Dynastat® parecoxib

Dynastat, parocoxib in on the approved list in the Netherlands and available for international shipment.

Dynastat® is a powder for solution for injection.

It is the first injectable COX-2 (cyclo-oxygenase-2) inhibitor

Dynastat's approved indication is in the short term treatment of postoperative pain.

Important Notice

Meerburg Pharmacy neither promotes nor encourages the use and importation of medications in any way.

Each country has its own laws and regulations for the importation of medication to protect their citizens.

e.g. USA: http://www.customs.gov/xp/cgov/travel/alerts/medication_drugs.xml

e.g. Australia: http://www.health.gov.au/tga/docs/html/bringmed/persimp.htm

e.g. Canada (EN): http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorat/imp_hum_drug_per_use_enf_dir_tc_e.html

e.g. Canada (FR): http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorat/imp_hum_drug_per_use_enf_dir_tc_f.html

Information and Ordering

If Dynastat ® is not approved in your country yet, it can be dispensed in situations where a patient cannot be treated with approved medication.

Email service doctors/pharmacists: I might need Dynastat for one of my patients (click here)

Scientific Publications : Medline through Pubmed (search on parecoxib)

European Committee Recommends Approval of Dynastat (Parecoxib) for Postoperative Pain

PEAPACK, NJ -- November 19, 2001 -- Pharmacia Corporation today announced that the Committee for Proprietary Medicinal Products (CPMP), which is responsible for evaluating drug products in the European Union for the European Agency for Evaluation of Medicinal Products (EMEA), has recommended granting a Marketing Authorization for Dynastat® (parecoxib sodium for injection) for the short term treatment of postoperative pain.
Dynastat -- the first injectable cyclooxygenase (COX)-2 specific inhibitor -- will have a single Marketing Authorization with unified labeling that will be valid in all 15 European Union (EU) member states, as well as Norway and Iceland.

"We are excited that CPMP has voted to approve Dynastat for the treatment of postoperative pain," said Carrie Cox, Executive Vice President and Head of Global Prescription Business at Pharmacia Corporation. "In clinical trials, Dynastat provided fast and long-lasting relief of post-operative pain with fewer of the gastrointestinal and platelet effects typically associated with previously available nonsteroidal anti-inflammatory drugs [NSAIDs], and reduced the need for opioid analgesics. We are confident that Dynastat will help fulfill the need for improved pain medications in the EU and around the globe."

The Committee for Proprietary Medicinal Products formed its positive opinion based on a review of the results of Dynastat clinical studies involving patients in a variety of surgical models, including hip and knee replacement, abdominal gynecologic surgery, coronary artery bypass graft surgery, and third molar extraction with bone resection.

In the clinical trials program, Dynastat was compared with placebo as well as with the opioid analgesic, morphine, and the conventional NSAID, ketorolac, both of which are widely used to control postoperative pain.

In a Phase III, double-blind, placebo-controlled study of 208 patients who had undergone knee-replacement surgery, a single intravenous (IV) dose of Dynastat (40 mg) was found to be as effective as a single IV dose of ketorolac (30 mg) and more effective than a single IV dose of morphine (4 mg). Dynastat 40 mg IV also provided superior and longer-lasting analgesia compared with morphine 4 mg IV in two Phase III, placebo-controlled, single-dose studies among patients who had undergone total hip-replacement or abdominal gynecologic surgery.

Multiple Phase III studies demonstrated that patients who received Dynastat 40 mg IV required significantly less opioid analgesics than patients treated with opioids alone, while still maintaining the desired level of pain control. In studies using three different surgical models, administration of Dynastat reduced morphine consumption by 20 to 40 percent. In addition, patients treated with Dynastat were more likely to discontinue morphine patient-controlled analgesia within 24 hours after surgery.

In clinical studies, administration of Dynastat was associated with significantly fewer of the side effects that typically accompany treatment with conventional NSAIDs (e.g., bleeding and gastrointestinal ulceration) or opioids (e.g., respiratory depression). The most common side effects of Dynastat were nausea, vomiting, and itching, all of which occurred at a similar rate among patients receiving placebo.

Dynastat should not be administered to patients with aspirin-sensitive asthma or allergic reactions to aspirin or other NSAIDs, or to women in their third trimester of pregnancy.

In addition, Dynastat should be used with caution to treat pain following coronary artery bypass graft surgery. As with all NSAIDs, serious gastrointestinal tract ulcerations can occur without warning symptoms.

Dynastat is the first injectable COX-2 specific inhibitor. Like other agents in its class, the drug works by selectively inhibiting the cyclooxygenase (COX)-2 enzyme, which plays a critical role in the response to injury (pain and inflammation). At therapeutic doses, Dynastat does not appear to affect the COX-1 enzyme, which helps to maintain normal function in the stomach and blood.

SOURCE: Pharmacia Corporation