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Tylenol with codeine
Acetaminophen reduces fever and mild-to-moderate pain through inhibition of prostaglandin synthesis, while codeine is an opioid agonist that enhances pain relief through central nervous system depression.
Acetaminophen reduces fever and mild-to-moderate pain through inhibition of prostaglandin synthesis, while codeine is an opioid agonist that enhances pain relief through central nervous system depression. Used for Mild to moderate pain, Pain management in adults and children.
At a glance
| Generic name | Tylenol with codeine |
|---|---|
| Sponsor | National Center for Complementary and Integrative Health (NCCIH) |
| Drug class | Opioid analgesic combination |
| Target | Mu opioid receptor (codeine); cyclooxygenase enzymes (acetaminophen) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | FDA-approved |
Mechanism of action
Acetaminophen (paracetamol) works primarily by inhibiting cyclooxygenase enzymes in the central nervous system, reducing prostaglandin production and lowering pain perception and body temperature set point. Codeine is a weak opioid that binds to mu opioid receptors in the brain and spinal cord, providing additional analgesic effects. The combination provides synergistic pain relief for moderate pain that does not respond adequately to acetaminophen alone.
Approved indications
- Mild to moderate pain
- Pain management in adults and children
Common side effects
- Drowsiness
- Dizziness
- Constipation
- Nausea
- Respiratory depression
Key clinical trials
- Examining Analgesic Synergy and Efficacy in Trauma Care (PHASE4)
- Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304) (PHASE2)
- E7 TCR T Cells for Human Papillomavirus-Associated Cancers (PHASE1, PHASE2)
- Opioid-Free Pain Protocol After Shoulder Arthroplasty (PHASE4)
- Opioid-Sparing Joint Replacement (PHASE3)
- An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service (PHASE3)
- Celecoxib for ENT Pain Management (PHASE2)
- Post-Op Pain Control for Prophylactic Intramedullary Nailing. (PHASE3)
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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