Recent Tramacet article. I have been taking it on and off and feel it helps me quite a bit. Usually I try Extra Strength Tylonol's. If I still can't walk, have a migraine, or can't use my hand, I switch to Tramacet. I was actually using Advil Gel Caps as a first choice, but my stomach can't take them more than once in a blue moon these days, so I have been going the Tylonol route. Toronto �?August 3, 2005 - Health Canada has approved TRAMACET* (tramadol hydrochloride / acetaminophen) for the short-term (five days or less) management of acute pain. TRAMACET combines tramadol, a widely prescribed pain medication outside Canada, with acetaminophen, a commonly used nonprescription pain treatment.
“TRAMACET bridges the treatment gap between over-the-counter pain medications and more potent prescription pain medications, giving Canadians who suffer from acute pain another treatment option,�?says Dr. Allan Gordon, Neurologist and Director of the Wasser Pain Management Centre at Mount Sinai Hospital in Toronto. “The availability of other treatment options is important to physicians and patients, especially in today’s changing pain treatment environment.�?BR>
Studies have demonstrated that TRAMACET provides better pain relief than either tramadol or acetaminophen alone, faster onset of action than tramadol, and longer duration of relief than acetaminophen. In clinical trials, TRAMACET was shown to be well tolerated with low rates of constipation, vomiting, and discontinuation. ,
“Tramadol and acetaminophen have been used separately worldwide for pain relief for over 25 and 50 years respectively,�?says Dr. André Bélanger, Member of the Geriatric Service at Centre hospitalier Chauveau, Québec. “Tramadol has been available for decades in many other countries and has over 400 million days of patient experience worldwide.�?BR>
Clinical trial information
In a randomized, double-blind, placebo-controlled trial of orthopaedic and abdominal surgery patients published in The American Journal of Surgery, TRAMACET demonstrated similar efficacy and better tolerability than a leading codeine combination treatment.
In the study, the rate of constipation for patients treated with TRAMACET was less than half the rate experienced by patients treated with the codeine combination (4.1 per cent vs. 10.1 per cent). Also, TRAMACET patients experienced less vomiting (9.2 per cent vs. 14.7 per cent) and discontinuation due to adverse events (8.2 per cent vs. 10.1 per cent).
In a study of osteoarthritic patients with flare-ups published in The Journal of The American Geriatrics Society, the addition of TRAMACET to non-selective or COX-2 selective NSAID therapy provided significant improvement in pain relief and reduction of pain intensity compared with placebo.
TRAMACET has also been shown to be effective at providing pain relief following oral surgical procedures.
About TRAMACET
TRAMACET is a centrally-acting analgesic prescription product containing tramadol (37.5 mg) and acetaminophen (325 mg). The combination product is being marketed in 25 countries. Although tramadol, a centrally-acting synthetic opioid analgesic, has been available for decades in many other countries, it is new to Canada.
In clinical trials, the most frequently reported side effects experienced with TRAMACET were nausea, dizziness, and sleepiness.
The recommended dose of TRAMACET is 1 or 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day. No overall differences with regard to safety or pharmacokinetics (absorption, distribution, metabolism and excretion) were noted between patients 65 years of age and older and younger patients. However, dose selection for an elderly patient should be cautious. In patients with creatinine (metabolic breakdown product) clearances of less than 30 mL/min, the dosing interval should be increased to not exceed 2 tablets every 12 hours. TRAMACET is not recommended for patients under 18 years of age.
TRAMACET should not be used in patients with an increased sensitivity to any component of the product and in any situation where opioids cannot be used. It is not recommended for patients with liver disease.
TRAMACET should be used with caution in patients with increased intracranial pressure (pressure within the brain) or head injury and in patients taking CNS depressants, SSRIs, neuroleptics (antipsychotics) and TCAs. It should be used with great caution in patients taking MOA inhibitors.
Patients with a history of extreme allergic reactions to codeine and other opioids should not receive TRAMACET. Serious and, rarely, fatal allergic reactions have been reported in patients receiving tramadol.
Seizures have been reported in patients receiving tramadol within the recommended dose range.
Drug Abuse and Dependence
Tramadol has a potential to cause psychic and physical dependence of the morphine-type (µ-opioid). The drug has been associated with craving, drug-seeking behaviour and tolerance development. Cases of abuse and dependence on tramadol have been reported. TRAMACET tablets should not be used in opioid-dependent patients. Tramadol can re-initiate physical dependence in patients that have been previously dependent or chronically using other opioids. Treatment with TRAMACET is not recommended in patients with a tendency to abuse drugs or a history of drug dependence, and in patients who use opioids chronically.
Withdrawal Symptoms
Withdrawal symptoms may occur if tramadol is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, chills/shivering, pain, nausea, tremors, diarrhea, upper respiratory symptoms, goose bumps, and rarely, hallucinations. Other symptoms that have been seen less frequently with TRAMACET discontinuation include: panic attacks, severe anxiety, and numbness or prickling/tingling sensations. Clinical experience suggests that withdrawal symptoms may be relieved by reinstitution of opioid therapy followed by a gradual, tapered dose reduction of the medication combined with symptomatic support.
TRAMACET should not be taken together with alcohol or with other products containing acetaminophen.
Janssen-Ortho Inc.
Janssen-Ortho Inc. is a brand-name pharmaceutical company headquartered in Toronto with a broad range of medications used in pain management, neurology, psychiatry, dementia, attention deficit hyperactivity disorder, women’s health, infectious disease, gastroenterology, and urology. For More Information Contact :
Rebecca Beitchman
Environics Communications
(416) 969-2744
[email protected]
Alexandra Gillespie
Janssen-Ortho Inc.
(416) 449-9444
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