Needed to read PDF's

Adobe Reader |
Indomethacin
-
Common Brand Name(s):
Indocin,
Indocin SR
-
Common Generic Name(s):
indomethacin
-
Pronunciation:
in-doh-METH-uh-sin
-
Drug Classes:
nonsteroidal anti-inflammatory drug (NSAID)
-
Availability: prescription only, generic available
-
How
is it used? suppository that is inserted into the
rectumcapsule or liquid that is swallowed, suppository that is
inserted into the rectum
Overview: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID),
which is a medicine that is used to help treat osteoarthritis,
rheumatoid arthritis, ankylosing spondylitis, shoulder pain caused by
bursitis or tendonitis, and gout. Indomethacin works to block specific
substances in the body that cause pain, inflammation, and fever. Common
side effects include headache, dizziness, upset stomach, and nausea.
Indomethacin comes in several formulations such as oral capsule,
extended-release oral capsule, oral liquid, and rectal suppository.
Indomethacin Uses
What is indomethacin used for?
Indomethacin is commonly used for the following conditions.
- Rheumatoid arthritis, an autoimmune
condition where your body attacks your joints
- Ankylosing spondylitis, an autoimmune condition where your body
attacks the joints in your spine
- Osteoarthritis, a condition that causes inflammation in the
joints when cartilage (a type of tissue) breaks down
- Shoulder pain caused by bursitis
or tendonitis
-
Gout, a type of arthritis that can cause swelling and pain in
your joints
Indomethacin may also be used for other conditions as
determined by your healthcare provider.
How does indomethacin work (mechanism of action)?
Indomethacin works by blocking certain substances in the
body that cause pain, inflammation, and fever.
How is indomethacin supplied (dosage forms)?
Brands and other names
Dosage forms and strengths
- 25 mg oral capsules
- 50 mg oral capsules
- 75 mg extended-release oral capsules
- 50 mg rectal suppository
- 25 mg/5 mL oral suspension
How should I store indomethacin?
Oral Capsule. Indomethacin should be
stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can
be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for
shorter periods of time, such as when transporting it. Store in a cool,
dry place, away from light and moisture.
Rectal Suppository. Indomethacin should be
stored in the refrigerator between 36 F to 46 F (2 C to 8 C).
Oral Liquid. Indomethacin should be stored
below 86 F (30 C). Do not freeze.
Proper Use
Take this medicine only as directed by your doctor. Do not
take more of it, do not take it more often, and do not take it
for a longer time than your doctor ordered. Taking too much of
this medicine may increase the risk of side effects.
This medicine should come with a Medication Guide. Read and
follow these instructions carefully. Ask your doctor if you have
any questions.
When used for severe or continuing arthritis, this medicine
must be taken regularly as ordered by your doctor in order for
it to help you. This medicine usually begins to work within 1
week, but in severe cases up to two weeks or even longer may
pass before you begin to feel better. Also, several weeks may
pass before you feel the full effects of this medicine.
Swallow the capsule whole. Do not open, crush, break, or chew
it.
Shake the oral suspension 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.
It is best to take this medicine with food.
Check with your doctor first before changing dosage forms (eg,
capsules, suspension). These forms are very different from each
other.
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 forms (capsules or suspension):
For acute gouty arthritis:
- Adults—50 milligrams (mg) three times a day. Your
doctor may decrease your dose as needed.
- Children 15 years of age and older—Dose is based on
body weight and must be determined by your doctor.
- Children younger than 14 years of age—Use and dose
must be determined by your doctor.
For acute painful shoulder (bursitis or tendinitis):
- Adults—75 to 150 milligrams (mg) per day, divided
into three or four equal doses, and taken for 1 to 2
weeks as determined by your doctor.
- Children 15 years of age and older—Dose is based on
body weight and must be determined by your doctor.
- Children younger than 14 years of age—Use and dose
must be determined by your doctor.
For mild to moderate acute pain:
- Adults—20 milligrams (mg) three times a day, or 40
mg two or three times a day.
- Children—Use and dose must be determined by your
doctor.
For moderate to severe ankylosing spondylitis,
osteoarthritis, or rheumatoid arthritis:
- Adults—25 milligrams (mg) two or three times a day.
Your doctor may increase your dose by 25 or 50 mg per
day, as needed. However, the total dose is usually not
more than 200 mg per day.
- Children 15 years of age and older—Dose is based on
body weight and must be determined by your doctor.
- Children younger than 14 years of age—Use and dose
must be determined by your doctor.
Side Effects
What are the most common side effects of indomethacin?
