Vioxx Information
The following Vioxx frequently asked question section is for informational
purposes only. The information has been compiled from a variety
of resources in order to give the reader an overview of the use
and various effects of Vioxx for the treatment of arthritis pain.
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What is Vioxx?
Vioxx is a nonsteroidal anti-inflamatory drug
(NSAID) that is prescribed to reduce pain and inflammation. Vioxx
is one of the first NSAIDs to selectively inhibit primarily the
Cox-2 enzyme, while sparing the Cox-1 enzyme that is responsible
for protecting the delicate lining of the stomach. Traditional
NSAIDs i.e. Voltaren, Naprosyn, Lodine, etc. target both of these
enzyme, subsequently, these medications are associated with a
high incidence of gastro-intestinal side effects including dyspepsia,
bleeding, ulceration and perforation of the stomach, small or
large intestine. Vioxx has shown to be as effective as the traditional
NSAIDs without the detrimental side effects.
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For what conditions is Vioxx generally prescribed?
Vioxx is usually prescribed for the following:
- Osteoarthritis (form of arthritis, occurring
mainly in older persons, that is characterized by chronic degeneration
of the cartilage of the joints)
- Rheumatoid arthritis (chronic autoimmune
disease with inflammation of the joints and marked deformities)
- Management of acute pain in adults (short
term pain secondary to dental procedure, surgery, etc.)
- Treatment of primary dysmenorrhea (moderate
to severe menstrual pain).
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Why is Vioxx sometimes referred to as
rofecoxib?
Rofecoxib is the generic name for Vioxx. The
generic name represents the medications nonproprietary or chemical
name, whereas, the brand name is the name a pharmaceutical give
to a medication for marketing purposes.
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What is the appropriate dose of Vioxx?
Osteoarthritis
The recommended starting dose of Vioxx is 12.5
mg once daily. Some patients may receive additional benefit by
increasing the dose to 25 mg once daily. The maximum recommended
daily dose is 25 mg (these doses are only generalizations; doses
may vary depending on the patient's medical history).
Management of Acute Pain and Treatment
of Primary Dysmenorrhea
The recommended initial dose of Vioxx is 50
mg once daily. Subsequent doses should be 50 mg once daily as
needed. Use of Vioxx for more than 5 days in management of pain
has not been studied (these doses are only generalizations; doses
may vary depending on the patient's medical history).
Vioxx Oral Suspension 12.5 mg/ 5 mL or 25 mg/
5 mL may be substituted for Vioxx Tablets 12.5 or 25 mg, respectively,
in any of the above indications. Shake before using.
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Can I get Vioxx over the counter?
No, Vioxx is a prescription medication and should
only be taken when prescribed by a licensed physician. Regulations
do not permit Vioxx to be taken without a prescription. Secondary
to the advent of the internet individuals can now order lifestyle
medication, such as, Vioxx online. Individuals are ask to complete
a medical questionnaire which is subsequently reviewed by a physician,
once approved your Vioxx order will be shipped discreetly to your
home or office in 1-2 business days.
(order Vioxx online now)
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How effective is Vioxx?
Clinical Studies:
Osteoarthritis (OA)
Vioxx has demonstrated significant reduction
in joint pain compared to placebo. Vioxx was evaluated for the
treatment of the signs and symptoms of OA of the knee and hip
in placebo- and active-controlled clinical trials of 6 to 86 weeks
duration that enrolled approximately 3900 patients. In patients
with OA, treatment with Vioxx 12.5 mg and 25 mg once daily resulted
in improvement in patient and physician global assessments and
in the WOMAC (Western Ontario and McMaster Universities) osteoarthritis
questionnaire, including pain, stiffness, and functional measures
of OA. In six studies of pain accompanying OA flare, Vioxx provided
a significant reduction in pain at the first determination (after
one week in one study, after two weeks in the remaining five studies);
this continued for the duration of the studies. In all OA clinical
studies, once daily treatment in the morning with Vioxx 12.5 and
25 mg was associated with a significant reduction in joint stiffness
upon first awakening in the morning. At doses of 12.5 and 25 mg,
the effectiveness of VIOXX was shown to be comparable to ibuprofen
800 mg TID and diclofenac 50 mg TID for treatment of the signs
and symptoms of OA. The ibuprofen studies were 6-week studies;
the diclofenac studies were 12-month studies in which patients
could receive additional arthritis medication during the last
6 months.
Rheumatoid Arthritis (RA)
Vioxx has demonstrated significant reduction
of joint tenderness/pain and joint swelling compared to placebo.
