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Duzallo
Overview
What is Duzallo?
DUZALLO (lesinurad and allopurinol) tablets contain 2 oral medications used in the treatment of hyperuricemia: lesinurad and allopurinol. Lesinurad is a URAT1 inhibitor and allopurinol is a xanthine oxidase inhibitor.
What does Duzallo look like?
What are the available doses of Duzallo?
Tablets:
What should I talk to my health care provider before I take Duzallo?
How should I use Duzallo?
DUZALLO®, a combination of lesinurad, a uric acid transporter 1 (URAT1) inhibitor, and allopurinol, a xanthine oxidase inhibitor, is indicated for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone [see ].
DUZALLO tablets are for oral use. DUZALLO should be taken once daily by mouth, in the morning with food and water. Patients should be instructed to stay well hydrated (e.g., 2 liters of liquid per day).
One tablet of DUZALLO contains the maximum daily lesinurad dose (200 mg).
Use of DUZALLO is not recommended for patients taking daily doses of allopurinol less than 300 mg (or less than 200 mg in patients with estimated creatinine clearance [eCLcr] less than 60 mL/min).
Use one tablet of DUZALLO in place of an equivalent portion of the total daily allopurinol dose. The total daily dose of allopurinol should be maintained at the time of initiating DUZALLO.
For patients currently on ZURAMPIC (lesinurad) in combination with allopurinol, DUZALLO may be initiated by using one tablet of DUZALLO in place of ZURAMPIC (lesinurad) and an equivalent portion of the daily allopurinol dose.
What interacts with Duzallo?
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What are the warnings of Duzallo?
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What are the precautions of Duzallo?
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What are the side effects of Duzallo?
Sorry No records found
What should I look out for while using Duzallo?
The use of DUZALLO is contraindicated in the following conditions:
Acute renal failure has occurred with lesinurad, one of the components of DUZALLO. [see , ]
What might happen if I take too much Duzallo?
How should I store and handle Duzallo?
Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [ ].Disulfiram Tablets, USP are white, round, unscored tablets debossed 607.Bottle of 100 NDC 60429-196-01Bottle of 30 NDC 60429-196-30Disulfiram Tablets, USP are white, round, unscored tablets debossed 607.Bottle of 100 NDC 60429-196-01Bottle of 30 NDC 60429-196-30Disulfiram Tablets, USP are white, round, unscored tablets debossed 607.Bottle of 100 NDC 60429-196-01Bottle of 30 NDC 60429-196-30
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
DUZALLO combines two medications with complementary mechanisms of action for treatment of hyperuricemia associated with gout: lesinurad, a uric acid reabsorption inhibitor, and allopurinol, a xanthine oxidase inhibitor. DUZALLO lowers serum uric acid levels by increasing excretion and inhibiting production of uric acid.
Non-Clinical Toxicology
The use of DUZALLO is contraindicated in the following conditions:Acute renal failure has occurred with lesinurad, one of the components of DUZALLO. [see , ]
Disulfiram appears to decrease the rate at which certain drugs are metabolized and therefore may increase the blood levels and the possibility of clinical toxicity of drugs given concomitantly.
DISULFIRAM SHOULD BE USED WITH CAUTION IN THOSE PATIENTS RECEIVING PHENYTOIN AND ITS CONGENERS, SINCE THE CONCOMITANT ADMINISTRATION OF THESE TWO DRUGS CAN LEAD TO PHENYTOIN INTOXICATION. PRIOR TO ADMINISTERING DISULFIRAM TO A PATIENT ON PHENYTOIN THERAPY, A BASELINE PHENYTOIN SERUM LEVEL SHOULD BE OBTAINED. SUBSEQUENT TO INITIATION OF DISULFIRAM THERAPY, SERUM LEVELS OF PHENYTOIN SHOULD BE DETERMINED ON DIFFERENT DAYS FOR EVIDENCE OF AN INCREASE OR FOR A CONTINUING RISE IN LEVELS. INCREASED PHENYTOIN LEVELS SHOULD BE TREATED WITH APPROPRIATE DOSAGE ADJUSTMENT.
It may be necessary to adjust the dosage of oral anticoagulants upon beginning or stopping disulfiram, since disulfiram may prolong prothrombin time.
Patients taking isoniazid when disulfiram is given should be observed for the appearance of unsteady gait or marked changes in mental status, the disulfiram should be discontinued if such signs appear.
In rats, simultaneous ingestion of disulfiram and nitrite in the diet for 78 weeks has been reported to cause tumors, and it has been suggested that disulfiram may react with nitrites in the rat stomach to form a nitrosamine, which is tumorigenic. Disulfiram alone in the rat's diet did not lead to such tumors. The relevance of this finding to humans is not known at this time.
Adverse reactions related to renal function, including acute renal failure, can occur after initiating DUZALLO. Treatment with lesinurad 200 mg in combination with allopurinol was associated with an increased incidence of serum creatinine elevations, most of which were reversible [see ]. A higher incidence of serum creatinine elevations and renal-related adverse reactions, including serious adverse reactions of acute renal failure, were observed with lesinurad 400 mg in combination with allopurinol, with the highest incidence when lesinurad was given alone. DUZALLO treatment should be interrupted if serum creatinine is elevated to greater than 2 times the value when lesinurad treatment was initiated. In patients who report symptoms that may indicate acute uric acid nephropathy including flank pain, nausea or vomiting, interrupt treatment and measure serum creatinine promptly. DUZALLO should not be restarted without another explanation for the serum creatinine abnormalities.
DUZALLO should not be initiated in patients with an eCLcr less than 45 mL/min. Renal function should be evaluated prior to initiation of DUZALLO and periodically thereafter, as clinically indicated. More frequent renal function monitoring is recommended in patients with an eCLcr less than 60 mL/min [see ] or with serum creatinine elevations 1.5 to 2 times the value when lesinurad treatment was initiated.
Some patients with pre-existing renal disease or poor urate clearance have shown a rise in BUN during administration of allopurinol.
The following adverse reactions are also discussed in other sections:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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