Parecoxib Noridem (Parecoxib) 40 mg
Generic injectable COX-2 inhibitor for short-term postoperative pain relief
Quick Facts About Parecoxib Noridem
Key Takeaways About Parecoxib Noridem
- Injectable postoperative analgesic: Parecoxib Noridem is a 40 mg powder that is reconstituted and given by intravenous or intramuscular injection to relieve moderate to severe pain after surgery in adults.
- Maximum 80 mg per day: The usual starting dose is 40 mg, with subsequent doses of 20–40 mg every 6–12 hours as needed, never exceeding 80 mg in 24 hours.
- Short-term use only: Treatment should be limited to the shortest duration necessary. There is limited clinical experience with treatment lasting longer than 3 days.
- Cardiovascular and gastrointestinal risks: It must not be given to patients with established heart disease, previous stroke, active peptic ulcers, gastrointestinal bleeding, or after coronary artery bypass graft (CABG) surgery.
- Bioequivalent to the originator Dynastat: As a generic medicinal product, Parecoxib Noridem contains the identical active substance (parecoxib sodium) at the same strength and produces the same clinical effect as the reference medicine.
What Is Parecoxib Noridem and What Is It Used For?
Parecoxib Noridem (parecoxib 40 mg) is an injectable selective COX-2 inhibitor used for the short-term management of postoperative pain in adults. It belongs to the class of medicines called coxibs, which reduce pain and inflammation by decreasing the production of prostaglandins at the site of tissue injury.
Parecoxib Noridem contains the active substance parecoxib, a prodrug that is rapidly hydrolysed in the body to valdecoxib, the pharmacologically active compound. Valdecoxib selectively inhibits the enzyme cyclooxygenase-2 (COX-2), which is primarily responsible for producing the prostaglandins that mediate pain, fever, and inflammation following surgical trauma. By preserving most of the activity of cyclooxygenase-1 (COX-1), which protects the gastric mucosa and supports platelet aggregation, selective COX-2 inhibition offers a theoretical advantage over traditional non-selective NSAIDs such as ibuprofen or diclofenac.
Pain and swelling following surgery are driven by substances called prostaglandins released from injured tissue. By blocking their synthesis through COX-2 inhibition, Parecoxib Noridem produces a measurable reduction in postoperative pain intensity and can reduce the amount of opioid analgesia required. This multimodal analgesic strategy is a cornerstone of modern enhanced recovery after surgery (ERAS) protocols, which aim to shorten hospital stays and reduce opioid-related side effects such as nausea, sedation, and respiratory depression.
Parecoxib Noridem is administered exclusively by trained healthcare professionals in hospitals, day-surgery units, and recovery wards. It is given as an intravenous (IV) bolus or as an intramuscular (IM) injection, making it particularly suitable for patients who cannot take oral medication in the immediate postoperative period – for example, those who have undergone gastrointestinal or oral surgery, or who are experiencing nausea, vomiting, or impaired gastric emptying.
Randomised controlled trials have established that parecoxib 40 mg provides analgesia comparable to ketorolac 30 mg and morphine 4 mg in the early postoperative period. According to the Cochrane systematic review on parecoxib for acute postoperative pain, a single 40 mg injection produces at least a 50% reduction in pain intensity in approximately half of treated patients over 4 to 6 hours. The onset of analgesia typically occurs within 7–13 minutes after intravenous administration and within 30–45 minutes after intramuscular injection, with peak plasma concentrations of valdecoxib reached at roughly 2 hours.
Parecoxib Noridem is considered a generic medicinal product, which means it is bioequivalent to the originator product (Dynastat) manufactured by the innovator. It contains the same active substance at the same strength, meets the same pharmacopoeial quality standards, and produces the same clinical effect. Healthcare systems and hospital formularies frequently use generic parecoxib as a cost-effective alternative to the originator, while preserving identical efficacy and safety.
Parecoxib Noridem is licensed only for short-term postoperative use. There is limited clinical experience with treatment beyond 3 days. Because the cardiovascular risk associated with COX-2 inhibitors may increase with dose and duration of treatment, the shortest possible treatment duration should always be used at the lowest effective daily dose.
What Should You Know Before Taking Parecoxib Noridem?
Parecoxib Noridem must not be used in patients with established cardiovascular disease, active gastrointestinal ulcers or bleeding, severe liver impairment, inflammatory bowel disease, or known hypersensitivity to parecoxib, sulfonamides, aspirin, or other NSAIDs. It is also contraindicated after coronary artery bypass graft (CABG) surgery and during the final trimester of pregnancy.
