Classifications: analgesic; narcotic (opiate) agonist; Therapeutic: narcotic analgesic; opiate agonist
Prototype: Morphine sulfate
Pregnancy Category: C
50 mg tablets; 50 mg orally disintegrating tablets
Centrally acting opiate receptor agonist that inhibits the uptake of norepinephrine and serotonin, suggesting both opioid
and nonopioid mechanisms of pain relief. May produce opioid-like effects, but causes less respiratory depression than morphine.
Effective agent for control of moderate to moderately severe pain.
Management of moderate to moderately severe pain.
Hypersensitivity to tramadol or other opioid analgesics; patients on MAO inhibitors; patients acutely intoxicated with alcohol,
hypnotics, centrally acting analgesics, opioids, or psychotropic drugs; substance abuse; patients on obstetric preoperative
medication; abrupt discontinuation; alcohol intoxication; pregnancy (category C); lactation; children <16 y.
Debilitated patients; chronic respiratory disorders; respiratory depression; older adults; liver disease; renal impairment;
myxedema, hypothyroidism, or hypoadrenalism; GI disease; acute abdominal conditions; increased ICP or head injury, increased
intracranial pressure; history of seizures; patients >75 y.
Route & Dosage
Adult: PO 50100 mg q46h prn (max: 400 mg/d), may start with 25 mg/d if not well tolerated, and increase by 25 mg q3d up
to 200 mg/d
Geriatric: PO 50100 mg q46h prn (max: 300 mg/d), may start with 25 mg/d if not well tolerated, and increase by 25 mg q3d up
to 200 mg/d
Clcr <30 mL/min: decrease to 50100 mg q12h
Cirrhosis: decrease to 50100 mg q12h
- Note: Dosage reduction is recommended for patients with renal insufficiency and hepatic impairment.
- Store at 15°30° C (59°86° F).
Adverse Effects (≥1%)CNS:
Drowsiness, dizziness, vertigo, fatigue, headache, somnolence,
restlessness, euphoria, confusion, anxiety, coordination disturbance, sleep disturbances, seizures. CV:
Palpitations, vasodilation. GI: Nausea, constipation,
vomiting, xerostomia, dyspepsia, diarrhea, abdominal pain, anorexia, flatulence. Body as a Whole:
Sweating, anaphylactic reaction
(even with first dose), withdrawal syndrome (anxiety, sweating, nausea, tremors, diarrhea, piloerection, panic attacks,
paresthesia, hallucinations) with abrupt discontinuation. Skin:
Rash. Special Senses:
Visual disturbances. Urogenital:
Urinary retention/frequency, menopausal symptoms.
Diagnostic Test Interference
Increased creatinine, liver enzymes; decreased hemoglobin; proteinuria.
significantly decreases tramadol levels (may need up to twice usual dose). Tramadol may increase adverse effects of mao inhibitors
. tricyclic antidepressants
, cyclobenzaprine, phenothiazines
, selective serotonin-reuptake inhibitors (ssri
s), mao inhibitors
may enhance seizure risk with tramadol. May increase CNS adverse effects when used with other cns depressants
. Herbal: St. John's wort
may increase sedation.
Rapidly absorbed from GI tract; 75% reaches systemic circulation. Onset:
3060 min. Peak:
2 h. Duration:
37 h. Distribution:
Approximately 20% bound to plasma proteins; probably crosses bloodbrain barrier; crosses placenta; 0.1% excreted
into breast milk. Metabolism:
Extensively in liver by cytochrome P450 system. Elimination:
Primarily in urine. Half-Life:
Assessment & Drug Effects
- Assess for level of pain relief and administer prn dose as needed but not to exceed the recommended total daily dose.
- Monitor vital signs and assess for orthostatic hypotension or signs of CNS depression.
- Discontinue drug and notify physician if S&S of hypersensitivity occur.
- Assess bowel and bladder function; report urinary frequency or retention.
- Use seizure precautions for patients who have a history of seizures or who are concurrently using drugs that lower the seizure
- Monitor ambulation and take appropriate safety precautions.
Patient & Family Education
- Exercise caution with potentially hazardous activities until response to drug is known.
- Understand potential adverse effects and report problems with bowel and bladder function, CNS impairment, and any other bothersome
adverse effects to physician.