea:
Drink lots of fluids, such as water or fruit juices, to keep yourself hydrated. Do not take any medicine on your own to treat diarrhoea. Contact your doctor if the symptom does not improve.
Itchy skin:
Avoid hot showers because hot water can irritate the skin. Do not scratch the affected area. Use sunscreen and protective clothing when outdoors. Regularly use unscented moisturizers to soothe and hydrate the affected area. Contact your doctor if the symptom does not improve.
WARNING & PRECAUTIONS
PREGNANCY
5 FLUCEL 500MG INJECTION is generally not recommended for use in pregnant women unless considered clearly necessary. Contact your doctor before receiving 5 FLUCEL 500MG INJECTION.
BREASTFEEDING
5 FLUCEL 500MG INJECTION is not recommended for use in breastfeeding women as it may pass through breast milk. Contact your doctor before receiving 5 FLUCEL 500MG INJECTION.
DRIVING AND USING MACHINES
Do not drive or operate any machinery if you have nausea and vomiting, acute cerebellar syndrome and neurologic symptoms like decreased alertness, confusion, disorientation, ataxia, visual disturbances, headache or nystagmus after receiving 5 FLUCEL 500MG INJECTION.
KIDNEY
5 FLUCEL 500MG INJECTION should be used with caution in patients with kidney disease. Contact your doctor before receiving 5 FLUCEL 500MG INJECTION.
LIVER
5 FLUCEL 500MG INJECTION is not recommended for use in patients with severe liver disease and should be used with caution in patients with jaundice. Contact your doctor before receiving 5 FLUCEL 500MG INJECTION.
ALLERGY
Do not receive 5 FLUCEL 500MG INJECTION if you are allergic to Fluorouracil or any of the other ingredients in this medicine.
HEART DISEASE
5 FLUCEL 500MG INJECTION should be used with caution in patients with heart diseases such as angina, myocardial infarction, cardiac shock, cardiomyopathy, myocarditis, ECG abnormalities, pericarditis, arrhythmia, and heart failure. Contact your doctor before receiving 5 FLUCEL 500MG INJECTION.
OTHERS
5 FLUCEL 500MG INJECTION is not recommended for use if you have:
Serious infections (Ex. Herpes zoster, chickenpox)
Non-malignant tumour
Poor nutrition
Weakened immunity due to long illness
Damaged bone marrow due to other antineoplastics or radiotherapy
Homozygotic or complete deficiency of dihydropyrimidine dehydrogenase (DPD) enzyme
Before receiving 5 FLUCEL 500MG INJECTION inform your doctor if you have:
Decreased blood cells
Oral ulcers, fever or haemorrhage at any site or weakness (due to decreased blood cells)
Reduced activity or deficiency of the enzyme DPD (dihydropyrimidine dehydrogenase)
Had high-dose radiation to the pelvic, spine, ribs, etc
Metastatic tumours with involvement of bone marrow
Severe bone marrow suppression includes neutropenia, thrombocytopenia, anaemia
Viral, bacterial, fungal, and/or parasitic infections
Encephalopathy
Mucositis or stomatitis, esophagopharyngitis, mucosal ulcers
Diarrhoea, bleeding from the G.I. tract or haemorrhage at any site
Family history of partial or complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD)
Palmar-plantar erythrodysesthesia or hand-foot syndrome
Had recent major surgery
Vaccinations
Urine test for bilirubin
Blood test for thyroid function
Low salt diet
Use in paediatrics:
5 FLUCEL 500MG INJECTION is not recommended for use in children. Contact your doctor before receiving 5 FLUCEL 500MG INJECTION.
Use in geriatrics:
5 FLUCEL 500MG INJECTION should be used with caution in elderly patients aged 65 years or above. Contact your doctor before receiving 5 FLUCEL 500MG INJECTION.
INTERACTIONS
A. Drug-Drug interactions:
Before receiving 5 FLUCEL 500MG INJECTION inform your doctor if you are receiving any of the following medicine:
Methotrexate (a medicine used to treat cancer and rheumatoid arthritis)
Metronidazole (a medicine used for bacterial infections)
Calcium leucovorin (a medicine used to reduce the harmful effects of anticancer medicines)
Allopurinol (a medicine used to treat gout)
Cimetidine (a medicine used for stomach ulcers)
Warfarin (a medicine used to treat blood clots)
Interferon alpha 2a, brivudine, sorivudine and analogues (medicines used to treat viral infections)
Medicines used to treat cancer (Ex. cisplatin, cyclophosphamide, vincristine, mitomycin, adriamycin, vinorelbine, tamoxifen, doxorubicin, epirubicin, cytarabine, PALA, hydroxyurea)
Phenytoin (a medicine used for seizures)
Vaccines (a medicine used to prevent infections)
Levamisole (a medicine used to treat worm infection)
Dipyridamole (a medicine used to prevent platelet clumping)
Diazepam (a medicine used for anxiety, seizures)
Overdosage:
5 FLUCEL 500MG INJECTION will be administered to you only by a doctor or a nurse in a hospital, and it is unlikely for you to receive an overdose. However, contact your physician or nurse if you experience any unusual symptoms like nausea, vomiting, diarrhoea, severe mucositis, or stomatitis, esophagopharyngitis, gastrointestinal ulceration, bleeding, and severe myelosuppression including thrombocytopenia, leukopenia, and agranulocytosis in chronic overdosage may occur.
