PARECOXIB-AFT POWDER FOR SOLUTION FOR INJECTION 40MG [SIN17012P]

Product Info

PARECOXIB-AFT POWDER FOR SOLUTION FOR INJECTION 40MG

[SIN17012P]

4.1 Therapeutic indications

Parecoxib-AFT is indicated for the short-term treatment of acute post-operative pain. There is limited clinical experience with parecoxib treatment beyond three days.

4.2 Posology and method of administration

Parecoxib-AFT may be administered as single or multiple IV or IM doses on a regular or as needed schedule. After initiation of therapy, dosage should be adjusted based on patient response.

Parecoxib-AFT is only indicated for patients with a need for parenteral therapy and for whom a similar benefit could not be obtained from alternative oral therapy. It is recommended that patients be transitioned to alternative oral therapy as soon as clinically indicated.

As the cardiovascular (CV) risk of cyclooxygenase-2 (COX-2) specific inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.

Management of Acute Pain: The recommended single or initial dose for treatment of acute pain is 40 mg, administered either IV or IM, followed by 20 mg every 6 to 12 hours, as required. The maximum daily dosage is 60 mg. The IV bolus injection may be given directly into a vein or into an existing IV line. The IM injection should be given slowly and deeply into the muscle.

Concomitant Use with Opioid Analgesics: Opioid analgesics can be used concurrently with parecoxib, dosing as described above. In clinical trials, the daily requirement for opioids was significantly reduced (20%–40%) when co-administered with parecoxib. An optimal effect is achieved when parecoxib is given prior to opioid administration. In all clinical assessments parecoxib was administered at a fixed time interval whereas the opioids were administered on as needed basis (PRN).

Elderly: No dosage adjustment is generally necessary. However, for elderly patients weighing less than 50 kg, it is advisable to reduce the initial dose of parecoxib by 50%. The maximum daily dose should be reduced to 40 mg in elderly patients weighing less than 50 kg.

Hepatic Impairment: No dosage adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). Treatment with parecoxib should be initiated at the lowest recommended dose and the maximum daily dose should be reduced to 40 mg in patients with moderate hepatic impairment (Child-Pugh Class B).

Patients with severe hepatic impairment (Child-Pugh Class C) have not been studied. The use of parecoxib in these patients is contraindicated (see section 4.3 Contraindications and section 5.2 Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal Impairment: In patients with severe renal impairment (creatinine clearance <30 mL/minute), or patients who may be predisposed to fluid retention, parecoxib should be initiated at the lowest recommended dose and the patient's kidney function closely monitored.

Co-administration with Fluconazole: When Parecoxib-AFT is co-administered with fluconazole, the lowest recommended dose of parecoxib should be used.

Paediatric Patients: Safety and efficacy have not been established in children under 18 years of age. Therefore, parecoxib is not recommended in these patients.

4.3 Contraindications

Parecoxib-AFT is contraindicated in:

• patients with known hypersensitivity to parecoxib or to any other ingredient of the product,

• history of previous serious allergic drug reaction of any type, especially cutaneous reaction such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme or patients with known hypersensitivity to sulphonamides (see section 4.4 Special warnings and precautions for use and section 4.8 Undesirable effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information),

• active peptic ulceration or gastrointestinal (GI) bleeding,

• patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or other allergic-type reactions after taking acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (NSAIDs), including other COX-2 specific inhibitors,

• the third trimester of pregnancy and breast-feeding,

• severe hepatic impairment (serum albumin <25 g/L or Child-Pugh Class C),

• inflammatory bowel disease,

• congestive heart failure (NYHA II–IV),

• treatment of post-operative pain following coronary artery bypass graft (CABG) surgery,

• established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.