The most common side effects of indomethacin are listed
below. Tell your healthcare provider if you have any of these side
effects that bother you.
- Headache (see below)
- Dizziness
- Upset stomach
- Nausea
There may be other side effects of indomethacin that
are not listed here. Contact your healthcare provider if you think
you are having a side effect of a medicine. In the U.S., you can
report side effects to the FDA at www.fda.gov/medwatch
or by calling 800-FDA-1088. In Canada, you can report side effects
to Health Canada at www.health.gc.ca/medeffect
or by calling 866-234-2345.
What are the serious side effects of indomethacin?
While less common, the most serious side effects of
indomethacin are described below, along with what to do if they
happen.
Severe Allergic Reactions.
Indomethacin may cause allergic
reactions, including a specific type of allergic reaction called
DRESS. DRESS stands for Drug Reaction with Eosinophilia and Systemic
Symptoms. It is also sometimes called multi-organ hypersensitivity.
This is a reaction that can affect multiple parts of the body
including your liver, kidneys, and heart. Stop taking the medicine
and get help right away if you have any of the following symptoms of
a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Itching, skin rash, or pale red
bumps on the skin called hives
- Fever or general ill feeling
- Swollen lymph
nodes
- Swelling of the face, lips, mouth,
tongue, or throat
- Shortness of breath, trouble
swallowing, or throat tightness
- Swelling in your feet, ankles, or
legs
- Nausea or vomiting
- Dizziness, feeling lightheaded, or
fainting
- Stomach cramps
- Joint pain
- Dark-colored pee
- Your skin or the whites of your
eyes turning yellowish in color (also called jaundice)
Heart Attack and Stroke. Indomethacin
can increase your risk of a heart
attack or stroke
that can lead to death. This risk is increased in people with
existing heart disease and with longer use of indomethacin and
higher doses. Do not take indomethacin if you have had a recent
heart attack without talking to your healthcare provider. This could
increase your risk of having another heart attack. Get emergency
help if you have any of the following symptoms of a heart attack or
stroke.
- Chest pain or pressure
- Fast or abnormal heartbeat
- Trouble breathing
- Pain in your back, jaw, throat, or
arm
- Sweating, upset stomach, vomiting,
or dizziness
- Sudden weakness on one side of your
body
- Sudden and severe headache
- Slurred speech or trouble
understanding speech
Stomach Bleeding. Indomethacin can
increase your risk of bleeding, ulcers, and tears
(perforation) in your gut. The risk is higher if you have a
history of stomach ulcers, bleeding problems, take higher doses of
indomethacin or take it for longer than directed, have poor health,
are of older age, have liver disease, smoke, drink alcohol, or take
certain other medicines. Stop taking indomethacin and get emergency
help if you have any of the following symptoms.
- Vomit blood
- Black or tarry poop
- Stomach pain that does not go away
- Upset stomach
- Feel faint
Liver Damage. Liver damage, also
called hepatotoxicity,
can happen when taking indomethacin. Call your healthcare provider
right away if you have any of the following symptoms of liver
damage.
- Nausea or vomiting
- Stomach or belly pain
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Light-colored poop
- Dark-colored urine (pee)
- Your skin or the whites of your
eyes turning yellowish in color (also called jaundice)
Increased Blood Pressure (Hypertension).
Indomethacin may increase your blood pressure or make it worse if
you have a history of high blood pressure. Call your healthcare
provider if your blood pressure increases while taking this
medicine.
If you measure your blood pressure and the top number
(systolic) is 180 mm Hg or higher or the bottom number (diastolic)
is 120 mm Hg or higher, get medical attention right away. Increases
in blood pressure may not be noticeable, but look out for and tell
your healthcare provider right away if you have any of the following
symptoms of severely high blood pressure.
- Sudden severe headache
- Chest pain
- Dizziness or confusion
- Trouble breathing
- Nausea or vomiting
- Blurry or other changes to vision
- Anxiety
- Buzzing in the ears
- Nosebleed
- Feeling of skipped heartbeats
Fluid Retention (Edema)
and Heart
Failure. Indomethacin can cause fluid
retention, also called edema which can lead to heart failure. Fluid
retention can also cause serious issues in people with heart
failure. Call your healthcare provider right away if you have any of
the following symptoms.
- Chest pain
- Irregular heartbeat
- Shortness of breath
- Stretched or shiny skin
- Swollen body parts, such as the
belly or ankles
- Unusually fast weight gain
- Unusual tiredness
Kidney Damage. Kidney
damage can happen when taking indomethacin. Call your healthcare
provider right away if you have any of the following symptoms of
kidney damage.