Before Parecoxib Noridem is administered, the prescribing clinician will carry out a careful pre-operative assessment to identify any conditions that make the medicine unsafe. Because the drug is almost always given in a controlled hospital setting, there is ample opportunity for this assessment to occur as part of the standard anaesthetic pre-operative review. Patients should be fully informed about their medical history, allergies, and current medications.
Contraindications
Several conditions absolutely prevent the use of Parecoxib Noridem. Your healthcare provider will review each of these before administering the medication. You should not receive Parecoxib Noridem if any of the following apply to you:
- Known hypersensitivity to parecoxib or any excipient in the formulation
- History of severe allergic reactions (particularly serious skin reactions) to any medicine
- Allergy to sulfonamides (including certain sulfa antibiotics used for urinary or respiratory infections)
- Active peptic ulcer, intestinal ulcer, or acute gastrointestinal bleeding
- History of bronchospasm, acute rhinitis, nasal polyps, angioedema, urticaria, or other allergic-type reactions after taking acetylsalicylic acid (aspirin) or other NSAIDs, including COX-2 inhibitors
- The last 3 months of pregnancy (third trimester)
- Breastfeeding
- Severe hepatic impairment (Child-Pugh class C, serum albumin <25 g/L)
- Inflammatory bowel disease (ulcerative colitis or Crohn's disease)
- Congestive heart failure (NYHA class II–IV)
- Treatment of post-operative pain following coronary artery bypass graft (CABG) surgery
- Established ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease (previous stroke or transient ischaemic attack)
Serious skin reactions, including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported post-marketing with parecoxib and its active metabolite valdecoxib. Some of these reactions have been fatal. Treatment with Parecoxib Noridem must be stopped at the first appearance of skin rash, mucosal lesions, blistering, peeling skin, or any other sign of hypersensitivity. The risk of serious reactions appears to be highest during the first month of treatment. Patients with a history of allergy to sulfonamides may be at higher risk.
Warnings and Precautions
Even when no absolute contraindication is present, several conditions require special caution and possibly dose adjustment before Parecoxib Noridem is given. Inform your doctor or anaesthetist before the operation if any of the following apply to you:
- Previous gastric or duodenal ulcer, bleeding, or perforation
- Any previous skin reaction (rash, hives, blisters, red streaks) to any medicine
- Concurrent use of aspirin or other NSAIDs (e.g., ibuprofen, naproxen, diclofenac)
- Cigarette smoking, heavy alcohol use, or advanced age (all increase the gastrointestinal risk)
- Diabetes mellitus, especially when poorly controlled
- Hypertension, angina pectoris, previous thromboembolic events, or hyperlipidaemia
- Use of antiplatelet medications (e.g., clopidogrel, ticagrelor)
- Oedema or congestive heart failure of any severity
- Moderate hepatic or renal impairment
- Dehydration from vomiting, diarrhoea, fasting, or limited fluid intake
- Concurrent infection (parecoxib may mask fever and inflammation)
- Use of oral anticoagulants (warfarin) or direct oral anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban)
- Long-term corticosteroid therapy (e.g., prednisolone, methylprednisolone)
- Selective serotonin reuptake inhibitors (SSRIs) such as sertraline, fluoxetine, or citalopram
Parecoxib Noridem can raise blood pressure or worsen pre-existing hypertension, which in turn may increase cardiovascular morbidity. Blood pressure should be monitored during treatment, particularly in patients with underlying hypertension or heart disease. Similar to other NSAIDs, the drug may precipitate or worsen fluid retention, oedema, and congestive heart failure in susceptible patients. Renal function should be monitored in patients with impaired renal function, hypovolaemia, heart failure, or concurrent use of diuretics, ACE inhibitors, or angiotensin II receptor blockers.
Parecoxib Noridem is not recommended for use in children and adolescents under 18 years of age, because safety and efficacy have not been established in paediatric populations. Alternative analgesics (paracetamol, weight-adjusted ibuprofen, or opioids under specialist supervision) should be considered for postoperative pain in younger patients.
Pregnancy, Breastfeeding, and Fertility
Parecoxib Noridem must not be used during the last 3 months (third trimester) of pregnancy because inhibition of prostaglandin synthesis may cause serious harm to the unborn child. Specific risks include premature closure of the ductus arteriosus in the foetal heart, foetal pulmonary hypertension, and renal impairment leading to oligohydramnios (low amniotic fluid). In the mother, prostaglandin inhibition may prolong bleeding time, delay or prolong labour, and increase the risk of haemorrhage at delivery.
