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Description of Uloric
ULORIC (febuxostat) is a xanthine oxidase inhibitor. The active ingredient in ULORIC is 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid, with a molecular weight of 316.38. The empirical formula is C 16 H 16 N 2 O 3 S. The chemical structure is: Febuxostat is a non-hygroscopic, white crystalline powder that is freely soluble in dimethylformamide; soluble in dimethylsulfoxide; sparingly soluble in ethanol; slightly soluble in methanol and acetonitrile; and practically insol...
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Uses of Uloric
ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who...
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Available dosage forms and strengths
40 mg tablets, light green to green, round, debossed with "TAP" and "40" 80 mg tablets, light green to green, teardrop shaped, debossed with "TAP" and "80" Tablet: 40 mg, 80 mg.
How should you take Uloric
Recommended dosage is 40 mg or 80 mg once daily. The recommended starting dosage is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after 2 weeks, the recommended dosage is 80 mg once daily. Patients with severe renal impairment: Limit the dosage to 40 mg once daily. Flare prophylaxis is recommended upon initiation of ULORIC. Can be administered without regard to food or antacid use. 2.1 Recommended Dosage The recommended ULORIC dosage is 40 mg or 80 mg once...
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Precautions and contraindications for Uloric
ULORIC is contraindicated in patients being treated with azathioprine or mercaptopurine . ULORIC is contraindicated in patients being treated with azathioprine or mercaptopurine.
In case of overdosage
ULORIC was studied in healthy patients in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities. No overdose of ULORIC was reported in clinical studies. Patients should be managed by symptomatic and supportive care should there be an overdose.
Warnings and Cautions
Gout Flares : An increase in gout flares is frequently observed after initiation of ULORIC. If a gout flare occurs during treatment, ULORIC need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug or colchicine) upon initiation of treatment may be beneficial for up to six months. Hepatic Effects : Cases of hepatic failure, some fatal, have been reported. If liver injury is detected, promptly interrupt ULORIC and treat cause, if possible, to resolution or stabilizati...
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Drug interactions
Concomitant administration of ULORIC with XO substrate drugs, azathioprine or mercaptopurine could increase plasma concentrations of these drugs resulting in severe toxicity. 7.1 Xanthine Oxidase Substrate Drugs ULORIC is an XO inhibitor. Based on a drug interaction study in healthy patients, febuxostat altered the metabolism of theophylline (a substrate of XO) in humans . Therefore, use with caution when coadministering ULORIC with theophylline. A drug interaction study of ULORIC and azathioprine, ...
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Pregnancy
Limited available data with ULORIC use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. No adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times, respectively, the exposure at the maximum recommended human dose (MRHD). No adverse developmental effects were observed in ...
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Notice: This medical information is provided to help you better understand this medical condition or process and may contain information about medication often used as part of a treatment plan prescribed by a doctor. It is not intended to be used as either a diagnosis or recommendation for treatment of your medical situation. If you are unwell, concerned about your physical or mental state, or are experiencing symptoms, you should speak with your doctor or primary health care provider. If you are in medical distress, please contact emergency services (such as 911).
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