Fobix
Generic Name
Febuxostat
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Description
Overview of the medicine
Febuxostat is a medication used to treat chronic gout and hyperuricemia. It works by reducing the production of uric acid in the body.
Uses & Indications
Dosage
Adults
Initial: 40 mg orally once daily. If serum uric acid is not <6 mg/dL after 2 weeks, increase to 80 mg once daily.
Elderly
No dosage adjustment is necessary for elderly patients.
Renal_impairment
No dosage adjustment necessary for mild to moderate renal impairment. Use with caution in severe renal impairment (CrCl <30 mL/min).
How to Take
Febuxostat can be taken orally once daily, with or without food. It should be swallowed whole with water.
Mechanism of Action
Febuxostat is a non-purine selective inhibitor of xanthine oxidase, the enzyme responsible for uric acid formation. It reduces serum uric acid levels by inhibiting both oxidized and reduced forms of xanthine oxidase.
Pharmacokinetics
Onset
Significant reduction in serum uric acid levels within 2 weeks.
Excretion
Approximately 49% excreted renally and 45% fecally (via biliary excretion).
Half life
Approximately 5-8 hours.
Absorption
Rapidly and extensively absorbed after oral administration, peak plasma concentrations occur within 1-1.5 hours.
Metabolism
Extensively metabolized in the liver, primarily by conjugation via UDP-glucuronosyltransferase (UGT) and oxidation via cytochrome P450 (CYP) enzymes (e.g., CYP1A2, 2C8, 2C9, 2C19).
Side Effects
Contraindications
- Hypersensitivity to febuxostat or any excipients.
- Concomitant use with azathioprine, mercaptopurine, or theophylline.
Drug Interactions
Warfarin
Monitor INR carefully when co-administering febuxostat with warfarin, as febuxostat may affect warfarin metabolism, although clinical significance is not fully established.
Theophylline
Febuxostat can increase theophylline plasma concentrations, leading to toxicity. Concomitant use is contraindicated.
Azathioprine, Mercaptopurine
Febuxostat increases plasma concentrations of these drugs, leading to increased toxicity. Concomitant use is contraindicated.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited information on febuxostat overdose. In case of overdose, supportive and symptomatic treatment is recommended.
Pregnancy & Lactation
Pregnancy: Category C. Use only if potential benefit justifies potential risk to the fetus. Lactation: Excreted in breast milk. A decision should be made whether to discontinue nursing or the drug, considering the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to febuxostat or any excipients.
- Concomitant use with azathioprine, mercaptopurine, or theophylline.
Drug Interactions
Warfarin
Monitor INR carefully when co-administering febuxostat with warfarin, as febuxostat may affect warfarin metabolism, although clinical significance is not fully established.
Theophylline
Febuxostat can increase theophylline plasma concentrations, leading to toxicity. Concomitant use is contraindicated.
Azathioprine, Mercaptopurine
Febuxostat increases plasma concentrations of these drugs, leading to increased toxicity. Concomitant use is contraindicated.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited information on febuxostat overdose. In case of overdose, supportive and symptomatic treatment is recommended.
Pregnancy & Lactation
Pregnancy: Category C. Use only if potential benefit justifies potential risk to the fetus. Lactation: Excreted in breast milk. A decision should be made whether to discontinue nursing or the drug, considering the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by FDA (2009), DGDA
Patent Status
Patent expired / Generic available
Clinical Trials
Extensive clinical trials (e.g., APEX, FACT, CARES, FAST) have evaluated its efficacy, safety, and cardiovascular outcomes compared to placebo and allopurinol.
Lab Monitoring
- Serum uric acid levels: Regularly to ensure target levels are reached.
- Liver function tests (LFTs): Periodically (e.g., at 2 and 4 months, then periodically) due to potential for liver enzyme elevations.
Doctor Notes
- Ensure patients are well-informed about the risk of initial gout flares and the importance of flare prophylaxis (e.g., colchicine, NSAIDs) during initiation.
- Regular monitoring of serum uric acid levels is crucial to ensure therapeutic targets are met.
- Monitor liver function tests periodically, especially in patients with pre-existing hepatic impairment.
- Discuss cardiovascular risk factors with patients and consider the black box warning in patients with established cardiovascular disease.
Patient Guidelines
- Take Febuxostat exactly as prescribed by your doctor.
- Continue taking Febuxostat even if you experience a gout flare, as it is a long-term treatment.
- Drink plenty of fluids to help prevent kidney stones.
- Initial gout flares may occur; your doctor may prescribe another medication to manage these flares.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Febuxostat may cause dizziness, somnolence, or blurred vision in some patients. If these effects occur, avoid driving or operating heavy machinery.
Lifestyle Advice
- Avoid purine-rich foods (e.g., organ meats, certain seafood, excessive alcohol).
- Maintain a healthy weight through diet and exercise.
- Stay adequately hydrated.
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Global Brand Names
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