Duzallo 200 mg-300 mg tablet

Generic name:
Lesinurad/allopurinol - oral

Pronunciation
(le-SIN-ure-ad/AL-oh-PURE-i-nol)

Brand name(s)
Duzallo

One ingredient in this combination product, lesinurad, has caused very serious kidney problems. Tell your doctor right away if you notice any signs of kidney problems, such as lower back pain, nausea/vomiting, painful/difficult urination, change in the amount of urine.

This medication is a combination of 2 ingredients: lesinurad and allopurinol. It works by decreasing the amount of uric acid your body makes, and by helping the kidneys get rid of uric acid. Increased uric acid levels can cause gout attacks. This combination medication is used to lower uric acid when allopurinol alone has not worked well enough. This effect helps prevent gout flares/attacks.

See also Warning section.

Read the Medication Guide provided by your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually once daily in the morning with a full glass of water (8 ounces/240 milliliters). Drink plenty of fluids (at least 8 full glasses a day) while taking this medication to help it work better, unless otherwise directed by your doctor.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

If you are switching from taking lesinurad or allopurinol to this combination product, be sure to stop taking the other lesinurad or allopurinol product to avoid taking too much medication(s) and increasing the risk of side effects.

You may have more gout attacks for several months after you start taking this medicine while your body gets rid of extra uric acid. Do not stop taking this medication if you have a gout flare/attack. This medication is not for treating gout attacks. Your doctor may prescribe other medication (including colchicine, NSAIDs such as ibuprofen, naproxen, or indomethacin) to prevent or treat a gout attack while you are taking this medication. Continue to take lesinurad/allopurinol and your prescribed medicines for gout attacks as directed by your doctor. Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Stomach upset, nausea, diarrhea, or drowsiness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• numbness/tingling of arms/legs
• easy bleeding/bruising
• unusual tiredness
• unusual weight loss
• signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)

Rarely, heart-related problems or stroke have occurred in people taking lesinurad in combination with allopurinol. However, it is not known if these medications caused these problems. Get medical help right away if you have any of these very serious side effects, including:

• weakness on one side of the body
• sudden vision changes
• trouble speaking
• confusion
• chest/jaw/left arm pain
• shortness of breath
• unusual sweating

This medication can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• fever
• swollen lymph nodes
• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor or pharmacist if you are allergic to lesinurad or allopurinol; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney disease
• liver problems
• cancer treatment
• a certain inherited disease (Lesch-Nyhan syndrome)

This drug may make you drowsy. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if lesinurad passes into breast milk. Allopurinol passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• capecitabine
• didanosine
• fezolinetant
• valproic acid
• "blood thinners" (such as warfarin, dicoumarol)

This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include daridorexant, elacestrant, lonafarnib, mavacamten, revumenib, certain products used to treat chronic hepatitis C (such as asunaprevir, ombitasvir/paritaprevir/ritonavir), among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Aspirin can decrease the effects of this medication. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as kidney/liver function, uric acid levels) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.