What is diclofenac and misoprostol?
Diclofenac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It
works by reducing hormones that cause inflammation and pain in the body.
Misoprostol reduces stomach acid and replaces protective substances in the stomach that are
reduced by NSAIDs.
The combination of diclofenac and misoprostol is used to treat osteoarthritis and rheumatoid
arthritis in people at high risk for developing stomach or intestinal ulcers.
Diclofenac and misoprostol may also be used for other purposes not listed in this medication
guide.
What should I discuss with my healthcare provider before taking diclofenac and misoprostol?
Taking an NSAID can increase your risk of life-threatening heart or circulation problems,
including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this
medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or
CABG).
NSAIDs can also increase your risk of serious effects on the stomach or intestines, including
bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects
can occur without warning at any time while you are taking an NSAID. Older adults may have an even
greater risk of these serious gastrointestinal side effects.
Do not use this medication if you are allergic to diclofenac (Cataflam) or misoprostol
(Cytotec), or if you have a history of allergic reaction to aspirin or other NSAIDs.
If you have any of these other conditions, you may need a dose adjustment or special tests to
safely take diclofenac and misoprostol.
-
a history of heart attack, stroke, or blood clot;
-
heart disease, congestive heart failure, high blood pressure;
-
a history of stomach ulcers or bleeding;
-
liver or kidney disease,
-
asthma;
-
polyps in your nose;
-
porphyria;
-
a bleeding or blood clotting disorder;
-
if you smoke; or
-
drink more than three alcoholic beverages a day.
FDA pregnancy category X.
Misoprostol can cause birth
defects, miscarriage, premature labor, or rupture of the uterus
if the medication is taken
during pregnancy.
Diclofenac can cause birth defects if it is taken during the last 3
months of pregnancy.
Do not use diclofenac and misoprostol if you are pregnant.
Tell
your doctor right away if you become pregnant during treatment. Use an effective form of birth control
while you are using this medication.
You will need to have a pregnancy test within 2 weeks before you start taking diclofenac
and misoprostol.
Diclofenac and misoprostol can pass into breast milk and may harm a nursing baby. Do not
use this medication without telling your doctor if you are breast-feeding a baby.
How should I take diclofenac and misoprostol?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger
amounts, or take it for longer than recommended by your doctor. Follow the directions on your
prescription label.
Take this medicine with a full glass of water.
Swallow the diclofenac and misoprostol tablet whole. Do not crush, break, or chew the
pill.
Take diclofenac and misoprostol with food or milk to lessen stomach upset.
Do not share this medication with anyone else, even if they have the same symptoms you
have.
Store diclofenac and misoprostol at room temperature away from moisture and heat.
What happens if I miss a dose of diclofenac and misoprostol?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the
missed dose and take the medicine at your next regularly scheduled time.
Do not
take
extra medicine to make up the missed dose.
Where can I get more information about diclofenac and misoprostol?
Your pharmacist has information about diclofenac and misoprostol written for health professionals that you may read.
What are the possible side effects of diclofenac and misoprostol?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking this medication and seek medical attention or call your doctor at once if you
have any of these serious side effects:
-
chest pain, weakness, shortness of breath, slurred speech, problems
with vision or balance;
-
black, bloody, or tarry stools;
-
coughing up blood or vomit that looks like coffee grounds;
-
swelling or rapid weight gain;
-
urinating less than usual or not at all;
-
increased blood pressure (severe headache, blurred vision,
trouble concentrating, chest pain, numbness, seizure);
-
nausea, stomach pain, low fever, loss of appetite, dark
urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
-
fever, sore throat, and headache with a severe blistering,
peeling, and red skin rash;
-
bruising, severe tingling, numbness, pain, muscle weakness;
or
-
fever with headache, neck stiffness, chills, increased
sensitivity to light, purple spots on the skin, and/or seizure (convulsions).
Less serious side effects may include:
-
mild stomach pain, nausea, diarrhea, bloating, gas;
-
dizziness, drowsiness, headache;
-
blurred vision, ringing in your ears; or
-
unusual vaginal bleeding.
This is not a complete list of side effects and others may occur. Call your
doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
What is the most important information I should know about diclofenac and misoprostol?
Misoprostol can cause birth defects, miscarriage, premature labor, or
rupture of the uterus
if the medication is taken during pregnancy.
Diclofenac can
cause birth defects if it is taken during the last 3 months of pregnancy.
Do not use diclofenac and misoprostol if you are pregnant.
Tell
your doctor right away if you become pregnant during treatment. Use an effective form of birth control
while you are using this medication.
This medicine can increase your risk of life-threatening heart or circulation problems, including
heart attack or stroke. This risk will increase the longer you use diclofenac. Do not use this medicine
just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).
Seek emergency medical help if you have symptoms of heart or circulation problems, such as
chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.
This medicine can also increase your risk of serious effects on the stomach or intestines,
including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal
effects can occur without warning at any time while you are taking diclofenac. Older adults may have
an even greater risk of these serious gastrointestinal side effects.
Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This
includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.
Do not drink alcohol while taking diclofenac and misoprostol. Alcohol can increase the risk
of stomach bleeding caused by diclofenac.
What should I avoid while taking diclofenac and misoprostol?
Avoid using antacids without your doctor's advice. Use only the specific type of antacid your
doctor recommends. Antacids contain different medicines and some types can make it harder for your
body to absorb diclofenac and misoprostol.
Do not use any other over-the-counter cold, allergy, or pain medication without first asking
your doctor or pharmacist. Many medicines available over the counter contain aspirin or other
medicines similar to diclofenac (such as ibuprofen, ketoprofen, or naproxen). If you take certain
products together you may accidentally take too much of this type of medication. Read the label of any
other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen.
Do not drink alcohol while taking diclofenac and misoprostol. Alcohol can increase the risk
of stomach bleeding caused by diclofenac.
Avoid prolonged exposure to sunlight. Diclofenac may increase the sensitivity of the skin to
sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.
What other drugs will affect diclofenac and misoprostol?
Before taking diclofenac and misoprostol, tell your doctor if you are taking any of the following
drugs:
-
a blood thinner such as warfarin (Coumadin);
-
cyclosporine (Neoral, Sandimmune);
-
digoxin (Lanoxin);
-
diuretics (water pills) such as furosemide (Lasix);
-
insulin or diabetes medicine you take by mouth;
-
lithium (Eskalith, Lithobid);
-
methotrexate (Rheumatrex, Trexall);
-
phenobarbital (Luminal, Solfoton);
-
steroids (prednisone and others);
-
aspirin or other NSAIDs (non-steroidal anti-inflammatory
drugs) such as etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), meloxicam
(Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), and others; or
-
an ACE inhibitor such as benazepril (Lotensin), captopril
(Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril
(Altace), and others.
This list is not complete and there may be other drugs that can interact with
diclofenac and misoprostol. Tell your doctor about all the prescription and over-the-counter
medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other
doctors. Do not start using a new medication without telling your doctor.
What happens if I have an overdose of diclofenac and misoprostol?