During the first 6 months of pregnancy, Parecoxib Noridem should only be used if the potential benefit clearly outweighs the potential risk to the foetus and under the explicit recommendation of the treating physician. If treatment is considered necessary, the lowest effective dose for the shortest possible duration should be used. If Parecoxib Noridem is administered for more than a few days from week 20 of pregnancy onwards, foetal renal dysfunction may occur and can lead to oligohydramnios and, in some cases, neonatal renal impairment. Monitoring with ultrasound should be considered in these rare circumstances.
Breastfeeding mothers should not receive Parecoxib Noridem, because parecoxib and its active metabolite valdecoxib are excreted in small amounts into breast milk. As with other NSAIDs, inhibition of prostaglandin synthesis may also impair female fertility. Women who are planning to become pregnant or who are undergoing investigation for infertility should discuss the risks and benefits of any NSAID with their physician before any elective surgery.
Parecoxib Noridem contains less than 1 mmol (23 mg) of sodium per dose, meaning it is essentially "sodium-free" and suitable for patients on a sodium-controlled diet. This is relevant for patients with advanced heart failure, severe hypertension, or chronic kidney disease who are restricted in their dietary sodium intake. However, when reconstituted with 0.9% sodium chloride, the total sodium content of the final solution is higher and should be factored into the overall sodium balance in such patients.
How Does Parecoxib Noridem Interact with Other Drugs?
Parecoxib Noridem interacts with several commonly prescribed medications, including anticoagulants (warfarin, apixaban, rivaroxaban), antihypertensive drugs, lithium, methotrexate, and fluconazole. Always inform your anaesthetist and surgical team of every medicine you take, including over-the-counter products and herbal supplements, because dose adjustments or additional monitoring may be required.
Drug interactions are a central consideration with Parecoxib Noridem, particularly in the perioperative period when patients are frequently receiving multiple anaesthetic, analgesic, and chronic medications simultaneously. Some interactions can substantially increase the risk of adverse effects such as bleeding or kidney injury, while others may alter the plasma concentration and therefore the effectiveness of either parecoxib or the interacting medication. For this reason, a complete medication reconciliation should be performed before surgery.
Parecoxib is metabolised in the liver to valdecoxib, primarily via the cytochrome P450 enzymes CYP3A4 and CYP2C9. Drugs that inhibit or induce these enzymes can meaningfully alter valdecoxib exposure. In addition, valdecoxib itself is a modest inhibitor of CYP2C9, CYP2C19, and CYP3A4, which can raise the plasma levels of several drugs metabolised by these pathways.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Warfarin and direct oral anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban) | Increased risk of bleeding; parecoxib may increase INR values in warfarin-treated patients | Monitor coagulation parameters closely, especially during the first few days of combined use; consider alternative analgesia if risk is high |
| ACE inhibitors, angiotensin II receptor blockers, beta-blockers, diuretics | Reduced antihypertensive effect; increased risk of acute renal impairment, especially in dehydrated or elderly patients | Monitor blood pressure and renal function; ensure adequate hydration; consider withholding diuretics on the day of surgery |
| Fluconazole (CYP2C9 inhibitor) | Approximately doubles plasma levels of valdecoxib (active metabolite) | Halve the Parecoxib Noridem dose: start with 20 mg, do not exceed 40 mg/day |
| Lithium | Increased plasma lithium concentration due to reduced renal clearance | Monitor serum lithium levels during and for several days after co-administration; adjust lithium dose as needed |
| Methotrexate | Increased plasma methotrexate concentrations; potential for haematological, hepatic, and renal toxicity | Monitor full blood count and hepatic/renal function; particular caution with high-dose methotrexate |
| Ciclosporin and tacrolimus | Increased risk of nephrotoxicity due to combined effects on renal prostaglandins and calcineurin inhibition | Monitor renal function closely during combined use; consider alternative analgesia in transplant recipients |
| Corticosteroids (prednisolone, dexamethasone, methylprednisolone) | Increased risk of gastrointestinal ulceration and bleeding | Consider gastroprotection (proton pump inhibitor) in patients on combined therapy |
Other Notable Interactions
| Interacting Drug | Effect | Action Required |
|---|---|---|