Vioxx was evaluated for the treatment of the signs and symptoms
of RA in two 12-week placebo- and active-controlled clinical trials
that enrolled a total of approximately 2,000 patients. Vioxx was
shown to be superior to placebo on all primary endpoints (number
of tender joints, number of swollen joints, patient and physician
global assessments of disease activity). In addition, Vioxx was
shown to be superior to placebo using the American College of
Rheumatology 20% (ACR20) Responder Index, a composite of clinical,
laboratory, and functional measures of RA. Vioxx 25 mg once daily
and naproxen 500 mg twice daily showed generally similar effects
in the treatment of RA. A 50-mg dose once daily of Vioxx was also
studied; however, no additional efficacy was seen compared to
the 25-mg dose.
Analgesia, including Dysmenorrhea
In acute analgesic models of post-operative
dental pain, post-orthopedic surgical pain, and primary dysmenorrhea,
Vioxx relieved pain that was rated by patients as moderate to
severe. The analgesic effect (including onset of action) of a
single 50-mg dose of Vioxx was generally similar to 550 mg of
naproxen sodium or 400 mg of ibuprofen. In single-dose post-operative
dental pain studies, the onset of analgesia with a single 50-mg
dose of Vioxx occurred within 45 minutes. In a multiple-dose study
of post-orthopedic surgical pain in which patients received Vioxx
or placebo for up to 5 days, 50 mg of Vioxx once daily was effective
in reducing pain. In this study, patients on Vioxx consumed a
significantly smaller amount of additional analgesic medication
than patients treated with placebo (1.5 versus 2.5 doses per day
of additional analgesic medication for Vioxx and placebo, respectively).
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Can I take aspirin while I am taking Vioxx?
Many individuals take aspirin on a daily basis
for the prevention of cardiovascular disease. Individuals may
take low doses of aspirin while on Vioxx, however, taking Vioxx
and aspirin together can increase your risk for developing stomach
ulcers as compared to taking Vioxx alone. Vioxx is not a substitute
for aspirin for the prevention of cardiovascular disease.
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Can I discontinue corticosteroids if I am taking Vioxx?
No Vioxx should not be used as a substitute
for corticosteroids. Abrupt discontinuation of corticosteroids
can result in serious side effects. The adrenal gland which has
been suppressed secondary to the use of the corticorsteroids needs
to begin to function again. Gradual tapering of the corticosteroids
enables the adrenal gland to return to normal functioning with
fewer side effects.
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May I use Vioxx if I am pregnant or breast feeding?
No Vioxx is not recommended in women who are
pregnant or breast feeding
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Who should not take Vioxx?
Special consideration should be taking prior
to a physician prescribing Vioxx in individuals with certain medical
conditions including the following:
- Kidney disease
- Heart failure (fluid retention)
- Liver disease
- Hypertension
- Pregnant or breast feeding women
- History of an allergic reaction to aspirin
or other NSAIDS
- Stomach complications i.e. ulcers, cancer,
burning in the stomach, tarry or bloody stools, etc.
- Individuals taking other prescription and/or
over the counter medications
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Are there any medications that can interact
with the use of Vioxx?
Individuals should report any prescription
and/or over the counter medications that they are taking prior
to beginning any new treatment plan. Special consideration in
dosing and the use of Vioxx should be considered when individuals
are taking the following medications:
- Aspirin
- when taken with Vioxx increase the risk for ulcers
- Rifampin (antibiotic) -can
decrease plasma concentrations of Vioxx
- Ace inhibitors (hypertensive medications)
- Vioxx decreases the effectiveness of ace inhibitors
- Lithium (used to treat psychiatric
conditions) - Vioxx have produced an elevation of plasma
lithium levels and a reduction in renal lithium clearance.
- Cimetidine (ulcer medication)
- when taken with Vioxx can increase the concentration of Vioxx
in the blood.
- Furosemide (diuretic)
- Vioxx may decrease the diuretic effects of certain diuretic
medications
- Theophylline (asthma medication)
- co administering Vioxx with theophylline can increase plasma
concentrations of theophylline, Adequate monitoring of theophylline
plasma concentrations should be considered when therapy with
Vioxx is initiated or changed in patients receiving theophylline.
- Warfarin (blood thinner)
- anticoagulant activity should be monitored, particularly in
the first few days after initiating or changing Vioxx therapy
in patients receiving warfarin or similar agents, since these
patients are at an increased risk of bleeding complications.
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What about an overdose with Vioxx?
Symptoms following acute NSAID overdoses are
usually limited to lethargy, drowsiness, nausea, vomiting, and
epigastric pain, which are generally reversible with supportive
care. Gastrointestinal bleeding can occur. Hypertension, acute
renal failure, respiratory depression and coma may occur, but
are rare. Anaphylactic reactions have been reported with therapeutic
ingestion of NSAIDs, and may occur following an overdose. If an
overdose should occur individuals should seek immediate medical
attention.
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Can Celebrex be used in pediatric populations?
Vioxx tablets have not been investigated in
pediatric patients below 18 years of age. Therefore, the use in
this population is not recommended at this time.
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Should Vioxx be prescribed in individuals
with a history of ulcers?
