Light green, round, semi-biconvex film-coated tablet engraved with 'ACME' on one face and a break line on the other face.
Each Film-Coated Tablet contains: Febuxostat 40 mg.
Pharmacology: Pharmacodynamics: Febuxostat is a xanthine oxidase inhibitor that achieves its therapeutics effect by decreasing serum uric acid. Febuxostat is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.
Pharmacokinetics: Absorption: The absorption of radiolabeled Febuxostat following oral dose administration was estimated to be at least 49%. Maximum plasma concentrations of Febuxostat occurred between 1 and 1.5 hours post-dose. Absolute bioavailability of Febuxostat tablet has not been studied.
Distribution: The mean apparent steady state of volume of distribution of Febuxostat was approximately 50L. While the plasma protein binding is approximately 99.2% (primarily to albumin).
Metabolism: Febuxostat is extensively metabolized by both conjugation via uridine diphosphate glucuronosyltransferase (UGT) enzymes including CYP1A2, 2C8 and 2C9 and non P-450 enzymes. The relative contribution of each enzyme isoform in the metabolism of Febuxostat is not clear. The oxidation of the isobutyl side chain leads to the formation of four pharmacologically active hydroxy metabolites, all of which occur in plasma of humans at a much lower extent than Febuxostat.
In urine and feces, acyl glucuronide metabolites of Febuxostat and oxidative metabolites, 67M-1, 67M-2 and 67M-4, a secondary metabolite from 67M-1 appeared to be the major metabolites of Febuxostat in vivo.
Elimination: Febuxostat is eliminated by both hepatic and renal pathways. The apparent mean terminal elimination half-life (t1/2) of Febuxostat was approximately 5-8 hours.
Febuxostat (Euricstat) is indicated for the chronic management of hyperuricemia in patients with gout.
The recommended starting dose of Febuxostat (Euricstat) 40mg tablet is once daily.
For patients who do not achieve serum uric acid (sUA) less than 6mg/dL after two weeks with 40mg, Febuxostat 80mg is recommended.
OR AS DIRECTED BY THE PHYSICIAN.
No overdose of Febuxostat was reported in clinical studies wherein up to 300mg daily of Febuxostat for seven days were administered to healthy patients and no evidence of dose-limiting toxicities were noticed. In case of overdose, patients should be managed by symptomatic and supportive care.
Febuxostat is contraindicated in patients being treated with azathioprine or mercaptopurine.
Gout flare: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents including Febuxostat. If a gout flare occurs during treatment, Febuxostat need not be discontinued. 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: Monitor for signs and symptoms of MI and stroke & discuss with physician.
Liver enzyme elevation: Transaminase elevations have been observed in Febuxostat treated patients. Monitor liver function tests periodically.
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Febuxostat should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Cautions should be exercised when Febuxostat is administered to a nursing woman.
The most common side effects of Febuxostat include: Liver problems; Nausea; Gout flares; Arthralgia; Rash.
Concomitant administration of Febuxostat with xanthine oxidase substrate drugs such as azathioprine and mercaptopurine could increase plasma concentrations of these drugs which results to severe toxicity.
Special Precautions for Handling and Disposal: Any unused medicine should be disposed properly. Consult the pharmacist or local waste management center for more details about how to safely discard expired or unused medicines.
Store at temperatures not exceeding 30°C. Protect from light.
M04AA03 - febuxostat ; Belongs to the class of preparations inhibiting uric acid production. Used in the treatment of gout.
Euricstat FC tab 40 mg
30's
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