Colchicine
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Description
Colchicine is used to prevent or
treat attacks of gout (also called gouty arthritis).
People with gout have too much uric acid in their blood
and joints. An attack of gout occurs when uric acid
causes inflammation (pain, redness, swelling, and heat)
in a joint. Colchicine does not cure gout or take the
place of other medicines that lower the amount of uric
acid in the body. It prevents or relieves gout attacks
by reducing inflammation. Colchicine is not an ordinary
pain reliever and will not relieve most kinds of pain.
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 the good
that Colchicine can do as well as the risks of using it.
Make sure you understand exactly how you are to use it,
and follow the instructions carefully, to lessen the
chance of unwanted effects.
Colchicine is available only with your doctor's
prescription, in the following dosage forms:
Oral
Tablets (U.S. and Canada)
Parenteral
Injection (U.S.)
Before Using Colchicine
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 colchicine, the
following should be considered:
Allergies-Tell your doctor if you have ever had any
unusual or allergic reaction to colchicine. Also tell
your health care professional if you are allergic to any
other substances, such as foods, preservatives, or dyes.
Pregnancy-Studies in humans taking large amounts of
colchicine to relieve attacks have not been done.
Fertility problems have occurred in some men taking
small amounts of colchicine regularly (preventive
treatment), but these problems went away after treatment
was stopped. Many other men taking preventive amounts of
colchicine have fathered children without stopping
treatment. Also, many women receiving preventive
treatment with colchicine have become pregnant and given
birth to normal, healthy babies. Some women receive
preventive amounts of colchicine regularly for a medical
condition that can cause fertility problems or
miscarriages. Treatment with colchicine does not
increase, and may actually decrease, the occurrence of
these problems in women with this condition.
Colchicine has caused birth defects and other
problems in animal studies.
Breast-feeding-Colchicine passes into breast milk.
When breast-feeding mothers receive preventive treatment
with one 0.6-milligram (mg) tablet twice a day, the
amount that appears in the breast milk is not likely to
cause problems in nursing babies. There is no
information about whether colchicine can cause problems
in nursing babies when the mother takes larger amounts
of it. Mothers who are taking Colchicine and who wish to
breast-feed should discuss this with their doctor.
Children-Studies on the effects of colchicine in
patients with gout have been done only in adults. Gout
is very rare in children. However, colchicine is used in
children 3 years of age and older who need preventive
treatment for other medical conditions. It has not been
reported to cause different side effects or problems in
these children than it does in adults.
Older adults-Elderly people are especially sensitive
to the effects of colchicine. Also, colchicine may stay
in the body longer in older patients than it does in
younger adults. This may increase the chance of side
effects during treatment.
Other medicines-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 colchicine, it is especially
important that your health care professional know if you
are taking any of the following: Amphotericin B by
injection (e.g., Fungizone) or
Antineoplastics
(cancer medicine) or
Antithyroid agents (medicine
for overactive thyroid) or
Azathioprine (e.g.,
Imuran) or
Chloramphenicol (e.g., Chloromycetin) or
Cyclophosphamide (e.g., Cytoxan) or
Flucytosine
(e.g., Ancobon) or
Ganciclovir (e.g., Cytovene) or
Interferon (e.g., Intron A, Roferon-A) or
Mercaptopurine (e.g., Purinethol) or
Methotrexate (e.g., Mexate) or
Phenylbutazone
(e.g., Butazolidin) or
Plicamycin (e.g., Mithracin)
or
Zidovudine (e.g., Retrovir)-The chance of serious
side effects caused by a decrease in the numbers of
certain blood cells may be increased
Other medical problems-The presence of other medical
problems may affect the use of colchicine. Make sure you
tell your doctor if you have any other medical problems,
especially:
Alcohol abuse or
Intestinal 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 wor
se Heart disease or
Kidney disease
or
Liver disease-The chance of serious side effects
may be increased because these conditions can cause
colchicine to build up in the body
Low white blood
cell count or
Low platelet count-The chance of
serious side effects may be increased because colchicine
can make these conditions worse
Proper Use of Colchicine
Colchicine can build up
in the body and cause serious side effects if too much
of it is taken or if it is taken too often. Therefore,
do not take more of Colchicine, and do not take it more
often, than directed by your doctor. This is especially
important for elderly patients, who are more likely than
younger adults to have colchicine build up in the body
and who are also more sensitive to its effects.
For patients taking small amounts of colchicine
regularly (preventive treatment):
Take Colchicine 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 Colchicine at the first sign of the
attack for best results. Stop taking Colchicine 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.
Dosing
The dose of colchicine 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 colchicine. If your
dose is different, do not change it unless your doctor
tells you to do so.
The number of doses you take each day, the time
allowed between doses, and the length of time you take
the medicine depend on how often your attacks occur and
on whether you are taking the medicine to prevent or to
relieve attacks. The amount of medicine you take will
also depend on how you react to the medicine.
