Indications And Usage

Osteoarthritis (OA)

Rheumatoid Arthritis (RA)

Juvenile Rheumatoid Arthritis (JRA)

Ankylosing Spondylitis (AS)

Acute Pain (AP)

Primary Dysmenorrhea (PD)

Administration

Osteoarthritis:

For relief of the signs and symptoms of OA the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.

Rheumatoid Arthritis:

For relief of the signs and symptoms of RA the recommended oral dose is 100 to 200 mg twice daily.

Juvenile Rheumatoid Arthritis:

For the relief of the signs and symptoms of JRA the recommended oral dose for pediatric patients (age 2 years and older) is based on weight. For patients >10 kg to <25 kg the recommended dose is 50 mg twice daily. For patients >25 kg the recommended dose is 100 mg twice daily.

Ankylosing Spondylitis:

For the management of the signs and symptoms of AS, the recommended dose of Selecoxir is 200 mg daily in single (once per day) or divided (twice per day) doses. If no effect is observed after 6 weeks, a trial of 400 mg daily may be worthwhile. If no effect is observed after 6 weeks on 400 mg daily, a response is not likely and consideration should be given to alternate treatment options.

Management of Acute Pain and Treatment of Primary Dysmenorrhea:

The recommended dose of Selecoxir is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed.

Special Populations:

Hepatic insufficiency: The daily recommended dose of Selecoxir capsules in patients with moderate hepatic impairment (Child- Pugh Class B) should be reduced by 50%. The use of Selecoxir in patients with severe hepatic impairment is not recommended.

Contraindications

Selecoxir is contraindicated:

• In patients with known hypersensitivity to Selecoxir, aspirin, or other NSAIDs.
• In patients who have demonstrated allergic-type reactions to sulfonamides.
• In patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe anaphylactoid reactions to NSAIDs, some of them fatal, have been reported in such patients.

• For the treatment of peri-operative pain in the setting of coronary artery bypass graft(CABG) surgery.

Precautions

Cardiovascular Thrombotic Events, Hypertension, Congestive Heart Failure and Edema, Gastrointestinal (GI) Effects, Hepatic Effects, Renal Effects, Anaphylactoid Reactions, Skin Reactions, Pregnancy,  Corticosteroid Treatment, Hematological Effects, Disseminated Intravascular Coagulation (DIC), Preexisting Asthma, Laboratory Tests, Inflammation, Concomitant NSAID Use

Adverse Reactions

In patients taking Selecoxir tablets, or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1%-10% of patients are:

Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting.

Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes and tinnitus.

Pregnancy and lactation

Renal and liver Impairment

Selecoxir is not recommended in patients with severe renal insufficiency.

Laboratory Tests