Fluda
Generic Name
Fludarabine Phosphate 50 mg Oral Suspension
Manufacturer
PharmaCo Oncology
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| fluda 50 mg suspension | ৳ 78.24 | N/A |
Description
Overview of the medicine
Fludarabine is an antineoplastic agent used in the treatment of certain leukemias and lymphomas. This 50 mg oral suspension formulation provides a convenient option for administration, especially in patients who may have difficulty swallowing tablets.
Uses & Indications
Dosage
Adults
For CLL: 40 mg/m² orally once daily for 5 consecutive days, repeated every 28 days. Duration of treatment should not exceed 6 cycles.
Elderly
Dosage adjustments for elderly patients should be based on renal function (creatinine clearance) and overall tolerability. Close monitoring is recommended.
Renal_impairment
For creatinine clearance (CrCl) between 30-70 mL/min, the dose should be reduced by 50%. Fludarabine is contraindicated in patients with CrCl < 30 mL/min.
How to Take
Administer orally, preferably at the same time each day. May be taken with or without food. Shake the bottle well before each use. Use an oral dosing syringe provided to measure the exact prescribed dose.
Mechanism of Action
Fludarabine phosphate is a purine analog that inhibits DNA synthesis and repair. It is phosphorylated intracellularly to the active metabolite, fludarabine triphosphate (F-ara-ATP), which inhibits DNA polymerase, ribonucleotide reductase, and DNA primase, leading to cell death by incorporation into DNA and RNA.
Pharmacokinetics
Onset
Therapeutic effects are typically observed days to weeks after initiation of treatment, depending on the disease and patient response.
Excretion
The primary route of elimination is renal excretion, with the active metabolite and its dephosphorylated form being excreted in the urine.
Half life
The terminal half-life of the active metabolite (F-ara-ATP) is approximately 18-20 hours.
Absorption
Rapid and extensive oral absorption after administration. Absolute bioavailability of oral fludarabine phosphate is approximately 50-65% relative to intravenous administration.
Metabolism
Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A in plasma, which is then transported into cells and phosphorylated intracellularly to the active F-ara-ATP.
Side Effects
Contraindications
- Known hypersensitivity to fludarabine or any excipients of the product.
- Severe renal impairment (creatinine clearance < 30 mL/min).
- Decompensated hemolytic anemia.
- Pregnancy and lactation.
- Concomitant use with pentostatin.
Drug Interactions
Pentostatin
Concomitant use is contraindicated due to an increased risk of fatal pulmonary toxicity.
Dipyridamole
May reduce fludarabine effectiveness by inhibiting cellular uptake.
Live attenuated vaccines
Increased risk of severe infection due to immunosuppression; avoid during and after fludarabine therapy until immune recovery.
Other myelosuppressive agents
Increased risk of severe myelosuppression when used concurrently.
Storage
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). Protect from light and moisture. Do not freeze.
Overdose
Symptoms of overdose include severe myelosuppression, profound neurotoxicity (e.g., irreversible central nervous system toxicity, blindness, coma), and death. There is no specific antidote. Management is supportive, including blood transfusions, growth factors, and intensive care as needed.
Pregnancy & Lactation
Contraindicated during pregnancy due to genotoxic and teratogenic potential. Women of childbearing potential must use highly effective contraception during treatment and for at least 6 months after. Avoid breastfeeding due to potential harm to the infant.
Side Effects
Contraindications
- Known hypersensitivity to fludarabine or any excipients of the product.
- Severe renal impairment (creatinine clearance < 30 mL/min).
- Decompensated hemolytic anemia.
- Pregnancy and lactation.
- Concomitant use with pentostatin.
Drug Interactions
Pentostatin
Concomitant use is contraindicated due to an increased risk of fatal pulmonary toxicity.
Dipyridamole
May reduce fludarabine effectiveness by inhibiting cellular uptake.
Live attenuated vaccines
Increased risk of severe infection due to immunosuppression; avoid during and after fludarabine therapy until immune recovery.
Other myelosuppressive agents
Increased risk of severe myelosuppression when used concurrently.
Storage
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). Protect from light and moisture. Do not freeze.
Overdose
Symptoms of overdose include severe myelosuppression, profound neurotoxicity (e.g., irreversible central nervous system toxicity, blindness, coma), and death. There is no specific antidote. Management is supportive, including blood transfusions, growth factors, and intensive care as needed.
Pregnancy & Lactation
Contraindicated during pregnancy due to genotoxic and teratogenic potential. Women of childbearing potential must use highly effective contraception during treatment and for at least 6 months after. Avoid breastfeeding due to potential harm to the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 1 to 2 years for unopened bottles. Once opened, use within a specified period (e.g., 28 days) as indicated in the package insert.
Availability
Hospitals, specialized pharmacies
Approval Status
Approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Ongoing clinical trials are investigating fludarabine in combination with novel agents for various hematological malignancies, as well as exploring its role in stem cell transplantation conditioning regimens.
Lab Monitoring
- Complete blood counts (CBC) with differential before each cycle and frequently during treatment.
- Renal function (serum creatinine, creatinine clearance) before and during treatment.
- Liver function tests (LFTs) periodically.
- Neurological evaluation periodically.
Doctor Notes
- Emphasize the importance of patient hydration and aggressive prophylactic antimicrobial therapy, especially for patients with a high risk of opportunistic infections.
- Educate patients on symptoms of myelosuppression and neurotoxicity, and stress immediate reporting.
- Monitor for tumor lysis syndrome, particularly during the first cycle.
Patient Guidelines
- Report any signs of infection (fever, chills, sore throat), unusual bleeding or bruising immediately to your doctor.
- Avoid live attenuated vaccines during and for a prolonged period after treatment.
- Maintain adequate hydration, especially during the first cycle, to help prevent tumor lysis syndrome.
- Use effective contraception during treatment and for at least 6 months after your last dose.
Missed Dose Advice
If a dose is missed, take it as soon as you remember on the same day. If it's already the next day, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Fludarabine may cause fatigue, dizziness, or visual disturbances. Patients should be advised to avoid driving or operating heavy machinery if they experience these effects.
Lifestyle Advice
- Practice good hand hygiene to minimize the risk of infection.
- Avoid contact with people who are sick or have recent vaccinations.
- Avoid activities that could cause injury or bleeding, such as contact sports.
- Discuss dietary restrictions or supplements with your doctor.
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