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Ultram ER(trade name),
Zytram XL(trade name)
Pregnancy Category: C
Moderate to moderately severe pain (extended-release formulations indicated for patients who require around-the-clock pain management).
Binds to μ-opioid receptors.
Inhibits reuptake of serotonin and norepinephrine in the CNS.
Absorption: Immediate-release—75% absorbed after oral administration; Extended-release (Ultram)—85–90% (compared with immediate-release).
Distribution: Crosses the placenta; enters breast milk.
Metabolism and Excretion: Mostly metabolized by the liver; one metabolite has analgesic activity; 30% is excreted unchanged in urine.
Half-life: Tramadol—6–8 hr, ER—7.9 hr; active metabolite—7–9 hr; both are ↑ in renal or hepatic impairment.
Time/action profile (analgesia)
|PO||1 hr||2–3 hr||4–6 hr|
|ER||unknown||12 hr||24 hr|
Contraindicated in: Hypersensitivity;Cross-sensitivity with opioids may occur;Patients who are acutely intoxicated with alcohol, sedatives/hypnotics, centrally acting analgesics, opioid analgesics, or psychotropic agents;Patients who are physically dependent on opioid analgesics (may precipitate withdrawal); Obstetric / Lactation: Pregnancy or lactation;ER only—CCr <30 mL/min or hepatic impairment.
Use Cautiously in: Geriatric: Immediate-release—Not to exceed 300 mg/day in patients >75 yr; ER—Use with extreme caution in patients >75 yr;Patients with a history of epilepsy or risk factors for seizures;Renal impairment (↑ dosing interval recommended if CCr <30 mL/min);Hepatic impairment (↑ dosing interval recommended in patients with cirrhosis);Patients receiving MAO inhibitors, neuroleptics, SSRIs, or TCAs, or other CNS depressants;Patients who are suicidal or prone to addiction (↑ risk of suicide);Excessive use of alcohol (↑ risk of suicide);↑ intracranial pressure or head trauma;Patients with a history of opioid dependence or who have recently received large doses of opioids; Pediatric: Children <16 yr (safety not established).
Adverse Reactions/Side Effects
Central nervous system
- seizures (life-threatening)
- dizziness (most frequent)
- headache (most frequent)
- somnolence (most frequent)
- CNS stimulation
- coordination disturbance
- sleep disorder
Ear, Eye, Nose, Throat
- visual disturbances
- constipation (most frequent)
- nausea (most frequent)
- abdominal pain
- dry mouth
- menopausal symptoms
- urinary retention/frequency
- serotonin syndrome (life-threatening)
- physical dependence
- psychological dependence
Drug-Drug interaction↑ risk of CNS depression when used concurrently with other CNS depressants, including alcohol, antihistamines, sedative/hypnotics, opioid analgesics, anesthetics, or psychotropic agents.↑ risk of seizures with high doses of penicillins, cephalosporins, phenothiazines, opioid analgesics, or antidepressants.Carbamazepine ↑ metabolism and ↓ effectiveness of tramadol (increased doses may be required).Use cautiously in patients who are receiving MAO inhibitors (↑ risk of adverse reactions).Quinidine, fluoxetine, paroxetine, amitriptyline, ketoconazole, and erythromycin may ↑ levels.↑ risk of serotonin syndrome when used with SSRI and SNRI antidepressants, TCAs, MAO inhibitors, 5HT1 agonists, CYP2D6 inhibitors, and CYP3A4 inhibitors.Concomitant use of kava-kava, valerian, or chamomile can ↑ CNS depression.↑ risk of serotonin syndrome when used with St. Johns' wort.
Oral (Adults ≥18 yr) Rapid titration—50–100 mg q 4–6 hr (not to exceed 400 mg/day [300 mg in patients >75 yr]). Gradual titration—25 mg/day initially, ↑ by 25 mg/day q 3 days to reach dose of 25 mg 4 times daily, then ↑ by 50 mg/day q 3 days to reach dose of 50 mg 4 times daily; may then use 50–100 mg q 4–6 hr (maximum dose = 400 mg/day).
Renal ImpairmentOral (Adults) CCr <30 mL/min—↑ dosing interval to q 12 hr (not to exceed 200 mg/day).
Hepatic ImpairmentOral (Adults) 50 mg q 12 hr.
