Generic Name: diclofenac and misoprostol
Brand Names: Arthrotec
What is the most important information I should know
about diclofenac and misoprostol?
•
Do not take misoprostol if you are pregnant
or if you are planning a pregnancy. Misoprostol can
induce a miscarriage or an abortion. Your doctor will
ask you to have a pregnancy test before you start treatment
with misoprostol, and therapy will begin only after your
next regular menstrual cycle begins. Also, you will need
to use appropriate contraception to prevent pregnancy
during therapy.
•
Do not share this medication with anyone else.
•
Take diclofenac and misoprostol with food, milk, or
an antacid to lessen stomach upset.
•
Do not crush, chew, or break diclofenac and
misoprostol tablets. Swallow them whole.
•
Watch for bloody, black, or tarry stools or blood in
your vomit. These symptoms could indicate damage to your
stomach.
•
If you drink more than three alcoholic beverages a
day, diclofenac and misoprostol may increase the risk of
stomach bleeding.
What is diclofenac and misoprostol?
•
Diclofenac is in a class of drugs called
nonsteroidal anti-inflammatory drugs (NSAIDs).
Diclofenac works by reducing substances that cause
inflammation and pain in the body.
•
Misoprostol replaces protective substances in your
stomach that are inhibited by nonsteroidal
anti-inflammatory drugs (NSAIDs) and aspirin.
•
The combination, 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
purposes other than those listed in this medication
guide.
What should I discuss with my healthcare provider
before taking diclofenac and misoprostol?
•
Before taking this medication, tell your doctor if
you
·
have an allergy to any other NSAID or to aspirin,
·
have an ulcer or bleeding in your stomach,
·
drink more than three alcoholic beverages a day,
·
have liver or kidney disease,
·
have a coagulation (bleeding) disorder,
·
have congestive heart failure,
·
have fluid retention,
·
have heart disease, or
·
have high blood pressure.
•
You may not be able to take diclofenac and
misoprostol, or you may require a lower dose or special
monitoring during treatment if you have any of the
conditions listed above.
•
Diclofenac and misoprostol is in the FDA pregnancy
category X. This means that it is known to harm an
unborn baby. Misoprostol can induce a miscarriage or a
spontaneous abortion.Do not take diclofenac and
misoprostol if you are pregnant or if you are planning a
pregnancy. Do not share this medication with any one
else. Your doctor will ask you to have a pregnancy test
before you start treatment with diclofenac and
misoprostol, and therapy will begin only after your next
regular menstrual cycle begins. Also, you will need to
use appropriate contraception to prevent pregnancy
during your therapy.
•
Diclofenac passes into breast milk and may affect a
nursing baby. It is not known whether misoprostol passes
into breast milk. Do not take this medication without
first talking to your doctor if you are breast-feeding a
baby.
How should I take diclofenac and misoprostol?
•
Take diclofenac and misoprostol exactly as directed
by your doctor. If you do not understand these
instructions, ask your pharmacist, nurse, or doctor to
explain them to you.
•
Take each dose with a full glass of water.
•
To lessen stomach upset and/ or diarrhea, take
diclofenac and misoprostol with food, milk, or an
aluminum or calcium antacid.
•
Do not crush, break, or chew diclofenac and
misoprostol tablets. Swallow them whole.
•
Store diclofenac and misoprostol at room temperature
away from moisture and heat.
What happens if I miss a dose?
•
Take the missed dose as soon as you remember. If it
is almost time for your next dose, skip the dose you
missed and take only your next regularly scheduled dose.
Do not take a double dose of this medication.
What happens if I overdose?
•
Seek emergency medical attention.
•
Symptoms of a diclofenac and misoprostol overdose
are not known but might include nausea, vomiting,
stomach pain, diarrhea, dizziness, drowsiness, tremor,
headache, ringing in the ears, blurred vision, seizures,
sweating, numbness or tingling, little or no urine
production, irregular heartbeats, and slow breathing.
What should I avoid while taking diclofenac and
misoprostol?
•
Avoid prolonged exposure to sunlight. Diclofenac and
misoprostol may increase the sensitivity of your skin to
sunlight. Use a sunscreen and wear protective clothing
when exposure to the sun is unavoidable.
•
If you drink more than three alcoholic beverages a
day, diclofenac and misoprostol may increase the risk of
stomach bleeding.
What are the possible side effects of diclofenac and
misoprostol?
•
If you experience any of the following serious side
effects, stop taking diclofenac and misoprostol and seek
medical treatment or call your doctor immediately:
·
an allergic reaction (difficulty breathing; closing
of your throat; swelling of your lips, tongue, or face;
or hives);
·
severe diarrhea, abdominal cramping, indigestion, or
heartburn;
·
jaundice (yellowing of the skin and eyes), nausea
and upper abdominal tenderness, a flulike feeling,
unusual fatigue, and itching;
·
ulcers (open sores) in the mouth;
·
rapid weight gain (fluid retention);
·
seizures;
·
black, bloody, or tarry stools;
·
blood in your urine or vomit; or
·
decreased hearing or ringing in the ears.