SYNOPSIS
Drug :??
Fluorouracil
Pharmacological Category :??
Nucleoside metabolic inhibitor
Therapeutic Indication :??
Treats common types of cancer
Dosage Forms :??
Injection, Cream
MORE INFORMATION
Keep 5 FLUCEL 500MG INJECTION out of reach from children
Store 5 FLUCEL 500MG INJECTION at room temperature
FAQs ABOUT 5 FLUCEL 500MG INJECTION
How to use 5 FLUCEL 500MG INJECTION?
5 FLUCEL 500MG INJECTION will be given to you only by a doctor or a nurse into a vein as an intravenous injection or infusion. Your physician will decide the correct dose and duration for you depending upon your age, body weight, and disease condition.
What are the possible side effects of receiving 5 FLUCEL 500MG INJECTION?
The most common side effects of receiving 5 FLUCEL 500MG INJECTION are anaemia, neutropenia, leukopenia, loss of appetite, watery diarrhoea, nausea, vomiting, hair loss, general weakness, etc. Contact your doctor if any of the symptoms worsen.
How 5 FLUCEL 500MG INJECTION work?
5 FLUCEL 500MG INJECTION works by interfering with the synthesis of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) of cancer cells and affects the rapidly growing cells, leading to cell death.
Can 5 FLUCEL 500MG INJECTION be used by children?
No. 5 FLUCEL 500MG INJECTION is not recommended for use in children. Contact your doctor before receiving 5 FLUCEL 500MG INJECTION.
Does 5 FLUCEL 500MG INJECTION cause bleeding?
Yes. 5 FLUCEL 500MG INJECTION may cause bleeding from the stomach. Stop receiving 5 FLUCEL 500MG INJECTION and immediately contact your physician if you experience unusual symptoms like blood or black-stained stools.
REFERENCES
1. K D Tripathi. Chemotherapy of Neoplastic diseases. Essentials of medical pharmacology. 7th edition. 2013. Page ? 864.
2. Casale J, Patel P. Mechanism of action of Fluorouracil. National Institute of Health. National Library of Medicine. National Centre for Biotechnology Information. Pubmed.gov. January 2022. [Accessed on 10th June 2022]?https://www.ncbi.nlm.nih.gov/books/NBK549808/
3. Accord Healthcare Limited. Electronic Medicines Compendium (EMC). [Revised in December 2021] [Accessed on 10th June 2022]?https://www.medicines.org.uk/emc/files/pil.6041.pdf
4. Pharmadox Healthcare Ltd. Health Products Regulatory Authority (HPRA). [Revised in May 2015] [Accessed on 10th June 2022]?https://www.hpra.ie/img/uploaded/swedocuments/2164234.PA0405_096_001.df3c67a1-d07a-4417-bfe1-090437d89682.000001Fluorouracil%20PIL.151021.pdf
5. Spectrum Pharmaceuticals, Inc. U.S. Food & Drug Administration. [Revised in July 2016] [Accessed on 10th June 2022]?https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012209s040lbl.pdf
6. Pfizer. Fluorouracil. [Revised in August 2019] [Accessed on 10th June 2022]?https://www.pfizer.ca/sites/default/files/201908/FLUOROURACIL_PM_E_227813_07Aug2019.pdf
7. Sandoz. Fluorouracil. [Revised in August 2014] [Accessed on 10th June 2022]?https://www.pfizer.ca/sites/default/files/201908/FLUOROURACIL_PM_E_227813_07Aug2019.pdf
USEFUL DIAGNOSTIC TESTS
Complete blood count
Peripheral smear examination
Prothrombin time
PRODUCT DETAILS
Net Qty
1 N
Ingredient
Fluorouracil 500mg
Hsn Code
30049042
Show more
Only logged in customers who have purchased this product may leave a review.
Reviews
There are no reviews yet.
Reviews
There are no reviews yet.