Probenecid and colchicine (Oral)

Probenecid and colchicine combination is used to treat gout or gouty arthritis.

The probenecid in this medicine helps to prevent gout attacks by removing extra uric acid from the body. The colchicine in this medicine also helps to prevent gout attacks. Although colchicine may also be used to relieve an attack of gout, this requires more colchicine than this combination medicine contains. Probenecid and colchicine combination does not cure gout. This medicine will help prevent gout attacks only as long as you continue to take it.

Probenecid and colchicine combination is available only with your doctor's prescription.

Your doctor should check your progress at regular visits while you are taking this medicine.

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 probenecid or by colchicine.

For diabetic patients:

• The probenecid in this combination medicine may cause false test results with copper sulfate urine sugar tests (e.g., Clinitest®), but not with glucose enzymatic urine sugar tests (e.g., Clinistix®). If you have any questions about this, check with your health care professional.

Taking aspirin or other salicylates may lessen the effects of the probenecid in this combination medicine. This will depend on the dose of aspirin or other salicylate that you take, and on how often you take it. Also, drinking large amounts of alcoholic beverages may increase the chance of stomach problems and may increase the amount of uric acid in your blood. Therefore, do not take aspirin or other salicylates or drink alcoholic beverages while you are taking this medicine, unless you have first checked with your doctor.

For patients taking 4 tablets or more of this medicine a day:

• Stop taking this medicine immediately and check with your doctor as soon as possible if severe diarrhea, nausea or vomiting, or stomach pain occurs while you are taking this medicine.

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

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have 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 combination medicine have only been done in adults, and there is no specific information about its use in children.

Geriatric

Older adults are especially sensitive to the effects of colchicine, which may increase the chance of side effects during treatment.

There is no specific information comparing the use of probenecid in older adults with its use in 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 during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In these cases, your doctor may change the dose or take other precautions. It’s very important that your healthcare professional knows if you are taking any of the following medicines while using this medicine. The following interactions are chosen for their potential significance and 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 your other medicines.

• Amiodarone
• Atazanavir
• Boceprevir
• Carvedilol
• Ceritinib
• Clarithromycin
• Cobicistat
• Conivaptan
• Cyclosporine
• Darunavir
• Dronedarone
• Erythromycin
• Flibanserin
• Idelalisib
• Indinavir
• Itraconazole
• Josamycin
• Ketoconazole
• Ketorolac
• Lapatinib
• Levoketoconazole
• Lonafarnib
• Lopinavir
• Mibefradil
• Mifepristone
• Nefazodone
• Nelfinavir
• Nirmatrelvir
• Posaconazole
• Quinidine
• Ranolazine
• Ribociclib
• Ritonavir
• Saquinavir
• Sunitinib
• Telaprevir
• Telithromycin
• Tipranavir
• Troleandomycin
• Tucatinib
• Vemurafenib
• Verapamil
• Voriconazole

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 change the dose or how often you use one or both of the medicines.

• Abametapir
• Abrocitinib
• Adagrasib
• Amprenavir
• Aprepitant
• Atorvastatin
• Avibactam
• Baricitinib
• Bezafibrate
• Capmatinib
• Cephalexin
• Cimetidine
• Ciprofibrate
• Ciprofloxacin
• Clofazimine
• Clofibrate
• Crizotinib
• Daridorexant
• Deferiprone
• Digoxin
• Diltiazem
• Doripenem
• Duvelisib
• Elacestrant
• Enasidenib
• Fedratinib
• Fenofibrate
• Fenofibric Acid
• Fexinidazole
• Fluconazole
• Fluvoxamine
• Fosamprenavir
• Fosnetupitant
• Gemfibrozil
• Imatinib
• Indomethacin
• Interferon Alfa-2a
• Lasmiditan
• Letermovir
• Lovastatin
• Mavacamten
• Methotrexate
• Naproxen
• Neratinib
• Netupitant
• Nilotinib
• Omaveloxolone
• Pegloticase
• Pexidartinib
• Phenobarbital
• Pitavastatin
• Pravastatin
• Primidone
• Reserpine
• Rosuvastatin
• Sacituzumab Govitecan-hziy
• Schisandra sphenanthera
• Selpercatinib
• Simvastatin
• Sodium Phenylbutyrate
• Sotorasib
• Sulbactam
• Tacrolimus
• Tocilizumab
• Treosulfan
• Venetoclax
• Vilazodone
• Voxelotor
• Zalcitabine

