Pronunciation:

proe-BEN-e-sid, KOL-chi-seen

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antigout

Uses of This Medicine:

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.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Studies on this combination medicine have been done only in adult patients, and there is no specific information about its use in children.

Older adults—

Elderly people are especially sensitive to the effects of colchicine. This may increase the chance of side effects during treatment.

There is no specific information comparing use of probenecid in the elderly with use in other age groups.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

• Alogliptin
• Amiodarone
• Asunaprevir
• Atazanavir
• Atorvastatin
• Azithromycin
• Berotralstat
• Boceprevir
• Canagliflozin
• Captopril
• Carvedilol
• Ceritinib
• Cimetidine
• Clarithromycin
• Cobicistat
• Conivaptan
• Cyclosporine
• Daclatasvir
• Darunavir
• Diltiazem
• Dronedarone
• Elagolix
• Eliglustat
• Enasidenib
• Entrectinib
• Enzalutamide
• Erythromycin
• Felodipine
• Flibanserin
• Fluvoxamine
• Fostamatinib
• Glecaprevir
• Ibrexafungerp
• Idelalisib
• Indinavir
• Isavuconazole
• Istradefylline
• Itraconazole
• Ketoconazole
• Ketorolac
• Ketorolac Tromethamine
• Lapatinib
• Lasmiditan
• Lenacapavir
• Levoketoconazole
• Lonafarnib
• Maribavir
• Mibefradil
• Mifepristone
• Mirabegron
• Nefazodone
• Nelfinavir
• Nifedipine
• Nirmatrelvir
• Osimertinib
• Paritaprevir
• Paroxetine
• Pexidartinib
• Pibrentasvir
• Pirtobrutinib
• Posaconazole
• Propafenone
• Quinidine
• Quinine
• Ranolazine
• Ribociclib
• Rifampin
• Ritonavir
• Rolapitant
• Rucaparib
• Saquinavir
• Sarecycline
• Simeprevir
• Sofosbuvir
• Sotagliflozin
• Spironolactone
• Sunitinib
• Suvorexant
• Telaprevir
• Telithromycin
• Telmisartan
• Tepotinib
• Ticagrelor
• Tipranavir
• Tolvaptan
• Troleandomycin
• Tucatinib
• Vandetanib
• Velpatasvir
• Vemurafenib
• Verapamil
• Vibegron
• Vorapaxar
• Voriconazole
• Zanubrutinib

Using this medicine with any of the following medicines is usually not recommended, but may be required 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
• Amoxicillin
• Amprenavir
• Aprepitant
• Asciminib
• Avacopan
• Avibactam
• Baricitinib
• Belinostat
• Belumosudil
• Bezafibrate
• Bictegravir
• Capivasertib
• Capmatinib
• Carbamazepine
• Cephalexin
• Chlorzoxazone
• Cilostazol
• Ciprofibrate
• Ciprofloxacin
• Clofazimine
• Clofibrate
• Clotrimazole
• Crizotinib
• Danicopan
• Daridorexant
• Deferiprone
• Delavirdine
• Deutivacaftor
• Digoxin
• Doripenem
• Duvelisib
• Elacestrant
• Erdafitinib
• Ezetimibe
• Fedratinib
• Fenofibrate
• Fenofibric Acid
• Fexinidazole
• Fluconazole
• Fluoxetine
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Furosemide
• Gemfibrozil
• Gilteritinib
• Glimepiride
• Glipizide
• Imatinib
• Indomethacin
• Interferon Alfa-2a
• Irinotecan
• Irinotecan Liposome
• Isavuconazonium Sulfate
• Ivacaftor
• Ketoprofen
• Lanreotide
• Larotrectinib
• Lazertinib
• Lefamulin
• Letermovir
• Lomitapide
• Lorazepam
• Lovastatin
• Mavorixafor
• Methotrexate
• Mitapivat
• Mitotane
• Mobocertinib
• Mycophenolate Mofetil
• Naproxen
• Neratinib
• Netupitant
• Nilotinib
• Nirogacestat
• Octreotide
• Omaveloxolone
• Pacritinib
• Palbociclib
• Pegloticase
• Pexidartinib
• Phenobarbital
• Pitavastatin
• Pravastatin
• Primidone
• Ranitidine
• Repotrectinib
• Reserpine
• Ritlecitinib
• Rosuvastatin
• Sacituzumab Govitecan-hziy
• Schisandra sphenanthera
• Seladelpar
• Selpercatinib
• Simvastatin
• Sodium Phenylbutyrate
• Sotorasib
• Sulbactam
• Sulopenem
• Suzetrigine
• Tacrolimus
• Taurursodiol
• Tazemetostat
• Tezacaftor
• Tocilizumab
• Tolbutamide
• Tovorafenib
• Treosulfan
• Trofinetide
• Vadadustat
• Venetoclax
• Vilazodone
• Voclosporin
• Vonoprazan
• Vorasidenib
• Voxelotor
• Zalcitabine

Using this medicine with any of the following medicines may cause an increased 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.

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

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable 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 the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse or
• Blood disease or
• Cancer being treated by antineoplastics (cancer medicine) or radiation (x-rays) or
• Heart disease (severe) or
• Intestinal disease (severe) 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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

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

or 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.