Fluorouracil 50mg/ml Inj20ml

Fluorouracil (5-FU) is a fluorinated pyrimidine antimetabolite. It acts as a prodrug that is converted intracellularly to several active metabolites: 5-fluoro-2'-deoxyuridine monophosphate (FdUMP), 5-fluorouridine triphosphate (FUTP), and 5-fluoro-2'-deoxyuridine triphosphate (FdUTP). FdUMP inhibits thymidylate synthase, an enzyme critical for DNA synthesis, leading to 'thymineless death' of rapidly dividing cells. FUTP is incorporated into RNA, interfering with RNA processing and protein synthesis. FdUTP is incorporated into DNA, leading to DNA damage and fragmentation. These actions primarily occur during the S-phase of the cell cycle, making 5-FU cell cycle-specific.

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of nervous system problems, including:
+ Changes in mood or behavior
+ Confusion
+ Fever
+ Numbness or tingling in the hands or feet
+ Stiff neck
+ Sensitivity to bright lights
+ Severe muscle weakness
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that get bigger
+ Uncontrollable bleeding
Feeling extremely tired or weak
Chest pain or pressure
Shortness of breath, significant weight gain, or swelling in the arms or legs
Abnormal heartbeat
Dizziness or fainting
Changes in vision
Redness or irritation on the palms of the hands or soles of the feet
Balance problems
Excessive sleepiness
Uncontrolled eye movements
Headache

Administration Site Reactions

This medication may cause irritation at the injection site. If the medication leaks from the vein, it can also cause irritation around the affected area. Inform your nurse if you experience any redness, burning, pain, swelling, or fluid leakage at the injection site.

Other Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you're bothered by any of the following side effects or if they don't go away, contact your doctor or seek medical help:

Diarrhea
Upset stomach or vomiting
Decreased appetite
Mouth irritation or mouth sores
Hair loss
Dry skin
Changes in nail condition

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Poor nutrition
+ Active infections
+ Bone marrow problems, such as:
- Low white blood cell count
- Low platelet count
- Low red blood cell count
A genetic condition called dihydropyrimidine dehydrogenase (DPD) deficiency
If you are breast-feeding, as you should not breast-feed while taking this medication

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests and other laboratory evaluations, as directed by your doctor, are crucial to monitor your condition.

This medication can cause low blood cell counts, which may increase the risk of bleeding problems, infections, or anemia. In severe cases, these complications can be life-threatening. If you have any concerns or questions, discuss them with your doctor. Additionally, you may be more susceptible to infections, so it is vital to practice good hygiene by washing your hands frequently and avoiding close contact with people who have infections, colds, or flu.

To minimize the risk of bleeding, be cautious and avoid injuries. Use a soft toothbrush and an electric razor to reduce the risk of bleeding gums or cuts. If you experience stomach upset, vomiting, diarrhea, or loss of appetite, consult your doctor, as there may be ways to alleviate these side effects. It is also crucial to manage diarrhea and vomiting to prevent dehydration and electrolyte imbalances.

Patients who lack the enzyme dihydropyrimidine dehydrogenase (DPD) are at a higher risk of developing severe and potentially life-threatening side effects, including mouth irritation or sores, diarrhea, low white blood cell counts, and nerve problems.

This medication may also increase the risk of heart problems, such as heart attack, heart failure, and abnormal heartbeat, particularly in individuals with a history of heart disease. Discuss your cardiovascular health with your doctor. Before receiving any vaccinations, consult your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

You may be more prone to sunburn while taking this medication, so take necessary precautions when exposed to the sun. Inform your doctor if you experience increased sensitivity to sunlight. This medication may also affect fertility, leading to difficulties in becoming pregnant or fathering a child. If you plan to conceive, discuss the potential risks with your doctor before starting treatment.

Women who are pregnant or may become pregnant should not take this medication, as it may harm the unborn baby. If you or your partner may become pregnant, it is essential to use birth control while taking this medication and for a specified period after the last dose. Your doctor will advise you on the duration of birth control use. If you or your partner becomes pregnant, notify your doctor immediately.

• Brivudine
• Sorivudine

• Leucovorin (enhances toxicity)
• Allopurinol (may decrease 5-FU efficacy)
• Capecitabine (prodrug of 5-FU, additive toxicity)
• Cimetidine (may increase 5-FU levels)
• Metronidazole (may increase 5-FU levels and toxicity)
• Warfarin (increased INR and bleeding risk)
• Live vaccines (risk of severe infection)

• Phenytoin (may alter phenytoin levels)
• Thiazide diuretics (may increase myelosuppression)
• Interferon alfa (may increase 5-FU toxicity)
• Tamoxifen (may increase 5-FU toxicity)

• Not specifically documented for minor interactions with significant clinical impact.

• Fever
• Chills
• Sore throat
• Unusual bleeding or bruising
• Fatigue
• Weakness
• Nausea
• Vomiting
• Diarrhea (especially severe or bloody)
• Mouth sores (mucositis)
• Pain, redness, swelling, or blistering on palms of hands or soles of feet (hand-foot syndrome)
• Chest pain
• Shortness of breath
• Dizziness
• Confusion
• Ataxia (loss of coordination)
• Headache
• Vision changes

Fluorouracil is classified as Pregnancy Category D. It can cause fetal harm when administered to a pregnant woman. It is teratogenic and embryotoxic in animals. Avoid use during pregnancy.

Fluorouracil is contraindicated during breastfeeding. It is unknown if fluorouracil is excreted in human milk, but due to the potential for serious adverse reactions in the breastfed infant, breastfeeding should be discontinued during treatment and for a period after the last dose (e.g., 1 week) as advised by the physician.

Safety and effectiveness in pediatric patients have not been established. Use in pediatric oncology is off-label and based on specific protocols for certain cancers. Dosing requires careful consideration and monitoring due to potential for increased toxicity.

Elderly patients may be at increased risk for toxicity (e.g., myelosuppression, mucositis, diarrhea, neurotoxicity) due to decreased organ function or comorbidities. Close monitoring and potential dose adjustments are recommended.

• DPD deficiency is a critical consideration; screening should be considered, especially in patients with severe or early-onset toxicity. Uridine triacetate is an antidote for severe toxicity or overdose.
• Leucovorin is often co-administered with fluorouracil to enhance its cytotoxic effects by stabilizing the binding of FdUMP to thymidylate synthase.
• Continuous infusion regimens are generally associated with less myelosuppression but more mucositis and hand-foot syndrome compared to bolus regimens.
• Patients should be educated on the importance of reporting any signs of toxicity promptly, especially fever, severe diarrhea, or mouth sores.
• Hydration and antiemetic prophylaxis are crucial for managing gastrointestinal toxicities.

• Other antimetabolites (e.g., Gemcitabine, Pemetrexed, Methotrexate)
• Other classes of chemotherapy agents (e.g., platinum compounds, taxanes, topoisomerase inhibitors)
• Targeted therapies (e.g., EGFR inhibitors, VEGF inhibitors)
• Immunotherapy (e.g., PD-1/PD-L1 inhibitors)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure your safety and the safety of others, never share your prescription medications with anyone, and do not take medications that have been prescribed to someone else.

All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best method for disposal, as some communities may have designated drug take-back programs.

Additionally, some medications may come with a separate patient information leaflet; if you have questions or concerns, consult with your pharmacist. If you have any questions or concerns about your medication, it is crucial to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid healthcare professionals in providing appropriate treatment.