| Aspirin and other NSAIDs | Increased risk of gastrointestinal ulceration and bleeding; no additional cardiovascular benefit from continuing low-dose aspirin | Avoid combination whenever possible; if both are needed, use lowest effective doses and consider gastroprotection |
| Rifampicin (CYP3A4 inducer) | Reduced plasma concentrations of valdecoxib, potentially lowering analgesic effect | May require higher dose or alternative analgesia; monitor pain control |
| Phenytoin, carbamazepine | Potential alteration of plasma levels of both drugs due to enzyme induction or competitive metabolism | Monitor anticonvulsant levels and clinical seizure control |
| Diazepam and other CYP2C19 substrates (e.g., omeprazole) | Reduced clearance and higher plasma concentrations of the substrate | Monitor for increased sedation with diazepam; clinically significant interaction with omeprazole is unlikely |
| Selective serotonin reuptake inhibitors (SSRIs) | Additive effect on platelet function, increasing bleeding risk | Consider gastroprotection; monitor for signs of bleeding, especially in elderly patients |
| General anaesthetics and neuromuscular blockers | No clinically significant pharmacokinetic interactions identified | No dose adjustment required; routine anaesthetic monitoring is sufficient |
| Antiarrhythmics (amiodarone, flecainide, propafenone) | Potential for altered drug metabolism and cardiac effects | Monitor cardiac rhythm and, where applicable, plasma drug levels |
It is especially important to inform the anaesthetist and the surgical team in advance about every medication you take, including prescription drugs, over-the-counter pain relievers, vitamins, and herbal supplements. Many interactions are not clinically apparent at rest but become significant in the perioperative period, when circulating volumes shift, renal perfusion may fall, and multiple drugs are given simultaneously. A written medication list brought to the pre-anaesthetic assessment is the safest and most reliable way to prevent avoidable interactions.
What Is the Correct Dosage of Parecoxib Noridem?
The recommended starting dose of Parecoxib Noridem in adults is 40 mg given intravenously or intramuscularly, followed by 20 mg or 40 mg every 6 to 12 hours as needed, up to a maximum of 80 mg per 24 hours. Treatment should be limited to the shortest duration necessary, with lower doses in the elderly, those with impaired hepatic or renal function, and patients taking fluconazole.
Parecoxib Noridem is always administered by a qualified healthcare professional, either an anaesthetist, a surgeon, or a specialist nurse. The 40 mg powder is reconstituted with a compatible diluent before administration. An intravenous bolus may be given rapidly and directly into a peripheral vein or through an existing intravenous line. An intramuscular injection should be given slowly and deeply into a large muscle (typically the gluteal or thigh muscle) to minimise local pain and ensure reliable absorption.
Adults
Standard Adult Dosing
- Initial dose: 40 mg IV or IM
- Subsequent doses: 20 mg or 40 mg every 6–12 hours as required, based on pain intensity
- Maximum daily dose: 80 mg per 24 hours
- Duration: Shortest duration necessary; limited clinical experience beyond 3 days
- Route: Intravenous bolus (rapid) or intramuscular (slow, deep injection into a large muscle)
- Timing: May be given pre-operatively, intraoperatively, or postoperatively as part of a multimodal analgesic plan
Special Populations Requiring Dose Adjustment
| Patient Group | Recommended Dose | Notes |
|---|---|---|
| Hepatic impairment (mild, Child-Pugh A) | No dose adjustment required | Use with caution; monitor liver function during treatment |
| Hepatic impairment (moderate, Child-Pugh B) | Reduce dose by half | Initial dose 20 mg; maximum daily dose 40 mg; monitor hepatic function |
| Hepatic impairment (severe, Child-Pugh C) | Contraindicated | Do not use; choose an alternative analgesic |
| Severe renal impairment (CrCl <30 mL/min) or at risk of renal hypoperfusion | Start with lowest possible dose | Careful monitoring of renal function; withhold in volume-depleted patients |
| Elderly (>65 years), especially if body weight <50 kg | Start with half the usual adult dose | Maximum daily dose 40 mg; elderly are at higher risk of GI, cardiovascular, and renal adverse effects |
| Patients receiving fluconazole | Halve the dose | Fluconazole doubles valdecoxib exposure; max 40 mg/day |
| Children and adolescents (<18 years) | Not recommended | Safety and efficacy not established |
Children and Adolescents
Parecoxib Noridem is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of parecoxib have not been established in paediatric populations, and no dosing recommendations can be made. Alternative postoperative analgesic strategies – including paracetamol, weight-adjusted ibuprofen (outside of contraindications), local or regional anaesthesia, and judicious use of opioids – should be employed under the supervision of a paediatric anaesthetist.
