Celecoxib · oral capsule
NSAID
Approved uses
Acute pain and primary dysmenorrhea
400 mg initially, followed by a further 200 mg if needed on the first day; thereafter 200 mg twice daily as required
A COX-2 selective NSAID, so it spares platelet function, which matters if bleeding risk is a concern
Osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis and ankylosing spondylitis
Osteoarthritis 200 mg once daily or 100 mg twice daily; rheumatoid arthritis 100 to 200 mg twice daily; ankylosing spondylitis 200 mg once daily; juvenile rheumatoid arthritis 50 mg twice daily at 10 to 25 kg and 100 mg twice daily above 25 kg
Contraindications
Celecoxib is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product. History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs, have been reported in such patients.
Celecoxib capsules, 50 mg, 100 mg, 200 mg and 400 mg.
Celecoxib has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of celecoxib is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of COX-2. Celecoxib is a potent inhibitor of prostaglandin synthesis in vitro. Celecoxib concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Since celecoxib is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
Warnings & Precautions
- Cardiovascular thrombotic events: NSAIDs raise the risk of myocardial infarction and stroke, which can be fatal; the risk may appear early in treatment and rises with dose and duration. Contraindicated for peri-operative pain in coronary artery bypass graft surgery.
- Gastrointestinal bleeding, ulceration and perforation can occur at any time, without warning, and may be fatal; the elderly and those with prior ulcer disease are at greatest risk.
- Hepatotoxicity, hypertension, heart failure and renal injury have been reported.
- Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, can occur without warning.
- Contraindicated in patients with a history of asthma, urticaria or other allergic reaction after aspirin or another NSAID, and in those with a sulfonamide allergy.
Common Side Effects
the most common reasons for discontinuation due to adverse events in the celecoxib treatment groups were dyspepsia and abdominal pain (cited as reasons for discontinuation in 0.
Pregnancy: Avoid from 30 weeks of gestation because of the risk of premature closure of the fetal ductus arteriosus; use between 20 and 30 weeks may cause fetal renal dysfunction and oligohydramnios.
Lactation: Celecoxib is present in human milk at low levels; consider the mother's clinical need alongside any potential effect on the infant.
Celecoxib is approved for relief of the signs and symptoms of Juvenile Rheumatoid Arthritis in patients 2 years and older. Safety and efficacy have not been studied beyond six months in children.