What is the recommended dose and frequency of Tramadol (Ultram)?

From the Guidelines

Tramadol should be prescribed at a maximum daily dose of 400 mg for immediate-release formulations (100 mg 4 times a day), or 300 mg/day for extended-release formulations, for adults with normal hepatic and renal function. The dosing of tramadol is crucial in managing pain effectively while minimizing the risk of adverse effects. According to the most recent guidelines 1, tramadol is a weak mu-opioid receptor agonist with some norepinephrine and serotonin reuptake inhibition, indicated for treating moderate to moderately severe pain.

Key Considerations for Tramadol Dosing

• The recommended starting dose is 50-100 mg every 4-6 hours as needed for pain.
• For extended-release formulations, the usual dosing is 100-300 mg once daily.
• Patients with kidney or liver impairment often require lower doses to reduce the risk of seizures.
• Tramadol works as both a weak opioid and by inhibiting serotonin and norepinephrine reuptake, providing pain relief through multiple mechanisms.
• Side effects may include dizziness, nausea, constipation, and drowsiness.

Important Safety Precautions

• It's essential to avoid abrupt discontinuation after prolonged use, as this can cause withdrawal symptoms.
• Patients should be aware that tramadol carries a risk of dependence and should not be combined with alcohol or other central nervous system depressants.
• Regular reassessment of pain control and continued need for the medication is recommended, as evidenced by studies such as 1 and 1.
• Tramadol should be used with caution or avoided in patients taking other serotonergic or monoamine oxidase inhibitors (MAOI)-like medications due to the risk of serotonin syndrome, as highlighted in 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 For the subset of patients for whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial doses, tramadol hydrochloride tablets, USP 50 mg to 100 mg can be administered as needed for pain relief every four to six hours, not to exceed 400 mg per day In all patients with creatinine clearance less than 30 mL/min, it is recommended that the dosing interval of tramadol hydrochloride tablets be increased to 12 hours, with a maximum daily dose of 200 mg. The recommended dose for adult patients with cirrhosis is 50 mg every 12 hours. In general, dose selection for an elderly patient over 65 years old should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. For elderly patients over 75 years old, total dose should not exceed 300 mg/day.

The recommended tramadol dose is:

• 50 to 100 mg every 4 to 6 hours as needed for pain relief, not to exceed 400 mg/day for adults with normal renal function
• 50 mg every 12 hours, with a maximum daily dose of 200 mg for patients with creatinine clearance less than 30 mL/min
• 50 mg every 12 hours for adult patients with cirrhosis
• Not to exceed 300 mg/day for elderly patients over 75 years old 2 Key points:
• The dose should be individualized according to patient need using the lowest beneficial dose
• Titration is recommended to improve tolerability in patients with moderate to moderately severe chronic pain
• Dose selection should be cautious in elderly patients over 65 years old, starting at the low end of the dosing range.

From the Research

Tramadol Dose and Frequency

• The provided studies do not directly address the specific dose and frequency of tramadol administration 3, 4, 5, 6.
• However, tramadol is mentioned as a treatment option for various pain conditions, including chronic pain 4, neuropathic pain 4, and spine-related pain in older adults 6.
• In the study on pharmacotherapy for spine-related pain in older adults, tramadol is noted to have some evidence of effectiveness in older patients, but more so in persons aged < 65 years 6.
• The study also mentions that tramadol can be well tolerated in older patients, but has risks of cognitive and classic opioid side effects 6.
• Another study compares the efficacy of pregabalin with tramadol/acetaminophen combination, suggesting that pregabalin is slightly less efficacious than the combination of tramadol/acetaminophen 5.