What is Dynastat?
Dynastat is a medicine that contains the active substance parecoxib. It is available as a powder for the preparation of a solution for injection, in vials containing 20 or 40 mg of parecoxib, with or without solvent.
What is Dynastat used for?
Dynastat is used for the short-term treatment of pain following surgery.
The medicine can only be obtained with a prescription.
How is Dynastat used?
Dynastat is given at a dose of 40 mg, followed by other doses of 20 and 40 mg, as needed, every six to 12 hours, with a maximum dose of 80 mg a day. The injection can be performed quickly and directly in a vein or in an existing intravenous line (a thin tube introduced into a vein) or it can be practiced slowly and deeply in a muscle. Dynastat can be given at the same time as opiate painkillers (medicines associated with morphine).
As with other medicines in the same group as Dynastat, the risk of heart and blood vessel problems may increase with high doses and longer duration of treatment. It is advised to use the shortest possible duration of treatment and to use the minimum effective dose of Dynastat.
For elderly patients weighing less than 50 kg and for patients with moderate liver problems, treatment is half the normally recommended dose of Dynastat, with a maximum daily dose of 40 mg. Dynastat should not be used in patients with severe liver problems. In patients with severe kidney problems or who are likely to develop fluid retention, treatment should begin with the lowest dose and the patient's kidneys should be closely monitored. Dynastat is not recommended for children or adolescents.
How does Dynastat work?
The active ingredient in Dynastat, parecoxib, is a "prodrug" of valdecoxib. That is to say, it converts to valdecoxib in the body. Valdecoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the group of medicines called "cyclo-oxygenase-2 inhibitors (COX-2)". It blocks the COX-2 enzyme, with a consequent reduction in the production of prostaglandins, substances that participate in the inflammatory process. By reducing the production of prostaglandins, Dynastat helps to reduce the symptoms of inflammation, including pain.
How has Dynastat been studied?
The effectiveness of Dynastat in the prevention of post-operative pain was studied on 2 582 adult patients who had undergone a variety of surgical operations including dental, orthopedic (bone), gynecological or coronary bypass (heart) operations. Dynastat was compared with placebo (a dummy treatment) and with other painkillers such as ketorolac, morphine, valdecoxib, ibuprofen and tramadol. Some of the studies have also observed the impact of the administration of Dynastat for post-operative pain on the use by the patient of morphine as an additional analgesic after the operation. The main measures of effectiveness were the changes in pain scores assessed by patients.
What benefit has Dynastat shown during the studies?
Dynastat has been shown to be effective in alleviating moderate to severe post-operative pain. The medicine has generally been shown to be superior to that of placebo and equivalent to that of other painkillers. Dynastat has also shown to reduce the need for morphine but this reduction did not seem to be accompanied by a reduction in the side effects associated with morphine.
What is the risk associated with Dynastat?
The most common side effects of Dynastat (seen in between 1 and 10 patients in 100) are anemia (low red blood cells), hypopotassemia (low levels of potassium in the blood), agitation, insomnia (difficulty in falling asleep), hypoesthesia (reduced sense of touch), high or low blood pressure, pharyngitis (sore throat), respiratory failure (difficulty in breathing), alveolar osteitis (inflammation following tooth extraction), dyspepsia (indigestion)), flatulence (gas), itching, back pain, oliguria (reduced urine output), peripheral edema (swelling, usually in the legs) and increased levels of creatinine in the blood (an indication of kidney problems). For the full list of all side effects reported with Dynastat, see the Package Leaflet.
Dynastat should not be used in people who may be hypersensitive (allergic) to parecoxib or any of the other ingredients. Dynastat should not be used in patients with:
- previous severe allergic reactions to medicines, particularly skin reactions;
- stomach ulcer or bleeding in the stomach or intestines;
- allergic-type reactions such as asthma, cold-like symptoms, polyps in the nose, swelling of the face or hives after taking aspirin or NSAIDs, including other COX-2 inhibitors;
- severe liver disease;
- inflammatory bowel disease;
- heart failure (inability of the heart to pump enough blood into the body), heart disease, peripheral artery disease (obstruction of the arteries of the arms or legs) or cerebrovascular disease (problems with the blood vessels of the brain).
Dynastat should not be given to pregnant women in the third trimester or to breast-feeding women. The medicine should not be used after coronary bypass surgery.
Why has Dynastat been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Dynastat's benefits are greater than its risks for the treatment of post-operative pain. The committee recommended issuing marketing authorization for Dynastat.
More information on Dynastat
On 22 March 2002, the European Commission issued a marketing authorization for Dynastat, valid throughout the European Union. The marketing authorization holder is Pfizer Limited. The marketing authorization was renewed on 22 March 2007.
The full EPAR for Dynastat can be found here.
Last update of this summary: 02-2009.
