Description
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 reduce the risk of heart attack, stroke, certain types of heart procedures, and cardiovascular death in patients with atherosclerosis (known buildup of plaque inside the arteries) or with multiple cardiovascular risk factors.
Colchicine is also used to treat a rare condition called familial Mediterranean fever (FMF).
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 as well as the risks of using this medicine.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
- Tablet
- Solution
Before Using
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:
Allergies
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of colchicine in children. 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 4 years of age and older. However, safety and efficacy of colchicine have not been established in children with FMF younger than 4 years of age.
Geriatric
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.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
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.
- Amiodarone
- Atazanavir
- Boceprevir
- Carvedilol
- Ceritinib
- Clarithromycin
- Cobicistat
- Conivaptan
- Cyclosporine
- Darunavir
- Dronedarone
- Erythromycin
- Flibanserin
- Idelalisib
- Indinavir
- Itraconazole
- Josamycin
- Ketoconazole
- Lapatinib
- Levoketoconazole
- Lonafarnib
- Lopinavir
- Mibefradil
- Mifepristone
- Nefazodone
- Nelfinavir
- Nirmatrelvir
- Posaconazole
- Quinidine
- Ranolazine
- Ribociclib
- Ritonavir
- Saquinavir
- Sunitinib
- Telaprevir
- Telithromycin
- Tipranavir
- Troleandomycin
- Tucatinib
- Vemurafenib
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.
- Abametapir
- Abrocitinib
- Adagrasib
- Amprenavir
- Aprepitant
- Asciminib
- Atorvastatin
- Avacopan
- Belumosudil
- Berotralstat
- Bezafibrate
- Capmatinib
- Carbamazepine
- Cimetidine
- Ciprofibrate
- Ciprofloxacin
- Clofazimine
- Clofibrate
- Crizotinib
- Danicopan
- Daridorexant
- Digoxin
- Diltiazem
- Duvelisib
- Elacestrant
- Enasidenib
- Enzalutamide
- Erdafitinib
- Ezetimibe
- Fedratinib
- Fenofibrate
- Fenofibric Acid
- Fexinidazole
- Fluconazole
- Fluvoxamine
- Fosamprenavir
- Fosnetupitant
- Gemfibrozil
- Gilteritinib
- Imatinib
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.
- Fluvastatin
Other Interactions
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 usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
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:
- Alcohol abuse or
- Stomach or bowel problems (eg, stomach ulcer)—May increase risk of stomach upset and can make these conditions worse.
- Blood disorders (eg, aplastic anemia, granulocytopenia, leukopenia, pancytopenia, thrombocytopenia) or
- Muscle or nerve problems—Use with caution. May make these conditions worse.
- Blood dyscrasias, pre-existing or
- Kidney disease, severe or
- Liver disease, severe—Should not be used in patients with these conditions.
- Kidney disease and
- Liver disease—Gloperba® oral solution should not be used in patients who have both these conditions.
- Kidney disease or
- Liver disease—Should not be used in patients with these conditions and also taking certain medicines (eg, medicine to treat HIV or AIDS, medicine to treat an infection, medicine to lower cholesterol).
- Kidney disease, severe or
- Liver disease, severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.
Proper Use
Take this medicine exactly as directed by your doctor. 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.
This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
For patients taking small amounts of colchicine regularly (preventive treatment):
- Take this medicine regularly as directed by your doctor, even if you feel well. If you are taking colchicine to prevent gout attacks, and you are also taking another medicine to reduce the amount of uric acid in your body, you probably will be able to stop taking colchicine after a while. However, if you stop taking it too soon, your attacks may return or get worse. If you are taking colchicine for certain other medical conditions, you may need to keep taking it for the rest of your life.
- If you are taking colchicine to prevent gout attacks, ask your doctor to recommend other medicines to be taken if an attack occurs. Most people receiving preventive amounts of colchicine should not take extra colchicine to relieve an attack. However, some people cannot take the other medicines that are used for gout attacks and will have to take extra colchicine. If you are one of these people, ask your doctor to tell you the largest amount of colchicine you should take for an attack and how long you should wait before starting to take the smaller preventive amounts again. Be sure to follow these directions carefully.
For patients taking large amounts of colchicine only when needed to relieve an attack:
- Start taking this medicine at the first sign of the attack for best results.
- Stop taking this medicine as soon as the pain is relieved or at the first sign of nausea, vomiting, stomach pain, or diarrhea. Also, stop taking colchicine when you have taken the largest amount that your doctor ordered for each attack, even if the pain is not relieved or none of these side effects occurs.
- The first few times you take colchicine, keep a record of each dose as you take it. Then, whenever stomach upset (eg, nausea, vomiting, stomach pain, or diarrhea) occurs, count the number of doses you have taken. The next time you need colchicine, stop taking it before that number of doses is reached. For example, if diarrhea occurs after your fifth dose of medicine, take no more than four doses the next time. If taking fewer doses does not prevent stomach upset from occurring after a few treatments, check with your doctor.