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

• Amoxicillin
• Aspirin
• Bismuth Subsalicylate
• Cefditoren Pivoxil
• Cefotaxime
• Cefpodoxime Proxetil
• Cefprozil
• Choline Magnesium Trisalicylate
• Ciprofloxacin
• Enprofylline
• Ertapenem
• Fluvastatin
• Gatifloxacin
• Lorazepam
• Magnesium Salicylate
• Meropenem
• Norfloxacin
• Phenprocoumon
• Piretanide
• Pralatrexate
• Sodium Salicylate
• Sodium Thiosalicylate
• Zidovudine
• Zomepirac

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are chosen for their potential significance and may not include all possible interactions.

Using this medicine with any of the following is usually not recommended but may be necessary in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about food, alcohol, or tobacco use.

• Grapefruit

Other Medical Problems

Having other medical problems may affect how you use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Alcohol abuse or
• Blood disease or
• Cancer being treated by antineoplastics (cancer medicine) or radiation (x-rays) or
• Severe heart disease or
• Severe intestinal disease or
• Kidney disease or stones (or history of) or
• Liver disease or
• Stomach ulcer or other stomach problems (or history of)—The chance of serious side effects may be increased.

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

• Fast or irregular breathing
• Puffiness or swelling of the eyelids or around the eyes
• Shortness of breath, troubled breathing, tightness in chest, or wheezing
• Changes in the skin color of the face occurring together with any of the other side effects listed here
• Skin rash, hives, or itching occurring together with any of the other side effects listed here

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

Symptoms of overdose

• Bloody urine
• Burning feeling in stomach, throat, or skin
• Convulsions (seizures)
• Diarrhea (severe or bloody)
• Fever
• Mood or mental changes
• Muscle weakness (severe)
• Nausea or vomiting (severe and continuing)
• Sudden decrease in amount of urine
• Troubled or difficult breathing

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

Less common

• Difficult or painful urination
• Lower back or side pain (especially if severe or sharp)
• Skin rash, hives, or itching (occurring without other signs of an allergic reaction)

Rare

• Black or tarry stools
• Cloudy urine
• Cough or hoarseness
• Fast or irregular breathing
• Numbness, tingling, pain, or weakness in hands or feet
• Pinpoint red spots on skin
• Sores, ulcers, or white spots on lips or in mouth
• Sore throat, fever, and chills
• Sudden decrease in the amount of urine
• Swelling of face, fingers, feet, and/or lower legs
• Swollen and/or painful glands
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Yellow eyes or skin
• 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

• Diarrhea (mild)
• Headache
• Loss of appetite
• Nausea or vomiting (mild)
• Stomach pain

Less common

• Dizziness
• Flushing or redness of face (occurring without any signs of an allergic reaction)
• Frequent urge to urinate
• Sore gums
• Unusual loss of hair

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.

Available Dosage Forms:

• Tablet

Therapeutic Class: Antigout agents

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

Take this medicine only as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered. The colchicine in this combination medicine may cause serious side effects if too much is taken.

After you begin to take this medicine, 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 than before. After you have been taking this medicine for several months, they may stop completely.

This medicine will help prevent gout attacks but 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.

When you first begin taking this medicine, the amount of uric acid in the kidneys is greatly increased. This may cause kidney stones or other kidney problems 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.

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 oral dosage form (tablets): For preventing gout attacks: Adults—One tablet a day for one week, then one tablet twice a day. If you are still having a lot of gout attacks a month after you start taking two tablets a day, your doctor may direct you to increase the dose. Children—Dose must be determined by your 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.