Colcrys

Generic name: colchicine
Brand names: Colcrys, Mitigare
Drug class: Antigout agents

Medically reviewed by  A Ras MD.

What is Colcrys?

Colcrys is a prescription medicine used to prevent and treat gout flares in adults treat familial Mediterranean fever (FMF) in adults and children age 4 or older.

Colcrys is not a pain medicine, and it should not be taken to treat pain related to other conditions unless specifically prescribed for those conditions.

Description

Colchicine is an alkaloid chemically described as (S)N- (5,6,7,9-tetrahydro- 1,2,3, 10-tetramethoxy-9-oxobenzo [alpha] heptalen-7-yl) acetamide with a molecular formula of C22H25NO6 and a molecular weight of 399.4. The structural formula of colchicine is given below.

Colchicine occurs as a pale yellow powder that is soluble in water.

COLCRYS® (colchicine, USP) tablets are supplied for oral administration as purple, film-coated, capsule-shaped tablets (0.1575″ × 0.3030″), debossed with ‘AR 374’ on one side and scored on the other, containing 0.6 mg of the active ingredient colchicine USP. Inactive ingredients: carnauba wax, FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin.

Mechanism of Action

The mechanism by which COLCRYS exerts its beneficial effect in patients with FMF has not been fully elucidated; however, evidence suggests that colchicine may interfere with the intracellular assembly of the inflammasome complex present in neutrophils and monocytes that mediates activation of interleukin-1β. Additionally, colchicine disrupts cytoskeletal functions through inhibition of β-tubulin polymerization into microtubules, and consequently prevents the activation, degranulation, and migration of neutrophils thought to mediate some gout symptoms.

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

Colcrys can cause serious side effects or death if levels of Colcrys are too high in your body.

• Taking certain medicines with Colcrys can cause your level of Colcrys to be too high, especially if you have kidney or liver problems.
• Tell your healthcare provider about all your medical conditions, including if you have kidney or liver problems. Your dose of Colcrys may need to be changed.
• Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.
• Even medicines that you take for a short period of time, such as antibiotics, can interact with Colcrys and cause serious side effects or death.
• Talk to your healthcare provider or pharmacist before taking any new medicine.
• Especially tell your healthcare provider if you take:
  • atazanavir sulfate (Reyataz)
  • cyclosporine (Neoral, Gengraf, Sandimmune)
  • fosamprenavir (Lexiva) with ritonavir
  • indinavir (Crixivan)
  • ketoconazole (Nizoral)
  • nefazodone (Serzone)
  • ritonavir (Norvir)
  • telithromycin (Ketek)
  • clarithromycin (Biaxin)
  • darunavir (Prezista)
  • fosamprenavir (Lexiva)
  • itraconazole (Sporanox)
  • lopinavir/ritonavir (Kaletra)
  • nelfinavir mesylate (Viracept)
  • saquinavir mesylate (Invirase)
  • tipranavir (Aptivus)

Ask your healthcare provider or pharmacist if you are not sure if you take any of the medicines listed above. This is not a complete list of all the medicines that can interact with Colcrys.

• Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
• Keep Colcrys out of the reach of children.

Who should not take Colcrys?

Do not take Colcrys if you have liver or kidney problems and you take certain other medicines. Serious side effects, including death, have been reported in these patients even when taken as directed. See “What is the most important information that I should know about Colcrys?”

What should I tell my healthcare provider before taking Colcrys?

See “What is the most important information that I should know about Colcrys?”

Before you take Colcrys, tell your healthcare provider about all your medical conditions, including if you:

• have liver or kidney problems.
• are pregnant or plan to become pregnant. It is not known if Colcrys will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. Colcrys passes into your breast milk. You and your healthcare provider should decide if you will take Colcrys or breastfeed. If you take Colcrys and breastfeed, you should talk to your child’s healthcare provider about how to watch for side effects in your child.

Tell your healthcare provider about all the medicines you take, including ones that you may only be taking for a short time, such as antibiotics. See “What is the most important information that I should know about Colcrys?” Do not start a new medicine without talking to your healthcare provider.

Using Colcrys with certain other medicines, such as cholesterol-lowering medications and digoxin, can affect each other, causing serious side effects. Your healthcare provider may need to change your dose of Colcrys. Talk to your healthcare provider about whether the medications you are taking might interact with Colcrys and what side effects to look for.

How should I take Colcrys?

• Take Colcrys exactly as your healthcare provider tells you to take it. If you are not sure about your dosing, call your healthcare provider.
• Colcrys can be taken with or without food.
• If you take too much Colcrys, go to the nearest hospital emergency room right away.
• Do not stop taking Colcrys even if you start to feel better, unless your healthcare provider tells you.
• Your healthcare provider may do blood tests while you take Colcrys.
• If you take Colcrys daily and you miss a dose, then take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take two doses at the same time.
• If you have a gout flare while taking Colcrys daily, report this to your healthcare provider.

What should I avoid while taking Colcrys?

• Avoid eating grapefruit or drinking grapefruit juice while taking Colcrys. It can increase your chances of getting serious side effects.

What are the possible side effects of Colcrys?

Colcrys can cause serious side effects or even cause death. See “What is the most important information that I should know about Colcrys?”

Get medical help right away if you have:

• Muscle weakness or pain
• Numbness or tingling in your fingers or toes
• Unusual bleeding or bruising
• Increased infections
• Feel weak or tired
• Pale or gray color to your lips, tongue or palms of your hands
• Severe diarrhea or vomiting

Gout Flares: The most common side effect of Colcrys in people who have gout flares is diarrhea.

FMF: The most common side effects of Colcrys in people who have FMF are abdominal pain, diarrhea, nausea and vomiting.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Colcrys. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Colcrys

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Colcrys for a condition for which it was not prescribed. Do not give Colcrys to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about Colcrys. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Colcrys that is written for healthcare professionals.

For more information, go to www.Colcrys.com or call 1-877-825-3327.

How should I store Colcrys?

• Store Colcrys at room temperature between 68°F and 77°F (20°C and 25°C).
• Keep Colcrys in a tightly closed container.
• Keep Colcrys out of the light.

Keep Colcrys and all medicines out of the reach of children.

What are the ingredients in Colcrys?

Active Ingredient: colchicine.

Inactive Ingredients: carnauba wax, FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide and triacetin.

Label

PRINCIPAL DISPLAY PANEL – 0.6 mg Tablet Bottle Label

• 100 TABLETS
  NDC 13310-119-01
• COLCRYS®
  (colchicine, USP) tablets
  0.6 mg
• PHARMACIST:
  PLEASE DISPENSE WITH
  MEDICATION GUIDE ATTACHED
• AR
  SCIENTIFIC
  Rx only