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Prescribing information can be found at the bottom of the page

DYNASTAT has a well-established tolerability profile

  • The decision to prescribe a COX-2 selective NSAID should be based on assessment of an individual patient’s overall risks. Caution is advised if treating patients most at risk of developing gastrointestinal (GI) or cardiovascular (CV) complications1
  • Incidence of gastrointestinal ulcers/erosions significantly lower than with NSAIDs1,2
  • The effect of DYNASTAT on platelet aggregation and bleeding time is similar to placebo3
  • Because COX-2 selective NSAIDs have been associated with increased risk of CV and thrombotic events in comparison to placebo, DYNASTAT should be used at the lowest effective dose for the shortest duration possible and not for more than 3 days1

Adverse event profile

  • Nausea is the most frequently reported adverse event (AE), with reported incidence in>10% of patients1
  • Apart from the incidence of nausea, all other AEs experienced by <10% of patients1
  • Serious skin reactions are rare but appropriate measures should be taken to monitor for any such reactions1

AEs reported in the Dynastat SmPC1

Incidence

AEs

Very common (≥1/10):

Nausea

Common (≥1/100, <1/10):

Vomiting, oedema peripheral, agitation, dizziness, hyper/ hypotension, hypoaesthesia, pharyngitis, respiratory insufficiency, dyspepsia, constipation, alveolar osteitis, flatulence, abdominal pain, hyperhidrosis, pruritus, insomnia, anaemia postoperative, oliguria, back pain, hypokalaemia, blood creatinine increased

Uncommon (≥1/1000, <1/100):

Rash, abnormal sternal serous wound drainage, wound infection, thrombocytopenia, hyperglycaemia, anorexia, cerebrovascular disorder, ear pain, myocardial infarction, bradycardia, hypertension (aggravated), orthostatic hypotension, pulmonary embolism, gastroduodenal ulceration, gastrooesophageal reflux disease, dry mouth, gastrointestinal sounds abnormal, ecchymosis, urticaria, arthralgia, asthenia, injection site pain, injection site reaction, blood creatine phosphokinase (CPK) increased, blood lactate dehydrogenase (LDH) increased, serum glutamic-oxaloacetic transaminase (SGOT) increased, serum glutamic pyruvic transaminase (SGPT) increased, blood urea nitrogen (BUN) increased, post procedural complication (skin)

Rare (≥1/10,000, <1/1000):

Anaphylactoid reaction, pancreatitis, oesophagitis, oedema mouth (perioral swelling), renal failure acute

Frequency not known:

Circulatory collapse, congestive heart failure, tachycardia, dyspnoea, Stevens Johnson syndrome, erythema multiforme, exfoliative dermatitis, renal failure, hypersensitivity reactions including anaphylaxis and angioedema

 

Please refer to the summary of Product Characteristics for a comprehensive overview of DYNASTAT safety information, warnings and precautions, contraindications and dosing information.

References

  1. Pfizer Ltd. Dynastat 40 mg Powder for Solution for Injection. Summary of Product Characteristics. 
  2. Stoltz RR, et al. Am J Gastroenterol. 2002;97:65–71. 
  3. Noveck RJ, et al. Clin Drug Invest. 2001;21:465–76.