Colchicine affects the way the body responds to uric acid crystals, which reduces swelling and pain.

Because colchicine was developed prior to federal regulations requiring FDA review of all marketed drug products, not all uses for colchicine have been approved by the FDA.

The Colcrys brand of colchicine is FDA-approved to treat or prevent gout in adults, and to treat a genetic condition called Familial Mediterranean Fever in adults and children who are at least 4 years old.

The Mitigare brand of colchicine is FDA-approved to prevent gout flares in adults.

Generic forms of colchicine have been used to treat or prevent attacks of gout, or to treat symptoms of Behcets syndrome (such as swelling, redness, warmth, and pain).

Colchicine is not a cure for gouty arthritis or Behcets syndrome, and it will not prevent these diseases from progressing. Colchicine should not be used as a routine pain medication for other conditions.

Colchicine may also be used for purposes not listed in this medication guide.

Serious drug interactions can occur when certain medicines are used together with colchicine. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Colchicine comes as a tablet and solution (liquid; Gloperba) to take by mouth with or without food. When colchicine is used to prevent gout attacks or to treat FMF, it is usually taken once or twice a day. When colchicine (Colcrys) is used to relieve the pain of a gout attack, one dose is usually taken at the first sign of pain and a second, smaller dose is usually taken one hour later. If you do not experience relief or have another attack within several days after treatment, talk to your doctor before taking additional doses of medication. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take colchicine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

It is important to use an oral syringe (measuring device) to accurately measure the correct amount of liquid for each dose; do not use a household spoon.

If you are taking colchicine (Colcrys) to treat FMF, your doctor may start you on a low dose and gradually increase your dose. Your doctor may decrease your dose if you experience side effects.

If you are taking colchicine to prevent gout attacks, call your doctor right away if you experience a gout attack during your treatment. Your doctor may tell you to take an extra dose of colchicine, followed by a smaller dose one hour later. If you take extra doses of colchicine to treat a gout attack, you should not take your next scheduled dose of colchicine until at least 12 hours have passed since you took the extra doses.

Colchicine can prevent attacks of gout and control FMF only as long as you take the medication. Continue to take colchicine even if you feel well. Do not stop taking colchicine without talking to your doctor.

Do not purchase colchicine on the Internet or from vendors outside of the United States. Using this medication improperly or without the advice of a doctor can result in serious side effects or death.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Colchicine can be taken with or without food.

To treat a gout attack, for best results take colchicine at the first sign of the attack. The longer you wait to start taking the medication, the less effective it may be.

You may need to take a second lower dose of colchicine 1 hour after the first dose if you still have gout pain. Follow your doctor's instructions.

Your dose will depend on the reason you are taking this medicine. Colchicine doses for gout and Mediterranean fever are different.

Do not stop using colchicine unless your doctor tells you to, even if you feel fine.

Call your doctor if your symptoms do not improve, or if they get worse.

If you use this medicine long-term, you may need frequent medical tests.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

You should not use colchicine if you are allergic to it.

Some medicines can cause unwanted or dangerous effects when used with colchicine, especially if you have liver or kidney disease. Your doctor may need to change your treatment plan if you use any of the following drugs:

• cyclosporine;

• nefazodone;

• tipranavir;

• clarithromycin or telithromycin;

• itraconazole or ketoconazole; or

• HIV or AIDS medicine--atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, or saquinavir.

To make sure colchicine is safe for you, tell your doctor if you have:

• liver disease;

• kidney disease; or

• if you take digoxin, or cholesterol-lowering medications.

It is not known whether colchicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Colchicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of colchicine can be fatal.

Overdose symptoms may include diarrhea, nausea, vomiting, stomach pain, muscle weakness, little or no urinating, numbness or tingling, weak pulse, slow heart rate, weak or shallow breathing, or fainting.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Do not eat grapefruit or drink grapefruit juice during your treatment with colchicine.

Grapefruit and grapefruit juice may interact with colchicine and lead to unwanted side effects. Avoid the use of grapefruit products while taking colchicine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Colchicine may cause serious side effects. Call your doctor at once if you have:

• muscle pain or weakness;

• numbness or tingly feeling in your fingers or toes;

• pale or gray appearance of your lips, tongue, or hands;

• severe or ongoing vomiting or diarrhea;

• fever, chills, body aches, flu symptoms; or

• easy bruising, unusual bleeding, feeling weak or tired.

Common side effects of colchicine may include:

• nausea, vomiting, stomach pain; or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can interact with colchicine, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with colchicine. Give a list of all your medicines to any healthcare provider who treats you.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to colchicine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.