Celebrex^® Abbreviated Prescribing Information

Composition: Celecoxib. Indication: For the management of acute pain in adults and for the treatment of primary dysmenorrhea. Relief of the acute and chronic pain and inflammation of rheumatoid arthritis (RA) and osteoarthritis (OA). Relief of signs and symptoms of ankylosing spondylitis. For the management of low back pain (100 mg and 200 mg only). Recommended Dosage: Celecoxib capsules can be taken with or without food. Acute pain and primary dysmenorrhea: The recommended dose of celecoxib 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. Ankylosing spondylitis: 200–400 mg daily. OA: 200 mg once daily. RA: 200 mg twice daily. Low back pain (LBP): Usual dosage for adults is 200 mg once daily. Elderly: No dosage adjustment is necessary. However, for elderly patients with a lower-than-average body weight (<50 kg), it is advisable to initiate therapy at the lowest recommended dose. Hepatic impairment: Patients with severe hepatic impairment have not been studied (Child-Pugh Class C). Renal impairment: No dosage adjustment is necessary in patients with mild or moderate renal impairment. There is no clinical experience in patients with severe renal impairment. Contraindications: Hypersensitivity to Celebrex^® or any ingredient of the product; known sulfonamide hypersensitivity; patients who have experienced asthma, urticaria or allergic-type reactions after taking ASA or other NSAIDs, including other COX-2 specific inhibitors; peri-operative from CABG surgery, established cardiovascular disease (ischemic heart disease and stroke). Special Warnings and Precautions for Use: Cardiovascular effect: May increase risk of serious cardiovascular thrombotic events, myocardial infarction and stroke. The lowest effective dose should be used for the shortest duration possible. May lead to the onset of new hypertension or worsening of pre-existing hypertension and should be used with caution in patients with hypertension and monitor blood pressure closely. Use with caution in patients with compromised cardiac function, pre-existing edema, or other conditions predisposing to, or worsened by, fluid retention including those taking diuretic treatment or otherwise at risk of hypovolemia. Gastrointestinal (GI) effect: Upper and lower GI perforations, ulcers or bleeds have occurred in patients treated with celecoxib. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with celecoxib. Other factors that increase the 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. The lowest effective dose should be used for the shortest duration possible. Renal: Caution should be used in dehydrated patients. It is advisable to rehydrate patients before starting celecoxib treatment. Renal function should be closely monitored in patients with advanced renal disease who are administered celecoxib. Anaphylactoid reactions: Refer to Contraindications. Celecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Hepatic: Celecoxib should be used with caution when treating patients with moderate hepatic impairment (Child-Pugh Class B) and initiated at half the recommended dose. Patients with severe hepatic impairment (Child-Pugh Class C) have not been studied and celecoxib is not recommended. Patients with symptoms and/or signs of liver dysfunction, or in whom an abnormal liver function test has occurred, should be monitored carefully for evidence of the development of a more severe hepatic reaction while on therapy with celecoxib. Anticoagulation/prothrombin time (INR): Should be monitored in patients taking a warfarin/coumarin-type anticoagulant after initiating treatment with celecoxib or changing the dose. The concomitant use of celecoxib and a non-aspirin NSAID should be avoided. Serious skin reactions: Some of them fatal, including drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of celecoxib. Patients appear to be at highest risk for these events early in the course of therapy, the onset of the event occurring in the majority of cases within the first month of treatment. Common Side Effects: Bronchitis, sinusitis, upper respiratory tract infection, urinary tract infection, insomnia, dizziness, hypertension (including aggravated hypertension), cough, vomiting, abdominal pain, diarrhea, dysphagia, irritable bowel syndrome, GERD, nausea, diverticulum, dyspepsia, flatulence, pruritus (includes pruritus generalized), rash, edema, peripheral edema, myocardial infarction, angina pectoris, dyspnea, hepatic enzyme increased, muscle spasms, nephrolithiasis, vaginal hemorrhage, prostatitis, benign prostatic hyperplasia, blood creatinine increased, prostatic specific antigen increased, weight increased. Formulation and Preparation: 200 mg capsules packs of 10, 30 and 100. 400 mg capsules packs of 10.

API-CELEBREX-1023

Reference: Celebrex^® Malaysia Prescribing Information dated 16 October 2023.