- Reduced need to pee
- Swelling in your feet, ankles, or
legs
- Weakness or unusual tiredness
- Difficulty catching your breath or
chest pain/pressure
- Confusion
- Nausea
- Seizures
High Potassium Levels (Hyperkalemia). Indomethacin
can cause a high potassium level (hyperkalemia), which can be
serious and may lead to death. Your healthcare provider may check
your potassium levels, especially if you take certain other
medicines. Call your healthcare provider right away if you have any
of the following symptoms of a high potassium level.
- Muscle weakness or unusual
tiredness
- Slow heartbeat or feeling of
skipped heartbeats
- Nausea or vomiting
- Trouble breathing
- Abnormal heart rhythm
Severe Skin Reactions. Indomethacin
can cause severe skin reactions, called Stevens-Johnson
Syndrome (SJS) and Toxic
Epidermal Necrolysis (TEN), that can lead to death if not
treated. If you develop a rash, stop indomethacin and call your
healthcare provider right away. Get emergency help if you have any
of the following symptoms of SJS or TEN.
- Painful red or purple skin that
looks burned and peels off
- Flat red rash or blisters on your
skin, mouth, nose, and genitals
- Red, painful, watery eyes
Anemia. Indomethacin may cause anemia,
which is when you have low levels of red blood cells. Tell your
healthcare provider if you have any of the following symptoms of
anemia.
- Unusual weakness or tiredness
- Cold hands and feet
- Fast or abnormal heartbeat
- Pale or yellowish skin
- Dizziness, lightheadedness, or
feeling like you are about to pass out
- Shortness of breath
Central Nervous System (CNS) Depression. Indomethacin may slow down your central nervous system
(CNS), which controls many vital functions throughout the body. Call
your healthcare provider right away if you have any of the following
symptoms of CNS depression.
- Confusion
- Excessive sleepiness or trouble
staying awake
- Memory problems
- Slow or shallow breathing
- Slowed response or reaction time
- Slurred speech
Headache. Indomethacin can cause
headaches. Call your healthcare provider right away if you have
headaches that do not go away or get worse.
Eye Problems. Indomethacin may cause eye
problems. Call your healthcare provider if you have any changes in
your vision.
Warnings & Precautions
Who should not use indomethacin?
Allergies to Ingredients.
People who are allergic to any of the following should not
take indomethacin.
- Indomethacin
- Indocin
- Aspirin or any other
medicine known as a non-steroidal anti-inflammatory
(NSAID)
- Any of the ingredients in
the specific product dispensed
Your pharmacist can tell you all of the
ingredients in the specific indomethacin products they
stock.
Heart Surgery. Do not take
indomethacin right before or after a heart surgery called
coronary artery bypass graft (CABG). Taking indomethacin
during this time can increase your risk of heart attack or
stroke.
Rectal Swelling or Bleeding
(Suppository). Indomethacin suppositories should
not be used if you have recent bleeding from your rectum or
a condition called proctitis
or a history of this condition. The rectum is the lower part
of your intestine that leads to your anus.
What should I know about indomethacin before using it?
Indomethacin can affect your alertness or
coordination. Do not drive or do other activities that
require alertness or coordination until you know how
indomethacin affects you.
People who are 65 and older can be at greater
risk for some side effects from indomethacin. Talk to your
healthcare provider about your risks if you are in this age
group.
Use an accurate measuring device to measure
your indomethacin oral liquid dose. A household spoon is not
an accurate measuring device and may cause you to take the
wrong dose. Ask your pharmacist to recommend an appropriate
measuring device.
Do not take indomethacin unless it has been
prescribed to you by a healthcare provider. Take it as
prescribed.
Do not share indomethacin with other people,
even if they have the same condition as you. It may harm
them.
Keep indomethacin out of the reach of children.
Since indomethacin suppository should be kept
in a refrigerator, take special precautions to keep it away
from children who also use the refrigerator.
What should I tell my healthcare provider before using
indomethacin?
Tell your healthcare provider about all of your
health conditions and any prescription or over-the-counter
(OTC) medicines, vitamins/minerals, herbal products, and
other supplements you are using. This will help them
determine if indomethacin is right for you.
In particular, make sure that you discuss any
of the following.
Current and Past Health Conditions. Tell your healthcare provider if you have any of
the following.
Other Medicines and Supplements. Indomethacin may interact with other medicines and
supplements. Before taking indomethacin, tell your
healthcare provider about any prescription or
over-the-counter (OTC) medicines, vitamins/minerals, herbal
products, and other supplements you are using. See
the Interactions section for more details.
