Download VIOXX (ROFECOXIB)

Composition
Each
ROFETAB is a non-steroidal anti-inflammatory drug (NSAID) that exhibits antiinflammatory, analgesic and antipyretic activity. It acts by selectively inhibiting the
enzyme cyclooxygenase-2 (COX-2), thus arresting the synthesis of inflammatory
prostaglandins. At therapeutic concentrations, ROFETAB does not inhibit the COX-1
isoform, thus is free from the side effects of conventional NSAIDs.
ROFETAB is rapidly and almost completely absorbed from the gastrointestinal tract
with a bioavailability of 93%. Food has no significant effect on either the peak plasma
concentration or extent of absorption of rofecoxib. ROFETAB can therefore be
administered without regard to timing of meals. It undergoes extensive distribution and
has been shown to cross the placenta. Rofecoxib is eliminated predominantly by
hepatic metabolism with little unchanged drug recovered in the urine. ROFETAB has a
long serum half-life of 17 hours, which makes it possible to administer it once a day.
Indications
ROFETAB is indicated for:
 The management of acute pain in adults.
 The management of post-surgical pain.
 The treatment of primary dysmenorrhea.
 Relief of the signs and symptoms of osteoarthritis.
Contraindications
ROFETAB is contraindicated in patients with known hypersensitivity to rofecoxib or any
other component of the formulation.
ROFETAB should not be given to patients who have experienced asthma, urticaria, or
allergic-type reactions after taking aspirin or other NSAIDs.
Precautions
In geriatric population therapy with ROFETAB should be initiated at the lowest possible
dose.
Safety of ROFETAB in patients below 18 years of age has not been investigated.
Use of ROFETAB in patients with moderate to severe renal or hepatic disease is not
recommended due to lack of safety data.
Pregnancy & Lactation
There are no adequate trials in pregnant women. ROFETAB should be used during
pregnancy only if the potential benefit justifies the potential risk to the fetus.
Like other NSAIDs, ROFETAB should be avoided in late pregnancy as it may cause
premature closure of the ductus arteriosus.
It is not known whether rofecoxib is excreted in human milk. Therefore, ROFETAB
should be avoided in nursing mother.
Drug Interactions
Studies demonstrate that rofecoxib might be an inducer for CYP 3A4. Therefore, drugs
metabolized by this enzyme, e.g., midazolam, may have an interaction.
Drug interaction studies with rofecoxib have identified potentially significant interactions
with ACE inhibitors, rifampin, methotrexate and warfarin. Patients receiving these
agents with ROFETAB should be appropriately monitored.
Drug interaction studies do not support the potential for clinically important interactions
between antacids, cimetidine, ketoconazole, prednisone/prednisolone, oral
contraceptives and digoxin with ROFETAB.
Adverse Reactions
Gastrointestinal adverse events may be experienced during treatment with ROFETAB.
Headache, dizziness and fatigue have also been reported. Rarely ankle oedema has
been observed.
Dosage & Administration
is 50 mg once a day for 5 days.
For the management of osteoarthritis the recommended dose of
ROFETAB