BEA-COXIB CAPSULE 200MG [SIN16297P]

Product Info

BEA-COXIB CAPSULE 200MG

[SIN16297P]

4.1 Therapeutic indications
Bea-Coxib Capsule 200mg is indicated for symptomatic treatment of osteoarthritis and rheumatoid arthritis, relief of signs and symptoms of ankylosing spondylitis, management of acute pain and chronic low back pain in adults and primary dysmenorrhea.

The decision to prescribe a selective cyclooxygenase-2 (COX-2) inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration
Posology
Celecoxib capsules, at doses up to 200 mg twice per day, can be taken with or without food.

As the cardiovascular risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.

Osteoarthritis
The usual recommended daily dose is 200 mg taken once daily or as 100 mg twice per day.

Rheumatoid Arthritis
The initial recommended daily dose is 100 mg twice per day. The dose may be increased to 200 mg twice per day if needed.

Ankylosing Spondylitis
The recommended daily dose is 200 mg administered as a single dose or as 100 mg twice per day.

The maximum recommended daily dose for the above indications is 400 mg for all indications.

Acute Pain in Adults
The initial recommended dose is 400 mg followed by an additional 200mg dose if needed. On subsequent days, the recommended dose is 200mg twice daily as needed.

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.

Primary Dysmenorrhea
The recommended dose of celecoxib is 400 mg, followed by an additional 200 mg if needed. On subsequent days, the recommended dose is 200 mg twice daily, as needed.

Special populations
Elderly (>65 years)
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 established moderate liver impairment with a serum albumin of 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). Use in patients with severe hepatic impairment (Child-Pugh Class C) 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). Use of celecoxib in patients with severe renal impairment is not recommended.

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

CYP2C9 Poor Metabolisers
Patients who are known, or suspected to be CYP2C9 poor metabolisers based on genotyping or previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution as the risk of dose-dependent adverse effects is increased. Consider starting treatment at half the lowest recommended dose (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
Celecoxib is not indicated for use in children.
The safety and efficacy of Bea-coxib in children has not been established. No data are available.

Method of administration
Oral use.
Bea-Coxib Capsule 200mg may be taken with or without food.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Hypersensitivity to sulphonamides.

• Active peptic ulceration or gastrointestinal (GI) bleeding.

• Patients who have experienced asthma, urticarial or allergic-type reactions after taking acetylsalicylic acid (ASA [aspirin]) or other non-steroidal anti-inflammatory drugs (NSAIDs), including other cyclo-oxygenase-2 (COX-2) specific inhibitors.

• Treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

• Congestive heart failure (NYHA II–IV).

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