Celecoxib

What it is and how it works

Mechanism of Action Celecoxib has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of celecoxib capsules are 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.

Mechanism class: Cyclooxygenase Inhibitors

Indications

Celecoxib capsules are indicated Celecoxib capsules are a nonsteroidal anti-inflammatory drug indicated for: • Osteoarthritis (OA) • Rheumatoid Arthritis (RA) • Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older • Ankylosing Spondylitis (AS) • Acute Pain (AP) • Primary Dysmenorrhea (PD) Osteoarthritis For the management of the signs and symptoms of OA [ see Clinical Studies ] Rheumatoid Arthritis For the management of the signs and symptoms of RA [ see Clinical Studies ] Juvenile Rheumatoid Arthritis For the management of the signs and symptoms of JRA in patients 2 years and older [ see Clinical Studies ] Ankylosing Spondylitis For the management of the signs and symptoms of AS [ see Clinical Studies ] Acute Pain For the management of acute pain in adults [ see Clinical Studies ] Primary Dysmenorrhea For the management of primary dysmenorrhea [ see Clinical Studies ]

Dosage and administration (summary)

• Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals • OA: 200 mg once daily or 100 mg twice daily ( 2.2 , 14.1 ) • RA: 100 mg to 200 mg twice daily ( 2.3 , 14.2 ) • JRA: 50 mg twice daily in patients 10 kg to 25 kg. 100 mg twice daily in patients more than 25 kg ( 2.4 , 14.3 ) • AS: 200 mg once daily single dose or 100 mg twice daily. If no effect is observed after 6 weeks, a trial of 400 mg (single or divided doses) may be of benefit ( 2.5 , 14.4 ) • AP and PD: 400 mg initially, followed by 200 mg dose if needed on first day.

Contraindications

• Celecoxib capsules are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product [ see Warnings and Precautions ( 5.7 , 5.9 ) ]. • 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 [ see Warnings and Precautions ( 5.7 , 5.8 ) ].

Warnings and precautions

• Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop • Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs.

Pregnancy

Pregnancy Pregnancy Category C. Pregnancy category D from 30 weeks of gestation onward. Risk Summary Use of NSAIDs, including celecoxib capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus.

Storage and supply

Celecoxib Capsules 100 mg Size '4', White opaque cap, white opaque body with 'C5' imprinted on the blue band on the cap and '100mg' imprinted on the blue band on the body and are available as follows: Bottles of 30 Capsules NDC 71205-439-30 Bottles of 60 Capsules NDC 71205-439-60 Bottles of 90 Capsules NDC 71205-439-90 Storage Store at 20° to 25°C …

Source: Celecoxib (Celecoxib) — US FDA prescribing information, 2022-08-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.