Colchicine is used to prevent or treat attacks of gout (also called gouty arthritis). This condition is caused by too much uric acid in the blood. An attack of gout occurs when uric acid causes inflammation (pain, redness, swelling, and heat) in a joint. Colchicine does not cure gout, but it will help prevent gout attacks. Colchicine is not an ordinary pain reliever and will not relieve most kinds of pain.
Colchicine is also used to treat a rare condition called familial Mediterranean fever (FMF) in adults and children older than 4 years of age.
Colchicine may be used in 2 ways. Most people take small amounts of it regularly for a long time (months or even years) to prevent severe attacks or other problems caused by inflammation. Other people take large amounts of colchicine during a short period of time (several hours) only when the medicine is needed to relieve an attack that is occurring. The chance of serious side effects is much lower with the first (preventive) kind of treatment.
Because some of colchicine's side effects can be very serious, you should discuss with your doctor about the benefits that this medicine can do as well as the risks of using it.
This medicine is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, colchicine is used in certain patients with the following medical conditions:
If you are taking colchicine for any of these conditions, the following information may apply:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of colchicine in children with gout. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of colchicine in children with FMF. However, safety and efficacy of colchicine have not been established in children with FMF younger than 4 years of age.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of colchicine in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems which may require caution and an adjustment in the dose for patients receiving colchicine.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take more of it, and do not take it for a longer time than your doctor ordered. Do not change your dose or stop using this medicine without checking first with your doctor.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
For patients taking small amounts of colchicine regularly (preventive treatment):
For patients taking large amounts of colchicine only when needed to relieve an attack:
Keep using this medicine for the full treatment time, even if you feel better after the first few doses.
Grapefruits and grapefruit juice may increase the effects of colchicine by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you taking this medicine.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
If you must take colchicine for a long time (preventive treatment), your doctor may want to check your progress at regular visits. Blood tests may be needed to check for unwanted effects.
Stomach problems may be more likely to occur if you drink large amounts of alcoholic beverages while taking colchicine. Also, drinking too much alcohol may increase the amount of uric acid in your blood. This may lessen the effects of colchicine when it is used to prevent gout attacks. Therefore, people who take colchicine should be careful to limit the amount of alcohol they drink.
For patients taking small amounts of colchicine regularly (preventive treatment):
Colchicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
If your doctor tells you to increase the amount of medicine you are taking or if you are just starting this medicine, make sure you tell the doctor right away if you get muscle pain, tenderness, or weakness.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.