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Tramadol ER

Class
Narcotic analgesics
Subclass
Synthetic opioids
Substance name
traMADol hydrochloride ER
Brand names
Conzip®
Common formulations
Capsule
See also
Tramadol (Ultram®, Qdolo®)
Dosage and administration
Adults patients
Symptomatic relief
Pain • Severe, requiring opioids
•
Start at: 100 mg PO daily
•
Maintenance: 100-300 mg PO daily
•
Maximum: 300 mg per day
Titrate in 100 mg increments every 5 days to response. Calculate the 24-hour tramadol IR dose, if used, and adjust the total daily dose rounded down to the nearest 100 mg increment. Consider tapering dose by < 10-25% every 2-4 weeks when discontinuing.
Treatment
Postherpetic neuralgia • Off-label
•
Maintenance: 100-200 mg PO daily
•
Maximum: 400 mg per day
Restless legs syndrome • Refractory • Off-label
•
Start at: 100 mg PO daily
•
Maintenance: 100-200 mg PO daily
Other off-label uses
•
Treatment of fibromyalgia
Indications for use
Labeled indications
Adults
•
Symptomatic relief of pain (severe, requiring opioids)
Off-label indications
Adults
•
Treatment of fibromyalgia
•
Treatment of postherpetic neuralgia
•
Treatment of restless legs syndrome (refractory)
Safety risks
Boxed warnings
Drug misuse, drug abuse, opioid use disorder
•
Use extreme caution in all patients, especially with a personal or family history of substance abuse or mental illness.
Increased serum tramadol levels, decreased serum tramadol levels
•
Use extreme caution in patients taking cytochrome CYP3A4 inducers or inhibitors or CYP2D6 inhibitors.
Neonatal abstinence syndrome
•
Use extreme caution in pregnant patients.
Profound sedation, respiratory depression, coma
•
Use extreme caution in patients receiving benzodiazepines or other CNS depressants, including alcohol.
Respiratory depression
•
Use extreme caution for accidental ingestion, especially in children.
Respiratory depression, apnea
•
Use extreme caution in all patients, especially in elderly, malnourished, or frail patients or patients with significant pulmonary disease. Monitor for respiratory depression, especially after initiation and dose titration.
Respiratory depression, death
•
Do not use in children < 12 years of age.
Contraindications
Hypersensitivity to tramadol or its components or other opioids
Acute or severe asthma
•
Do not use hydrocodone in patients with acute or severe asthma in an unmonitored setting or in the absence of resuscitative equipment.
Circulatory shock
Gastrointestinal obstruction
•
Do not use tramadol in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.
Impaired consciousness or coma
Significant respiratory depression
Suicidal ideation or prone to addiction
Concomitant use of MAOIs
•
Do not use tramadol with or within 14 days of switching to or from MAOIs.
Warnings and precautions
Adrenal insufficiency, opioid-induced hyperalgesia
•
Maintain a high level of suspicion, as tramadol has been associated with an increased risk for these adverse events.
Decreased blood glucose
•
Use caution in patients with predisposing risk factors, such as diabetes.
Decreased serum sodium, decreased blood glucose
•
Maintain a high level of suspicion, as tramadol has been associated with an increased risk for these adverse events.
Exacerbation of increased ICP
•
Use caution in patients with increased ICP, brain tumor, or head injury.
Hypotension, syncope
•
Use caution in patients with reduced blood volume or taking other CNS depressants. Monitor BP after initiation and dose titration. Avoid use in patients with circulatory shock.
Mask symptoms of head injury
•
Use caution in patients with head injury. Avoid use in patients with impaired consciousness or coma.
Opioid withdrawal syndrome
•
Use extreme caution in patients taking mixed agonist/antagonist analgesics (such as pentazocine, nalbuphine, or butorphanol) or partial agonist analgesics (such as buprenorphine).
•
Do not discontinue abruptly in patients physically dependent on opioids.
Respiratory depression
•
Use caution in patients with significant COPD, cor pulmonale, substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression. Obtain monitoring, especially after initiation and dose titration.
Seizure
•
Use caution in patients taking higher doses of tramadol, concomitant use of SSRIs, TCAs, other tricyclic compounds, other opioids, neuroleptics, or naloxone, or with a history of a seizure disorder.
Serotonin syndrome
•
Use caution in patients taking serotonergic drugs.
Somnolence
•
Use extreme caution in patients performing activities requiring mental alertness, such as driving or operating machinery.
Sphincter of Oddi dysfunction
•
Use caution in patients with gastrointestinal disorders. Monitor patients with biliary tract disease for disease worsening, including acute pancreatitis.
Suicidal ideation
•
Use caution in patients with a history of misuse and/or taking CNS-active drugs, including tranquilizers or antidepressant drugs, excessive alcohol use, or having emotional disturbance or depression. Do not use in suicidal or addiction-prone patients.
Specific populations
Renal impairment
CrCl ≥ 30 mL/min
•
Use acceptable. No dose adjustment required.
CrCl < 30 mL/min
•
Do not use.
Renal replacement therapy
Continuous renal replacement
•
Do not use.
Intermittent hemodialysis
•
Do not use.
Peritoneal dialysis
•
Do not use.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required.
Child-Pugh C (severe)
•
Do not use.
Substantial chronic alcohol consumption
•
Use with caution.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: C
•
Avoid use. Evidence of fetal harm in humans. Monitor for neonatal opioid withdrawal syndrome. Monitor neonates for respiratory depression.
Breastfeeding
Do not use during breastfeeding.
Very low levels in breastfed infants (< 5%).
Unlikely to cause adverse effects in breastfed infants.
No overt adverse effects on lactation reported.
Adverse reactions
Very common > 10%
•
Constipation, dizziness, vertigo, headache, itching, nausea, skin flushing, somnolence, vomiting
Common 1-10%
•
Agitation, tremor, spasticity, emotional lability, hallucinations, hypotension, anxiety, confusion, euphoria, nervousness, hypertonia, hypertension, visual disturbances, blurred vision, ↑ serum CK, miosis, weakness, lethargy, fatigue, rhinorrhea, nasal congestion, sleeping disorder, abdominal pain, loss of appetite, skin rash, hypoesthesia, restlessness, arthralgia, asthenia, chills, flu-like symptoms, chest pain, diarrhea, dry mouth, dyspepsia, insomnia, malaise, fever, cough, back pain, paresthesia, dyspnea, peripheral edema, myalgia, flatulence, sweating, urinary frequency, urinary retention
Uncommon < 1%
•
Acute pancreatitis, serotonin syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, ↓ platelet count, myocardial infarction, anaphylaxis, serotonin syndrome, palpitations, accidental injury, weight loss, suicidal ideation, orthostatic hypotension, gait disturbance, memory impairment, cognitive impairment, depression, difficulty concentrating, paresthesia, seizure, tachycardia, syncope, mydriasis, cardiac arrhythmias, urticaria, dysgeusia, dysuria, ↓ libido
Unknown frequency
•
↓ blood glucose, ↓ serum sodium, ↑QT interval, angioedema, bronchospasm, respiratory depression, opioid use disorder, opioid withdrawal syndrome, adrenal insufficiency, pulmonary edema
Interactions
Drug(s)
Check Interactions
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