Active Ingredients: Gabapentin
Optionally, the oral solid dosage form includes a sustained release carrier that effectuates the sustained release of tramadol or its analog, or both the tramadol or its analog and the NMDA antagonist when the dosage form contacts gastrointestinal fluid.
In yet other embodiments, the oral solid dosage form comprises a tablet core containing the drugs within a normal or prompt release matrix with the tablet core being coated with a sustained release coating comprising the sustained release carrier.
In various embodiments, the tablet or capsule contain the drugs within a sustained release matrix comprising the sustained release carrier. Another embodiment of the invention is directed to a method of alleviating pain without the use of a narcotic analgesic.
In addition, the present invention can avoid the liability of gastrointestinal and liver toxicity by omitting acetaminophen, aspirin and other NSAID's.
Acetaminophen toxicity is well known and represents a significant drawback of all formulations that contain it.
The limiting dose of acetaminophen is on the order of 2 grams per day. It has also been determined that intentional overdose of acetaminophen is the second most common method of committing suicide in Europe.
Thus, reducing or eliminating exposure to acetaminophen is of significant importance. In further aspects, the invention relates to a method of alleviating pain without the use of a narcotic analgesic.
Furthermore, compositions of the invention can be used to achieve methods of the invention.
Other objects, features and advantages of the present invention will become 5 apparent from the following detailed description. In general, systemic absorption is minimal if up to 3 patches are used over 12 hours FDA-approved dosing regimen.
One should assess skin integrity and body surface area when considering use of the patch. Post-marketing information includes reports of disorientation, confusion, somnolence, and dizziness.