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Acetaminophen-Hydrocodone
Acetaminophen reduces fever and pain through central nervous system effects, while hydrocodone is an opioid agonist that binds to mu opioid receptors to provide additional pain relief.
Acetaminophen reduces fever and pain through central nervous system effects, while hydrocodone is an opioid agonist that binds to mu opioid receptors to provide additional analgesia. Used for Moderate pain in pediatric patients, Post-operative pain management in children.
At a glance
| Generic name | Acetaminophen-Hydrocodone |
|---|---|
| Also known as | Lortab |
| Sponsor | Le Bonheur Children's Hospital |
| Drug class | Opioid analgesic combination |
| Target | Mu opioid receptor (hydrocodone component); prostaglandin synthesis inhibition (acetaminophen component) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | FDA-approved |
Mechanism of action
Acetaminophen's exact mechanism is not fully understood but is believed to involve inhibition of prostaglandin synthesis in the central nervous system and modulation of serotonergic and noradrenergic pathways. Hydrocodone is a semi-synthetic opioid that binds to mu opioid receptors in the brain and spinal cord, reducing the perception of pain and emotional response to pain. The combination provides synergistic analgesic and antipyretic effects.
Approved indications
- Moderate to moderately severe pain in pediatric patients
- Fever management in pediatric patients
Common side effects
- Drowsiness
- Dizziness
- Constipation
- Nausea
- Respiratory depression
- Hepatotoxicity (acetaminophen-related)
Key clinical trials
- Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction (PHASE2, PHASE3)
- The Efficacy and Safety of Liposomal Bupivacaine for Transversus Abdominis Plane Block in Relieving Postoperative Pain After Laparoscopic Surgery (NA)
- The Efficacy and Safety of Liposomal Bupivacaine for Transversus Abdominis Plane Block in Relieving Postoperative Pain After Laparoscopic Surgery in Gynecologic Oncology (NA)
- A Study on Reducing Opioid Use After Minimally Invasive Ankle Surgery (NA)
- The Efficacy and Safety of Liposomal Bupivacaine for Rhomboid Intercostal Nerve Block in Relieving Postoperative Pain After Video-assisted Thoracoscopic Surgery (NA)
- Post-operative Pain Management in Children With Supracondylar Humerus Fractures (PHASE4)
- Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery (PHASE4)
- SCHF Post-Op Study Between Opioid and Non-Opioid Pain Management (PHASE4)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Acetaminophen-Hydrocodone CI brief — competitive landscape report
- Acetaminophen-Hydrocodone updates RSS · CI watch RSS
- Le Bonheur Children's Hospital portfolio CI