Tramadol recommendations
Usual Adult Dose for Chronic Pain
Extended-Release (ER):
18 years or older (tramadol-naive): 100 mg orally once a day
-Individually titrate in 100 mg increments every 5 days to an effective dose that minimizes adverse reactions
-Maximum Dose: 300 mg/day
For patients CURRENTLY receiving Immediate-Release (IR) Tramadol:
Initial Dose: Calculate 24-hour IR requirement and initiate with a total daily ER dose rounded down to the next lowest 100 mg increment orally once a day
Conversion from OTHER Opioids: Discontinue all other around the clock opioid drugs prior to initiating therapy
-Initial dose: 100 mg ER orally once a day
-Individually titrate in 100 mg increments every 5 days to an effective dose that minimizes adverse reactions
-Maximum Dose: 300 mg/day
Comments:
-Due to limitations of dose selection with ER formulations, some patients may not be able to convert from the IR to ER.
-The ER products should not be used with other tramadol products and should not be taken more often than once a day.
-Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of therapy and following dose increases.
-For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, tolerability can be improved by initiating slowly, possibly with the immediate-release product.
-This drug is not recommended for patients less than 18 years old.
Use: For the management of pain severe enough to require around-the-clock long-term opioid treatment for which alternative treatment options are inadequate.
Usual Geriatric Dose for Pain
Dose selection should be cautious generally starting at the low end of the dose range
Over 75 years:
Maximum dose of Immediate-release: 300 mg per day
Comments:
-Respiratory depression is the chief risk for elderly patients treated with opioids; titrate dose slowly and monitor closely for signs of central nervous system and respiratory depression.
-Because this drug is substantially excreted by the kidney, consider monitoring renal function.
Usual Geriatric Dose for Chronic Pain
Dose selection should be cautious generally starting at the low end of the dose range
Over 75 years:
Maximum dose of Immediate-release: 300 mg per day
Comments:
-Respiratory depression is the chief risk for elderly patients treated with opioids; titrate dose slowly and monitor closely for signs of central nervous system and respiratory depression.
-Because this drug is substantially excreted by the kidney, consider monitoring renal function.
Usual Pediatric Dose for Pain
Tramadol is not recommended for use in pediatric patients
17 years or older: See Adult Dose
Renal Dose Adjustments
Immediate-release:
-CrCl less than 30 mL/min: Increase dosing interval to every 12 hours; Maximum dose should not exceed 200 mg per day
Extended-release:
-CrCl less than 30 mL/min: Use is not recommended
Liver Dose Adjustments
Immediate-release:
-Patients with cirrhosis: 50 mg orally every 12 hours
Extended-release:
-Severe hepatic impairment (Child-Pugh Class C): Use is not recommended
Dose Adjustments
Concomitant use of Drugs affecting CYP450 Isoenzymes:
-CYP450 3A4 inhibitors/inducers and CYP450 2D6 inhibitors: Interactions are complex, consult drug interaction monographs
For patients who have received this drug for an extended-period:
-Gradually decrease dose by 25% to 50% every 2 to 4 days
-If patient develops signs or symptoms of withdrawal, raise the dose to the previous level and taper more slowly by either increasing the interval between decreases, decreasing the amount of change in dose, or both.
-Do not abruptly discontinue therapy, especially for patients receiving extended-release product.
Precautions
US BOXED WARNINGS: ADDICTION, ABUSE AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYP450 ISOENZYMES; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS:
-Addiction, Abuse, and Misuse: Use of this drug exposes patients and other users to the risks of opioid addiction and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions.
-Opioid Analgesic REMS: To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, a REMS is required for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program; counsel patients and/or their caregivers, with every prescription on safe use, serious risks, storage, and disposal of these products; emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.
-Life-Threatening Respiratory Depression: Serious life-threatening or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase.
-Accidental Ingestion of/exposure to even one dose, especially by children, can result in a fatal overdose.
-Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threatening Respiratory Depression in Children: Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases occurred following tonsillectomy and/or adenoidectomy, and in at least 1 case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP450 2D6 polymorphism. This drug is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid use in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol.
-Neonatal Opioid Withdrawal Syndrome may result from prolonged maternal opioid use during pregnancy; it may be life-threatening if not recognized and treated; management according to protocols developed by neonatology experts will be required. If opioid use is needed for a prolonged period in a pregnant woman, she should be advised of the risk of neonatal opioid withdrawal syndrome and ensure appropriate treatment be available.
-Concomitant use or discontinuation of CYP450 isoenzymes including CYP450 3A4 inducers, CYP450 3A4 inhibitors, or CYP450 2D6 inhibitors are complex; concomitant use requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1.
-Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.
CONTRAINDICATIONS:
-Children less than 12 years of age
-Postoperative pain management in pediatric patients undergoing tonsillectomy and/or adenoidectomy
-Hypersensitivity (e.g., anaphylaxis) to the active substance
-Significant respiratory depression
-Acute or severe bronchial asthma, in an unmonitored setting or in the absence of resuscitative equipment
-Known or suspected gastrointestinal obstruction, including paralytic ileus
-Concomitant use or within 2 weeks of monoamine oxidase inhibitors (MAOIs)
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
US Controlled Substance: Schedule IV
Dialysis
Hemodialysis patients can receive their regular dose on dialysis days since only 7% of dose is removed
Peritoneal dialysis: No data available
