Colcrys

The active ingredient in Colcrys is Colchicine USP. As colchicine is indicated to treat gout and FMF, it primarily has anti-inflammatory properties. Gout and acute gout flares are caused by too much uric acid building up in your joints. Colchicine works by inhibiting the inflammatory effects of the uric acid build-up. Specifically, colchicine works by binding to tubulin (a protein that is an important building block of microtubules) and preventing the formation of microtubules. It also stops the activation and migration of white blood cells (neutrophils) that are linked to gout symptoms.

For the treatment of familial Mediterranean fever, it is less known how colchicine helps. It is thought to interfere with interleukin-1-beta, a protein related to inflammation.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Colchicine. However, the following is a synopsis of the general guidelines for the use of Colchicine:

For gout flares:

• Prophylaxis of gout flares:
• 0.6 mg once or twice daily in patients 16 years or older. Do not exceed 1.2 mg per day.
• Treatment of gout flares:
• 1.2 mg (two tablets) when you first suspect a gout flare, followed by 0.6mg (one tablet) an hour later.
• The maximum recommended dose is 1.8 mg in a one-hour period. Ask your doctor how often you can repeat treatment if you have another gout attack.
• For FMF, you can give the daily dose in either one or two divided doses. You most likely will start on a low dose and slowly increase it. Your doctor may decrease your dose if you experience side effects. However, the recommended doses for:
• Children 4 to 6 years is 0.3 mg – 1.8 mg
• Children 6 to 12 years is 0.9 mg – 1.8 mg
• Adults and children older than 12 years is 1.2 mg – 2.4 mg

If you miss a dose of colchicine, take the missed dose as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at its regular time.

The most common side effects of Colcrys seen in clinical trials as compared to placebo include:

• Diarrhea
• Nose and throat pain
• Nausea
• Abdominal pain or cramping
• Vomiting

Some individuals may experience serious side effects while using Colcrys. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Unusual bleeding
• Myopathy, muscle weakness, muscle pain, or muscle damage (rhabdomyolysis)
• Infections (ex: sore throat, chills, fever)

These are not all of the possible side effects of Colchicine. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Colcrys, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Any renal (kidney) or hepatic (liver) impairment
• Undergone or undergoing dialysis
• Any allergies to colchicine, the inactive ingredients in it, or any other allergies.
• Kidney issues
• Liver issues
• A pregnancy, plan to be pregnant, or are breastfeeding
• An infection or are taking antibiotics
• Examples: azithromycin, clarithromycin, erythromycin, telithromycin
• A fungal infection or are taking antifungals
• Examples: fluconazole, itraconazole, ketoconazole
• A condition that requires cholesterol-lowering medications
• Examples: atorvastatin, pravastatin, simvastatin, gemfibrozil
• HIV or AIDS and are taking medications
• Examples: atazanavir, ritonavir

Severe renal impairment in patients with significantly reduced kidney function.

• Severe kidney or liver impairment.
• Concurrent use with strong CYP3A4 inhibitors or P-glycoprotein (P-gp) inhibitors, such as clarithromycin or ketoconazole, especially in patients with kidney or liver issues, due to increased risk of colchicine toxicity.
• Hypersensitivity to colchicine or its components.

Colchicine typically begins to work within 24 to 48 hours for acute gout attacks, providing relief from pain and inflammation. For other conditions, like familial Mediterranean fever or chronic gout prevention, it may take several days to weeks to see full benefits. Always follow your doctor's instructions for use and monitoring.

When Colcrys is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• CYP3A4 enzyme inhibitors (ex: diltiazem, verapamil, or clarithromycin).
• This would also include grapefruit juice; avoid grapefruit juice.
• Protease inhibitors
• P-glycoprotein inhibitors such as cyclosporine and ranolazine
• Digoxin

Colcrys comes in 0.6 mg tablets.

You should store colchicine at room temperature 77ºF (25ºC). Keep away from direct sunlight and out of the reach of children.

Colchicine is a generic medication, so each brand is manufactured by its own company. Those companies include Scilex Holding Company and Takeda Pharmaceuticals U.S.A., Inc.

Colchicine is a generic medicine for the brand-name drugs Colcrys, Mitigare, and Gloperba.

Consult your doctor before stopping colchicine, as they may recommend tapering or alternatives. Avoid stopping abruptly without medical guidance.

Studies have not found any birth defects, adverse maternal or fetal outcomes, or miscarriage due to colchicine. However, talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you. Colchicine has also been found in breast milk. However, it has not been found to have an adverse reaction on infants. Furthermore, studies have not found an effect on milk production in mothers taking the medication.