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tramadol and other non-opioid analgesics

N02AJ15

Forms & Strengths

Combination tablets: Tramadol hydrochloride / non-opioid analgesic (e.g., acetaminophen 37.5 mg / tramadol 325 mg)

Adult Dosing

1-2 tablets every 4 to 6 hours as needed for pain
Maximum dose: 8 tablets (300 mg tramadol / 3000 mg acetaminophen) per day

Pediatric Dosing

Not recommended for pediatric patients under 12 years of age
Safety and efficacy not established in children and adolescents

Indications

Management of moderate to moderately severe acute pain

Mechanism of Action

Dual-action analgesic: tramadol is a mu-opioid receptor agonist and weak inhibitor of norepinephrine and serotonin reuptake
Acetaminophen component acts centrally to inhibit prostaglandin synthesis, elevating the pain threshold

Contraindications

Hypersensitivity to tramadol, acetaminophen, or any component of the product
Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or lack of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus
Concurrent use with monoamine oxidase inhibitors (MAOIs) or use within 14 days

Adverse Reactions

Dizziness, somnolence, headache, fatigue
Nausea, vomiting, constipation, dry mouth
Sweating, flushing
Risk of severe skin reactions (acetaminophen component)
Seizures and serotonin syndrome associated with tramadol overdose or co-administration with serotonergic agents

Drug Interactions

CYP3A4 and CYP2D6 inhibitors or inducers may alter tramadol clearance and efficacy
Central nervous system (CNS) depressants (alcohol, sedatives, tranquilizers) increase risk of profound sedation, respiratory depression, and coma
Serotonergic drugs (SSRIs, SNRIs, MAOIs, triptans) increase risk of serotonin syndrome
Warfarin: potential for increased International Normalized Ratio (INR) and bleeding events with chronic acetaminophen use

Curated Content: Needs Vetting Before Put to Clinical Use