Sulfinpyrazone (Oral)

Sulfinpyrazone is used to treat chronic gout (gouty arthritis), which happens when there is too much uric acid in the blood. The medicine helps remove the extra uric acid from the body. Sulfinpyrazone does not cure gout, but after you have been taking it for a few months, it may help prevent gout attacks. This medicine will help prevent gout attacks only as long as you continue to take it.

Sulfinpyrazone is sometimes used to prevent or treat other health issues that can occur if there is too much uric acid in the body.

Sulfinpyrazone may also be used for other conditions as decided by your doctor.

Sulfinpyrazone is available only with your doctor's prescription.

Your doctor should check your progress at regular visits to make sure that this medicine does not cause unwanted effects.

Before you have any medical tests, tell the person in charge that you are taking this medicine. The results of some tests may be affected by sulfinpyrazone.

For patients taking sulfinpyrazone for gout or to help remove uric acid from the body:

• Taking aspirin or other salicylates may lessen the effects of sulfinpyrazone. This will depend on the dose of aspirin or other salicylate that you take, and on how often you take it. Also, drinking too much alcohol may increase the amount of uric acid in the blood and lessen the effects of sulfinpyrazone. Therefore, do not take aspirin or other salicylates or drink alcoholic beverages while taking this medicine, unless you have first checked with your doctor.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your healthcare professional know about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have only been conducted in adults, and there is no specific information comparing the use of sulfinpyrazone in children to other age groups.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be clear whether they work the same way in older people as they do in younger adults or if they cause different side effects or issues. There is no specific information comparing the use of sulfinpyrazone in elderly patients with other age groups.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together. In other cases, two different medicines may be used together even if an interaction might happen. If you are taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the following medicines. The interactions listed here are significant, but they may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Abrocitinib
• Defibrotide

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both medicines.

• Aceclofenac
• Acemetacin
• Alipogene Tiparvovec
• Alteplase, Recombinant
• Amtolmetin Guacil
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Bemiparin
• Betrixaban
• Bivalirudin
• Bromfenac
• Bufexamac
• Caplacizumab-yhdp
• Celecoxib
• Certoparin
• Choline Salicylate
• Cilostazol
• Citalopram
• Clonixin
• Clopidogrel
• Curcumin
• Cyclosporine
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Dicumarol
• Diflunisal
• Dipyridamole
• Dipyrone
• Droxicam
• Duloxetine
• Edoxaban
• Enoxaparin
• Eptifibatide
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Heparin
• Ibrutinib
• Ibuprofen
• Indomethacin
• Inotersen
• Ketoprofen
• Ketorolac
• Lepirudin
• Levomilnacipran
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Melphalan
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Parnaparin
• Paroxetine
• Pegloticase
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Piracetam
• Piroxicam
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Selumetinib
• Sertraline
• Sodium Salicylate
• Sulindac
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Ticagrelor
• Tinzaparin
• Tolfenamic Acid
• Tolmetin
• Trazodone
• Turmeric
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vortioxetine

Using this medicine with any of the following medicines may increase the risk of certain side effects, but it may be necessary to use both drugs for the best treatment. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both medicines.

• Anisindione
• Bismuth Subsalicylate
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The interactions listed here are significant, but they may not include all possible interactions.

Other Medical Problems

Other medical conditions may affect the use of this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

• Blood disease (or history of) or
• Cancer being treated with antineoplastics (cancer medicine) or radiation (x-rays) or
• Kidney stones (or history of) or other kidney disease or
• Stomach ulcer or other stomach or intestinal issues (or history of)—The risk of serious side effects may be higher; also, sulfinpyrazone may not work properly for treating gout if certain kidney diseases are present.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Shortness of breath, troubled breathing, tightness in chest, and/or wheezing
• sores, ulcers, or white spots on lips or in mouth
• sore throat and fever with or without chills
• swollen and/or painful glands
• unusual bleeding or bruising

Symptoms of overdose

• Clumsiness or unsteadiness
• convulsions (seizures)
• diarrhea
• nausea or vomiting (severe or continuing)
• stomach pain (severe or continuing)
• difficulty in breathing

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Lower back and/or side pain
• painful urination (possibly with blood)

Less common

• Skin rash

Rare

• Bloody or black, tarry stools
• fever
• increased blood pressure
• pinpoint red spots on skin
• sudden decrease in amount of urine
• swelling of face, fingers, feet, and/or lower legs
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Joint pain, redness, and/or swelling
• nausea or vomiting
• stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

If sulfinpyrazone upsets your stomach, it may be taken with food. If this does not work, an antacid may be taken. If stomach upset (nausea, vomiting, or stomach pain) continues, check with your doctor.

In order for sulfinpyrazone to help you, it must be taken regularly as ordered by your doctor.

When you first begin taking sulfinpyrazone, the amount of uric acid in the kidneys is greatly increased. This may cause kidney stones in some people. To help prevent this, your doctor may want you to drink at least 10 to 12 full glasses (8 ounces each) of fluids each day, or to take another medicine to make your urine less acid. It is important that you follow your doctor's instructions very carefully.

For patients taking sulfinpyrazone for gout:

• After you begin to take sulfinpyrazone, gout attacks may continue to occur for a while. However, if you take this medicine regularly as directed by your doctor, the attacks will gradually become less frequent and less painful. After you have been taking sulfinpyrazone for several months, they may stop completely.
• Sulfinpyrazone helps to prevent gout attacks. It will not relieve an attack that has already started. Even if you take another medicine for gout attacks, continue to take this medicine also.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treating gout or removing uric acid from the body: Adults: The starting dose of sulfinpyrazone is usually 100 mg or 200 mg a day (one-half of a 100-mg tablet two times a day, one 100-mg tablet one or two times a day, or one 200-mg capsule or tablet once a day). Then, the dose is usually increased by 100 mg or 200 mg every few days, up to 800 mg a day. Starting with a low dose and increasing the dose gradually helps prevent kidney stones and other side effects. After a while, the dose may be changed again, depending on the amount of uric acid in your blood or urine. Children: It is not likely that sulfinpyrazone will be needed to treat gout or remove uric acid from the body in children. However, if a child needs this medicine, the dose would have to be determined by the doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.