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

From the Guidelines

Tramadol should be prescribed at a starting dose of 50-100 mg every 4-6 hours as needed for pain, with a maximum daily dose of 400 mg, as recommended by the most recent guidelines 1. The dosage and frequency of tramadol may vary depending on the patient's condition, age, and renal function.

• For adults with normal hepatic and renal function, the maximum daily dose is 400 mg, which can be taken as 100 mg four times a day 1.
• For elderly patients or those with liver or kidney impairment, lower doses are recommended, usually starting at 50 mg and not exceeding 300 mg daily 1.
• Extended-release formulations are dosed once or twice daily, often starting at 100 mg daily and increasing as needed 1. Tramadol works by binding to opioid receptors and inhibiting the reuptake of serotonin and norepinephrine, providing pain relief through dual mechanisms 1. Some key points to consider when prescribing tramadol include:
• Patients should take tramadol with or without food consistently, and never crush or chew extended-release tablets.
• Tramadol carries risks of dependence and withdrawal symptoms, so it should be tapered gradually when discontinuing after prolonged use 1.
• Patients should avoid alcohol and use caution when driving or operating machinery while taking this medication 1. It's essential to weigh the benefits and risks of tramadol, considering its potential for adverse events, misuse, diversion, and addiction, especially when used as a second- or third-line treatment for chronic nonneuropathic pain 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
• 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
• Total dose should not exceed 300 mg/day for elderly patients over 75 years old 2 Key points to consider:
• Dose titration: The total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day
• Individualization of dose: Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose
• Elderly patients: Dose selection 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.

From the Research

Tramadol Dose and Frequency

• The ideal dose and frequency of tramadol are not explicitly stated in the provided studies, but we can gather some information about its usage from the following points:

Usage in Chronic Pain

• Tramadol is an effective analgesic for chronic pain syndromes, with a favorable adverse-effect profile 3.
• The level of evidence on the efficacy of tramadol for the treatment of chronic pain is globally low 4.

Combination Therapies

• Combination of tramadol with acetaminophen is postulated to act synergistically, potentially reducing adverse effects without reduction in analgesic efficacy 5.
• Tramadol and acetaminophen are a rational combination product, with mechanisms of action that do not overlap, and preclinical studies show that this combination acts synergistically 6.

Dosage Information

• A fixed-dose combination of paracetamol (325 mg) and tramadol (37.5 mg) is mentioned, but no information is provided about the optimal dosage or frequency of tramadol alone 7.
• A study mentions that a single dose of paracetamol 650 mg + tramadol 75 mg was used in acute dental pain studies, and paracetamol 975 mg + tramadol 112.5 mg was used in studies after gynaecological and orthopaedic surgery 7.
• Another study mentions that tramadol 75 mg plus acetaminophen 650 mg was used in acute dental pain studies, and the combination provided a rapid onset of action and sustained pain relief 6.