CELEBREX CAPSULE 400MG [SIN13653P]

Product Info

CELEBREX CAPSULE 400MG

[SIN13653P]

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 Contraindications and 4.4 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.

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.

Method of Administration

For patients who have difficulty swallowing capsules, the contents of a celecoxib capsule can be added to applesauce, rice gruel, yogurt or mashed banana. To do so, the entire capsule contents must be carefully emptied onto a level teaspoon of cool or room temperature applesauce, rice gruel, yogurt or mashed banana and should be ingested immediately with water. The sprinkled capsule contents on applesauce, rice gruel or yogurt are stable for up to 6 hours under refrigerated conditions (2–8°C). The sprinkled capsule contents on mashed banana should not be stored under refrigerated conditions and should be ingested immediately.

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 Special warnings and precautions for use – Hepatic Effects – 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 Special warnings and precautions for use – Renal Effects – 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 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 Interaction with other medicinal products and other forms of interaction – 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 Interaction with other medicinal products and other forms of interaction and 5.2 Pharmacokinetic properties, Metabolism – 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 other ingredient of the product (see Section 6.1 List of excipients – 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 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.