CELECOXIB SANDOZ CAPSULE 200MG [SIN14560P]

Product Info

CELECOXIB SANDOZ CAPSULE 200MG

[SIN14560P]

4.1 Therapeutic indications

• Symptomatic treatment of osteoarthritis (OA) and rheumatoid arthritis (RA)

• Management of acute pain in adults

• Treatment of primary dysmenorrhea

• Relief of signs and symptoms of ankylosing spondylitis (AS)

• Management of chronic 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 4.3 and 4.4), taking into consideration other available therapeutic options – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.2 Posology and method of administration
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.

Hepatic impairment: No dosage adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). Treatment should be initiated at half the recommended dose in patients with moderate hepatic impairment (with serum albumin 25–35 g/L or Child-Pugh Class B).

Patients with severe hepatic impairment (Child-Pugh Class C) have not been studied (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The use of celecoxib in this patient population is not recommended.

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 (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The use of celecoxib in this patient population is not recommended.

Co-administration with Fluconazole: Celecoxib should be introduced at the half the recommended dose in patients receiving fluconazole, a CYP2C9 inhibitor. Caution is advised when co-administering celecoxib with other CYP2C9 inhibitors (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric Patients: Celecoxib has not been studied in subjects under 18 years of age.

CYP2C9 Poor Metabolizers: Patients who are known, or suspected to be CYP2C9 poor metabolizers based on previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution. Consider starting treatment at half the lowest recommended dose (see sections 4.5 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications
Celecoxib is contraindicated in:

• Patients with known hypersensitivity to celecoxib or any ingredient of the product (see section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• 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 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Congestive heart failure (NYHA II–IV).

• Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.