Classes
DEA Class: Rx
COX-II Inhibitor Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
Other Anti-migraine Agents
Description
Oral, selective cyclooxygenase-2 (COX-2) inhibitor nonsteroidal anti-inflammatory drug (NSAID)
Used for osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), ankylosing spondylitis, primary dysmenorrhea, acute pain, and migraine with or without aura
As with other NSAIDs, serious GI and CV adverse events may occur; use lowest effective dose for shortest possible duration
Indications
Celecoxib is primarily indicated in conditions like osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and can also be given in adjunctive therapy as an alternative drug of choice in acute moderate pain or severe pain, dysmenorrhea and toothache.
Contraindications
Celecoxib is contraindicated in conditions like Asthma, Urticaria, Hypersensitivity.
In the setting of coronary artery bypass graft.
Demonstrated allergic-type reactions to sulfonamides.
Known hypersensitivity (eg, anaphylactic reactions, serious skin reactions) to celecoxib or its components.
Adverse Effects
Headache
Hypertension
Fever
Dyspepsia
Upper respiratory track infections
Arthralgia
Vomiting, Diarrhea
Warnings
Congestive heart failure, hypertension
Increased risk of adverse cardiovascular events and skin reactions
Caution in asthma (bronchial), bleeding disorder, bronchospasm, duodenal/gastric/peptic ulcer, renal impairment.
Risk of GI bleeding, ulceration, and perforation; factors that increase risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, antiplatelet drugs (such as aspirin), anticoagulants; or selective serotonin reuptake inhibitors (SSRIs); smoking; use of alcohol; older age; and poor general health status
Pregnancy and Lactation
Pregnancy; ( Category C) Avoid celecoxib use during the third trimester of pregnancy (starting at 30 weeks of gestation) due to the risk of premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension in the neonate.
If NSAID treatment is deemed necessary between 20 to 30 weeks of pregnancy, limit use to the lowest effective dose and shortest duration possible.
Lactation; Limited data from 12 breastfeeding women showed low levels of celecoxib in breast milk
Maximum Dosage
Adults
800 mg/day PO for capsules; 120 mg/day PO for oral solution.
Geriatric
400 mg/day PO for capsules; 120 mg/day PO for oral solution.
Adolescents
200 mg/day PO for capsules for juvenile rheumatoid arthritis. Safety and efficacy have not been established for other indications or for oral solution.
Children
2 to 12 years weighing more than 25 kg: 200 mg/day PO for capsules for juvenile rheumatoid arthritis. Safety and efficacy have not been established for other indications or for oral solution.
2 to 12 years weighing 10 to 25 kg: 100 mg/day PO for capsules for juvenile rheumatoid arthritis. Safety and efficacy have not been established for other indications or for oral solution.
1 year: Safety and efficacy have not been established.
Infants
Safety and efficacy have not been established.
Neonates
Safety and efficacy have not been established.
How supplied
Capsules
50mg
100mg
200mg
400mg
Oral Solution
25mg/mL (120mg/4.8mL)