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In the U.S.—

ColBenemid Col-Probenecid

Proben-C

• Antigout agent

Probenecid and colchicine (proe-BEN-e-sid and KOL-chi-seen) 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, in the following dosage form:

Oral
• Tablets (U.S.)

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 probenecid and colchicine combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to probenecid or to colchicine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Probenecid has not been shown to cause birth defects or other problems in humans. Although studies with colchicine have not been done in pregnant women, some reports have suggested that use of colchicine during pregnancy can cause harm to the fetus. Also, studies in animals have shown that colchicine causes birth defects. Therefore, do not begin taking this medicine during pregnancy, and do not become pregnant while taking it, unless you have first discussed this problem with your doctor. Also, check with your doctor immediately if you suspect that you have become pregnant while taking this medicine.

Breast-feeding—This medicine has not been reported to cause problems in nursing babies.

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.

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 probenecid and colchicine combination, it is especially important that your health care professional know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antineoplastics (cancer medicine) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Cyclophosphamide (e.g., Cytoxan) or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Mexate) or
• Phenylbutazone (e.g., Butazolidin) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., AZT, Retrovir)—Taking any of these medicines together with colchicine may increase the chance of serious side effects. Also, the chance of serious side effects may be increased when antineoplastics (cancer medicine), methotrexate, phenylbutazone, or zidovudine are taken together with probenecid

• Aspirin or other salicylates, including bismuth subsalicylate (e.g., Pepto-Bismol)—These medicines may keep probenecid from working properly for treating gout, depending on the amount of aspirin or other salicylate that you take and how often you take it

• Heparin—Probenecid may increase the effects of heparin, which increases the chance of side effects

• Indomethacin (e.g., Indocin) or
• Ketoprofen (e.g., Orudis)—Probenecid may increase the blood levels of these medicines, which increases the chance of side effects

• Medicine for infection, including tuberculosis or virus infection—Probenecid may increase the blood levels of many of these medicines, which may increase the chance of side effects. Also, the chance of serious side effects may be increased when some of these medicines are taken together with colchicine

• Nitrofurantoin (e.g., Furadantin)—Probenecid may keep nitrofurantoin from working properly

Other medical problems—The presence of other medical problems may affect the use of probenecid and colchicine combination. 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

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 probenecid and colchicine combination 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.

• 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—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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.

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.

The following side effects may mean that you are having an allergic reaction to this medicine. 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 
  
  

Also 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 
  
  

Also, 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 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• 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 above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 08/27/1994