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parecoxib

Dynastat · ATC code M01AH04

Also known as: Parekoksib

Key facts
Active substance
parecoxib
Drug class
COX-2 inhibitor
ATC code
M01AH04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Dynastat 40 mg powder for solution for injection · Dynastat 40 mg powder and solvent for solution for injection
Marketing authorisation holder
Pfizer Europe MA EEIG
Information as of
2026-10-28

Key facts

Parecoxib (Dynastat) is a selective COX-2 inhibitor given by intravenous or intramuscular injection. It is used for the short-term treatment of postoperative pain in adults.

What it is used for

  • Short-term treatment of postoperative pain in adults.
  • Prescribing should be based on an assessment of the individual patient's overall risks.

Dosing

  • Recommended dose: 40 mg IV or IM, then 20 mg or 40 mg every 6 to 12 hours as required, not to exceed 80 mg/day.
  • Use the shortest duration and lowest effective dose; limited experience beyond three days.
  • Elderly patients under 50 kg and moderate hepatic impairment (Child-Pugh 7-9): start with half the usual dose, maximum daily dose 40 mg.
  • Severe renal impairment (creatinine clearance <30 ml/min) or predisposition to fluid retention: start at 20 mg and monitor kidney function.
  • Reduce the dose with fluconazole; not recommended in children under 18 years.

Contraindications

  • Hypersensitivity to the active substance or to sulfonamides; history of serious allergic drug reactions (e.g. Stevens-Johnson syndrome, DRESS).
  • Active peptic ulceration or GI bleeding; inflammatory bowel disease.
  • Allergic-type reactions (e.g. bronchospasm, nasal polyps, urticaria) after acetylsalicylic acid or NSAIDs.
  • Third trimester of pregnancy and breast-feeding; severe hepatic impairment.
  • Congestive heart failure (NYHA II-IV), post-operative pain after CABG surgery, established ischaemic heart disease, peripheral arterial disease or cerebrovascular disease.

Important warnings

  • Increased risk of cardiovascular and thrombotic events with COX-2 inhibitors.
  • Upper GI complications (perforations, ulcers, bleeding), some fatal; caution in the elderly and with acetylsalicylic acid.
  • Serious skin reactions (erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome), some fatal.
  • Use only IV or IM; other routes have not been studied.

Side effects

  • Very common: nausea.
  • Common: postoperative anaemia, hypokalaemia, agitation, insomnia, dizziness, hypertension, hypotension, abdominal pain, vomiting, constipation, pruritus, back pain, peripheral oedema.
  • Serious (uncommon to rare): myocardial infarction, severe hypotension, anaphylaxis, angioedema and severe skin reactions; after CABG a higher risk of thromboembolic events and wound complications.

Interactions

  • Warfarin and other anticoagulants: monitor INR closely, especially in the first days.
  • Low-dose acetylsalicylic acid increases the risk of GI complications.
  • ACE inhibitors or angiotensin-II antagonists, and ciclosporin or tacrolimus: monitor renal function.
  • Fluconazole increases exposure to the active metabolite valdecoxib; reduce the parecoxib dose.

Pregnancy and breastfeeding

  • Contraindicated in the third trimester and during breast-feeding.
  • In the first and second trimester only if clearly necessary; from the 20th week, risk of oligohydramnios.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • DynastatPfizer Europe MA EEIG · EMEA/H/C/000381

Source: European Medicines Agency (EMA), product information

Germany

  • Parecoxib ChenponChenpon De Gmbh · 1 register entry
  • Parecoxib NoridemNoridem Enterprises Ltd · 1 register entry
  • Parecoxib SeacrossSeacross Pharma (Europe) Ltd · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Brand names in 12 more European countries
Denmark
Parecoxib Macure, Parecoxib Noridem
Finland
Parecoxib Macure
Greece
Coxidem, Pyrixip
Iceland
Dynastat, Parecoxib Macure
Ireland
Parecoxib Noridem Enterprises Limited
Liechtenstein
Dynastat
Malta
Parecoxib Noridem
Netherlands
Parecoxib Chenpon, Parecoxib Seacross
Norway
Dynastat, Parecoxib Macure, Parecoxib Noridem
Portugal
Parecoxib Noridem, Pyrixip
Romania
Parecoxib Noridem
Sweden
Parecoxib Macure, Parecoxib Noridem

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Dynastat – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/dynastat-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. Wikidata (CC0): ATC M01AH.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.