- After taking colchicine tablets to treat an attack, do not take any more colchicine for at least 3 days. Also, after receiving the medicine by injection for an attack, do not take any more colchicine (tablets or injection) for at least 7 days. Elderly patients may have to wait even longer between treatments and should check with their doctor for directions.
- If you are taking colchicine for an attack of gout, and you are also taking other medicine to reduce the amount of uric acid in your body, do not stop taking the other medicine. Continue taking the other medicine as directed by your doctor.
Shake the oral liquid well before each use. Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
Keep using this medicine for the full treatment time, even if you feel better after the first few doses.
Grapefruit 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 are using this medicine.
Dosing
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.
- For oral dosage form (capsules):
- For prevention of gout attacks:
- Adults—0.6 milligram (mg) 1 or 2 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 1.2 mg per day.
- Children—Use and dose must be determined by your doctor.
- For prevention of gout attacks:
- For oral dosage form (solution):
- For prevention of gout attacks:
- Adults and children 16 years of age and older—0.6 milligram (mg) (5 milliliters [mL]) 1 or 2 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 1.2 mg (10 mL) per day.
- Children younger than 16 years of age—Use and dose must be determined by your doctor.
- For prevention of gout attacks:
- For oral dosage form (tablets):
- For prevention of gout attacks:
- Adults—0.6 milligram (mg) 1 or 2 times a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 1.2 mg per day.
- Children—Use and dose must be determined by your doctor.
- For treatment of gout attacks:
- Adults—1.2 milligrams (mg) at the first sign of a gout attack, followed by 0.6 mg after 1 hour. The dose is usually 1.8 mg over a 1-hour period.
- Children—Use is not recommended.
- For treatment of familial Mediterranean fever (FMF):
- Adults and children older than 12 years of age—1.2 to 2.4 milligrams (mg) given in one or two divided doses a day. Your doctor may adjust your dose as needed and tolerated.
- Children 6 to 12 years of age—0.9 to 1.8 mg given in one or two divided doses a day.
- Children 4 to 6 years of age—0.3 to 1.8 mg given in one or two divided doses a day.
- Children younger than 4 years of age—Use and dose must be determined by your doctor.
- To reduce the risk of heart attack, stroke, certain types of heart procedures, and cardiovascular death in patients with atherosclerosis or with multiple cardiovascular risk factors:
- Adults—0.5 milligrams (mg) once a day.
- Children—Use and dose must be determined by your doctor.
- For prevention of gout attacks:
Missed Dose
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.
For patients taking the tablet to prevent gout attack: Take a dose as soon as you remember. If your next dose is 12 hours away, wait until then and take a regular dose.
Storage
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.
Precautions
If you must take colchicine for a long time (preventive treatment), it is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Do not use this medicine together with atazanavir (Reyataz®), clarithromycin (Klaricid®), cyclosporine (Gengraf®), darunavir/ritonavir (Prezista®), indinavir (Crivixan®), itraconazole (Sporanox®), ketoconazole (Nizoral), lopinavir/ritonavir (Kaletra®), nefazodone (Serzone®), nelfinavir (Viracept®), ranolazine (Ranexa®), ritonavir (Norvir®), saquinavir (Invirase®), telithromycin (Ketek®), tipranavir/ritonavir (Aptivus®).
Stomach problems may be more likely to occur if you drink large amounts of alcoholic beverages while using 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 use colchicine should be careful to limit the amount of alcohol they drink.
For patients taking small amounts of colchicine regularly (preventive treatment):
- Attacks of gout or other problems caused by inflammation may continue to occur during treatment. However, the attacks or other problems should occur less often, and they should not be as severe as they were before you started taking colchicine. Even if you think the colchicine is not working, do not stop taking it and do not increase the dose. Check with your doctor instead.
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 you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
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.
If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become temporarily infertile (unable to have children).
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.
Side Effects
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:
More common
- Diarrhea
- nausea
- stomach pain
- vomiting
Rare
- 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 (usually mild)
- pain
- peeling of the skin
- pinpoint red spots on the skin
- redness of the skin
- skin rash or hives
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swelling
- tenderness
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- Bleeding gums
- chest pain or tightness
- cough
- dark urine
- headache
- high fever
- muscle cramps, spasms, or stiffness
- muscular pain, tenderness, or wasting
- painful or difficult urination
- pale skin
- sensation of pins and needles
- stabbing pain
- swollen or painful glands
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Bleeding
- burning feeling in the stomach, throat, or skin
- chest pain or discomfort
- chills
- cold, clammy, pale skin
- confusion
- cough
- diarrhea (severe or bloody)
- dizziness
- eye pain
- fever
- general feeling of illness
- headache
- irregular heartbeat
- irregular, fast, slow, or shallow breathing
- muscle weakness (very severe)
- nausea, stomach pain, or vomiting (severe)
- seizures
- slow heart rate
- sore throat
- unusual tiredness
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:
Less common
- Hair loss or thinning of hair
- loss of appetite
Incidence not known
- Stomach bloating from increased gas
- stomach cramping
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.
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