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Febulitt

Febulitt

febuxostat

Manufacturer:

Cooper Pharma

Distributor:

Littman
Concise Prescribing Info
Contents
Febuxostat
Indications/Uses
Adults w/ chronic hyperuricemia in conditions where urate deposition has already occurred (including history, or presence of, tophus &/or gouty arthritis).
Dosage/Direction for Use
40 mg once daily. May consider 80 mg once daily if serum uric acid is >6 mg/dL (357 micromol/L) after 2-4 wk. Gout flare prophylaxis of at least 6 mth is recommended. Patient w/ mild hepatic impairment 80 mg.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue use if serious allergic/hypersensitivity reactions, including SJS, occur. Not recommended in patients w/ ischemic heart disease or CHF; patients in whom rate of urate formation is greatly increased eg, malignant disease & its treatment, Lesch-Nyhan syndrome; organ transplant recipients. Not to be started until an acute attack of gout has completely subsided. Flare prophylaxis w/ NSAID or colchicine at treatment initiation for at least 6 mth is recommended. Patients w/ alteration of thyroid function. Perform LFT prior to initiation of therapy & periodically thereafter. Not recommended in concomitant use w/ mercaptopurine/azathioprine. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Severe renal impairment (CrCl <30 mL/min). Severe hepatic impairment (Child Pugh class C). Not to be used during pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Gout flares, liver function abnormalities, diarrhea, nausea, headache, rash & edema.
Drug Interactions
May increase plasma conc of mercaptopurine/azathioprine leading to toxicity. Concomitant use w/ cytotoxic chemotherapy. Metabolism may be increased & efficacy be decreased w/ potent UGT enzyme inducers. Delayed absorption & decreased Cmax w/ Mg & Al hydroxide-containing antacid.
MIMS Class
Hyperuricemia & Gout Preparations
ATC Classification
M04AA03 - febuxostat ; Belongs to the class of preparations inhibiting uric acid production. Used in the treatment of gout.
Presentation/Packing
Form
Febulitt FC tab 40 mg
Packing/Price
30's
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