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 BRAND NAMES
- International: Tramacet, Ultracet, Zaldiar
- Canada: Tramacet
- France:Ixprim, Zaldiar
- India: Tramacet
- U.S.: Ultracet PI
 MECHANISM OF ACTION
Tramadol is a centrally acting synthetic opioid analgesic. Tramadol's analgesia derives from relatively weak µ-opioid receptor agonism plus norepinephrine and serotonin reuptake inhibition.
Paracetamol is centrally acting analgesic and antipyretic agent with negligible anti-inflammatory properties. Paracetamol is thought to produce analgesia by inhibiting prostaglandin synthesis centrally and elevating the pain threshold.
Short-term (five days or less) management of acute pain.
For the short-term (five days or less) management of acute pain, the recommended dose is 2 tablets of [tramadol(37.5 mg)/acetaminophen (325 mg)] every 4 to 6 hours as needed for pain relief, up to a maximum of 8 tablets per day.
- Hypersensitivity to tramadol or Paracetamol
- Acute intoxication with alcohol, hypnotics, centrally-acting analgesics, opioids, or psychotropic drugs. Tramadol may worsen central nervous system and respiratory depression in these patients
- Severe and active hepatic impairment
 WARNINGS AND PRECAUTIONS
- Administer with caution in patients at risk for respiratory depression. In these patients alternative non-opioid analgesics should be considered
- May impair alertness or ability to drive
- Tramadol can be abused and may be subject to criminal diversion
- Seizures have been reported in patients receiving tramadol within the recommended dosage range.
- Potentially life-threatening serotonin syndrome may occur with the use of tramadol (See interactions)
- Paracetamol (Acetaminophen) has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of Paracetamol at doses that exceed 4000 mg/day. The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who drink alcohol while taking Paracetamol.
- Hypersensitivity reactions to paracetamol: There have been post-marketing reports of hypersensitivity and anaphylaxis associated with the use of Paracetamol. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. In case a hypersensitivity reaction occurs, the drug should be discontinued.
- Decreased effect:
- Increased effect:
- Serotonin Syndrome Risk: particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs, and triptans, with drugs which impair metabolism of serotonin (including MAOIs), and with drugs which impair metabolism of tramadol (CYP2D6 and CYP3A4 inhibitors). Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
 PREGNANCY AND LACTATION
- Pregnancy Category C (US). Tramadol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonatal seizures, neonatal withdrawal syndrome, fetal death and still birth have been reported during post-marketing
- Nursing mothers: Tramadol is not recommended for obstetrical preoperative medication or for postdelivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.
 SIDE EFFECTS
Possible side effects: Dizziness, nausea, vertigo, constipation, headache, somnolence, vomiting, pruritis, CNS stimulation (a composite of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional lability and hallucinations) and asthenia