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colchicine

Pronunciation

Generic Name: colchicine (KOL chi seen)
Brand Name: Colcrys

What is colchicine?

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. As of 2009, Colcrys is the only brand of colchicine that has been approved by the FDA.

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

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.

What is the most important information I should know about colchicine?

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. As of 2009, Colcrys is the only brand of colchicine that has been approved by the FDA.

You should not use this medication if you are allergic to colchicine. Do not take colchicine if you have liver or kidney disease and are also taking any of the medications listed below under "What other drugs can affect colchicine."

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Before taking colchicine, tell your doctor if you have liver or kidney disease, heart disease, a stomach ulcer, ulcerative colitis, Crohn's disease, intestinal bleeding, or any other severe gastrointestinal disorder.

If you take colchicine over a long period of time, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Call your doctor at once if you have a serious side effect such as muscle pain or weakness, numbness or tingly feeling in your fingers or toes, severe vomiting or diarrhea, easy bruising or bleeding, feeling weak or tired, flu symptoms, blood in your urine, urinating less than usual or not at all, or a pale or gray appearance of your lips, tongue, or hands.

What should I discuss with my healthcare provider before taking colchicine?

You should not use this medication if you are allergic to colchicine. Do not take colchicine if you have liver or kidney disease and are also taking any of the medications listed below under "What other drugs can affect colchicine."

To make sure you can safely take colchicine, tell your doctor if you have any of these other conditions:

  • liver disease;

  • kidney disease;

  • heart disease;

  • a stomach ulcer or severe gastrointestinal disorder;

  • ulcerative colitis;

  • Crohn's disease; or

  • intestinal bleeding or other disorder.

FDA pregnancy category C. It is not known whether colchicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether colchicine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take colchicine?

If your doctor has prescribed the Colcrys brand of colchicine, do not use any other type or brand of the medication. Colcrys is the only brand of colchicine that has been approved by the FDA. If you use a generic brand of colchicine, you may be using an unapproved dose of this medication, which could be dangerous. 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.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

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 medication. Colchicine doses for gout and Mediterranean fever are different.

If you use this medication over a long period of time, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Keep using colchicine as directed, even if you feel well. Tell your doctor if the medicine seems to stop working as well in preventing gout attacks. Do not stop using colchicine without first talking to your doctor.

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

What happens if I miss a dose?

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.

What happens if I overdose?

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 (may be bloody and severe), nausea, vomiting, stomach pain, heartburn, a burning feeling in your throat or stomach, muscle weakness, urinating less than usual, numbness or tingling, fainting, or seizure (convulsions).

What should I avoid while taking colchicine?

Grapefruit and grapefruit juice may interact with colchicine and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Colchicine side effects

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

Call your doctor at once if you have a serious side effect such as:

  • muscle pain or weakness;

  • numbness or tingly feeling in your fingers or toes;

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

  • severe vomiting or diarrhea;

  • easy bruising or bleeding, feeling weak or tired;

  • fever, chills, body aches, flu symptoms;

  • blood in your urine; or

  • urinating less than usual or not at all.

Less serious side effects may include:

  • mild nausea or vomiting, stomach pain; or

  • mild 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.

See also: Side effects (in more detail)

Colchicine dosing information

Usual Adult Dose for Acute Gout:

Oral:

Initial: Gout Flare: 1.2 mg orally at the first sign of the flare followed by 0.6 mg one hour later.
Maximum: Gout Flare: 1.8 mg orally over a one hour period

Coadministration with strong CYP450 3A4 inhibitors:
0.6 mg orally followed by 0.3 mg one hour later. Dose to be repeated no earlier than 3 days.

Coadministration with moderate CYP450 3A4 inhibitors:
1.2 mg orally for one dose only. Dose to be repeated no earlier than 3 days.

Coadministration with P-glycoprotein inhibitors:
0.6 mg orally for one dose only. Dose to be repeated no earlier than 3 days.

Usual Adult Dose for Familial Mediterranean Fever:

1.2 mg to 2.4 mg orally daily, administered in 1 or 2 divided doses

The dose should be increased as needed to control disease and as tolerated in increments of 0.3 mg/day to a maximum recommended daily dose. If intolerable side effects develop, the dose should be decreased in increments of 0.3 mg/day.