Use with Opioid Analgesics in Multimodal Analgesia
When Parecoxib Noridem is used together with an opioid analgesic such as morphine or fentanyl, the dose of Parecoxib Noridem remains the same as described above. Combining a COX-2 inhibitor with opioids is a well-established strategy in modern perioperative analgesia that has been shown in randomised controlled trials to reduce total opioid consumption by 20–40% in the first 24 hours after surgery. This opioid-sparing effect may translate into lower rates of opioid-related side effects such as postoperative nausea and vomiting, sedation, ileus, and respiratory depression.
Missed Dose
Because Parecoxib Noridem is given by a healthcare professional under controlled hospital conditions, a "missed dose" in the usual sense of self-administered medication does not generally apply. If a scheduled dose is delayed, the clinical team will decide whether to give the next dose immediately based on the patient's current pain score, the time since the last dose, and the 80 mg daily maximum. A delayed dose should never be doubled to "catch up".
Overdose
If more Parecoxib Noridem than recommended is administered, the adverse effects typically seen at therapeutic doses may occur with greater severity. Possible features of overdose include nausea, vomiting, epigastric pain, gastrointestinal bleeding, hypertension, acute renal failure, respiratory depression, and, rarely, seizures or coma. There is no specific antidote; management is supportive and symptomatic, with attention to airway, breathing, circulation, and renal function.
Parecoxib and its active metabolite valdecoxib are not removed to any significant extent by haemodialysis, but haemoperfusion may theoretically be helpful because of high protein binding. If overdose is suspected, the healthcare team should be informed immediately and close clinical monitoring instituted for at least 24 hours.
What Are the Side Effects of Parecoxib Noridem?
The most common side effect of Parecoxib Noridem is nausea, affecting more than 1 in 10 patients. Other common effects include changes in blood pressure, back pain, fluid retention in the limbs, numbness, vomiting, constipation, dizziness, and insomnia. Less common but serious effects include heart attack, stroke, gastrointestinal bleeding, severe skin reactions, and acute renal failure.
Like all medicines, Parecoxib Noridem can cause adverse effects, although they do not occur in every patient. The frequency and severity of side effects vary between individuals and depend on dose, duration, age, coexisting disease, and concomitant medications. Many adverse reactions resolve spontaneously once treatment is stopped, but some serious effects require immediate medical attention. Patients, carers, and ward staff should be aware of the warning signs that mandate urgent review.
A new skin rash, blistering, peeling skin, or sores anywhere on the body (including the mouth, eyes, face, lips, or tongue); swelling of the face, lips, tongue, or throat causing wheezing, breathing difficulty, or difficulty swallowing (angioedema); chest pain, shortness of breath, or sudden weakness on one side of the body; black or tarry stools, vomiting of blood or "coffee-ground" material; yellowing of the skin or eyes (jaundice); or a sudden decrease in urine output. Skin reactions can occur at any time but are most common during the first month of exposure.
Very Common
May affect more than 1 in 10 patients (>10%)
- Nausea
Common
May affect up to 1 in 10 patients (1%–10%)
- Blood pressure changes (hypertension or hypotension)
- Back pain
- Peripheral oedema (swelling of ankles, legs, and feet)
- Paraesthesia (numbness, tingling, or loss of sensation)
- Vomiting, stomach pain, dyspepsia, constipation, flatulence
- Abnormal kidney function test results
- Anxiety and insomnia
- Dizziness
- Anaemia (reduced red blood cell count) causing fatigue and breathlessness
- Pharyngitis (sore throat), dyspnoea (difficulty breathing)
- Pruritus (itching)
- Oliguria (decreased urine output)
- Post-extraction alveolitis (inflammation after dental extraction)
- Hyperhidrosis (increased sweating)
- Hypokalaemia (low blood potassium)
Uncommon
May affect up to 1 in 100 patients (0.1%–1%)
- Myocardial infarction (heart attack)
- Stroke or transient ischaemic attack (TIA / mini-stroke)
- Pulmonary embolism (blood clots in the lungs)
- Worsening of pre-existing hypertension
- Peptic ulcer, gastro-oesophageal reflux disease
- Bradycardia (slow heart rate)
- Postural hypotension (low blood pressure on standing)
- Elevated liver function tests (ALT, AST, bilirubin)
- Thrombocytopenia (low platelet count, with easy bruising)
- Wound infection, abnormal wound discharge, or delayed wound healing
- Skin discolouration or ecchymosis
- Hyperglycaemia (elevated blood sugar)
- Injection-site pain or reaction
