Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
CAPSULE
**RECOMMENDED DOSAGE:** Celecoxib capsules, at doses up to 200 mg twice per day, can be taken with or without food. As the cardiovascular (CV) risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. _**Symptomatic Treatment of Osteoarthritis (OA):**_ The recommended dose of celecoxib is 200 mg administered as a single dose or as 100 mg twice per day. _**Symptomatic Relief in the Treatment of Rheumatoid Arthritis (RA):**_ The recommended daily dose of celecoxib is 100 mg or 200 mg twice per day. _**Ankylosing Spondylitis (AS):**_ The recommended dose of celecoxib is 200 mg administered as a single dose or as 100 mg twice per day. The maximum recommended daily dose is 400 mg for above indications. _**Management of Acute Pain in Adults:**_ 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. _**Management of Chronic Low Back Pain in Adults:**_ The recommended dose of celecoxib is 200 or 400 mg daily, administered as a 200 mg single dose, or as 100 or 200 mg twice per day. Some patients may benefit from a total daily dose of 400 mg. _**Treatment of 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. _**Elderly:**_ No dosage adjustment is generally necessary. However, for elderly patients weighing less than 50 kg, it is advisable to initiate therapy at the lowest recommended dose. _**Anaphylactoid Reactions:**_ As with NSAIDs in general, anaphylactoid reactions have occurred in patients exposed to celecoxib.
ORAL
Medical Information
**INDICATIONS:** - Symptomatic treatment of osteoarthritis (OA) and rheumatoid arthritis (RA). - Relief of signs and symptoms of ankylosing spondylitis (AS). - Management of acute pain. - Treatment of primary dysmenorrhea. - Management of low back pain. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient’s overall risks (see Sections Contraindications and Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), taking into consideration other available therapeutic options.
**CONTRAINDICATIONS:** Celecoxib is contraindicated in: Patients with known hypersensitivity to celecoxib or any other ingredient of the product. Patients with known sulfonamide hypersensitivity. Patients with active peptic ulceration or gastrointestinal (GI) bleeding. Patients who have experienced asthma, urticaria or allergic-type reactions after taking acetylsalicylic acid (ASA \[aspirin\]) or other non-steroidal anti-inflammatory drugs (NSAIDs), including other cyclooxygenase-2 (COX-2) specific inhibitors. Treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see Section Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Congestive heart failure (NYHA II–IV). Established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
M01AH01
celecoxib
Manufacturer Information
NAINA MOHAMED & SONS PRIVATE LIMITED
Micro Labs Limited
Active Ingredients
Documents
Package Inserts
Coxib-200 Capsule PI.pdf
Approved: September 13, 2022