- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of febuxostat.
Chronic hyperuricaemia where urate deposition has already occurred
Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of tophus and/or gouty arthritis).
80mg once daily. If serum uric acid is greater than 6mg/dl (357micromol/l) after 2 to 4 weeks, 120mg once daily may be considered.
Patients with Hepatic Impairment
Mild hepatic impairment: 80mg once daily
Additional Dosage Information
Serum uric acid may be retested after 2 weeks. The therapeutic target is to decrease and maintain serum uric acid below 6mg/dl (357micromol/l).
Gout flare prophylaxis for at least 6 months is recommended.
Children under 18 years
Organ transplant recipients
Severe cardiovascular disorder
Precautions and Warnings
Congestive cardiac failure
Glucose-galactose malabsorption syndrome
Ischaemic heart disease
Renal impairment - creatinine clearance below 30 ml/minute
Do not initiate during an acute attack of gout
Advise ability to drive/operate machinery may be affected by side effects
Perform liver function tests before commencing therapy and during therapy
Monitor for signs and symptoms of allergic reaction
Advise patient to report symptoms of allergic type hypersensitivity
Suspend treatment if Stevens-Johnson syndrome is suspected
Discontinue permanently if severe hypersensitivity reactions occur
If a gout flare occurs during treatment, it should not be discontinued. The gout flare should be managed concurrently as appropriate for the patient. Continuous treatment with febuxostat decreases the frequency and intensity of gout flares.
Patients should be advised of the signs and symptoms of severe hypersensitivity; febuxostat must be stopped immediately if these occur, and must not be restarted in patients who have ever developed a hypersensitivity reaction to febuxostat. Most cases occur during the first month of treatment; a prior history of hypersensitivity to allopurinol and or renal disease may indicate potential hypersensitivity to febuxostat.
Avoid treatment with febuxostat in patients with pre-existing major cardiovascular disease, unless no other therapy options are appropriate.
Pregnancy and Lactation
Febuxostat is contraindicated during pregnancy.
Use of febuxostat during pregnancy is contraindicated by the manufacturer. Available reports indicate no increased risk of teratogenic or development effects. However, human data is limited and as such a potential risk cannot be ruled out.
Febuxostat is contraindicated during breastfeeding.
Use of febuxostat when breastfeeding is contraindicated by the manufacturer. Animal data reports significant levels of febuxostat in the breast milk, however presence in human breast milk is unknown. The effects on exposed infants are unknown.
Altered thyroid hormone levels
Blood urea increased
Creatine kinase increased
Disturbances of appetite
Elevated amylase levels
Elevated serum potassium
Elevated triglyceride levels
Gastroesophageal reflux disease
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Increase in plasma cholesterol
Increase in serum glucose
Increased partial thromboplastin time
Liver function disturbances
Reduced lymphocyte count
Reduced platelet count
Serum creatinine increased
Upper respiratory tract infection
White blood cell count decreased
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: August 2019
Summary of Product Characteristics: Adenuric 80mg film-coated tablets. A.Menarini Pharma U.K. S.R.L. Revised July 2019.
Summary of Product Characteristics: Adenuric 120mg film-coated tablets. A.Menarini Pharma U.K. S.R.L. Revised July 2019.
Summary of Product Characteristics: Febuxostat 80mg film-coated tablets. Accord UK Ltd. Revised September 2018.
Summary of Product Characteristics: Febuxostat 120mg film-coated tablets. Accord UK Ltd. Revised September 2018.
Summary of Product Characteristics: Febuxostat 80mg film-coated tablets. Dr Reddy's Laboratories (UK) Ltd. Revised February 2019.
Summary of Product Characteristics: Febuxostat 120mg film-coated tablets. Dr Reddy's Laboratories (UK) Ltd. Revised February 2019.
MHRA Drug Safety Update July 2019
Available at: https://www.mhra.gov.uk
Last accessed: 07 August 2019
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.