- Rash or urticaria (hives)
- Anorexia (loss of appetite)
- Arthralgia (joint pain), myalgia (muscle pain)
- Elevated creatine kinase
- Dry mouth, muscle weakness, ear pain
Rare
May affect up to 1 in 1,000 patients (0.01%–0.1%)
- Acute renal failure
- Hepatitis (liver inflammation)
- Oesophagitis (inflammation of the oesophagus)
- Pancreatitis (inflammation of the pancreas)
- Anaphylactic or anaphylactoid reactions
Frequency Not Known
Cannot be estimated from available data
- Circulatory collapse due to severe hypotension
- Congestive heart failure
- Acute kidney injury progressing to renal failure
- Palpitations, atrial fibrillation, or other arrhythmias
- Acute dyspnoea and bronchospasm
- Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis (all potentially life-threatening)
- Fixed drug eruption
- DRESS syndrome (drug reaction with eosinophilia and systemic symptoms)
If you notice any side effects not listed here, or if any side effect becomes severe, inform your doctor, nurse, or pharmacist without delay. Patients and caregivers can also report suspected adverse drug reactions to their national medicines regulatory authority (such as the EMA in Europe, the FDA's MedWatch in the United States, or the MHRA's Yellow Card scheme in the United Kingdom). Voluntary reporting contributes to ongoing surveillance of the benefit-risk profile of the medicine and helps protect other patients.
How Should You Store Parecoxib Noridem?
Store Parecoxib Noridem in its original packaging, out of the sight and reach of children. No special temperature conditions are required for the unopened powder. Once reconstituted, the solution should be used immediately or, if stored under validated aseptic conditions, within 24 hours at 25°C.
The unreconstituted powder for solution for injection does not require any special storage conditions. It should be kept in the original carton to protect it from light and should not be used after the expiry date printed on the carton and vial label. The expiry date refers to the last day of the stated month. Because Parecoxib Noridem is almost always stored in hospital pharmacy environments or theatre drug cabinets, routine temperature monitoring and stock rotation are the responsibility of the clinical facility.
Once the powder has been reconstituted with a compatible diluent, chemical and physical in-use stability has been demonstrated for up to 24 hours at 25°C. However, because injectable products carry a significant risk of microbiological contamination, the reconstituted solution should be used immediately unless preparation has taken place under controlled and validated aseptic conditions (for example, in a certified hospital sterile compounding unit). If aseptic conditions cannot be assured, in-use storage times and conditions become the responsibility of the user and should normally not exceed 12 hours at 25°C.
Before administration, the reconstituted solution must be inspected visually. It should be a clear, colourless liquid, free of particles. If the powder or the reconstituted solution is discoloured, contains any visible particulate matter, or the vial is damaged, it must not be used. Any unused solution remaining in the vial after administration should be discarded in accordance with local waste disposal requirements for pharmaceuticals, rather than returned to stock.
As with all medicines, do not dispose of Parecoxib Noridem via wastewater or household waste. In hospital settings, unused vials are routed through the pharmacy's controlled drug disposal system. These measures help to protect the environment from trace pharmaceutical contamination.
What Does Parecoxib Noridem Contain?
Each Parecoxib Noridem vial contains 40 mg of parecoxib (equivalent to 42.36 mg of parecoxib sodium). When reconstituted with 2 mL of diluent, the resulting solution has a concentration of 20 mg/mL. Excipients in the powder include disodium hydrogen phosphate and pH-adjusting agents (phosphoric acid and/or sodium hydroxide).
Active Ingredient
The active substance is parecoxib, supplied as parecoxib sodium. Each glass vial of Parecoxib Noridem contains 40 mg of parecoxib, present as 42.36 mg of parecoxib sodium. When reconstituted with 2 mL of a compatible diluent, the resulting solution contains parecoxib at a concentration of 20 mg/mL. Parecoxib is a prodrug: once administered, it is rapidly and almost completely hydrolysed in the liver by hepatic carboxyesterases to the pharmacologically active metabolite valdecoxib, which is responsible for the analgesic and anti-inflammatory effects.
Other Ingredients
Powder: The powder contains disodium hydrogen phosphate and pH-adjusting agents (phosphoric acid and/or sodium hydroxide).
Solvent (if supplied with the product): Sodium chloride, hydrochloric acid or sodium hydroxide (for pH adjustment), and water for injections.