For oral dosage form (tablets):
Adults:
For
preventing gout attacks-Most people start with one
0.5-milligram (mg) or 0.6-mg tablet a day. If gout
attacks continue to occur, the doctor may direct you to
increase the dose to one tablet two or even three times
a day for a while. Some people with mild gout may need
only one tablet every other day, or even less.
For
treating a gout attack that has already started-Your
doctor will probably recommend one of the following
treatment plans:
One or two 0.5-mg or 0.6-mg tablets
for the first dose, then one 0.5-mg or 0.6-mg tablet
every one or two hours, or Two 0.5-mg or 0.6-mg tablets
or one 1-mg tablet every two hours. For both plans, stop
taking Colchicine after you have taken the largest
amount ordered by your doctor. If your doctor has not
told you the largest amount that you should take for one
attack, do not take more than 6 mg of Colchicine (a
total of twelve 0.5-mg tablets, ten 0.6-mg tablets, or
six 1-mg tablets, spread over a period of several
hours).
Children: Use and dose must be determined by
the doctor.
For parenteral dosage form (injection):
Adults:
For preventing gout attacks-0.5 or 1 mg
one or two times a day, injected into a vein.
For
treating an attack of gout that has already started-1 or
2 mg for the first dose, then 0.5 mg or 1 mg every six
to twelve hours, injected into a vein. After a total of
4 mg has been given, no more colchicine (tablets or
injections) should be given for at least seven days.
Children: Use and dose must be determined by the
doctor.
Missed dose
If you are taking colchicine
regularly (for example, every day) and you miss a dose,
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
To store Colchicine:
Keep out of the reach of children. Store away from
heat and direct light.
Do not store Colchicine in
the bathroom, near the kitchen sink, or in other damp
places. Heat or moisture may cause the medicine to break
down.
Do not keep outdated medicine or medicine no
longer needed. Be sure that any discarded medicine is
out of the reach of children.
Precautions While Using Colchicine
If you must
take colchicine for a long time (preventive treatment),
your doctor may want to check your progress at regular
visits. He or she may also want to check for certain
side effects. Finding these side effects early can help
to keep them from becoming serious.
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.
Side Effects of Colchicine
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.
Stop taking Colchicine immediately if any of the
following side effects occur:
More common
Diarrhea; nausea or vomiting; stomach
pain
If any of these side effects continue for 3 hours or
longer after you have stopped taking colchicine, check
with your doctor.
Also, check with your doctor immediately if any of
the following side effects occur:
Rare
Black, tarry stools; blood in urine or
stools; difficulty in breathing when exercising ; fever
with or without chills; headache; large, hive-like
swellings on the face, eyelids, mouth, lips, and/or
tongue; pinpoint red spots on skin; sores, ulcers, or
white spots on lips or in mouth; sore throat; unusual
bleeding or bruising; unusual tiredness or weakness
Signs and symptoms of overdose
Burning feeling
in the stomach, throat, or skin; diarrhea (severe or
bloody); nausea, stomach pain, or vomiting (severe)
These side effects are usually the first signs of an
overdose of colchicine tablets. They are not likely to
occur when too much colchicine has been given by
injection. Other signs and symptoms that may occur after
an overdose of either the tablets or the injection
include bleeding; fast, shallow breathing; convulsions
(seizures); fever; and very severe muscle weakness. An
overdose of colchicine can cause damage to the blood,
heart, intestines, kidneys, liver, lungs, and muscles.
The following side effects may occur after an
injection of colchicine. Check with your doctor as soon
as possible if any of the following occur at or near the
place of injection:
Rare
Burning, ``crawling,'' or tingling feeling
in the skin; pain; peeling of skin; redness; swelling;
tenderness
Also, check with your doctor as soon as possible if
any of the following side effects occur:
Rare Muscle weakness; numbness in fingers or toes
(usually mild); skin rash or hives
Other side effects may occur that usually do not need
medical attention. However, check with your doctor if
either of the following side effects continues or is
bothersome:
Less common
Loss of appetite
With long-term use
Loss of hair
Other side effects not listed above may also occur in
some patients. If you notice any other effects, check
with your doctor.
Additional Information
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
Behcet's syndrome
Calcium
pyrophosphate deposition disease (pseudogout)
Cirrhosis of the liver
Familial Mediterranean
fever
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.
For patients taking
colchicine for familial Mediterranean fever:
Preventive treatment with colchicine may be helping
you even if it does not reduce the number of severe
attacks. Colchicine helps prevent other serious
problems, such as kidney disease, that can occur in
people with this condition. Therefore, even if you think
that the colchicine isn't working, do not stop taking
it. Check with your doctor instead.
Other than the
above information, there is no additional information
relating to proper use, precautions, or side effects for
these uses.
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