Coadministration with strong CYP450 3A4 inhibitors: 0.6 mg orally daily, may be given as 0.3 mg twice a day.

Coadministration with moderate CYP450 3A4 inhibitors: 1.2 mg orally daily, may be given as 0.6 mg twice a day.

Coadministration with P-glycoprotein inhibitors: 0.6 mg orally daily, may be given as 0.3 mg twice a day.

Usual Adult Dose for Gout -- Prophylaxis:

(Unlabeled use):
Oral:
0.5 to 0.6 mg orally once a day for 3 to 4 days a week (less than 1 attack/year).
0.5 to 0.6 mg orally once a day (greater than 1 attack/year).
Severe cases may require 1 to 1.8 mg/day.

Usual Adult Dose for Biliary Cirrhosis:

(Unlabeled use):
0.6 mg orally twice a day.

Usual Adult Dose for Sarcoidosis:

(Unlabeled use):
0.6 mg orally twice a day.

Usual Adult Dose for Pseudogout -- Prophylaxis:

(Unlabeled use):
0.6 mg orally twice a day.

Usual Adult Dose for Fibromatosis:

(Unlabeled use):
Initial: 0.6 to 1.2 mg orally once a day each day for the first 1 to 2 weeks.
Maintenance: 0.6 to 1.2 mg orally once a day 1 to 2 times per week is often used to prevent recurrence of fibromatosis.

Usual Adult Dose for Aphthous Stomatitis -- Recurrent:

(Unlabeled use):
0.5 to 0.6 mg orally daily. The dose may be titrated upward while the patient is observed for signs of toxicity.

Usual Adult Dose for Behcet's Disease:

(Unlabeled use):
0.5 to 1.5 mg orally once a day.

Study (n=116)
Dosage adjusted to body weight:
less than 50 Kg: 1 mg daily
50 to 59 Kg: 1 mg and 1.5 mg on alternate days
60 to 75 Kg: 1.5 mg daily
76 to 84 Kg: 1.5 and 2 mg on alternate days
greater than or equal to 85 Kg: 2 mg daily

Usual Adult Dose for Constipation -- Chronic:

(Unlabeled use):
Study (n=16)
0.6 mg orally three times daily for 4 weeks

Usual Adult Dose for Sweet's Syndrome:

(Unlabeled use):
0.6 mg orally twice daily.

Usual Pediatric Dose for Familial Mediterranean Fever:

Oral:

4 to 6 years: 0.3 to 1.8 mg daily, administered in 1 or 2 divided doses.

6 to 12 years: 0.9 to 1.8 mg daily, administered in 1 or 2 divided doses.

Over 12 years: 1.2 to 2.4 mg daily, administered in 1 or 2 divided doses.

The dose should be increased as needed to control disease and as tolerated in increments of 0.3 mg/day to a maximum recommended daily dose. If intolerable side effects develop, the dose should be decreased in increments of 0.3 mg/day.

What other drugs will affect colchicine?

Colchicine can interact with certain other drugs. A colchicine drug interaction can be fatal. Tell your doctor about all other medications you use, especially:

  • conivaptan (Vaprisol);

  • digoxin (Lanoxin, digitalis);

  • imatinib (Gleevec);

  • isoniazid (for treating tuberculosis);

  • an antidepressant such as nefazodone;

  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);

  • antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

  • cholesterol-lowering medicines such as atorvastatin (Lipitor), fenofibrate (Antara, Lipofen, TriCor), fluvastatin (Lescol), gemfibrozil (Lopid), lovastatin (Mevacor, Altoprev, Advicor), pravastatin (Pravachol), simvastatin (Zocor, Simcor, Vytorin), and others;

  • heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Nifedical, Procardia), quinidine (Quin-G), reserpine, verapamil (Calan, Covera, Isoptin, Verelan), and others;

  • HIV or AIDS medication such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), ritonavir (Kaletra, Norvir), tipranavir (Aptivus); or

  • medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf).

This list is not complete and there may be other drugs that can interact with colchicine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about colchicine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 6.02. Revision Date: 2012-03-05, 11:13:10 AM.

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