Alternatively, the 40 mg powder may be reconstituted using other compatible sterile diluents listed below.
Appearance and Packaging
Parecoxib Noridem is supplied as a white to off-white powder contained in a colourless glass vial sealed with a rubber stopper and an aluminium flip-off cap. The carton contains one or more vials of powder together with, depending on the national presentation, the matching solvent ampoules or single-use prefilled syringes for reconstitution. When properly reconstituted, the resulting solution is clear, colourless, and free of visible particles.
Reconstitution Instructions
Parecoxib Noridem may be reconstituted only with the following compatible sterile diluents, in line with the approved Summary of Product Characteristics:
- 0.9% sodium chloride solution for injection or infusion
- 5% glucose (dextrose) solution for infusion
- 0.45% sodium chloride with 5% glucose solution for injection or infusion
Do not reconstitute Parecoxib Noridem with Ringer's lactate solution or Ringer's lactate with 5% glucose, because this combination causes precipitation of parecoxib. Sterile water for injections is also not recommended, as the resulting solution would not be isotonic. Parecoxib Noridem must not be mixed in the same syringe or infusion line with any other medicinal product during preparation or administration. If the same IV line is used for other drugs, it should be adequately flushed with a compatible solution (typically 0.9% sodium chloride) before and after each dose.
Pharmaceutical Classification
Parecoxib Noridem is classified under the Anatomical Therapeutic Chemical (ATC) code M01AH04, placing it within "Musculo-skeletal system / Anti-inflammatory and antirheumatic products / Coxibs." It is a prescription-only medicinal product (Rx), authorised for use only in the hospital setting or under direct supervision of a qualified healthcare professional. It is not available for self-administration or outpatient prescription dispensing.
Frequently Asked Questions About Parecoxib Noridem
Parecoxib Noridem is used exclusively for the short-term treatment of postoperative pain in adults. It is a selective COX-2 inhibitor given by injection (intravenous or intramuscular) in hospital or clinical settings and is administered by healthcare professionals when patients cannot take oral pain medication after surgery, or when rapid onset of pain relief is required. It is not indicated for long-term pain management, chronic inflammatory conditions, or musculoskeletal pain such as arthritis.
When given intravenously, Parecoxib Noridem typically begins to provide noticeable pain relief within 7 to 13 minutes of injection. When given intramuscularly, the onset is slower, usually between 30 and 45 minutes. Peak analgesic effect is generally reached approximately 2 hours after administration regardless of the route, and the duration of pain relief is typically 6 to 12 hours, depending on the individual patient and the surgical procedure.
Parecoxib Noridem and Dynastat contain the same active substance – parecoxib 40 mg per vial as parecoxib sodium – in the same pharmaceutical form (powder for solution for injection). Parecoxib Noridem is a generic product authorised on the basis of bioequivalence with the originator product Dynastat. This means the two medicines have the same clinical effect, the same safety profile, and the same dosing recommendations. Hospitals and healthcare systems often use generic parecoxib to reduce costs while maintaining identical therapeutic benefit.
If you feel dizzy, drowsy, or unusually tired after a Parecoxib Noridem injection, you should not drive or operate machinery until the effects have fully worn off. Because Parecoxib Noridem is almost always given in hospital after surgery, driving is rarely an immediate concern in the first 24 hours. However, you should ensure you have fully recovered from both the surgery itself, the anaesthesia, and any other pain medications before resuming driving. Discuss with your healthcare provider when it is safe to drive again, especially after major procedures.
As a selective COX-2 inhibitor, Parecoxib Noridem was designed to produce fewer gastrointestinal side effects than non-selective NSAIDs such as ibuprofen, diclofenac, or ketorolac. By selectively inhibiting COX-2 while sparing COX-1 (which protects the stomach lining and supports platelet function), the short-term risk of peptic ulcer, gastric erosion, and gastrointestinal bleeding may be lower, which can be clinically important in the postoperative period. However, gastrointestinal complications can still occur, especially in high-risk patients, and Parecoxib Noridem remains contraindicated in those with active peptic ulcer disease or gastrointestinal bleeding.
Before you receive Parecoxib Noridem, tell your doctor or anaesthetist about all your medical conditions, especially: heart disease, hypertension, or a history of stroke or transient ischaemic attack; any history of stomach ulcers or gastrointestinal bleeding; liver or kidney disease; asthma, nasal polyps, or allergies to aspirin or NSAIDs; allergies to sulfonamide antibiotics; diabetes; bleeding disorders; any active infection; and whether you are pregnant, breastfeeding, or planning to become pregnant. Provide a complete list of all medications, including over-the-counter pain relievers, vitamins, and herbal supplements, because parecoxib interacts with many commonly used medicines.
