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Tramadol 150 mg tablets are administered with food once nightly. A dose may vary from 10 to 100 mg, depending on metabolism and response. There are limited data regarding the pharmacokinetics of tramadol 150 mg tablets on body surface area (TBSA). At steady state, the half-life of tramadol 150 mg tablets is 7 ½ hours and the terminal half-life is 11 hours. In postmarketing clinical studies, the median elimination half-life was 8 hours for tramadol 150 mg tablets and 10 hours for tramadol 200 mg tablets when compared to tramadol 300 mg tablets (Bayer Australia Pty Ltd, 2012; Clinical Trials and Pharmaceutical Evaluation Division - APhA Biopharmaceutical Corporation, May 17, 2011). It is noted that the terminal half-life of tramadol is approximately 12 hours when given in a single dose and approximately 14 hours when given in two to four divided doses (Davies-Prowse et al., 2012). The pharmacodynamic profiles following chronic treatment with tramadol 300 mg tablets or without placebo were compared and it was concluded that these effects were not different for the two dosage forms (Roche Australia Pty Ltd, 2011). There are no data regarding the pharmacokinetics of tramadol 150 mg tablets on thyroid function or thyroxine concentrations. Clinical Trials In a multi-centre, placebo-controlled, multicentre, randomised, double-blind, 24-week trial, patients with chronic migraine aura, who received 30 mg of tramadol 150 capsules twice daily (n=12) or placebo (n=23) for four weeks, were compared (Bayer Australia Pty Ltd, 2013). The primary efficacy outcome was reduction in the primary migraine type (including disabling headache, as defined by the National Headache Classification) as measured by a visual analog scale (VAS) at week 24. Primary efficacy and tolerability endpoints of the study were also evaluated as the primary outcome. Outcome Measure: Mean change on the visual analog scale for week 24. The primary efficacy endpoint showed significant reduction on the visual analog scale for week 24 in the tramadol group only, where a mean change was -0.61 points (CI 93 to 10), and no significant change was seen in the placebo group. tramadol group, there was a significant reduction in the number of people who achieved a full rating of relief their migraine headache(s), where a mean reduction was -6.2 (CI 12.6 to -10.2) in the tramadol group and -2.5 (CI 2.1 to -4.2) in the placebo group on a 100 mm visual analogue scale (VAS). The tolerability endpoints showed a mean decrease on the patient rating of nausea and vomiting -7.1 (CI 8.7 to 0.5) in the tramadol group and no significant changes (reductions) were seen in both groups. A mean decrease on the patient rating of pain for week 24 (from 14.4 to 4.4) in the tramadol group and a means change of -5.6 (CI 7.3 to 3.0) in the placebo group were reported on the VAS. In the tramadol group, no new safety concerns were identified following dose administration. In the tramadol group, a total of 11 patients withdrew due to adverse events compared 14 in the placebo group, and two dropped out due to treatment-emergent adverse events (TEAEs) in the tramadol group, and none in the placebo group. There was no difference between the number of patients reporting a pain-free interval or duration in either the tramadol (1.4±0.27, 2.5±0.24) or placebo (1.0±0.4, 2.0±0.5) groups. The mean pain-free interval in tramadol group was 13±1 hours and the mean pain-free duration was 10 hours. The mean pain-free interval in placebo group was 12±2 hours and longer than the mean pain-free duration in both tramadol (7.7±2.7) and placebo groups. The most common adverse events, which were reported at least twice by 80% of tramadol-treated patients, were nausea, fatigue, headache, somnolence, dizziness, rash, rash related to the study drug, and rash related to the placebo (n=12), with no other serious or life-threatening events reported. Sixteen patients (21%) reported at least 1 TEAE, none in the tramadol group(n=2), 50 mg tablet of tramadol and five (7%) in the placebo group(n=1). The mean increase on visual.
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