This medicine is indicated for the short-term management of postoperative pain in adults. The decision to use a selective cyclooxygenase-2 (COX-2) inhibitor should be based on an individual assessment of the patient’s overall risk profile.

Parecoxib is a prodrug of valdecoxib. Valdecoxib is a selective COX-2 inhibitor within the therapeutic dose range. Cyclooxygenase enzymes are responsible for the production of prostaglandins. Two isoenzymes, COX-1 and COX-2, have been identified. COX-2 is induced by inflammatory stimuli and is mainly responsible for producing prostaglandin mediators involved in pain, inflammation, and fever. COX-2 is also involved in ovulation, implantation, closure of the ductus arteriosus, regulation of renal function, and central nervous system activities such as fever, pain perception, and cognitive function. It may also contribute to ulcer healing. Although COX-2 has been detected in tissues surrounding gastric ulcers, its exact role in ulcer healing is not fully established.

Differences in antiplatelet effects between COX-1 inhibiting NSAIDs and COX-2 selective inhibitors may be clinically relevant in patients at risk of thromboembolic events. COX-2 inhibitors reduce systemic prostacyclin production without affecting platelet thromboxane levels. However, the clinical significance of these effects has not been clearly established.

Adult: The recommended dose is 40 mg administered intravenously (IV) or intramuscularly (IM), followed every 6 to 12 hours by 20 mg or 40 mg as required, not to exceed 80 mg/day. As the cardiovascular risk of 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. There is limited clinical experience with Parecoxib treatment beyond three days.

Elderly: No dose adjustment is generally necessary in elderly patients (≥65 years). However, for elderly patients weighing less than 50 kg, treatment should be initiated with half the usual recommended dose of Parecoxib and reduce the maximum daily dose to 40 mg.

Children: The safety and efficacy of parecoxib in children under 18 years old have not been established. No data are available. Therefore, parecoxib is not recommended in these patients.

The IV bolus injection may be given rapidly and directly into a vein or into an existing IV line. The IM injection should be given slowly and deeply into the muscle. For instructions on reconstitution of the medicinal product before administration. Precipitation may occur when Parecoxib is combined in solution with other medicinal products and therefore Parecoxib must not be mixed with any other medicinal product, either during reconstitution or injection. In those patients where the same IV line is to be used to inject another medicinal product, the line must be adequately flushed prior to and after Parecoxib injection with a solution of known compatibility.

Hypersensitivity to parecoxib or to any of the excipients in the formulation.

Common side effects may include

• changes in blood pressure (increase or decrease),
• back pain, and swelling of ankles, legs,
• and feet due to fluid retention.
• Patients may experience numbness or reduced skin sensitivity to pain and touch.
• Gastrointestinal symptoms such as vomiting, stomach pain,
• indigestion, constipation, bloating, and flatulence may occur.
• Kidney function tests may show abnormalities.
• Other possible effects include agitation, difficulty sleeping, dizziness,
•  risk of anemia (changes in red blood cells after surgery causing fatigue and shortness of breath).
• Some patients may develop sore throat or breathing difficulty (shortness of breath), itchy skin,
• Areduced urine output, dry socket (pain and inflammation after tooth extraction), increased sweating, 
• low potassium levels in blood tests.

Parecoxib may cause serious fetal abnormalities when used during the last trimester of pregnancy, as it may lead to premature closure of the ductus arteriosus or uterine inertia. NSAID use in the second or third trimester may cause fetal kidney dysfunction, resulting in reduced amniotic fluid or oligohydramnios. These effects may occur early in treatment and are usually reversible. Pregnant women using NSAIDs should be closely monitored for amniotic fluid levels. Parecoxib is contraindicated in the third trimester of pregnancy.

A single dose in breastfeeding women after caesarean section shows transfer of small amounts of parecoxib and its active metabolite into breast milk, resulting in low exposure to the infant (about 1% of maternal dose). Therefore, Parecoxib should not be used during breastfeeding.

Parecoxib has been studied mainly in dental, orthopedic, gynecological (especially hysterectomy), and coronary artery bypass surgery. Limited data exist for other surgeries such as gastrointestinal or urological procedures. Routes other than IV or IM (such as intra-articular or intrathecal) have not been studied and should not be used. Higher doses of parecoxib or other COX-2 inhibitors/NSAIDs may increase adverse effects; therefore, patients should be reviewed after dose escalation. If no additional benefit is observed, alternative therapy should be considered. Clinical experience beyond 3 days is limited. If organ function deteriorates during treatment, appropriate action should be taken and discontinuation considered.

Overdose has been associated with adverse reactions similar to those seen at recommended doses. Management should be symptomatic and supportive. Valdecoxib is not removed by hemodialysis. Diuresis or urine alkalinization is not useful due to high protein binding.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Store below 30°C, protect from light and moisture. Keep out of the reach of children.