Parecoxib Noridem is intended for short-term use only, and there is limited clinical experience with treatment beyond 3 days. Because the cardiovascular risk associated with COX-2 inhibitors may increase with higher daily doses and longer treatment durations, the shortest possible course should always be used at the lowest effective daily dose. In practice, the surgical and anaesthetic team will normally transition patients to oral analgesics (for example, paracetamol and a short course of oral NSAIDs or opioids) as soon as the patient can tolerate oral intake. The exact duration depends on the type of surgery and the individual clinical situation.
Parecoxib Noridem can be used in elderly patients (over 65 years of age), but additional caution is required because older patients are more susceptible to gastrointestinal, cardiovascular, and renal adverse effects. In elderly patients who weigh less than 50 kg, treatment should be initiated at half the usual adult dose, with a maximum daily dose of 40 mg. Renal function, hydration status, and blood pressure should be monitored during treatment, and concomitant medications (especially ACE inhibitors, diuretics, and anticoagulants) should be reviewed for interactions.
References
- European Medicines Agency (EMA). Parecoxib – Summary of Product Characteristics (EPAR). Updated 2025. Available at: ema.europa.eu – Parecoxib EPAR.
- U.S. Food and Drug Administration (FDA). Drug Safety Communication – COX-2 selective and non-selective NSAIDs, cardiovascular and gastrointestinal risks. FDA Center for Drug Evaluation and Research.
- Lloyd R, Derry S, Moore RA, McQuay HJ. Intravenous or intramuscular parecoxib for acute postoperative pain in adults. Cochrane Database of Systematic Reviews. 2009;(2):CD004771. doi:10.1002/14651858.CD004771.pub4.
- Schug SA, Parsons B, Li C, Xia F. The safety profile of parecoxib for the treatment of postoperative pain: a pooled analysis of 28 randomized, double-blind, placebo-controlled clinical trials. Journal of Pain Research. 2017;10:1489–1500. doi:10.2147/JPR.S138687.
- Nussmeier NA, Whelton AA, Brown MT, et al. Complications of the COX-2 inhibitors parecoxib and valdecoxib after cardiac surgery. New England Journal of Medicine. 2005;352(11):1081–1091. doi:10.1056/NEJMoa050330.
- Ott E, Nussmeier NA, Duke PC, et al. Efficacy and safety of the cyclooxygenase 2 inhibitors parecoxib and valdecoxib in patients undergoing coronary artery bypass surgery. Journal of Thoracic and Cardiovascular Surgery. 2003;125(6):1481–1492.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List (2023). Geneva: World Health Organization; 2023.
- British National Formulary (BNF). Parecoxib. National Institute for Health and Care Excellence (NICE). Available at: bnf.nice.org.uk.
- WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD Index 2025: M01AH04 parecoxib. Oslo, Norway; 2025.
- Chou R, Gordon DB, de Leon-Casasola OA, et al. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists. Journal of Pain. 2016;17(2):131–157. doi:10.1016/j.jpain.2015.12.008.
- Beloeil H, Albaladejo P, Sion A, et al. Multicentre, prospective, double-blind, randomised controlled clinical trial comparing different non-opioid analgesic combinations with morphine for postoperative analgesia: the OCTOPUS study. British Journal of Anaesthesia. 2019;122(6):e98–e106.
About Our Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, which consists of licensed physicians and pharmacists with specialist expertise in pharmacology, pain medicine, and perioperative care. Our team follows international evidence-based guidelines from the World Health Organization (WHO), the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the British National Formulary (BNF) to ensure the highest accuracy and clinical reliability of every medicine monograph we publish.
Evidence-Based Methodology
All medical claims in this article are graded according to the GRADE evidence framework. We use Level 1A evidence (systematic reviews and meta-analyses of randomised controlled trials) wherever available and clearly indicate the strength of each recommendation. Where high-quality evidence is limited, we state this explicitly and describe the reasoning behind any guidance we provide.
Independent and Unbiased
iMedic receives no funding from pharmaceutical companies, medical device manufacturers, or commercial advertisers. Our editorial team declares no conflicts of interest related to the medicines we describe. All content is independently researched, written, and peer-reviewed to provide patients and caregivers with accurate, unbiased, and clinically relevant medical information.