Fluorouracil 5gm/100ml Inj, 100ml

Fluorouracil (5-FU) is a pyrimidine analog that acts as an antimetabolite. It is converted intracellularly to several active metabolites, including 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 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 strand breaks. These actions collectively disrupt DNA and RNA synthesis, leading to cell cycle arrest and apoptosis, primarily in the S-phase.

Urgent 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
+ Coffee ground-like vomit
+ Blood in the urine
+ Black, red, or tarry stools
+ Gum bleeding
+ 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 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 Possible 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 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.

Be cautious, as this medication can increase your risk of bleeding easily. To minimize this risk, use a soft toothbrush and an electric razor, and avoid injuries. If you experience stomach upset, vomiting, diarrhea, or loss of appetite, consult your doctor, as there may be ways to alleviate these side effects. If you have diarrhea or vomiting, it is crucial to discuss with your doctor how to prevent dehydration and electrolyte imbalances.

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 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 vaccines, consult your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

Be aware that this medication can increase your sensitivity to the sun, making you more prone to sunburn. Take necessary precautions when exposed to the sun, and inform your doctor if you experience sunburn easily while taking this medication.

This medication may affect fertility, potentially leading to difficulty conceiving or fathering a child. If you plan to become pregnant or father a child, discuss this 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. Consult your doctor to determine 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. Fatalities have occurred.
• Live vaccines: Risk of severe infection in immunosuppressed patients.

• 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).
• Allopurinol: May reduce fluorouracil toxicity by interfering with its metabolism, potentially reducing efficacy. Not recommended for concomitant use.
• Cimetidine: May increase fluorouracil plasma concentrations by inhibiting its metabolism.
• Metronidazole: May increase fluorouracil plasma concentrations and toxicity.
• Thiazide diuretics: May increase myelosuppression.
• Warfarin: May increase INR and bleeding risk.

• Phenytoin: Fluorouracil may increase phenytoin levels.
• Tamoxifen: May increase fluorouracil levels.
• Other myelosuppressive agents: Increased risk of bone marrow suppression.
• Cardiotoxic agents (e.g., anthracyclines): Increased risk of cardiotoxicity.

• Not available

• Myelosuppression (fever, chills, signs of infection, unusual bleeding/bruising, fatigue)
• Gastrointestinal toxicity (stomatitis/mucositis, diarrhea, nausea, vomiting, abdominal pain)
• Hand-foot syndrome (palmar-plantar erythrodysesthesia: redness, swelling, pain, blistering on palms/soles)
• Cardiotoxicity (chest pain, shortness of breath, palpitations, ECG changes)
• Neurotoxicity (ataxia, confusion, lethargy, headache, visual disturbances)
• Dermatologic reactions (rash, skin discoloration, nail changes)
• Ocular toxicity (conjunctivitis, excessive tearing, blurred vision)

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. Women of childbearing potential should be advised to use effective contraception during treatment and for at least 6 months after the last dose.

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 at least 1 month after the last dose.

Safety and effectiveness in pediatric patients have not been established in controlled clinical trials. Use in pediatric oncology is based on experience in specific protocols, often for solid tumors. Dosing is highly individualized and requires careful monitoring for toxicity.

Elderly patients may be more susceptible to the toxic effects of fluorouracil, particularly myelosuppression, mucositis, and diarrhea. Careful monitoring and potential dose adjustments may be necessary. Renal and hepatic function should be assessed prior to and during therapy.

• DPD deficiency is a critical risk factor for severe toxicity; consider testing, especially for continuous infusions or high doses.
• Leucovorin is often co-administered to enhance efficacy, but it also increases toxicity; careful monitoring is essential.
• Hand-foot syndrome (palmar-plantar erythrodysesthesia) is a common and dose-limiting toxicity, especially with continuous infusions. Management includes dose reduction, interruption, and topical emollients/corticosteroids.
• Cardiotoxicity, though less common, can be severe and life-threatening (e.g., angina, MI, arrhythmias). Patients with pre-existing cardiac disease are at higher risk.
• Diarrhea can be severe and lead to dehydration and electrolyte imbalances; aggressive supportive care (antidiarrheals, IV fluids) is crucial.
• Mucositis/stomatitis is a common and painful side effect; oral hygiene and pain management are important.
• Uridine triacetate (Vistogard) is an important antidote for severe or overdose situations, but must be administered within 96 hours of fluorouracil exposure.

• Oxaliplatin (e.g., FOLFOX regimen)
• Irinotecan (e.g., FOLFIRI regimen)
• Bevacizumab (VEGF inhibitor)
• Cetuximab (EGFR inhibitor)
• Regorafenib (multikinase inhibitor)
• Trifluridine/tipiracil (TAS-102)

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 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.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Properly dispose of any unused or expired medications. Unless instructed to do so by a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices or inform you about potential drug take-back programs in your area.

Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. 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 contact your local poison control center or seek emergency medical attention. Be prepared to provide critical information, including the name of the medication taken, the amount, and the time it was taken, to ensure prompt and effective treatment.