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HOFXIB 90 is administered orally. HOFXIB 90 may be taken with or without food. HOFXIB 90 should be administered for the shortest duration possible and the lowest effective daily dose should be used.
Osteoarthritis: The recommended dose is 30 mg or 60 mg once daily.
Rheumatoid arthritis: The recommended dose is 90 mg once daily.
Ankylosing spondylitis: The recommended dose is 90 mg once daily.
Chronic musculo-skeletal pain, including low back pain: The recommended dose is 60 mg once daily.
Acute pain: For acute pain conditions, HOFXIB 90 should be used only for the acute symptomatic period limited to a maximum of 8 days.
Acute Gouty Arthritis: The recommended dose is 120 mg once daily.
Primary Dysmenorrhea: The recommended dose is 120 mg once daily.
Post-operative Dental Pain: The recommended dose is 90 mg once daily.
Post-operative Gynecological Pain: The recommended dose is 90 mg once daily.
The initial dose should be administered shortly before surgery. The dose can be increased to a maximum 120 mg daily.
Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied. Therefore, the dose for OA should not exceed 60 mg daily.
The dose for RA should not exceed 90 mg daily.
The dose for ankylosing spondylitis should not exceed 90 mg daily.
The dose for acute gout should not exceed 120 mg daily.
The dose for acute pain and primary dysmenorrhea should not exceed 120 mg daily.
The dose for chronic pain should not exceed 60 mg daily.
The dose for post-operative acute dental surgery pain should not exceed 90 mg daily.
The dose for post-operative acute gynecological surgery pain should not exceed 120 mg daily.
As the cardiovascular risks of selective COX-2 inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically (see Precautions).
Elderly, Gender, Race: No dosage adjustment in HOFXIB 90 is necessary for the elderly or based on gender or race.
Hepatic insufficiency: In patients with mild hepatic insufficiency (Child-Pugh score 5-6), a dose of 60 mg once daily should not be exceeded. In patients with moderate hepatic insufficiency (Child-Pugh score 7-9), the dose should be reduced; a dose of 60 mg every other day should not be exceeded, administration of 30 mg once daily can also be considered. There arc no clinical or pharmacokinetic data in patients with severe hepatic insufficiency (Child-Pugh score >9). (See Precautions.)
Renal insufficiency: In patients with advanced renal disease (creatinine clearence <30 mL), treatment with HOFXIB 90 is not recommended. No dosage adjustment is necessary for patients with lesser degrees of renal insufficiency (creatinine clearence ≥30 mL/min). (See Precautions.)