•
Other, less serious side effects may be more likely
to occur. Continue to take diclofenac and misoprostol
and talk to your doctor if you experience
·
nausea, gaseousness, or abdominal pain;
·
diarrhea;
·
dizziness or headache;
·
fatigue or weakness;
·
dry mouth; or
·
irregular menstrual periods.
•
Side effects other than those listed here may also
occur. Talk to your doctor about any side effect that
seems unusual or that is especially bothersome.
What other drugs will affect diclofenac and
misoprostol?
•
To reduce the incidence of diarrhea, do not take
antacids that contain magnesium while you are taking
diclofenac and misoprostol. If you need an antacid, take
one with aluminum or calcium instead of magnesium.
•
Before taking diclofenac and misoprostol, tell your
doctor if you are taking any of the following medicines:
·
another nonsteroidal anti-inflammatory drug (NSAID)
such as ibuprofen (Motrin, Advil, Nuprin, others),
ketoprofen (Orudis, Orudis KT, Oruvail), naproxen
(Naprosyn, Aleve, Anaprox), etodolac (Lodine),
fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin
(Indocin), ketorolac (Toradol), nabumetone (Relafen),
oxaprozin (Daypro), piroxicam (Feldene), sulindac
(Clinoril), or tolmetin (Tolectin);
·
aspirin or another salicylate (form of aspirin) such
as salsalate (Disalcid), bismuth subsalicylate
(Pepto-Bismol), choline salicylate, or magnesium
salicylate (watch the aspirin content of other
over-the-counter products such as cough, cold, and
allergy medicines);
·
a diuretic (water pill) such as hydrochlorothiazide
(Hydrodiuril, others), chlorothiazide (Diuril, others),
chlorthalidone (Hygroton, Thalitone), bumetanide
(Bumex), ethacrynic acid (Edecrin), furosemide (Lasix),
spironolactone (Aldactone), triamterene (Dyrenium,
Dyazide, Maxzide), or amiloride (Midamor);
·
an angiotensin-converting-enzyme (ACE) inhibitor
such as benazepril (Lotensin), captopril (Capoten),
enalapril (Vasotec), fosinopril (Monopril), lisinopril
(Prinivil, Zestril), moexipril (Univasc), quinapril
(Accupril), or ramipril (Altace);
·
a beta-blocker such as acebutolol (Sectral),
metoprolol (Lopressor), propranolol (Inderal), atenolol
(Tenormin), or carteolol (Cartrol);
·
an anticoagulant such as warfarin (Coumadin);
·
insulin or an oral diabetes drug such as glipizide
(Glucotrol) or glyburide (Micronase, Diabeta);
·
a steroid such as prednisone (Orasone, Deltasone,
others), methylprednisolone (Medrol), dexamethasone
(Decadron), prednisolone (Prelone, others), and others;
·
digoxin (Lanoxin);
·
phenobarbital (Luminal, Solfoton);
·
lithium (Eskalith, Lithobid, others);
·
cyclosporine (Sandimmune, Neoral);
·
tacrolimus (Prograf);
·
methotrexate (Rheumatrex); or
·
alcohol.
•
You may not be able to take diclofenac and
misoprostol, or you may require a dosage adjustment or
special monitoring if you are taking any of the
medicines listed above.
•
Drugs other than those listed here may also interact
with diclofenac and misoprostol. Talk to your doctor and
pharmacist before taking any prescription or
over-the-counter medicines.
Where can I get more information?
•
Your pharmacist has additional information about
diclofenac and misoprostol written for health
professionals that you may read.
•
Remember, keep this and all other medicines out of
the reach of children, never share your medicines with
others, and use this medication only for the indication
prescribed.
•
Every effort has been made to ensure that the
information provided is accurate, up-to-date, and
complete, but no guarantee is made to that effect. Drug
information contained herein may be time sensitive. The
information has been compiled for use by healthcare
practitioners and consumers in the United States and U.K,
unless specifically indicated otherwise. This drug
information does not endorse drugs, diagnose patients or
recommend therapy. It is an informational resource
designed to assist licensed healthcare practitioners in
caring for their patients and/ or to serve consumers
viewing this service as a supplement to, and not a
substitute for, the expertise, skill, knowledge and
judgment of healthcare practitioners. The absence of a
warning for a given drug or drug combination in no way
should be construed to indicate that the drug or drug
combination is safe, effective or appropriate for any
given patient. We do not assume any responsibility for
any aspect of healthcare administered with the aid of
information we provide. The information contained herein
is not intended to cover all possible uses, directions,
precautions, warnings, drug interactions, allergic
reactions, or adverse effects. If you have questions
about the drugs you are taking, check with your doctor,
nurse or pharmacist.
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