Smoking. Tell your healthcare
provider if you smoke. Smoking while taking indomethacin can
increase the risk of stomach bleeding.
Pregnancy. Do not take
indomethacin 20 weeks or later in pregnancy without talking
to your healthcare provider. Taking indomethacin during this
time may cause harm to an unborn baby and complications
during delivery. Tell your healthcare provider if you are or
plan to become pregnant. Your healthcare provider will
advise you if you should take indomethacin while you are
pregnant or trying to get pregnant.
Breastfeeding. Indomethacin passes into
breast milk. Tell your healthcare provider if you are
breastfeeding or plan to breastfeed. Your healthcare
provider will advise you if you should take indomethacin
while breastfeeding.
Interactions
Does indomethacin interact with foods or drinks?
There are no known interactions between
indomethacin and foods or drinks.
It is unknown if drinking alcohol will affect
indomethacin, but both indomethacin and alcohol can increase
your risk of bleeding. It is best to limit the amount of alcohol
you drink.
Does indomethacin interact with other medicines (drug
interactions)?
Always tell your healthcare provider about any
prescription or over-the-counter (OTC) medicines,
vitamins/minerals, herbal products, and other supplements you
are using.
In particular, make sure that you discuss if you
are using any of the following before taking indomethacin.
- A blood thinner, such as
warfarin, which is a medicine used to treat or prevent blood
clots
- An antiplatelet medicine, such
as clopidogrel (Plavix), ticagrelor (Brilinta),
aspirin/dipyridamole, or cilostazol, which is a medicine
used to prevent blood clots
- Aspirin, which is in many
prescription and OTC products, including those for pain,
swelling, and fever
- A selective serotonin reuptake
inhibitor (SSRI), such as fluoxetine, paroxetine, or
sertraline, which is a medicine commonly used for anxiety
and depression
- A serotonin and norepinephrine
reuptake inhibitor (SNRI), which is a medicine commonly used
for anxiety and depression
- An angiotensin-converting
enzyme (ACE) inhibitor, such as enalapril or lisinopril,
which is a medicine for high blood pressure, heart failure,
and certain kidney problems
- An angiotensin II receptor
blocker (ARB), such as losartan or valsartan, which is a
medicine for high blood pressure, heart failure, and other
heart conditions
- A beta-blocker, such as
metoprolol (Lopressor, Toprol XL, and others), atenolol
(Tenormin), or propranolol (Inderal LA, Innopran XL), which
is a medicine that may be used for certain heart conditions
or to reduce blood pressure
- A diuretic, also called a water
pill, which is a medicine used to reduce edema (fluid
retention) and blood pressure
- Digoxin (Lanoxin), which is a
medicine used to treat irregular heartbeat and some types of
heart failure
- Lithium, which is a medicine
for certain mental health conditions
- Methotrexate (Trexall and
others), which is a medicine commonly used for rheumatoid
arthritis or certain types of cancer
- Cyclosporine (Gengraf, Neoral,
Sandimmune, and others), which is a medicine that suppresses
your immune system
- A nonsteroidal
anti-inflammatory drug (NSAID), such as ibuprofen, naproxen,
sulindac, and others, which is in many prescription and OTC
products for pain, swelling, and fever
- A salicylate, such as
diflunisal or salsalate, which is a medicine used for
osteoarthritis or rheumatoid arthritis
- Pemetrexed (Alimta, Pemfexy),
which is a medicine to treat certain cancers
- Probenecid, which is a medicine
commonly used for gout
This may not be a complete list of medicines that
can interact with indomethacin. Always check with your
healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much indomethacin?
If you or someone else has used too much
indomethacin, get medical help right away, call
911, or contact
a Poison Control center at
1-800-222-1222.
What should I do if I miss a dose of indomethacin?
If you miss a dose, take it as soon as you
remember. If it is almost time for your next dose, skip the
missed dose and only take the next dose. Do not take double or
extra doses.
FAQ's
What is indomethacin used for?
A healthcare provider might prescribe indomethacin to you to manage
symptoms, including:
- Pain.
- Inflammation (swelling).
- Stiffness.
- Tenderness.
Providers commonly prescribe indomethacin to treat different types of
arthritis, including:
- Osteoarthritis.
- Rheumatoid arthritis.
- Ankylosing spondylitis (arthritis that affects joints in your
spine and causes
lower back pain).
-
Gout.
Your provider might prescribe indomethacin to manage symptoms of other
issues, including:
- Bursitis — especially
shoulder bursitis.
