Ultracet has been approved by the FDA for the short-term (five days or less) management of acute pain. This medication is a centrally acting analgesic that controls pain through different mechanisms of action than non-steroidal anti-inflammatory drugs (NSAIDs), the most commonly used pain medications. As a result, Ultracet is not associated with the side effects that can result from NSAID use, such as gastrointestinal ulcers or bleeding.
Ultracet combines Ultram (tramadol HCl), a leading prescription pain reliever, with the common non-prescription pain treatment, acetaminophen. Clinical trials have shown that the combination is more effective than either drug alone, providing longer duration than acetaminophen and a faster onset of action than tramadol.
Ultracet has been evaluated for efficacy and safety in pivotal single-dose trials in subjects with acute pain. In these trials, subjects with pain following oral surgical procedures who received two tablets of Ultracet experienced greater relief than placebo-treated subjects. Additionally, subjects treated with Ultracet experienced greater relief than subjects on either of the individual components given at the same dose. The onset of pain relief after Ultracet (occurring in less than one hour) was faster than with tramadol alone, whereas the duration of pain relief after Ultracet was longer than with acetaminophen alone. Analgesia was found to be generally comparable to ibuprofen.
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