NSAIDs should be prescribed with extreme caution
in patients with a prior history of ulcer disease or gastrointestinal
bleeding. Most spontaneous reports of fatal GI events are in elderly
or debilitated patients and therefore special care should be taken
in treating this population. To minimize the potential risk for
an and who use NSAIDs, have a greater than 10-fold higher risk
for developing a GI bleed than patients with neither of these
risk factors. In addition to a past history of ulcer disease,
pharmacoepidemiological studies have identified several other
co-therapies or co-morbid conditions that may increase the risk
for GI bleeding such as: treatment with oral corticosteroids,
treatment with anticoagulants, longer duration of NSAID therapy,
smoking, alcoholism, older age, and poor general health status.
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What effects does Vioxx have on the
renal system?
Long-term administration of NSAIDs has resulted
in renal papillary necrosis and other renal injury. Renal toxicity
has also been seen in patients in whom renal prostaglandins have
a compensatory role in the maintenance of renal perfusion. In
these patients, administration of a nonsteroidal anti-inflammatory
drug may cause a dose-dependent reduction in prostaglandin formation
and, secondarily, in renal blood flow, which may precipitate overt
renal decompensation. Patients at greatest risk of this reaction
are those with impaired renal function, heart failure, liver dysfunction,
those taking diuretics and ACE inhibitors, and the elderly. Discontinuation
of NSAID therapy is usually followed by recovery to the pretreatment
state.
Caution should be used when initiating
treatment with Vioxx in patients with considerable dehydration.
It is advisable to rehydrate patients first and then start therapy
with Vioxx. Caution is also recommended in patients with pre-existing
kidney disease.
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What effect does Vioxx have on the hepatic system?
Borderline elevations of one or more liver
tests may occur in up to 15% of patients taking NSAIDs, and notable
elevations of ALT or AST (approximately three or more times the
upper limit of normal) have been reported in approximately 1%
of patients in clinical trials with NSAIDs. These laboratory abnormalities
may progress, may remain unchanged, or may be transient with continuing
therapy. Rare cases of severe hepatic reactions, including jaundice
and fatal fulminant hepatitis, liver necrosis and hepatic failure
(some with fatal outcome) have been reported with NSAIDs, including
Vioxx. In controlled clinical trials of Vioxx, the incidence of
borderline elevations of liver tests at doses of 12.5 and 25 mg
daily was comparable to the incidence observed with ibuprofen
and lower than that observed with diclofenac. In placebo-controlled
trials, approximately 0.5% of patients taking rofecoxib (12.5
or 25 mg QD) and 0.1% of patients taking placebo had notable elevations
of ALT or AST.
A patient with symptoms and/or signs suggesting
liver dysfunction, or in whom an abnormal liver test has occurred,
should be monitored carefully for evidence of the development
of a more severe hepatic reaction while on therapy with Vioxx.
Use of Vioxx is not recommended in patients with severe hepatic
insufficiency (see Pharmacokinetics, Special Populations). If
clinical signs and symptoms consistent with liver disease develop,
or if systemic manifestations occur (e.g., eosinophilia, rash,
etc.), Vioxx should be discontinued.
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Is Vioxx associated with hematological effects?
Anemia is sometimes seen in patients receiving
Vioxx. In placebo-controlled trials, there were no significant
differences observed between Vioxx and placebo in clinical reports
of anemia. Patients on long-term treatment with Vioxx should have
their hemoglobin or hematocrit checked if they exhibit any signs
or symptoms of anemia or blood loss. Vioxx does not generally
affect platelet counts, prothrombin time (PT), or partial thromboplastin
time (PTT), and does not inhibit platelet aggregation at indicated
dosages.
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Should patients with preexisting asthma use Vioxx?
Patients with asthma may have aspirin-sensitive
asthma. The use of aspirin in patients with aspirin-sensitive
asthma has been associated with severe bronchospasm which can
be fatal. Since cross reactivity, including bronchospasm, between
aspirin and other nonsteroidal anti-inflammatory drugs has been
reported in such aspirin-sensitive patients, Vioxx should not
be administered to patients with this form of aspirin sensitivity
and should be used with caution in patients with preexisting asthma.
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How does Vioxx effect fluid retention, edema and hypertension?
Fluid retention, edema, and hypertension have
been reported in some patients taking Vioxx. In clinical trials
of Vioxx at daily doses of 25 mg in patients with rheumatoid arthritis
the incidence of hypertension was twice as high in patients treated
with Vioxx as compared to patients treated with naproxen 1000
mg daily. Clinical trials with Vioxx at daily doses of 12.5 and
25 mg in patients with osteoarthritis have shown effects on hypertension
and edema similar to those observed with comparator NSAIDs; these
occurred with an increased frequency with chronic use of Vioxx
at daily doses of 50 mg.
Vioxx should be used with caution, and
should be introduced at the lowest recommended dose in patients
with fluid retention, hypertension, or heart failure.
