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If Colchicine overdose is suspected

March 20th, 2010 No comments

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blood in the urine or decreased urination; bloody diarrhea; burning of the throat, stomach, or skin; delirium; muscle weakness; seizures; severe or persistent diarrhea, nausea, stomach pain, or vomiting.

Proper storage of Colchicine:
Store Colchicine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, light, and moisture. Do not store in the bathroom. Keep Colchicine out of the reach of children and pets.

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Possible side effects of Colchicine

March 20th, 2010 No comments

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; mild sore throat; nausea; stomach pain or cramping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); muscle pain, tenderness, or weakness (with or without fever or fatigue); numbness or tingling in the fingers or toes; pale or gray color of the lips, tongue, or palms of the hands; severe or persistent diarrhea, nausea, stomach pain, or vomiting; signs of infection (eg, fever, chills, severe or persistent sore throat); unusual bleeding or bruising; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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Colchicine important safety information

March 20th, 2010 No comments

* 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.
* Colchicine use in 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.

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How to use Colchicine

March 20th, 2010 No comments

Use Colchicine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Some brands of Colchicine come with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Colchicine refilled.
  • Take Colchicine by mouth with or without food.
  • Do not eat grapefruit or drink grapefruit juice while you are using Colchicine .
  • Continue to use Colchicine even if you feel well. Do not miss any doses.
  • If you miss a dose of Colchicine , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Colchicine.

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Before using Colchicine

March 19th, 2010 No comments

Some medical conditions may interact with Colchicine . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

* if you are pregnant, planning to become pregnant, or are breast-feeding
* if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
* if you have allergies to medicines, foods, or other substances
* if you have a blood disorder, stomach or bowel problems, heart problems, or liver or kidney problems, or if you are having dialysis
* if you are in very poor health

Some MEDICINES MAY INTERACT with Colchicine . Tell your health care provider if you are taking any other medicines, especially any of the following:

* Digoxin, fibrates (eg, fenofibric acid), gemfibrozil, or HMG-Co A reductase inhibitors (eg, simvastatin) because the risk of severe or fatal muscle problems may be increased
* Aprepitant, atazanavir, clarithromycin, cyclosporine, diltiazem, erythromycin, fluconazole, HIV protease inhibitors (eg, fosamprenavir), indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ranolazine, ritonavir or any medicine that contains ritonavir, saquinavir, telithromycin, or verapamil because they may increase the risk of Colchicine ’s side effects, including severe or fatal side effects
* Sympathomimetics (eg, pseudoephedrine, albuterol) because the risk of their side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Colchicine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

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Do NOT use Colchicine if

March 19th, 2010 No comments

* you are allergic to any ingredient in Colchicine
* the patient is a CHILD with gout
* you have liver or kidney problems and you are also taking certain other medicines (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir or any medicine that contains ritonavir, saquinavir, telithromycin)

Contact your doctor or health care provider right away if any of these apply to you.

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Colchicine is used for

March 19th, 2010 No comments

Treating and preventing gout flares. It may also be used for other conditions as determined by your doctor.

Colchicine is a beta-tubulin interactor. Exactly how Colchicine works is not known. However, it may affect certain proteins in the body, which may relieve gout symptoms.

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What other drugs will affect Colchicine?

March 19th, 2010 No comments

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);
* 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).

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.

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Colchicine dosing information

March 19th, 2010 No comments

Colchicine 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

Co-administration with strong CYP3A4 inhibitors:
0.6 mg orally followed by 0.3 mg one hour later. Dose to be repeated no earlier than 3 days.

Co-administration with moderate CYP3A4 inhibitors:
1.2 mg orally for one dose only. Dose to be repeated no earlier than 3 days.

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

Colchicine 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.

Co-administration with strong CYP3A4 inhibitors: 0.6 mg orally daily, may be given as 0.3 mg twice a day.

Co-administration with moderate CYP3A4 inhibitors: 1.2 mg orally daily, may be given as 0.6 mg twice a day.

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

Colchicine 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.

Colchicine Usual Adult Dose for Biliary Cirrhosis:
(Unlabeled use):
0.6 mg orally twice a day.

Colchicine Usual Adult Dose for Sarcoidosis:
(Unlabeled use):
0.6 mg orally twice a day.

Colchicine Usual Adult Dose for Pseudogout — Prophylaxis:
(Unlabeled use):
0.6 mg orally twice a day.

Colchicine 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.

Colchicine 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.

Colchicine 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

Colchicine Usual Adult Dose for Constipation — Chronic:
(Unlabeled use):
Study (n=16)
0.6 mg orally three times daily for 4 weeks

Colchicine Usual Adult Dose for Sweet’s Syndrome:
(Unlabeled use):
0.6 mg orally twice daily.

Colchicine 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.

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Colchicine side effects

March 18th, 2010 No comments

Get emergency medical help if you have any of these signs of an allergic reaction: 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.

Colchicine less serious side effects may include:

* mild nausea or 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.

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