Vioxx
"What are COX-2 inhibitors, and how do they work?
COX-2 inhibitors are a subclass of nonsteroidal antiinflammatory drugs (NSAIDs). NSAIDs work by reducing the production of prostaglandins, chemicals that promote inflammation, pain, a"...
Vioxx
Please Note: This Brand Name drug is no longer available in the US.(Generic versions may still be available.)
INDICATIONS
VIOXX (rofecoxib) is indicated:
For relief of the signs and symptoms of osteoarthritis.
For relief of the signs and symptoms of rheumatoid arthritis in adults.
For relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older and who weigh 10 kg (22 lbs) or more.
For the management of acute pain in adults.
For the treatment of primary dysmenorrhea.
For the acute treatment of migraine attacks with or without aura in adults.
The safety and effectiveness of VIOXX (rofecoxib) have not been established for cluster headache, which is present in an older, predominantly male, population.
DOSAGE AND ADMINISTRATION
VIOXX (rofecoxib) is administered orally. The lowest dose of VIOXX (rofecoxib) should be sought for each patient.
Osteoarthritis
The recommended starting dose of VIOXX (rofecoxib) 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.
Rheumatoid Arthritis
The recommended dose is 25 mg once daily. The maximum recommended daily dose is 25 mg.
| Pauciarticular and Polyarticular Course Juvenile Rheumatoid Arthritis | |
| Pediatric Patients | Daily Dose |
| ≥ 2 years to ≤ 11 years of age and ≥ 10 to < 42 kg | 0.6 mg/kg to a maximum of 25 mg* |
| ≥ 2 years to ≤ 11 years of age and ≥ 42 kg | 25 mg |
| ≥ 12 years to ≤ 17 years of age | 25 mg |
| *Oral suspension dosage form is recommended. To improve dosing accuracy in smaller weight children, the use of 12.5 mg/5 mL oral suspension (2.5 mg/mL) is recommended. | |
Management of Acute Pain and Treatment of Primary Dysmenorrhea
The recommended dose of VIOXX (rofecoxib) is 50 mg once daily. The maximum recommended daily dose is 50 mg. Use of VIOXX (rofecoxib) for more than 5 days in management of pain has not been studied. Chronic use of VIOXX (rofecoxib) 50 mg daily is not recommended. (See ADVERSE REACTIONS, Clinical Studies in OA and RA with VIOXX (rofecoxib) 50 mg).
Acute Treatment of Migraine Attacks with or without aura
The recommended starting dose of VIOXX (rofecoxib) is 25 mg once daily. Some patients may receive additional benefit with 50 mg as compared to 25 mg. The maximum recommended daily dose is 50 mg. The safety of treating more than 5 migraine attacks in any given month has not been established. Chronic daily use of VIOXX (rofecoxib) for the acute treatment of migraine is not recommended.
Hepatic Insufficiency
Because of significant increases in both AUC and Cmax in patients with moderate hepatic impairment (Child-Pugh score: 7-9), the maximum recommended chronic daily dose is 12.5 mg. (See CLINICAL PHARMACOLOGY, Special Populations). The efficacy of 12.5 mg in rheumatoid arthritis patients with moderate hepatic insufficiency has not been studied.
VIOXX (rofecoxib) Tablets may be taken with or without food.
Oral Suspension
VIOXX (rofecoxib) Oral Suspension 12.5 mg/5 mL or 25 mg/5 mL may be substituted for VIOXX (rofecoxib) Tablets 12.5 or 25 mg, respectively, in any of the above indications. Shake before using.
HOW SUPPLIED
No. 3810 Tablets VIOXX (rofecoxib) , 12.5 mg, are cream/off-white, round, shallow cup tablets engraved MRK 74 on one side and VIOXX (rofecoxib) on the other. They are supplied as follows:
NDC 0006-0074-31 unit of use bottles of 30
NDC 0006-0074-28 unit dose packages of 100
NDC 0006-0074-68 bottles of 100
NDC 0006-0074-82 bottles of 1000
NDC 0006-0074-80 bottles of 8000.
No. 3834 Tablets VIOXX (rofecoxib) , 25 mg, are yellow, round tablets engraved MRK 110 on one side and VIOXX (rofecoxib) on the other. They are supplied as follows:
NDC 0006-0110-31 unit of use bottles of 30
NDC 0006-0110-28 unit dose packages of 100
NDC 0006-0110-68 bottles of 100
NDC 0006-0110-82 bottles of 1000
NDC 0006-0110-80 bottles of 8000.
No. 3835 Tablets VIOXX (rofecoxib) , 50 mg, are orange, round tablets engraved MRK 114 on one side and VIOXX (rofecoxib) on the other. They are supplied as follows:
NDC 0006-0114-31 unit of use bottles of 30
NDC 0006-0114-28 unit dose packages of 100
NDC 0006-0114-68 bottles of 100
NDC 0006-0114-74 bottles of 500
NDC 0006-0114-81 bottles of 4000.
No. 3784 Oral Suspension VIOXX (rofecoxib) , 12.5 mg/5 mL, is an opaque, white to faint yellow suspension with a strawberry flavor that is easily resuspended upon shaking.
NDC 0006-3784-64 unit of use bottles containing 150 mL (12.5 mg/5 mL).
No. 3785 Oral Suspension VIOXX (rofecoxib) , 25 mg/5 mL, is an opaque, white to faint yellow suspension with a strawberry flavor that is easily resuspended upon shaking.
NDC 0006-3785-64 unit of use bottles containing 150 mL (25 mg/5 mL).
Storage
VIOXX (rofecoxib) Tablets
Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.]
VIOXX (rofecoxib) Oral Suspension
Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.]
RX Only
Issued August 2004 Printed in USA
Last reviewed on RxList: 12/28/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Vioxx Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Arthritis
Get the latest treatment options
Updated & New
