rofecoxib (Vioxx): Drug Facts, Side Effects and Dosing

What is rofecoxib, and how does it work (mechanism of action)?

Rofecoxib is a nonsteroidal
anti-inflammatory drug (NSAID) that is used to treat pain,
particularly the pain of osteoarthritis and menstrual cramps.
Prostaglandins are chemicals that are important in promoting
inflammation and its signs–pain, fever, swelling and tenderness.
Rofecoxib blocks the enzyme that makes prostaglandins (cyclooxygenase-
2) and thereby reduces the amounts of prostaglandins. As a
consequence, inflammation and its accompanying pain, fever, swelling
and tenderness also are reduced. Rofecoxib is similar to celecoxib
(Celebrex). Both drugs differ from other NSAIDs
in that they cause less irritation and ulceration of the stomach and
intestine
(at least during short-term treatment), and they do not interfere
with the clotting
of blood.

What brand names are available for rofecoxib?

Vioxx

Is rofecoxib available as a generic drug?

GENERIC AVAILABLE: No

Do I need a prescription for rofecoxib?

Yes

What are the side effects of rofecoxib?

Although stomach and intestinal
ulcers occur
with the use of rofecoxib, they occur less frequently than with other
NSAIDs in
short-term studies. Rofecoxib does not interfere with the function
of the platelets in the blood, and, as a result, it does not
interfere with blood clotting and promote bleeding like other
NSAIDs.

The most common side effects of rofecoxib are headache, abdominal
pain, dyspepsia,
diarrhea, nausea, heartburn and water retention. Other side effects
include insomnia,
urinary retention (inability to urinate), heart failure, aggravation
of hypertension, chest pain, ringing in the ears, stomach and
intestinal ulcers, bleeding, blurred vision, anxiety, weight gain,
flu-like symptoms, drowsiness and weakness.

Allergic type reactions can occur with rofecoxib. Persons
who have developed allergic reactions (rash, itching, difficulty breathing) from aspirin
or other
NSAIDs may experience an allergic reaction to rofecoxib and should
not use rofecoxib.

Vioxx should be used cautiously in patients with heart disease.

What is the dosage for rofecoxib?

The lowest effective dose should be used. For the
management of
osteoarthritis, the usual dose is 12.5 mg (tablet or suspension) once
daily.
The maximum dose is 25 mg once daily. For the treatment of acute
pain and menstrual cramps the usual dose is 50 mg once daily. It may
be taken with or without food.

Which drugs or supplements interact with rofecoxib?

Concomitant use of rofecoxib with
aspirin or other NSAIDs (e.g., ibuprofen, naproxen, etc.) may
increase the occurrence of stomach
and intestinal ulcers. Since NSAIDs may increase the concentration of
lithium in the
body, lithium levels should be monitored during and after therapy
with rofecoxib.

Rofecoxib may accentuate the effect of the anticoagulant (blood
thinner) warfarin
(Coumadin), and promote bleeding. Persons taking warfarin should have
the clotting of their blood tested, particularly during the first few
days after starting or stopping rofecoxib.

Rifampin decreases the concentration of rofecoxib in the body by 50%
and thus may reduce the effectiveness of rofecoxib.

Rofecoxib may increase the concentration of methotrexate by 23% and
may lead to increased side effects of methotrexate. Persons taking
both drugs should be closely monitored for these side effects.

Persons who drink more than three alcoholic beverages per day may be
at increased
risk of developing stomach ulcers when taking NSAIDs. This also may
be true with
rofecoxib.




QUESTION

Medically speaking, the term “myalgia” refers to what type of pain?
See Answer

Is rofecoxib safe to take if I’m pregnant or breastfeeding?

The use of rofecoxib in pregnant women has not
been studied. In studies in rats, doses that were 10 or 28 fold
higher than the recommended
human dose were not harmful to fetuses; however, in studies in
rabbits, doses twice the
recommended dose for humans were harmful to the fetuses. Therefore,
rofecoxib should be used in pregnant women only when the potential
benefits outweigh the potential risk to the fetus.

The use of rofecoxib in nursing mothers
has not been evaluated.

What else should I know about rofecoxib?

What preparations of rofecoxib are available?

Tablets: 12.5 mg, 25 mg, and 50mg. Oral
Suspension: 12.5 mg/5 mland 25mg/5ml

How should I keep rofecoxib stored?

Store at room temperature, 15-30°C (59-86°F)

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