What is the dosing regimen for long-acting tramadol (tramadol hydrochloride) for pain management?

From the Guidelines

Long-acting tramadol (tramadol hydrochloride extended-release) should be initiated at 100 mg once daily for pain management, with the dose gradually increased by 100 mg every 5 days as needed, up to a maximum of 300 mg daily, as recommended by the NCCN panel 1. The dosing regimen for long-acting tramadol is crucial for effective pain management while minimizing the risk of adverse effects.

• The maximum daily dose of 300 mg for ER formulations is recommended for adults with normal hepatic and renal function 1.
• Elderly patients (75 years and older) and those with hepatic and/or renal dysfunction require lower doses to reduce the risk of seizures 1.
• Tramadol is less potent than other opioids, approximately one-tenth as potent as morphine, and its use should be carefully considered in the context of other available pain management options 1.
• Patients should be monitored for side effects, including dizziness, constipation, nausea, and the potential for dependence, and the medication should not be abruptly discontinued after prolonged use to prevent withdrawal symptoms.
• The use of long-acting tramadol should also take into account its potential interactions with other medications, such as MAO inhibitors and CNS depressants, and it is contraindicated in patients taking MAO inhibitors 1.

From the FDA Drug Label

DOSAGE & ADMINISTRATION Adults (17 years of age and over) For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, the tolerability of tramadol hydrochloride tablets, USP can be improved by initiating therapy with a titration regimen: The total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day (50 mg q.i.d.) After titration, tramadol hydrochloride tablets, USP 50 to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg/day The dosing regimen for long-acting tramadol (tramadol hydrochloride) for pain management is as follows:

• Initiation: Start with a titration regimen, increasing the total daily dose by 50 mg every 3 days to reach 200 mg/day (50 mg q.i.d.)
• Maintenance: Administer 50 to 100 mg as needed for pain relief every 4 to 6 hours, not to exceed 400 mg/day
• Individualization: Dose should be individualized according to patient need using the lowest beneficial dose 2 Key considerations:
• Patients with creatinine clearance less than 30 mL/min: increase dosing interval to 12 hours, with a maximum daily dose of 200 mg
• Dialysis patients: receive regular dose on the day of dialysis
• Patients with cirrhosis: 50 mg every 12 hours
• Elderly patients over 65 years old: cautious dose selection, starting at the low end of the dosing range
• Elderly patients over 75 years old: total dose should not exceed 300 mg/day 2

From the Research

Dosing Regimen for Long-Acting Tramadol

The dosing regimen for long-acting tramadol (tramadol hydrochloride) for pain management is as follows:

• The recommended dose is 100-300 mg once daily, with some studies using a flexible-dose approach and others using a fixed-dose approach 3
• The dose can be titrated by the patient between 100 and 400 mg once daily, according to the intensity of pain 4
• Tramadol ER can be administered once daily, with prolonged absorption and lower peak plasma concentrations compared to immediate-release tramadol 3
• The treatment can be administered for a continuous period of 4 weeks, followed by an intermittent intake of 5 months 4

Transitioning from Short-Acting to Long-Acting Tramadol

• Patients who are receiving short-acting tramadol for chronic/persistent pain can be transitioned to tramadol ER by calculating the current total daily dose of short-acting tramadol and starting tramadol ER at the nearest lower 100-mg-dose increment 5

Efficacy and Safety of Long-Acting Tramadol

• Long-acting tramadol has been shown to be effective in reducing pain in patients with chronic pain from osteoarthritis and improving pain-related sleep parameters, joint stiffness, and physical function 5, 6, 3
• Long-acting tramadol has been shown to be safe and well-tolerated, with common adverse events including dizziness, nausea, constipation, somnolence, and flushing 6, 4, 3
• Long-term use of tramadol LP was reasonably well tolerated, with most reported adverse events occurring within the first month of treatment 4