Febox 40 mg (Tablet)

Unit Price: ৳ 12.00 (3 x 10: ৳ 360.00)
Strip Price: ৳ 120.00

Medicine Details

Category Details
Generic Febuxostat
Company Drug international ltd

Title

  • Febox Tablets

Categories

  • Medicine
  • Pharmaceuticals
  • Gout Treatment

Description

  • Febox tablets are indicated for the chronic management of hyperuricemia in patients with gout.
  • Febuxostat is a non-purine, selective xanthine oxidase (XO) inhibitor.

Dosage and Administration

  • Recommended starting dose: Febuxostat 40 mg tablet once daily.
  • For patients who do not achieve a serum uric acid level less than 6 mg per dL after 2 weeks with Febuxostat 40 mg tablet, one Febuxostat 80 mg tablet once daily is recommended.
  • Renal impairment: No dose adjustment is necessary.
  • Hepatic impairment: No dose adjustment is necessary.
  • Pediatric Use: Safety and effectiveness in pediatric patients under 18 years of age have not been established.

Interaction

  • Mercaptopurine/Azathioprine: Concomitant use is not recommended.
  • Naproxen and other inhibitors of glucuronidation: Febox metabolism depends on Uridine Glucuronosyl Transferase (UGT) enzymes.

Contraindications

  • Febuxostat is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.

Side Effects

  • The most commonly reported adverse reactions are gout flares, liver function abnormalities, diarrhoea, nausea, headache, rash, and oedema.
  • Rare serious hypersensitivity reactions to Febuxostat have been observed.

Pregnancy and Lactation

  • Pregnancy Category C. Caution should be exercised when Febuxostat is administered to a nursing woman.

Precautions and Warnings

  • An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including Febuxostat.
  • Cardiovascular Events: Monitor for signs and symptoms of MI and stroke.
  • Liver Enzyme Elevation: Transaminase elevations have been observed in Febuxostat-treated patients.

Overdose Effects

  • Febustat was studied in healthy subjects in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities.

Therapeutic Class

  • Drugs used in Gout

Storage Conditions

  • Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Indications

  • Chronic management of hyperuricemia in patients with gout.

Pharmacology

  • Decreases serum uric acid level by inhibiting xanthine oxidase, which is responsible for uric acid production.

Tumor Lysis Syndrome Dose

  • One Febuxostat 120 mg tablet once daily.

Gout Flares Management

  • Non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended upon initiation of Febuxostat tablets.

Antacids Interaction

  • Concomitant ingestion of an antacid containing magnesium hydroxide and aluminum hydroxide has been shown to delay absorption of Febuxostat.

Inducers of Glucuronidation Interaction

  • Monitoring of serum uric acid is recommended 1-2 weeks after start of treatment with a potent inducer of glucuronidation.

Colchicine/Indometacin/Hydrochlorothiazide/Warfarin Interaction

  • Febox can be co-administered with colchicine or indomethacin with no dose adjustment of Febox.

Rosiglitazone/CYP2C8 Substrates Interaction

  • Co-administration of Febuxostat with rosiglitazone or other CYP2C8 substrates is not expected to require any dose adjustment for those compounds.

Mercaptopurine/Azathioprine Interaction

  • Inhibition of XO by Febuxostat may cause increased plasma concentrations of mercaptopurine and azathioprine leading to toxicity.

Gout Flare Continuation

  • If a gout flare occurs during treatment, Febuxostat tablets need not be discontinued. The gout flare should be managed concurrently, as appropriate for the individual patient.

NSAID/Gout Flare Prophylaxis

  • Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months.

Cardiovascular Events Monitoring

  • A higher rate of cardiovascular thromboembolic events was observed in patients treated with Febuxostat than allopurinol in clinical trials.

Liver Enzyme Elevation Monitoring

  • Monitor liver function tests periodically.

Usability for Hyperuricemia Management

  • Indicated for the chronic management of hyperuricemia in patients with gout.

Xanthine Oxidase Inhibition

  • Decreases serum uric acid level by inhibiting xanthine oxidase, which is responsible for uric acid production.

Renal Impairment Dose Adjustment

  • No dose adjustment is necessary when administering Febuxostat in patients with mild to moderate renal impairment.

Hepatic Impairment Dose Adjustment

  • No dose adjustment is necessary in patients with mild to moderate hepatic impairment.

Pediatric Use Safety

  • Safety and effectiveness in pediatric patients under 18 years of age have not been established.

Mercaptopurine/Azathioprine Contraindication

  • Contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.

Gout Flares Side Effect

  • Gout flares may occur after initiation of Febuxostat tablets due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits.

Liver Function Abnormalities Side Effect

  • The most commonly reported adverse reaction is liver function abnormalities.

Diarrhea Side Effect

  • The most commonly reported adverse reaction is diarrhea.

Nausea Side Effect

  • The most commonly reported adverse reaction is nausea.

Headache Side Effect

  • The most commonly reported adverse reaction is headache.

Rash Side Effect

  • The most commonly reported adverse reaction is rash.

Oedema Side Effect

  • The most commonly reported adverse reaction is oedema.

Hypersensitivity Reactions Side Effect

  • Rare serious hypersensitivity reactions to Febuxostat have been observed.

Pregnancy Category C Caution

  • It is not known whether this drug is excreted in human milk. Caution should be exercised when Febuxostat is administered to a nursing woman.

Gout Flare Prophylaxis

  • Gout flares may be managed with a non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of Febuxostat tablets.

Antacid Delayed Absorption

  • Concomitant ingestion of an antacid containing magnesium hydroxide and aluminum hydroxide has been shown to delay absorption of Febuxostat.

Inducers of Glucuronidation Monitoring

  • Monitoring of serum uric acid is recommended 1-2 weeks after start of treatment with a potent inducer of glucuronidation.

Colchicine/Indometacin/Hydrochlorothiazide/Warfarin Dose Adjustment

  • No dose adjustment is necessary for colchicine, indomethacin, hydrochlorothiazide, or warfarin when co-administered with Febuxostat.

Rosiglitazone/CYP2C8 Substrates Dose Adjustment

  • Co-administration of Febuxostat with rosiglitazone or other CYP2C8 substrates is not expected to require any dose adjustment for those compounds.

Mercaptopurine/Azathioprine Toxicity

  • Inhibition of XO by Febuxostat may cause increased plasma concentrations of mercaptopurine and azathioprine leading to toxicity.

NSAID/Gout Flare Prophylaxis Duration

  • Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months.

Cardiovascular Events Monitoring Recommendation

  • Monitor for signs and symptoms of myocardial infarction (MI) and stroke.

Liver Enzyme Elevation Monitoring Recommendation

  • Monitor liver function tests periodically.

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