Fluorouracil 1gm/20ml Inj 20ml

Fluorouracil (5-FU) is a pyrimidine analog antimetabolite. It is converted intracellularly to several active metabolites, including fluorodeoxyuridine monophosphate (FdUMP), fluorouridine triphosphate (FUTP), and fluorodeoxyuridine triphosphate (FdUTP). FdUMP inhibits thymidylate synthase, an enzyme critical for DNA synthesis, thereby blocking the methylation of deoxyuridylic acid to thymidylic acid. FUTP is incorporated into RNA, leading to dysfunctional RNA. FdUTP is incorporated into DNA, leading to DNA damage and inhibition of DNA synthesis and function. These actions ultimately lead to cell death, particularly in rapidly dividing 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
+ 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 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 bruising that worsens
+ 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

If you experience any of these symptoms, notify your doctor or seek medical attention immediately.

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. However, many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or 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 breastfeeding, as you should not breastfeed 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 you 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 lead to bleeding problems, infections, or anemia. In severe cases, these complications 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, so it is crucial to be cautious and avoid injuries. To minimize the risk of bleeding, 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 essential to discuss this with your doctor 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 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. If you experience increased sensitivity to the sun, inform your doctor. This medication may also affect fertility, leading to difficulties in becoming pregnant or fathering a child. If you plan to conceive, discuss this with your doctor before starting treatment.

If you are pregnant or plan to become pregnant, it is essential to note that this medication may harm the unborn baby. If you or your partner may become pregnant, you must use effective birth control during treatment 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.

• Live vaccines (due to immunosuppression)

• Leucovorin (enhances fluorouracil's cytotoxic effects and toxicity, particularly gastrointestinal and hematologic)
• Allopurinol (may decrease fluorouracil's efficacy by interfering with its activation)
• Cimetidine (may increase fluorouracil levels and toxicity)
• Metronidazole (may increase fluorouracil levels and toxicity)
• Warfarin (may increase INR and risk of bleeding)
• Thiazide diuretics (may increase myelosuppression)
• Phenytoin (may increase phenytoin levels and toxicity)

• Other myelosuppressive agents (additive myelosuppression)
• Drugs causing QT prolongation (potential additive effect)
• Folinic acid (leucovorin) - while often co-administered, it significantly modifies 5-FU's toxicity profile, requiring careful dosing and monitoring.
• Tamoxifen (may increase risk of thromboembolic events)

• Not available

• Signs of myelosuppression (fever, chills, sore throat, unusual bleeding/bruising, fatigue)
• Gastrointestinal toxicity (severe diarrhea, mucositis/stomatitis, nausea, vomiting, abdominal pain)
• Dermatologic reactions (hand-foot syndrome/palmar-plantar erythrodysesthesia, rash, nail changes)
• Neurological symptoms (ataxia, confusion, lethargy, headache, visual disturbances)
• Cardiotoxicity (chest pain, dyspnea, ECG changes)
• Signs of infection

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 (Lactation Risk L5). It is unknown if fluorouracil is excreted in human milk, but due to its potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric patients have not been established for all indications. Use in pediatric oncology is limited to specific protocols where the benefits outweigh the risks. Dosing is highly individualized and requires careful monitoring.

Elderly patients may be at increased risk for fluorouracil-related toxicities, particularly myelosuppression, mucositis, and diarrhea. Close monitoring of hematologic parameters and gastrointestinal symptoms is essential. Dose adjustments may be necessary based on tolerance and renal/hepatic function.

• DPD (dihydropyrimidine dehydrogenase) deficiency is a critical pharmacogenomic factor; patients with partial or complete DPD deficiency are at significantly increased risk of severe, life-threatening, or fatal fluorouracil toxicity. Consider DPD testing, especially for continuous infusion regimens or if severe early toxicity occurs.
• Hand-foot syndrome (palmar-plantar erythrodysesthesia) is a common and often dose-limiting toxicity, particularly with continuous infusion. Management includes dose reduction, topical emollients, and sometimes pyridoxine.
• Mucositis and diarrhea are common and can be severe. Aggressive supportive care, including antiemetics, antidiarrheals, and oral hygiene, is crucial.
• Cardiotoxicity, though rare, can occur (e.g., angina, ECG changes, myocardial infarction), especially in patients with pre-existing cardiac disease. Monitor for cardiac symptoms.
• Neurological toxicities (e.g., ataxia, confusion) are less common but can occur, particularly with high doses or prolonged infusions.
• Leucovorin (folinic acid) is often co-administered with fluorouracil to enhance its cytotoxic effects, but it also increases toxicity, requiring careful dose titration and monitoring.

• Other antimetabolites (e.g., Gemcitabine, Pemetrexed, Methotrexate)
• Platinum-based agents (e.g., Oxaliplatin, Cisplatin, Carboplatin)
• Taxanes (e.g., Paclitaxel, Docetaxel)
• Targeted therapies (e.g., EGFR inhibitors, VEGF inhibitors, BRAF inhibitors, depending on cancer type)
• Immunotherapy (e.g., PD-1/PD-L1 inhibitors, depending on cancer type)

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 flush medications down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the best method for disposing of medications, consult with your pharmacist, who can provide guidance on safe disposal practices. Additionally, you may want to inquire about potential drug take-back programs in your area.

Some medications may have additional patient information leaflets available. Your pharmacist can provide more information on this. If you have any questions or concerns about your medication, it is recommended that you 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.