Duzallo contains a combination of allopurinol and lesinurad. Allopurinol reduces the production of uric acid in your body. Uric acid buildup can lead to gout.

Lesinurad helps the kidneys remove uric acid from the body.

Duzallo is used to reduce blood levels of uric acid in adults with gout.

This medicine is usually given when taking allopurinol alone has not been effective.

You should not use Duzallo if you have severe kidney problems, Lesch-Nyhan syndrome, tumor lysis syndrome, or if you are on dialysis or have received a kidney transplant.

Duzallo can cause kidney failure. Call your doctor right away if you urinate less than usual or not at all, or if you have lower back pain, swelling in your feet or ankles, or shortness of breath.

Stop taking Duzallo and get emergency medical help if you have signs of a severe skin reaction, such as a painful, itchy, or blistering skin rash. You may also have a fever, swollen glands, or joint pain.

Duzallo side effects

Get emergency medical help if you have signs of an allergic reaction to Duzallo (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Call your doctor at once if you have:

• a painful, itchy, or blistering skin rash (especially if you also have a fever, swollen glands, or joint pain);

• kidney problems - pain in your side or lower back, nausea, vomiting, little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

• liver problems - loss of appetite, upper stomach pain (right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• heart problems - chest pain or pressure, pain spreading to your jaw or shoulder; or

• signs of a blood clot - sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common Duzallo side effects may include:

• heartburn, nausea, diarrhea;

• headache;

• rash; or

• abnormal kidney function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take Duzallo exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

The usual dose of Duzallo is 1 tablet every morning.

Take Duzallo with food and a full glass of water.

Drink at least 2 liters (68 ounces) of liquids every day to keep your kidneys working properly.

You may need medical tests to check your kidney function before and during treatment with this medicine. Your blood cells may also need to be tested often.

Gout symptoms may get worse when you first start taking Duzallo. Even if you have a gout flare-up, keep using the medication as directed.

Call your doctor if your gout symptoms do not eventually improve.

You should not take Duzallo together with Zurampic (single-ingredient lesinurad) or you could get an overdose of lesinurad.

Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Store Duzallo at room temperature away from moisture and heat.

Usual Adult Dose of Duzallo for Gout:

Initial dose:
-Patients taking allopurinol doses greater than 300 mg/day: Allopurinol 300 mg-lesinurad 200 mg orally once a day
-Patients taking allopurinol doses of 300 mg/day: Allopurinol 300 mg-lesinurad 200 mg orally once a day
-Patients taking allopurinol doses of 200 mg/day: Allopurinol 200 mg-lesinurad 200 mg orally once a day

Comments:
-This drug should be taken as an equivalent portion of the total daily allopurinol dose.
-Patients taking allopurinol concurrently with lesinurad should take this drug in place of lesinurad and at an equivalent portion of allopurinol.
-Gout flare prophylaxis should be considered in patients not currently taking lesinurad.
-Patients who develop gout flares during treatment should be managed; discontinuation of treatment is not necessary.

Use: Treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with medically appropriate doses of allopurinol alone

You should not use Duzallo if you are allergic to allopurinol or lesinurad, or if you have:

• severe kidney disease (or if you are on dialysis);

• tumor lysis syndrome (fast breakdown of tumor cells);

• Lesch-Nyhan syndrome; or

• if you have received a kidney transplant.

To make sure Duzallo is safe for you, tell your doctor if you have ever had:

• kidney disease;

• liver disease;

• heart disease; or

• a stomach disorder called gastroesophageal reflux disease (GERD).

It is not known whether Duzallo will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Lesinurad can make birth control pills less effective. Ask your doctor about using a non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

Other forms of hormonal contraception (injections, implants, skin patches, vaginal rings, and certain intrauterine devices) may not be effective enough to prevent pregnancy during your treatment with Duzallo.

It is not known whether allopurinol and lesinurad passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Skip the missed dose and take the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause dizziness, nausea, vomiting, and diarrhea.

Avoid becoming dehydrated while taking this medicine. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. Dehydration could lead to kidney failure.

Duzallo may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have signs of an allergic reaction to Duzallo (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Call your doctor at once if you have:

• a painful, itchy, or blistering skin rash (especially if you also have a fever, swollen glands, or joint pain);

• kidney problems - pain in your side or lower back, nausea, vomiting, little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

• liver problems - loss of appetite, upper stomach pain (right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• heart problems - chest pain or pressure, pain spreading to your jaw or shoulder; or

• signs of a blood clot - sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common Duzallo side effects may include:

• heartburn, nausea, diarrhea;

• headache;

• rash; or

• abnormal kidney function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can interact with allopurinol and lesinurad. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• aspirin;

• azathioprine or mercaptopurine;

• valproic acid;

• an antibiotic or antifungal medicine;

• a blood thinner (warfarin, Coumadin, Jantoven);

• cholesterol medication;

• heart or blood pressure medication;

• hormonal birth control (pills, patches, implants, or certain intrauterine devices); or

• other gout medications.

This list is not complete and many other drugs can interact with allopurinol and lesinurad. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.