Fluorouracil 500mg/10ml Inj 10ml

Fluorouracil (5-FU) is a pyrimidine analog antimetabolite. It acts by interfering with DNA and RNA synthesis. 5-FU is metabolized intracellularly to several active metabolites: fluorodeoxyuridine monophosphate (FdUMP), fluorouridine triphosphate (FUTP), and fluorodeoxyuridine triphosphate (FdUTP). FdUMP inhibits thymidylate synthase (TS), an enzyme critical for DNA synthesis, leading to 'thymineless death' of cells. FUTP is incorporated into RNA, disrupting RNA function and protein synthesis. FdUTP is incorporated into DNA, leading to DNA damage and fragmentation. These actions primarily affect rapidly dividing cells, including cancer cells.

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 immediate medical attention:

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
+ Difficulty 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 discolored sputum
+ 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 enlarge
+ 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-Related Side Effects

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 Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you're concerned about any of the following side effects or if they persist, contact your doctor:

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, consult 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. Be sure to describe the allergic reaction you experienced, including any symptoms.
Certain health conditions, such as:
+ Poor nutrition
+ Infections
+ Bone marrow problems, including low white blood cell count, low platelet count, or low red blood cell count
+ 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. Do not 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 work and laboratory tests, as directed by your doctor, are crucial to monitor your condition.

This medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. In severe cases, these conditions can be life-threatening. If you have any questions or concerns, discuss them with your doctor. 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.

Bleeding can occur more easily while taking this medication. To minimize the risk of injury, be cautious and use a soft toothbrush and an electric razor. If you experience stomach upset, vomiting, diarrhea, or loss of appetite, consult your doctor, as there may be ways to reduce these side effects. If you have diarrhea or vomiting, it is crucial to prevent dehydration and electrolyte imbalances; therefore, discuss the best course of action with your doctor.

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

This medication may 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 vaccines, 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. Take necessary precautions when exposed to the sun, and 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.

Additionally, this medication may harm an unborn baby if taken during pregnancy. 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 (and other antiviral nucleoside analogs like sorivudine): Potentiates fluorouracil toxicity due to inhibition of DPD, leading to fatal outcomes. Co-administration is contraindicated. A washout period of at least 4 weeks is recommended between brivudine and fluorouracil.

• Leucovorin: Enhances the cytotoxic effects of fluorouracil by stabilizing the binding of FdUMP to thymidylate synthase, leading to increased efficacy but also increased toxicity (e.g., myelosuppression, mucositis, diarrhea).
• Warfarin: Increased INR and bleeding risk due to inhibition of warfarin metabolism or displacement from protein binding.
• Cimetidine: May increase fluorouracil plasma concentrations by inhibiting its metabolism.
• Metronidazole: May increase fluorouracil plasma concentrations and toxicity.
• Thiazide diuretics: May increase myelosuppression.
• Live vaccines: Risk of severe infection due to immunosuppression.

• Phenytoin: May alter phenytoin levels (increase or decrease).
• Allopurinol: May reduce fluorouracil efficacy by interfering with its activation, but also may reduce toxicity. Clinical significance varies.
• Tamoxifen: May increase risk of thromboembolic events.
• Interferon alfa: May increase fluorouracil toxicity.

• Not available

• Fever (sign of infection/neutropenic fever)
• Sore mouth/throat, difficulty swallowing (mucositis)
• Diarrhea (frequency, consistency, presence of blood)
• Nausea, vomiting
• Redness, swelling, pain, blistering on palms of hands and soles of feet (Hand-Foot Syndrome)
• Chest pain, shortness of breath, palpitations (cardiotoxicity)
• Unusual bleeding or bruising
• Fatigue, weakness
• Signs of neurotoxicity (ataxia, confusion, lethargy, headache)

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.

It is not known whether fluorouracil is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, breastfeeding is contraindicated during fluorouracil therapy and for a period after the last dose (e.g., 1 week).

Safety and effectiveness in pediatric patients have not been established in controlled clinical trials for most indications. Use is limited to specific pediatric oncology protocols where the benefits outweigh the risks. Dosing is typically based on body surface area (BSA). Pediatric patients may be more susceptible to certain toxicities.

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may have reduced renal or hepatic function, or more comorbidities, requiring careful monitoring and potential dose adjustments. Increased risk of myelosuppression and diarrhea may be observed.

• DPD deficiency is a critical pharmacogenomic consideration. Pre-screening for DPD deficiency is highly recommended, especially for patients receiving bolus or high-dose continuous infusion regimens, as it can lead to severe, life-threatening, or fatal toxicity.
• Leucovorin is often co-administered with fluorouracil to enhance its cytotoxic effect, but this also increases toxicity. The sequence and timing of administration are crucial.
• Monitor closely for myelosuppression (neutropenia, thrombocytopenia) and gastrointestinal toxicities (mucositis, diarrhea), which are dose-limiting. Aggressive supportive care is essential.
• Hand-Foot Syndrome (palmar-plantar erythrodysesthesia) is a common and often dose-limiting toxicity, particularly with continuous infusions. Patient education on prevention and management is important.
• Cardiotoxicity, though less common, can be severe and includes angina, myocardial infarction, and arrhythmias. Patients with pre-existing cardiac disease should be monitored carefully.
• Uridine triacetate (Vistogard) is an antidote for fluorouracil overdose or severe, early-onset toxicity, but must be administered within 96 hours of fluorouracil administration.

• Other antimetabolites (e.g., Methotrexate, Gemcitabine, Pemetrexed, Cytarabine)
• Other classes of chemotherapy agents depending on cancer type (e.g., platinum agents, 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 evaluation and guidance.

To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which your pharmacist can help you locate.

Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call 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 occurred, as this will aid in prompt and effective treatment.