Oral (Adults) Ultram ER and Conzip (not currently receiving immediate-release)—100 mg once daily initially, may then titrate q 5 days up to 300 mg/day; Ultram ER and Conzip (currently receiving immediate-release)—calculate 24-hr total dose of immediate-release product and give same dose (rounded down to next lowest 100-mg increment) of ER once daily (maximum dose = 300 mg/day).
Availability (generic available)
Tablets: 50 mg Cost: Generic — $83.40 / 100
Extended-release capsules (Conzip): 100 mg, 200 mg, 300 mg Cost: 100 mg $232.19 / 30, 200 mg $289.79 / 30, 300 mg $365.98 / 30
Extended-release tablets (Ultram ER): 100 mg, 200 mg, 300 mg Cost: Generic — 100 mg $126.95 / 30, 200 mg $209.95 / 30, 300 mg $292.93 / 30In combination with: acetaminophen (Ultracet). See combination drugs.
- Assess type, location, and intensity of pain before and 2–3 hr (peak) after administration.
- Assess BP and respiratory rate before and periodically during administration. Respiratory depression has not occurred with recommended doses.
- Assess bowel function routinely. Prevention of constipation should be instituted with increased intake of fluids and bulk and with laxatives to minimize constipating effects.
- Assess previous analgesic history. Tramadol is not recommended for patients dependent on opioids or who have previously received opioids for more than 1 wk; may cause opioid withdrawal symptoms.
- Prolonged use may lead to physical and psychological dependence and tolerance, although these may be milder than with opioids. This should not prevent patient from receiving adequate analgesia. Most patients who receive tramadol for pain do not develop psychological dependence. If tolerance develops, changing to an opioid agonist may be required to relieve pain.
- Monitor patient for seizures. May occur within recommended dose range. Risk is increased with higher doses and in patients taking antidepressants (SSRIs, SNRIs, tricyclics, or MAO inhibitors), opioid analgesics, or other drugs that decrease the seizure threshold. Also monitor for serotonin syndrome (mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) in patients taking these drugs concurrently.
- Lab Test Considerations: May cause ↑ serum creatinine, ↑ liver enzymes, ↓ hemoglobin, and proteinuria. Overdose may cause respiratory depression and seizures. Naloxone may reverse some, but not all, of the symptoms of overdose. Treatment should be symptomatic and supportive. Maintain adequate respiratory exchange. Hemodialysis is not helpful because it removes only a small portion of administered dose. Seizures may be managed with barbiturates or benzodiazepines; naloxone increases risk of seizures.
Potential Nursing DiagnosesAcute pain (Indications)
Risk for injury (Side Effects)
- Do not confuse tramadol with trazodone.
- Tramadol is considered to provide more analgesia than codeine 60 mg but less than combined aspirin 650 mg/codeine 60 mg for acute postoperative pain.
- For chronic pain, daily doses of 250 mg of tramadol provide pain relief similar to that of 5 doses/day of acetaminophen 300 mg/codeine 30 mg, 5 doses/day of aspirin 325 mg/codeine 30 mg, or 2–3 doses/day of acetaminophen 500 mg/oxycodone 5 mg.
- Explain therapeutic value of medication before administration to enhance the analgesic effect.
- Regularly administered doses may be more effective than prn administration. Analgesic is more effective if given before pain becomes severe.
- Tramadol should be discontinued gradually after long-term use to prevent withdrawal symptoms.
- Oral: Tramadol may be administered without regard to meals. Swallow extended-release tablets and capsules whole; do not crush, break, dissolve, or chew .
- Instruct patient on how and when to ask for pain medication.
- May cause dizziness and drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
- Advise patient to change positions slowly to minimize orthostatic hypotension.
- Caution patient to avoid concurrent use of alcohol or other CNS depressants with this medication. Advise patient to notify health care professional before taking other RX, OTC, or herbal products concurrently.
- Advise patient to notify health care professional if seizures or if symptoms of serotonin syndrome occur.
- Encourage patient to turn, cough, and breathe deeply every 2 hr to prevent atelectasis.
- Advise female patients to notify health care professional if pregnancy is planned or suspected, or if breast feeding.
- Decrease in severity of pain without a significant alteration in level of consciousness or respiratory status.
A trademark for the drug tramadol hydrochloride.