Uses

This medication is used to prevent gout and gouty arthritis. It will not treat a sudden/severe attack of gout and may make it worse. Gout occurs when your uric acid level gets too high, forming uric acid crystals in the joints that cause pain. Sulfinpyrazone belongs to a class of drugs known as uricosurics. It helps the kidneys to get rid of uric acid, thereby lowering high levels of uric acid and preventing crystals from forming. Lowering uric acid levels may also help your kidneys.

How To Use

Take this medication by mouth, usually twice daily or as directed by your doctor. Take it with food, milk, or antacids to reduce stomach upset. To prevent kidney stones, it is best to drink a full glass of water (8 ounces or 240 milliliters) with each dose and at least another 8 glasses a day while taking this drug. If your doctor has directed you to restrict your fluid intake, consult your doctor for further instructions. Your doctor may also instruct you on how to decrease acidity in your urine (such as by avoiding large amounts of ascorbic acid/vitamin C) to prevent kidney stones. Your doctor may direct you to take other medications (such as sodium bicarbonate, citrate) to make your urine less acidic.

Dosage is based on your condition and response to treatment. Your doctor may direct you to take a low dose at first, then adjust your dose based on uric acid levels and your gout symptoms. After you have been symptom-free for several months and your uric acid levels are normal, your doctor may lower your dose to the lowest effective dose. Follow your doctor's directions carefully.

If you are also taking cholestyramine, take sulfinpyrazone at least 1 hour before or 4-6 hours after cholestyramine. Consult your doctor for more details.

Sulfinpyrazone should not be started during a sudden/severe gout attack. Wait until your current attack is over before starting this medication. You may experience an increase in the number of gout attacks for several months after starting this medicine while the body removes extra uric acid. If you have a gout attack while taking sulfinpyrazone, continue taking it along with your medications for gout pain.

Sulfinpyrazone is not a pain reliever. To relieve pain from gout, continue to take your medicines prescribed for pain from gout attacks (such as colchicine, ibuprofen, indomethacin) as directed by your doctor.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Tell your doctor if your condition lasts or gets worse.

Side Effects

Nausea, heartburn, dizziness, and ringing in the ears 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 any of these unlikely but serious side effects occur:

• lower back pain
• swelling of the arms/legs/feet
• difficult/painful urination
• change in amount/color of urine

Tell your doctor right away if any of these rare but very serious side effects occur:

• easy bruising/bleeding
• bloody/black/tarry stools
• fast/irregular heartbeat
• signs of infection (such as fever, sore throat)
• severe stomach/abdominal pain
• vomit that looks like coffee grounds
• unusual tiredness

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including:

• 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.

Precautions

Before taking sulfinpyrazone, tell your doctor or pharmacist if you are allergic to it; or to phenylbutazone or other pyrazoles; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:

• bleeding/inflammation in the stomach or intestines (such as active peptic ulcer disease)
• severe kidney disease
• a certain type of kidney stone (urate/uric acid)

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

• bleeding problems (such as low platelets, blood clotting problems)
• low blood counts (such as anemia, low white blood cells)
• cancer of the blood (such as leukemia)
• radiation treatment for cancer
• diabetes
• kidney disease
• history of peptic ulcer disease

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

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because a very serious interaction may occur:

• cancer chemotherapy
• "clot-busting" drugs/thrombolytics (such as streptokinase)

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting sulfinpyrazone.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of:

• "blood thinners" (such as warfarin, dipyridamole)
• nitrofurantoin
• NSAIDs (such as ibuprofen, indomethacin, naproxen)
• salicylates (such as high-dose aspirin)
• certain anti-seizure medication (hydantoins such as phenytoin)

Alcohol can decrease this drug's effectiveness. Limit alcohol while taking this medication.

Aspirin can prevent this medication from being fully effective. Avoid aspirin and other salicylates while taking this medication. Many nonprescription products contain aspirin. Consult your pharmacist before using nonprescription medicines if you are uncertain whether they contain aspirin. Low-dose aspirin should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually 81-162 milligrams a day). Ask your doctor or pharmacist for more details.

This document does not contain all possible interactions. Before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe vomiting, loss of consciousness, seizures.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as uric acid blood levels, kidney function tests, complete blood count) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Your doctor may recommend a low-purine diet to help treat your gout. Follow your doctor's instructions carefully.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature between 59 and 86 degrees F (15 and 30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.