COLCHICINE

Colchicine is used to prevent gout attacks (sudden, severe pain in one or more joints caused by abnormally high levels of a substance called uric acid in the blood) in adults, and to relieve the pain of gout attacks when they occur. Colchicine is also used to treat familial Mediterranean fever (FMF; an inborn condition that causes episodes of fever, pain, and swelling of the stomach area, lungs, and joints) in adults and children 4 years of age and older. Colchicine is not a pain reliever and cannot be used to treat pain that is not caused by gout or FMF. Colchicine is in a class of medications called anti-gout agents. It works by stopping the natural processes that cause swelling and other symptoms of gout and FMF.

Colchicine comes as a tablet 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 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.

If you are taking colchicine 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.

Inactive Ingredients
0.5 mg tablet: Calcium carbonate, confectioner†s sugar (contains corn starch), D& C Yellow No. 10, dextrin, stearic acid, sucrose and talc.

0.6 mg tablet: Acacia, corn starch, D& C Yellow No. 10, lactose, stearic acid and talc.

Important safety information:

• Do NOT take more than the recommended dose without checking with your doctor.
• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Colchicine; it may increase their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Colchicine may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Colchicine may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
• Accidental ingestion or overdose of Colchicine has been fatal in children and adults. Keep Colchicine out of the reach of children. In case of an overdose, call a doctor or poison control center right away.
• If nausea, vomiting, or diarrhea occurs, ask your doctor for ways to lessen these effects. Contact your doctor right away if you experience severe or persistent diarrhea, nausea, or vomiting.
• Tell your doctor or dentist that you take Colchicine before you receive any medical or dental care, emergency care, or surgery.
• Rarely, Colchicine may decrease fertility in men. Discuss any questions or concerns with your doctor.
• Colchicine may interfere with certain lab tests, including urine tests for red blood cells or hemoglobin. Be sure your doctor and lab personnel know you are taking Colchicine.
• Lab tests, including complete blood cell counts, kidney function, and liver function, may be performed while you use Colchicine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Colchicine with caution in the ELDERLY; they may be more sensitive to its effects, including muscle and nerve problems.
• Colchicine should be used with extreme caution in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Colchicine while you are pregnant. Colchicine is found in breast milk. If you are or will be breast-feeding while you use Colchicine, check with your doctor. Discuss any possible risks to your baby.

DRUG INTERACTIONS: Several drugs reduce the breakdown and elimination of colchicine from the body by reducing the activity of enzymes that breakdown colchicine. In order to avoid side effects from colchicine the dose of colchicine should be reduced when it is combined with or used within 14 days of drugs that reduce its elimination.

Examples of drugs that reduce the elimination of colchicine include:

• atazanavir (Reyataz),
• clarithromycin (Biaxin),
• indinavir,
• itraconazole (Sporanox),
• ketoconazole,
• lopinavir/ritonavir (Kaletra),
• nelfinavir (Viracept),
• saquinavir (Invirase),
• telithromycin (Ketek),
• ritonavir (Norvir),
• amprenavir (Agenerase),
• aprepitant (Emend),
• diltiazem (Cardizem),
• erythromycin,
• fluconazole (Diflucan),
• fosamprenavir (Lexiva),
• grapefruit juice,
• verapamil (Calan),
• cyclosporine, and
• ranolazine (Ranexa).

Combining colchicine with statins, for example atorvastatin (Lipitor), simvastatin (Zocor), and lovastatin (Mevacor), Lopid (gemfibrozil), or fenofibrate increases the risk of muscle related adverse effects because these drugs also cause muscle related side effects.

SIDE EFFECTS: Diarrhea, nausea, cramping, abdominal pain, and vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Stop taking this medication and seek immediate medical attention if any of these rare but serious side effects occur: unusual bleeding/bruising, severe diarrhea or vomiting, muscle weakness or pain, numbness/tingling in your fingers or toes, pale or gray color of the lips/tongue/palms of hands, signs of infection (such as fever, persistent sore throat), unusual weakness/tiredness.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems (such as cirrhosis).Alcohol can decrease this drug's effectiveness. Limit alcohol while taking this drug.This medication can affect how well your body absorbs some foods and nutrients (such as vitamin B12). Consult your doctor or pharmacist for more details.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Colchicine can decrease sperm production, which may affect the ability of a male to father a child. Consult your doctor for more information.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding. Your doctor may recommend that you separate the time(s) you take your medication apart from breast-feeding.