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|Colchicine

COLCHICINE (Systemic)

Description

Colchicine (KOL-chi-seen) is used to prevent or treat attacks of gout (also called gouty arthritis). People with gout have too much uric acid in their blood and joints. An attack of gout occurs when uric acid causes inflammation (pain, redness, swelling, and heat) in a joint. Colchicine does not cure gout or take the place of other medicines that lower the amount of uric acid in the body. It prevents or relieves gout attacks by reducing inflammation. Colchicine is not an ordinary pain reliever and will not relieve most kinds of pain.

Colchicine may also be used for other conditions as determined by your doctor.

Colchicine may be used in 2 ways. Most people take small amounts of it regularly for a long time (months or even years) to prevent severe attacks or other problems caused by inflammation. Other people take large amounts of colchicine during a short period of time (several hours) only when the medicine is needed to relieve an attack that is occurring. The chance of serious side effects is much lower with the first (preventive) kind of treatment.

Because some of colchicine"s side effects can be very serious, you should discuss with your doctor the good that this medicine can do as well as the risks of using it. Make sure you understand exactly how you are to use it, and follow the instructions carefully, to lessen the chance of unwanted effects.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Tablets (U.S. and Canada)

• Parenteral
• Injection (U.S.)

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 colchicine, the following should be considered:

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

Pregnancy—Studies in humans taking large amounts of colchicine to relieve attacks have not been done. Fertility problems have occurred in some men taking small amounts of colchicine regularly (preventive treatment), but these problems went away after treatment was stopped. Many other men taking preventive amounts of colchicine have fathered children without stopping treatment. Also, many women receiving preventive treatment with colchicine have become pregnant and given birth to normal, healthy babies. Some women receive preventive amounts of colchicine regularly for a medical condition that can cause fertility problems or miscarriages. Treatment with colchicine does not increase, and may actually decrease, the occurrence of these problems in women with this condition.

Colchicine has caused birth defects and other problems in animal studies.

Breast-feeding—Colchicine passes into breast milk. When breast-feeding mothers receive preventive treatment with one 0.6-milligram (mg) tablet twice a day, the amount that appears in the breast milk is not likely to cause problems in nursing babies. There is no information about whether colchicine can cause problems in nursing babies when the mother takes larger amounts of it. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on the effects of colchicine in patients with gout have been done only in adults. Gout is very rare in children. However, colchicine is used in children 3 years of age and older who need preventive treatment for other medical conditions. It has not been reported to cause different side effects or problems in these children than it does in adults.

Older adults—Elderly people are especially sensitive to the effects of colchicine. Also, colchicine may stay in the body longer in older patients than it does in younger adults. This may increase the chance of side effects during treatment.

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 colchicine, 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
• Chloramphenicol (e.g., Chloromycetin) 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., Retrovir)—The chance of serious side effects caused by a decrease in the numbers of certain blood cells may be increased

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

• Alcohol abuse or
• Intestinal disease or
• Stomach ulcer or other stomach problems—The chance of stomach upset may be increased. Also, colchicine can make some kinds of stomach or intestinal problems worse

• Heart disease or
• Kidney disease or
• Liver disease—The chance of serious side effects may be increased because these conditions can cause colchicine to build up in the body

• Low white blood cell count or
• Low platelet count—The chance of serious side effects may be increased because colchicine can make these conditions worse

Proper Use of This Medicine

Colchicine can build up in the body and cause serious side effects if too much of it is taken or if it is taken too often. Therefore, do not take more of this medicine, and do not take it more often, than directed by your doctor . This is especially important for elderly patients, who are more likely than younger adults to have colchicine build up in the body and who are also more sensitive to its effects.

For patients taking small amounts of colchicine regularly (preventive treatment) :

• Take this medicine regularly as directed by your doctor, even if you feel well. If you are taking colchicine to prevent gout attacks, and you are also taking another medicine to reduce the amount of uric acid in your body, you probably will be able to stop taking colchicine after a while. However, if you stop taking it too soon, your attacks may return or get worse. If you are taking colchicine for certain other medical conditions, you may need to keep taking it for the rest of your life.
• If you are taking colchicine to prevent gout attacks, ask your doctor to recommend other medicine to be taken if an attack occurs. Most people receiving preventive amounts of colchicine should not take extra colchicine to relieve an attack. However, some people cannot take the other medicines that are used for gout attacks and will have to take extra colchicine. If you are one of these people, ask your doctor to tell you the largest amount of colchicine you should take for an attack and how long you should wait before starting to take the smaller preventive amounts again. Be sure to follow these directions carefully.

