- relief of osteoarthritis (the
arthritis caused by age-related "wear and tear" on
bones and joints)
- management of acute pain in adults
(like the short-term pain you can get after a dental or surgical
operation)
- treatment of menstrual pain (pain
during women’s monthly periods).
Who
should not take VIOXX?
Do not take VIOXX if you:
- have had an allergic reaction
such as asthma attacks, hives, or swelling of the throat and
face to aspirin or other NSAIDs (for example, ibuprofen and
naproxen).
- have had an allergic reaction
to rofecoxib, which is the active ingredient of VIOXX, or to
any of its inactive ingredients. (See Inactive Ingredients at
the end of this document.)
What
should I tell my doctor before and during treatment with VIOXX?
Tell your doctor if you are:
- pregnant or plan to become pregnant.
VIOXX should not be used in late pregnancy because it may harm
the fetus.
- breast-feeding or plan to breast-feed.
It is not known whether VIOXX is passed through to human breast
milk and what its effects could be on a nursing child.
Tell your doctor if you have:
- kidney disease
- liver disease
- heart failure
- high blood pressure
- had an allergic reaction to aspirin
or other NSAIDs
- had a serious stomach problem
in the past.
Tell your doctor about:
- any other medical problems or
allergies you have now or have had.
- all medicines that you are taking
or plan to take, even those you can get without a prescription.
Tell your doctor if you develop:
- ulcer or bleeding symptoms (for
instance, stomach burning or black stools, which are signs of
possible stomach bleeding).
- unexplained weight gain or swelling
of the feet and/or legs.
- skin rash or allergic reactions.
If you have a severe allergic reaction, get medical help right
away.
How
should I take VIOXX?
VIOXX should be taken once a day.
Your doctor will decide what dose of VIOXX you should take and
how long you should take it. You may take VIOXX with or without
food.
Can
I take VIOXX with other medicines?
Tell your doctor about all of the
other medicines you are taking or plan to take while you are on
VIOXX, even other medicines that you can get without a prescription.
Your doctor may want to check that your medicines are working
properly together if you are taking other medicines such as:
- methotrexate (a medicine used
to suppress the immune system)
- warfarin (a blood thinner)
- rifampin (an antibiotic)
- ACE inhibitors (medicines used
for high blood pressure and heart failure).
What
are the possible side effects of VIOXX?
Serious but rare side effects that
have been reported in patients taking VIOXX and/or related medicines
have included:
- Serious stomach problems, such
as stomach and intestinal bleeding, can occur with or without
warning symptoms. These problems, if severe, could lead to hospitalization
or death. Although this happens rarely, you should watch for
signs that you may have this serious side effect and tell your
doctor right away.
- Serious allergic reactions including
swelling of the face, lips, tongue, and/or throat which may
cause difficulty breathing or swallowing occur rarely but may
require treatment right away.
- Serious kidney problems occur
rarely, including acute kidney failure and worsening of chronic
kidney failure.
- Severe liver problems occur rarely
in patients taking NSAIDs. Tell your doctor if you develop symptoms
of liver problems. These include nausea, tiredness, itching,
tenderness in the right upper abdomen, and flu-like symptoms.
In addition, the following side
effects have been reported: hallucinations, unusual headache with
stiff neck (aseptic meningitis).
More common, but less serious side
effects reported with VIOXX have included the following:
Upper and/or lower respiratory infection
and/or inflammation
Headache
Dizziness
Diarrhea
Nausea and/or vomiting
Heartburn, stomach pain and upset
Swelling of the legs and/or feet
High blood pressure
Back pain
Tiredness
Urinary tract infection.
These side effects were reported
in at least 2% of osteoarthritis patients receiving daily doses
of VIOXX 12.5 mg to 25 mg in clinical studies.
The side effects described above
do not include all of the side effects reported with VIOXX. Do
not rely on this document alone for information about side effects.
Your doctor or pharmacist can discuss with you a more complete
list of side effects. Any time you have a medical problem you
think may be related to VIOXX, talk to your doctor.
What
else can I do to help manage my osteoarthritis pain?
Talk to your doctor about:
- Exercise
- Controlling your weight
- Hot and cold treatments
- Using support devices.
What
else should I know about VIOXX?
This document provides a summary
of certain information about VIOXX. If you have any questions
or concerns about VIOXX, osteoarthritis or pain, talk to your
health professional. Your pharmacist can give you an additional
document that is written for health professionals.
Do not share VIOXX with anyone else;
it was prescribed only for you. It should be taken only for the
condition for which it was prescribed.
Keep VIOXX and all medicines out
of the reach of children.
Inactive Ingredients:
Oral suspension: citric acid (monohydrate),
sodium citrate (dihydrate), sorbitol solution, strawberry flavor,
xanthan gum, sodium methylparaben, sodium propylparaben.
Tablets: croscarmellose sodium,
hydroxypropyl cellulose, lactose, magnesium stearate, microcrystalline
cellulose, and yellow ferric oxide.
VIOXX is a registered trademark
of Merck & Co., Inc.
Issued March 2000
See
Prescribing Information
COPYRIGHT © MERCK & CO., INC.,
1998
All rights reserved.
Whitehouse Station, NJ 08889, USA 9183901