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Tramadol HCl/acetaminophen Extended Release
Tramadol inhibits norepinephrine and serotonin reuptake while acting as a weak opioid agonist, and acetaminophen reduces pain through central analgesic and antipyretic effects.
Tramadol inhibits norepinephrine and serotonin reuptake while acting as a weak opioid agonist, and acetaminophen reduces pain through central analgesic and antipyretic effects. Used for Moderate to moderately severe pain (chronic pain management).
At a glance
| Generic name | Tramadol HCl/acetaminophen Extended Release |
|---|---|
| Also known as | Ultracet Extended Relaese, Ultracet, Ultracet ER semi |
| Sponsor | Janssen Korea, Ltd., Korea |
| Drug class | Opioid analgesic combination with NSAID alternative |
| Target | Mu-opioid receptor; norepinephrine transporter; serotonin transporter |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | FDA-approved |
Mechanism of action
Tramadol is a synthetic opioid that works through dual mechanisms: it binds to mu-opioid receptors and also inhibits the reuptake of norepinephrine and serotonin in the central nervous system, enhancing pain modulation. Acetaminophen complements this by inhibiting prostaglandin synthesis in the CNS. The extended-release formulation provides sustained analgesia over an extended dosing interval.
Approved indications
- Moderate to moderately severe pain (chronic pain management)
Common side effects
- Dizziness
- Nausea
- Constipation
- Headache
- Somnolence
- Vomiting
- Pruritus
Key clinical trials
- A Study to Assess the Improvement of Pain and Health-Related Quality of Life in Patients With Chronic Non-Malignant Pain Taking Tramadol Hydrochloride and Acetaminophen
- A Study to Assess the Bioequivalence of a New ULTRACET Extended Release (ER) Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition (PHASE1)
- An Efficacy and Safety Study of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen in Participants With Chronic Low-Back Pain (PHASE3)
- A Study Comparing the Effectiveness and Safety of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen With Immediate Release (IR) Tramadol HCl/Acetaminophen in Participants With Moderate to Severe Postoperative Pain (PHASE3)
- A Comparative Bioavailability/Food Effect Study of Immediate-Release and Extended-Release Tramadol HCl/Acetaminophen Combination Products Following Single-Dose and Multiple-Dose Administration in Healthy Adult Volunteers (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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