Therapeutic Classification: analgesics (centrally acting), opioid analgesics
Pharmacologic Classification: opioid agonists
High Alert
Absorption: Immediate-release: 75% absorbed after oral administration; Extended-release: 8590% (compared with immediate-release).
Distribution: Crosses the placenta; enters breast milk.
Half-Life: Tramadol (immediate release): 68 hr, Extended release: 7.9 hr; Active metabolite: 79 hr; both are ↑ in renal or hepatic impairment.
(analgesia)
ROUTE | ONSET | PEAK | DURATION |
---|---|---|---|
PO-immediate release | 1 hr | 23 hr | 46 hr |
PO-extended release | unknown | 12 hr | 24 hr |
Contraindicated in:
Use Cautiously in:
Derm: pruritus, sweating
EENT: visual disturbances
Endo: hypoglycemia
F and E: hyponatremia
GI: constipation, nausea, abdominal pain, anorexia, diarrhea, dry mouth, dyspepsia, flatulence, vomiting
GU: ↓fertility, menopausal symptoms, urinary retention/frequency
Neuro: dizziness, headache, somnolence, anxiety, confusion, coordination disturbance, euphoria, hypertonia, malaise, nervousness, SEIZURES, sleep disorder, stimulation, weakness
Resp: RESPIRATORY DEPRESSION (INCLUDING CENTRAL SLEEP APNEA AND SLEEP-RELATED HYPOXEMIA)
Misc: physical dependence, psychological dependence, tolerance
Drug-drug:
Drug-Natural Products:
Immediate Release
Extended Release
Renal Impairment
Hepatic Impairment
Lab Test Considerations:
Toxicity and Overdose:
FDA strongly encourages health care professionals to complete a REMS-compliant education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain, available at www.fda.gov/OpioidAnalgesicREMSBlueprint. Information on programs can be found at 1-800-503-0784 or www.opioidanalgesicrems.com.
Instruct patient on how and when to ask for pain medication. Do not stop taking without discussing with health care professional; may cause withdrawal symptoms if discontinued abruptly after prolonged use. Do not increase doses without discussing with health care professional; may lead to overdose. Discuss safe use, risks, and proper storage and disposal of opioid analgesics with patients and caregivers with each Rx. The Patient Counseling Guide is available at https://opioidanalgesicrems.com/patientCounselingGuide.html.
NDC Code