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Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013) is a fixed-dose combination tablet developed by Janssen containing 37.5 mg of tramadol hydrochloride and 325 mg of acetaminophen. It is designed to provide synergistic, intermediate-level pain relief between non-opioid analgesics (such as NSAIDs) and strong narcotics. Tramadol acts as a weak μ-opioid receptor agonist and a serotonin-norepinephrine reuptake inhibitor (SNRI), while acetaminophen acts centrally to inhibit prostaglandin synthesis (primarily via COX-1 and COX-2 inhibition). In Japan, JNS013 was approved in 2011 under the brand name Tramcet for the treatment of chronic non-cancer pain (including osteoarthritis and chronic low back pain) and post-tooth-extraction pain that are inadequately controlled by non-opioid analgesics. Globally, the combination is widely marketed under the brand name Ultracet.
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