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 (100 mg 4 times daily) for adults with normal hepatic and renal function, with lower doses recommended for older adults (age ≥75 years) and those with hepatic and/or renal dysfunction. When considering the use of tramadol, it is essential to weigh the potential benefits against the risks, including the potential for adverse effects such as vomiting, dizziness, and weakness, as well as the risk of seizures in patients with hepatic and/or renal dysfunction 1. The medication works by binding to opioid receptors and inhibiting the reuptake of serotonin and norepinephrine, providing pain relief through multiple mechanisms.

Some key points to consider when prescribing tramadol include:

• Starting at the lowest effective dose, especially in elderly patients or those with liver or kidney impairment
• Monitoring for side effects, such as dizziness, nausea, constipation, and drowsiness
• Being aware of the risks of dependence and withdrawal, and using the medication for the shortest duration necessary
• Avoiding abrupt cessation of tramadol after regular use, as this can cause withdrawal symptoms
• Individualizing dosing based on the patient's specific condition, medical history, and other medications they may be taking, as recommended by the NCCN panel 1.

It is also important to note that tramadol is less potent than other opioids and is considered to be approximately one-tenth as potent as morphine 1. Additionally, a Cochrane review of tramadol (with or without acetaminophen) concluded that limited evidence supports the use of tramadol for treatment of cancer pain and that tramadol is likely not as effective as morphine in this setting 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 specify a particular dose and frequency for tramadol administration 3, 4, 5, 6, 7.
• However, it is mentioned that tramadol is a mixed-mechanism opioid drug that exerts its effects via binding mu receptors and blocking the reuptake of monoamines 3.
• The therapeutic dose of tramadol does not cause major side effects in comparison to other opioid analgesics, but long-term utilization is associated with various neurological disorders 4.
• Tramadol-acetaminophen tablets are effective for reducing low back pain and have a prophylactic antidepressant effect in chronic low back pain patients with depression 5.
• Tramadol's serotonin and norepinephrine reuptake inhibitory effects result in a unique adverse effect profile, including the risk of serotonin syndrome and seizures 6.
• The risk of adverse drug interactions involving tramadol and other prescription or over-the-counter analgesic agents should be considered, particularly with regard to serotonin syndrome and gastrointestinal bleeding 7.