Colsalide

Generic Name: colchicine (Oral route)

KOL-chi-seen

Commonly used brand name(s):

In the U.S.

• Colcrys
• Colsalide

Available Dosage Forms:

• Tablet

Therapeutic Class: Antigout

Uses For Colsalide

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 above 4 years of age.

Colchicine may also be used for other conditions as determined by your doctor.

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 good 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:

• Amyloidosis.
• Behçet's syndrome.
• Calcium pyrophosphate deposition disease (pseudogout).
• Cirrhosis of the liver.
• Pericarditis.
• Sarcoid arthritis.

If you are taking colchicine for any of these conditions, the following information may apply:

• For all of these conditions, colchicine is usually given regularly in small amounts to reduce inflammation (preventive treatment). This usually decreases the occurrence of severe attacks or other problems caused by inflammation.
• Colchicine is not a cure for these conditions. It will help prevent problems caused by inflammation only as long as you continue to take it.
• Some patients with calcium pyrophosphate deposition disease (pseudogout) or familial Mediterranean fever may take larger amounts of colchicine only when an attack occurs, to relieve the attack.

Before Using Colsalide

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 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.

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.

Pregnancy

	Pregnancy Category	Explanation
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.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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.

• Amprenavir
• Aprepitant
• Atazanavir
• Clarithromycin
• Cyclosporine
• Diltiazem
• Erythromycin
• Fluconazole
• Fosamprenavir
• Gemfibrozil
• Indinavir
• Interferon Alfa-2a
• Itraconazole
• Ketoconazole
• Lovastatin
• Nefazodone
• Nelfinavir
• Pravastatin
• Quinidine
• Ranolazine
• Reserpine
• Ritonavir
• Saquinavir
• Tacrolimus
• Telithromycin
• Verapamil

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.

• Atorvastatin
• Bezafibrate
• Ciprofibrate
• Clofibrate
• Digoxin
• Fenofibrate
• Fluvastatin
• Simvastatin

Interactions with Food/Tobacco/Alcohol

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
• Bowel disease or
• Stomach ulcer or other stomach problems—The chance of stomach upset may be increased. Also, colchicine can make some kinds of stomach or intestinal problems worse.

• Blood disorders (e.g., aplastic anemia, granulocytopenia, leukopenia, pancytopenia) or
• Muscle or nerve problems—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Should not be used in patients with these conditions.

Proper Use of colchicine

This section provides information on the proper use of a number of products that contain colchicine. It may not be specific to Colsalide. Please read with care.

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.

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 medicine 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 (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.

You may take this medicine with or without food.

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 (tablets):
  • For familial mediterranean fever (FMF):
    • Adults and teenagers—1.2 to 2.4 milligrams (mg) given in one or two divided doses a day. Your doctor may adjust your dose as needed.
    • Children 6 to 12 years of age—0.9 to 1.8 milligrams (mg) given in one or two divided doses a day.
    • Children 4 to 6 years of age—0.3 to 1.8 milligrams (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.
  • For gout attacks:
    • Adults—1.2 milligrams (mg) at the first sign of a gout attack, followed by 0.6 mg after one hour. The dose is usually 1.8 mg over a 1 hour period.
    • Children—Use is not recommended.

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.

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 While Using Colsalide

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):

• 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.

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.

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.

Colsalide 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 or vomiting
• stomach pain

Rare

• Black, tarry stools
• blood in the urine or stools
• burning, "crawling", or tingling feeling in the skin
• difficulty in 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
• 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

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
• convulsions (seizures)
• diarrhea (severe or bloody)
• fast, shallow breathing
• muscle weakness (very severe)
• nausea, stomach pain, or vomiting (severe)

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
• loss of appetite

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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