- Tendinitis.
- Patent ductus arteriosus (PDA) — a heart condition some babies
have when they’re born.
- Plantar fasciitis.
- Preterm labor.
- Chronic (frequent)
headaches.
Does indomethacin make you sleepy?
Yes, indomethacin can cause drowsiness and make you feel sleepy. Talk to
a healthcare provider if indomethacin makes you feel extremely tired.
Don’t stop taking it unless your provider says to.
Talk to your healthcare provider if you experience drowsiness along with
other side effects like headaches, confusion or disorientation (not
knowing where you are or what’s going on around you). It’s rare, but
these can be signs of indomethacin toxicity (overdose).
How long does indomethacin stay in your system?
How long indomethacin stays in your system depends on how much you’re
taking (the dosage). It usually stays in your body anywhere from two to
16 hours.
Indomethacin leaves your body in your pee and poop as your body
processes it and breaks it down.
Can I take ibuprofen with indomethacin?
No, you shouldn’t take ibuprofen while you’re taking indomethacin.
Ibuprofen is another type of
NSAID (nonsteroidal anti-inflammatory drug). Taking it while you’re
taking indomethacin can greatly increase your risk of experiencing
serious side effects like ulcers and internal bleeding.
One Final Note..
Indomethacin is a prescription NSAID — a medication that reduces
inflammation and relieves pain. Your provider might prescribe it for
a temporary issue like bursitis, or you may need it as part of a
longer-term way to manage arthritis symptoms.
No matter why you’re taking it, never mix indomethacin with other
NSAIDs or over-the-counter medications. Talk to your provider about
all the medicines and supplements you’re taking before you start
indomethacin. They’ll tell you what’s safe and what you should
avoid.
Important Warning:
People who take nonsteroidal anti-inflammatory drugs (NSAIDs) (other
than aspirin) such as indomethacin may have a higher risk of having a
heart attack or a stroke than people who do not take these medications.
These events may happen without warning and may cause death. This risk
may be higher for people who take NSAIDs for a long time. Do not take an
NSAID such as indomethacin if you have recently had a heart attack,
unless directed to do so by your doctor. Tell your doctor if you or
anyone in your family has or has ever had heart disease, a heart attack,
or a stroke, if you smoke, and if you have or have ever had high
cholesterol, high blood pressure, or diabetes. Get emergency medical
help right away if you experience any of the following symptoms: chest
pain, shortness of breath, weakness in one part or side of the body, or
slurred speech.
If you will be undergoing a coronary artery bypass graft (CABG; a
type of heart surgery), you should not take indomethacin right before or
right after the surgery.
NSAIDs such as indomethacin may cause ulcers, bleeding, or holes in
the stomach or intestine. These problems may develop at any time during
treatment, may happen without warning symptoms, and may cause death. The
risk may be higher for people who take NSAIDs for a long time, are older
in age, have poor health, or drink large amounts of alcohol while taking
indomethacin. Tell your doctor if you take any of the following
medications: anticoagulants ('blood thinners') such as warfarin (Coumadin,
Jantoven); aspirin; other NSAIDs such as diflunisal (Dolobid), ibuprofen
(Advil, Motrin) and naproxen (Aleve, Naprosyn); oral steroids such as
dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos);
selective serotonin reuptake inhibitors (SSRIs) such as citalopram
(Celexa), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax),
fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and
sertraline (Zoloft); or serotonin norepinephrine reuptake inhibitors (SNRIs)
such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), and
venlafaxine (Effexor XR). Also tell your doctor if you have or have ever
had ulcers or bleeding in your stomach or intestines, or other bleeding
disorders. If you experience any of the following symptoms, stop taking
indomethacin and call your doctor: stomach pain, heartburn, vomit that
is bloody or looks like coffee grounds, blood in the stool, or black and
tarry stools.
Keep all appointments with your doctor and the laboratory. Your
doctor will monitor your symptoms carefully and will probably order
certain tests to check your body's response to indomethacin. Be sure to
tell your doctor how you are feeling so that your doctor can prescribe
the right amount of medication to treat your condition with the lowest
risk of serious side effects.
Your doctor or pharmacist will give you the manufacturer's patient
information sheet (Medication Guide) when you begin treatment with
indomethacin and each time you refill your prescription. Read the
information carefully and ask your doctor or pharmacist if you have any
questions. You can also visit the Food and Drug Administration (FDA)
website (https://www.fda.gov/Drugs)
or the manufacturer's website to obtain the Medication Guide.
|