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## Overview
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## Primary Indications
* Management of moderate to moderately severe pain.
## Adult Dosing
* **Immediate-release:** 1 to 2 tablets (containing acetaminophen 325 mg/tramadol 32.5 mg per tablet) every 4 to 6 hours as needed for pain.
* **Maximum daily dose:** 8 tablets (2600 mg acetaminophen, 260 mg tramadol) per 24 hours.
## Pediatric Dosing
* Safety and efficacy in pediatric patients have not been established.
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. A reduced dose may be necessary. Specific recommendations vary; consult prescribing information.
* **Renal Impairment:** Use with caution. A reduced dose and/or extended dosing interval may be necessary, particularly for moderate to severe impairment. Consult prescribing information.
## Contraindications
* Hypersensitivity to acetaminophen, tramadol, or any component of the formulation.
* Significant respiratory depression.
* Acute or severe asthma or other obstructive airway disease.
* Concurrent use with or use within 14 days of stopping a monoamine oxidase inhibitor (MAOI).
* In patients who are ultra-rapid metabolizers of CYP2D6.
## Adverse Effects
* **Common:** Nausea, vomiting, constipation, dizziness, somnolence, headache.
* **Serious:** Respiratory depression, seizures, serotonin syndrome, opioid withdrawal syndrome, liver damage (with exceeding recommended acetaminophen dose), hypersensitivity reactions, adrenal insufficiency, severe hypotension.
## Key Drug Interactions
* **CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine):** May increase tramadol plasma concentrations, increasing the risk of tramadol-related adverse effects, including potentially fatal respiratory depression.
* **CYP3A4 inhibitors (e.g., ketoconazole, erythromycin):** May increase concentrations of O-desmethyltramadol (M1), the active metabolite, potentially increasing the risk of seizures.
* **MAOIs:** Contraindicated due to risk of hypertensive crisis and other severe reactions.
* **CNS depressants (e.g., alcohol, benzodiazepines, sedatives):** Additive CNS depression, including respiratory depression and death.
* **Serotonergic agents (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants):** Increased risk of serotonin syndrome.
## Monitoring
* Pain assessment and efficacy.
* Signs and symptoms of respiratory depression.
* Signs and symptoms of serotonin syndrome.
* Signs of seizure activity.
* Signs of opioid withdrawal.
* Liver function tests if exceeding recommended acetaminophen dose or in patients with risk factors for liver toxicity.
## Clinical Pearls
* Due to the acetaminophen component, consider the total daily dose of acetaminophen from all sources to avoid exceeding the maximum recommended daily limit (typically 4000 mg/day for adults, but lower in certain populations or with chronic use).
* Tramadol is a Schedule IV controlled substance.
* The risk of seizures is increased with tramadol use, especially at higher doses or in patients with a history of seizures or taking medications that lower the seizure threshold.
* Advise patients about the risks of CNS depression and to avoid activities requiring mental alertness until they know how the drug affects them.
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*This information is intended for healthcare professionals. Always consult the most current prescribing information and relevant clinical guidelines for complete details and to ensure patient safety.*