For patients taking large amounts of colchicine only when needed to relieve an attack :

• Start taking this medicine at the first sign of the attack for best results.
• Stop taking this medicine as soon as the pain is relieved or at the first sign of nausea, vomiting, stomach pain, or diarrhea . Also, stop taking colchicine when you have taken the largest amount that your doctor ordered for each attack, even if the pain is not relieved or none of these side effects occurs.
• The first few times you take colchicine, keep a record of each dose as you take it. Then, whenever stomach upset (nausea, vomiting, stomach pain, or diarrhea) occurs, count the number of doses you have taken. The next time you need colchicine, stop taking it before that number of doses is reached. For example, if diarrhea occurs after your fifth dose of medicine, take no more than four doses the next time. If taking fewer doses does not prevent stomach upset from occurring after a few treatments, check with your doctor.
• After taking colchicine tablets to treat an attack, do not take any more colchicine for at least 3 days. Also, after receiving the medicine by injection for an attack, do not take any more colchicine (tablets or injection) for at least 7 days . Elderly patients may have to wait even longer between treatments and should check with their doctor for directions.
• If you are taking colchicine for an attack of gout, and you are also taking other medicine to reduce the amount of uric acid in your body, do not stop taking the other medicine . Continue taking the other medicine as directed by your doctor.

Dosing—The dose of colchicine 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 colchicine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on how often your attacks occur and on whether you are taking the medicine to prevent or to relieve attacks. The amount of medicine you take will also depend on how you react to the medicine .

• For oral dosage form (tablets):
  • Adults:
    • For preventing gout attacks —Most people start with one 0.5-milligram (mg) or 0.6-mg tablet a day. If gout attacks continue to occur, the doctor may direct you to increase the dose to one tablet two or even three times a day for a while. Some people with mild gout may need only one tablet every other day, or even less.
    • For treating a gout attack that has already started —Your doctor will probably recommend one of the following treatment plans:
      • One or two 0.5-mg or 0.6-mg tablets for the first dose, then one 0.5-mg or 0.6-mg tablet every one or two hours, or
      • Two 0.5-mg or 0.6-mg tablets or one 1-mg tablet every two hours.
        For both plans, stop taking this medicine after you have taken the largest amount ordered by your doctor . If your doctor has not told you the largest amount that you should take for one attack, do not take more than 6 mg of this medicine (a total of twelve 0.5-mg tablets, ten 0.6-mg tablets, or six 1-mg tablets, spread over a period of several hours).
  • Children: Use and dose must be determined by the doctor.
• For parenteral dosage form (injection):
  • Adults:
    • For preventing gout attacks —0.5 or 1 mg one or two times a day, injected into a vein.
    • For treating an attack of gout that has already started —1 or 2 mg for the first dose, then 0.5 mg or 1 mg every six to twelve hours, injected into a vein. After a total of 4 mg has been given, no more colchicine (tablets or injections) should be given for at least seven days .
  • Children: Use and dose must be determined by the doctor.

Missed dose—If you are taking colchicine regularly (for example, every day) and you miss a dose, 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.

Precautions While Using This Medicine

If you must take colchicine for a long time (preventive treatment), your doctor may want to check your progress at regular visits. He or she may also want to check for certain side effects. Finding these side effects early can help to keep them from becoming serious.

Stomach problems may be more likely to occur if you drink large amounts of alcoholic beverages while taking colchicine. Also, drinking too much alcohol may increase the amount of uric acid in your blood. This may lessen the effects of colchicine when it is used to prevent gout attacks. Therefore, people who take colchicine should be careful to limit the amount of alcohol they drink.

For patients taking small amounts of colchicine regularly (preventive treatment) :

• Attacks of gout or other problems caused by inflammation may continue to occur during treatment. However, the attacks or other problems should occur less often, and they should not be as severe as they were before you started taking colchicine. Even if you think the colchicine is not working, do not stop taking it and do not increase the dose . Check with your doctor instead.

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.

Stop taking this medicine immediately if any of the following side effects occur:

Also, check with your doctor immediately if any of the following side effects occur:

The following side effects may occur after an injection of colchicine. Check with your doctor as soon as possible if any of the following occur at or near the place of injection:

Also, check with your doctor as soon as possible if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. However, check with your doctor if either of the following side effects continues or is bothersome:

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

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, colchicine is used in certain patients with the following medical conditions:

• Amyloidosis
• Beh[ccedil]et"s syndrome
• Calcium pyrophosphate deposition disease (pseudogout)
• Cirrhosis of the liver
• Familial Mediterranean fever
• Pericarditis
• Sarcoid arthritis

If you are taking colchicine for any of these conditions, the following information may apply:

• For all of these conditions, colchicine is usually given regularly in small amounts to reduce inflammation (preventive treatment). This usually decreases the occurrence of severe attacks or other problems caused by inflammation.
• Colchicine is not a cure for these conditions. It will help prevent problems caused by inflammation only as long as you continue to take it.
• Some patients with calcium pyrophosphate deposition disease (pseudogout) or familial Mediterranean fever may take larger amounts of colchicine only when an attack occurs, to relieve the attack.

For patients taking colchicine for familial Mediterranean fever :

• Preventive treatment with colchicine may be helping you even if it does not reduce the number of severe attacks. Colchicine helps prevent other serious problems, such as kidney disease, that can occur in people with this condition. Therefore, even if you think that the colchicine isn"t working, do not stop taking it . Check with your doctor instead.

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 01/31/1994

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