Nurses Compass
Drug Guide
Tramadol Hydrochloride and Acetaminophen
Classification
Therapeutic: Analgesic combination (opioid and non-opioid)
Pharmacological: Central analgesic (opioid receptor activity) and analgesic (acetaminophen)
FDA Approved Indications
- Moderate to severe pain
Mechanism of Action
Tramadol binds to mu-opioid receptors and inhibits reuptake of norepinephrine and serotonin, contributing to analgesia. Acetaminophen inhibits prostaglandin synthesis in the CNS and differs from NSAIDs in its mechanism.
Dosage and Administration
Adult: Typically 37.5 mg/325 mg every 4 to 6 hours as needed, not to exceed 4 grams of acetaminophen per day.
Pediatric: Not approved for children under 12 years.
Geriatric: Start at lower end of dosing range, monitor hepatic function.
Renal Impairment: Use with caution; dose adjustments may be required.
Hepatic Impairment: Avoid or use at reduced doses, especially in severe liver disease.
Pharmacokinetics
Absorption: Rapid for both components.
Distribution: Widely distributed, crosses blood-brain barrier.
Metabolism: Tramadol metabolized in the liver via CYP2D6 and CYP3A4; acetaminophen metabolized in the liver.
Excretion: Renal excretion of metabolites.
Half Life: Tramadol approximately 6-7 hours; acetaminophen approximately 2-3 hours.
Contraindications
- Hypersensitivity to tramadol or acetaminophen
- Severe hepatic impairment
- Use with monoamine oxidase inhibitors (MAOIs).
Precautions
- History of seizures, drug abuse, respiratory depression, use in pregnancy and lactation.
Adverse Reactions - Common
- Nausea (Common)
- Dizziness (Common)
- Drowsiness (Common)
Adverse Reactions - Serious
- Serotonin syndrome (Rare)
- Respiratory depression (Rare)
- Hepatotoxicity (due to acetaminophen overdose) (Rare)
Drug-Drug Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs) — risk of serotonin syndrome
- CYP2D6 inhibitors — alter tramadol metabolism
- Ethanol and hepatotoxic drugs — increase risk of hepatotoxicity.
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor pain relief, respiratory status, liver function, and signs of serotonin syndrome.
Diagnoses:
- Risk for respiratory depression
- Impaired renal or hepatic function
- Risk for substance abuse.
Implementation: Administer with food or water to minimize gastrointestinal upset; monitor patient closely for adverse effects.
Evaluation: Assess pain relief, monitor for adverse reactions, and evaluate liver function periodically.
Patient/Family Teaching
- Take exactly as prescribed.
- Do not exceed recommended dose of acetaminophen to avoid hepatotoxicity.
- Report signs of allergic reactions, difficulty breathing, or signs of serotonin syndrome.
- Avoid alcohol and sedatives while on this medication.
Special Considerations
Black Box Warnings:
- Serious, potentially life-threatening respiratory depression and accidental ingestion, especially in children.
- Hepatotoxicity associated with overdose of acetaminophen.
Genetic Factors: Polymorphisms in CYP2D6 may alter tramadol metabolism and effectiveness.
Lab Test Interference: May affect liver function tests.
Overdose Management
Signs/Symptoms: Nausea, vomiting, sweating, confusion, respiratory depression, coma, elevated liver enzymes (acetaminophen overdose).
Treatment: Naloxone for opioid toxicity; acetylcysteine for acetaminophen overdose; supportive care.
Storage and Handling
Storage: Store at room temperature, away from moisture and heat.
Stability: Stable until the expiration date printed on the package.