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Colcrys 0.6mg Tablets
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What is Colcrys:

Colcrys (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.

Colcrys 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. Colcrys should not be used as a routine pain medication for other conditions.

Important information about Colcrys

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 Colcrys if you are allergic to colchicine. Do not take Colcrys if you have liver or kidney disease and are also taking any of Colcryss listed below under "What other drugs can affect Colcrys."

Before taking Colcrys, 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 Colcrys 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.

Before taking Colcrys

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

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take Colcrys:

  • liver disease;
  • kidney disease;
  • heart disease;

  • a stomach ulcer or severe gastrointestinal disorder;

  • ulcerative colitis;

  • Crohn's disease; or

  • intestinal bleeding or other disorder.

It is not known whether Colcrys is harmful to an unborn baby. Before taking Colcrys, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether colchicine passes into breast milk or if it could harm a nursing baby. Do not use Colcrys without telling your doctor if you are breast-feeding a baby.

How should I take Colcrys:

If your doctor has prescribed the Colcrys brand of colchicine, do not use any other type or brand of Colcrys. 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 Colcrys, which could be dangerous. Do not purchase colchicine on the Internet or from vendors outside of the United States. Using Colcrys improperly or without the advice of a doctor can result in serious side effects or death.

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

Colcrys can be taken with or without food.

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

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

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

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

Store Colcrys at room temperature away from moisture, heat, and light.

What happens if I miss a dose:

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take Colcrys and skip the missed dose. Do not take extra Colcrys to make up the missed dose.

What happens if I overdose:

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of Colcrys 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 Colcrys:

Grapefruit and grapefruit juice may interact with Colcrys and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Colcrys side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Colcrys: hives; difficulty 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 Colcrys side effects may include:

  • mild nausea or stomach pain; or

  • mild diarrhea.

What other drugs will affect Colcrys:

Colcrys 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);

  • diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);

  • imatinib (Gleevec);

  • isoniazid (for treating tuberculosis);

  • quinidine (Quinaglute, Quinidex, Quin-Release);

  • an antidepressant such as nefazodone;

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

  • an antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

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

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

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

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

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