Colchicine Oral: MedlinePlus Drug Information

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Other drug names:	A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9

Colchicine Oral

(kol' chi seen)

Contents of this page:
Why is this medication prescribed? How should this medicine be used? What special precautions should I follow? What should I do if I forget a dose? What side effects can this medication cause?	What storage conditions are needed for this medicine? In case of emergency/overdose What other information should I know?

IMPORTANT WARNING: Return to top

[Posted 07/30/2009] FDA notified healthcare professionals of the approval of the first single-ingredient oral colchicine product, Colcrys, for the treatment of familial Mediterranean fever (FMF) and acute gout flares and of two previously uncharacterized safety concerns associated with the use of colchicine. Oral colchicine has been used for many years as an unapproved drug with no FDA-approved prescribing information, dosage recommendations, or drug interaction warnings.

FDA analyzed safety data for colchicine from adverse events reported to the Agency, the published literature, and company-sponsored pharmacokinetic and drug interaction studies. This analysis revealed cases of fatal colchicine toxicity reported in certain patients taking standard therapeutic doses of colchicine and concomitant medications that interact with colchicine, such as clarithromycin. These reports suggest that drug interactions affecting the gastrointestinal absorption and/or hepatic metabolism of colchicine play a central role in the development of colchicine toxicity. Data submitted supporting the safety and efficacy of Colcrys in acute gout flares demonstrated that a substantially lower dose of colchicine was as effective as the higher dose traditionally used. Moreover, patients receiving the lower dose experienced significantly fewer adverse events compared to the higher dose.

Based on this information, FDA has included important safety considerations in the approved prescribing information to assure safe use of Colcrys and is providing background information, a data summary and recommendations in this alert.

For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.

Why is this medication prescribed? Return to top

Colchicine relieves swelling and pain caused by attacks of gout or gouty arthritis. It may also be taken regularly to prevent gout or gouty arthritis attacks.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used? Return to top

Colchicine comes as a tablet to take by mouth. 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.

If you are taking colchicine to relieve gout attack symptoms, start taking it at the first sign of pain. Relief usually begins within 12 hours, and symptoms disappear within 48-72 hours. This medicine will not be fully effective if you do not take it as soon as you feel pain.

What special precautions should I follow? Return to top

Before taking colchicine,

tell your doctor and pharmacist if you are allergic to colchicine or any other drugs.
tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially vitamin B12 and other vitamins.
tell your doctor if you have or have ever had stomach, intestinal, blood disorder, kidney, liver, or heart problems.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking colchicine, call your doctor.
if you are to have a urine test, tell your doctor and laboratory personnel that you are taking colchicine because it may affect the test results.

What should I do if I forget a dose? Return to top

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause? Return to top

Colchicine may cause side effects. If you experience any of the following symptoms, call your doctor immediately:

upset stomach
vomiting
diarrhea
fever
severe rash
difficulty breathing
seizures
unusual bleeding or bruising
blood in the urine or stool

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine? Return to top

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). Throw away medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose Return to top

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know? Return to top

Keep all appointments with your doctor and the laboratory. Your doctor will 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.

Last Revised - 08/01/2009

American Society of Health-System Pharmacists, Inc. Disclaimer

AHFS^® Consumer Medication Information. © Copyright, 2009. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.