Colcrys

1 What is Colcrys?

Brand: Colcrys, Mitigare

Generic: Colchicine

Colchicine is an alkaloid used to prevent or treat attacks of gout caused by excess levels of uric acid in the blood resulting to inflammation in a joint. This drug is also used to treat a rare condition called familial Mediterranean fever (FMF) in adults and children older than 4 years of age.

This drug is usually taken in small amounts for a prolonged time to prevent severe attacks or other problems caused by inflammation. A larger dose is taken relieve an attack that is occurring. Side effects are more likely to happen in larger doses. This drug requires a prescription.

2 What to Know Before Using

Before taking this drug, the risks and benefits for your body should be discussed with your healthcare provider. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Studies in children with gout have not determined the relationship of age to the effects of colchicines while safety and efficacy have not been established.  Pediatric-specific problems have not been reported in studies that would limit the usefulness of colchicine in children with FMF.

Studies have not determined any geriatric-specific problems that would limit the usefulness of colchicine in the elderly. Adjustments in the dose of elderly patients may be required since they are more likely to have age-related kidney or liver problems.

Adverse effects have been reported in animals but studies in pregnant women or animals are still inadequate. This drug poses minimal risk to infant when used during breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as Digoxin, fibrates, HMG-Co A reductase inhibitors, Amprenavir, aprepitant, atazanavir, azole antifungal, boceprevir, cyclosporine, darunavir, diltiazem, fosamprenavir, fosaprepitant, indinavir, macrolide antibiotics, nefazodone, nelfinavir, ranolazine, ritonavir or any medicine that contains ritonavir, saquinavir, telaprevir, telithromycin, tipranavir, or verapamil or sympathomimetics. Inform your healthcare professional if you are taking any other prescription or non-prescription drugs.

Intake of specific food or using alcohol or tobacco with magnesium is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco. Inform your healthcare provider for any other medical problems such as alcohol abuse, bowel problems, stomach ulcer, stomach problems, blood disorders, muscle or nerve problems, kidney or liver problems.

3 Proper Usage

Take this drug as directed by your doctor. Follow the instruction on the label or as prescribed by your healthcare professional. Take this drug by mouth with or without food. Do not eat grapefruit or drink grapefruit juice while you are using colchicine. 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.

Seek advice from your healthcare provider for any concerns. Colchicine may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Inform your healthcare provider 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.

Use colchicine with caution in the elderly as they may be more sensitive to its effects, including muscle and nerve problems. 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. Adults with gout are given 0.6 mg orally once or twice a day. The dose must not exceed 1.2 mg per day.

For treatment of Mediterranean fever, children of age 4 to 6 years are given 0.3 to 1.8 mg orally daily, administered in 1 or 2 divided doses. Children of age 6 to 12 years are given 0.9 to 1.8 mg orally daily, administered in 1 or 2 divided doses. Children older than 12 years are given 1.2 to 2.4 mg orally daily, administered in 1 or 2 divided doses.

A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to take

Your healthcare provider should closely monitor the effectiveness of this drug as well as check for unwanted effects. Unwanted effects may be screened using blood tests. Alcohol can decrease this drug's effectiveness. Limit alcohol while taking this drug.

This drug can affect how well your body absorbs some foods and nutrients. Before having surgery, tell your healthcare professional or dentist about all the products you use. Older adults may be more sensitive to the side effects of this drug, especially muscle weakness/pain and numbness/tingling in their fingers or toes.

Colchicine can decrease sperm production, which may affect the ability of a male to father a child. Consult your healthcare professional for more information. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your healthcare professional. This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your healthcare professional before breast-feeding.

Your healthcare professional may recommend that you separate the time you take your medication apart from breast-feeding. Consult with your healthcare provider if you experience any unusual symptoms, and before you take any other prescription or non-prescription drugs.

5 Potential Side Effects

Side effects may vary for each individual and prompt medical attention should be given if they occur. Inform you healthcare provider immediately if you experience any unusual symptoms such as diarrhea, nausea or vomiting, stomach pain, black, tarry stools, blood in the urine or stools, burning, "crawling", or tingling feeling in the skin, difficulty with breathing when exercising, fever with or without chills, headache, large, hive-like swellings on the face, eyelids, mouth, lips, or tongue, muscle weakness, numbness in the fingers or toes, pain, peeling of the skin, pinpoint red spots on the skin, redness, skin rash or hives, sores, ulcers, or white spots on the lips or in the mouth, sore throat, swelling tenderness, unusual bleeding or bruising, unusual tiredness or weakness, burning feeling in the stomach, throat, or skin convulsions, diarrhea, fast, shallow breathing, muscle weakness, nausea, stomach pain, or vomiting.

Some side effects may occur that usually do not need medical attention. As your body adjusts to the drug, these side effects may eventually disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects. If any of the following side effects persists, or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. If any of the following side effects persists, or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088. 

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