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    DEA Class; Rx

    Common Brand Names; Ultram, ConZip, Qdolo

    • Opioid Analgesics; 

    Oral opioid analgesic
    Used for the treatment of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate
    Associated with risk for seizures and suicidal tendency

    Indicated for moderate-to-severe pain management in adults which alternative therapies are inadequate

    Initiate dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse

    For the treatment of osteoarthritis of the hand, knee, or hip.
    For the treatment of diabetic neuropathy.
    For the treatment of refractory restless legs syndrome (RLS).
    For postherpetic neuralgia.
    For the treatment of refractory restless legs syndrome (RLS).

    Hypersensitivity to tramadol or opioids

    Known or suspected gastrointestinal obstruction, including paralytic ileus

    Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within last 14 days

    Children <12 years

    Postoperative management in children <18 years following tonsillectomy and/or adenoidectomy

    Severe/acute bronchial asthma in an unmonitored setting or in absence of resuscitative equipment

    Significant respiratory depression

    Immediate release

    • Constipation (24-46%)

    • Nausea (24-40%)

    • Dizziness/vertigo (26-33%)

    • Headache (18-32%)

    • Somnolence (16-25%)

    • Vomiting (9-17%)

    • CNS stimulation (7-14%)

    • Dyspepsia (5-13%)

    • Asthenia (6-12%)

    • Pruritus (8-11%)

    Extended release

    • Nausea (5.7-25.1%)

    • Headache (19-23.1%)

    • Constipation (4.2-21.3%)

    • Somnolence (4-16.1%)

    • Dizziness (4.8-13.6%)

    • Dry mouth (3.4-13.1%)

    • Vomiting (1.9-10.4%)

    Contains a Schedule IV controlled substance; exposes users to risks of addiction, abuse, and misuse

    Serotonin syndrome may occur; may be life-threatening; may occur with use of tramadol alone, with concomitant use of serotonergic drugs, with drugs that impair metabolism of serotonin or tramadol

    Serious, life-threatening, or fatal respiratory depression has been reported; also occurred in children treated with tramadol

    Opioids can cause sleep-related breathing disorders including central sleep apnea and sleep-related hypoxemia

    Prolonged use during pregnancy can result in withdrawal in the neonate

    Seizures have been reported; spontaneous postmarketing reports indicate that seizure risk is increased with doses

    May increase the risk of suicide

    Cases of adrenal insufficiency have been reported with opioid use, more often following >1 month of use; if adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids

    May cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients; monitor for signs of hypotension after initiating or titrating

    May impair mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery; advise not to drive or operate dangerous machinery unless tolerant to effects and aware of reaction to medication

    Spasm of the sphincter of Oddi reported; opioids may cause increases in serum amylase; monitor with biliary tract disease, including acute pancreatitis for worsening symptoms

    Serious and rarely fatal anaphylactic reactions have been reported

    Cases of tramadol-associated hypoglycemia reported; some resulting in hospitalization; in most cases, patients had predisposing risk factors (eg, diabetes); if hypoglycemia suspected, monitor blood glucose levels and consider drug discontinuation as appropriate

    Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome

    Tramadol and its active metabolite, O-desmethyltramadol (M1), are present in human milk


    400 mg/day PO for immediate-release formulations; 300 mg/day PO for extended-release formulations.


    65 to 75 years: 400 mg/day PO for immediate-release formulations; 300 mg/day PO for extended-release formulations.
    76 years and older: 300 mg/day PO.


    Safety and efficacy have not been established.


    12 years: Safety and efficacy have not been established.
    1 to 11 years: Use is contraindicated.


    Use is contraindicated.


    Use is contraindicated.

    Tramadol hydrochloride

    tablet, immediate-release: Schedule IV

    • 50mg (Ultram, generic)
    • 100mg (generic)

    capsule, extended release: Schedule IV

    • 100mg (ConZip)
    • 150mg (ConZip)
    • 200mg (ConZip)
    • 300mg (ConZip)

    solution, oral: Schedule IV

    • 5mg/mL (Qdolo)
    • Equivalent to tramadol 4.4 mg/mL