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Dosage Efficacy Indications Multimodal approach to post-operative pain Prescribing Information Safety and Tolerability Safety Information
Safety Information

Administration other than IV or IM1
Modes of administration other than IV or IM (e.g. intra-articular, intrathecal) have not been studied and should not be used.

Administration other than IV or IM1
Modes of administration other than IV or IM (e.g. intra-articular, intrathecal) have not been studied and should not be used.

Hypertension1
RAYZON® (parecoxib sodium) can lead to the onset of hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular events. NSAIDs, including RAYZON® (parecoxib sodium), should be used with caution in patients with hypertension. Blood pressure should be monitored closely during the initiation of therapy with RAYZON® (parecoxib sodium) and throughout the course of therapy.

Gastrointestinal (GI) effects1
Caution is advised in the treatment of patients most at risk of developing a gastrointestinal complication with RAYZON® (parecoxib sodium): the elderly, patients with cardiovascular disease, patients using any other NSAID or acetylsalicylic acid concomitantly, glucocorticoids, selective serotonin reuptake inhibitors or patients with a prior history of gastrointestinal disease, such as ulceration, GI bleeding, or inflammatory conditions. There is further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications), when RAYZON® (parecoxib sodium) is taken concomitantly with acetylsalicylic acid (aspirin) (even at low doses).

Skin effects1
Serious skin reactions which may be fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in post-marketing experience with RAYZON® (parecoxib sodium). RAYZON® (parecoxib sodium) injection should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Because of its lack of platelet aggregation effects, RAYZON® (parecoxib sodium) is not a substitute for aspirin for prophylaxis of cardiovascular disease. Concomitant use of RAYZON® (parecoxib sodium) with other anti-coagulant medicines may increase the risk of intra- and postoperative bleeding.

Renal effects1
RAYZON® (parecoxib sodium) injection should not be used in patients with severe renal impairment (creatinine clearance < 30 mL/min) or severe hepatic impairment (Child-Pugh scale ≥ 9). Caution should be used when initiating treatment with RAYZON® (parecoxib sodium) injection in patients with moderate hepatic impairment (Child-Pugh scale 7-9), and in patients with any form of dehydration. It is advisable to rehydrate patients first and then start therapy with RAYZON® (parecoxib sodium) injection.

Fluid retention and oedema1
Due to inhibition of prostaglandin synthesis, fluid retention and oedema may occur in patients taking RAYZON® (parecoxib sodium); therefore, RAYZON® (parecoxib sodium) should not be used in patients with compromised cardiac function, pre-existing oedema, or other conditions predisposing to, or worsened by, fluid retention including those taking diuretic treatment or otherwise at risk of hypovolaemia. Patients with pre-existing congestive heart failure or hypertension should be closely monitored

Anaphylactoid reactions1
Hypersensitivity reactions such as anaphylaxis and angioedema have been reported in post-marketing experience with RAYZON® (parecoxib sodium) injection. Some of these reactions have occurred in patients with a history of allergic type reactions to sulphonamides.

Severe hypotension1
Cases of severe hypotension shortly following RAYZON® (parecoxib sodium) administration have been reported. Some of these cases have occurred without other signs of anaphylaxis. The practitioner should be prepared to treat severe hypotension.

General1
RAYZON® (parecoxib sodium) injection may mask fever.

In addition, caution should be exercised with respect to monitoring the incision for signs of infection in patients receiving RAYZON® (parecoxib sodium) injection.

Safety and efficacy of RAYZON® (parecoxib sodium) injection has not been established for periods of use exceeding 96 hours.

The concomitant use of RAYZON® (parecoxib sodium) injection with other non-specific NSAIDs should be avoided.

Contraindications1

  • Hypersensitivity to parecoxib or to any of the excipients of RAYZON® (parecoxib sodium)
  • History of hypersensitivity to sulphonamides
  • Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioedema, urticaria or allergic-type reactions after taking acetylsalicylic acid or NSAIDs or other cyclooxygenase-2 (COX-2) specific inhibitors
  • Severe impairment of hepatic function
  • Severe renal impairment
  • Post- and peri-operative analgesia in the setting of coronary artery bypass surgery (CABG)
  • Heart failure, established ischaemic heart disease and/or cerebrovascular disease (stroke) and peripheral arterial disease
  • History of gastrointestinal perforation, ulceration or bleeding (PUBs) related to previous NSAIDs, including RAYZON® (parecoxib sodium)
  • Active or history of recurrent ulcer/haemorrhage/perforations
  • Concomitant therapy with lithium or digoxin
  • Porphyria
  • Pregnancy and lactation
  • Children younger than 18 years of age
References RAYZON® Package Insert, approved 15 June 2021.
PP-DYN-ZAF-0164
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