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Tramadol Sustained-Release Capsules

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Abstract

▴ Tramadol is a synthetic, centrally acting analgesic. A sustained-release (SR) capsule formulation of tramadol gradually releases active drug, allowing for twice-daily dosing.

▴ Compared with tramadol SR tablets, tramadol SR capsules produced a smoother plasma concentration profile, with more gradual absorption and lower peak concentrations. There was less intra- and inter-subject variability in tramadol plasma concentrations with SR capsules versus SR tablets.

▴ Tramadol SR capsules had identical bioavailability to tramadol immediate-release (IR) capsules with lower peak concentrations and less fluctuation in plasma concentrations.

▴ Tramadol SR 100mg capsules administered twice daily had equivalent efficacy to tramadol IR 50mg capsules administered four times daily in the treatment of moderate to severe chronic low back pain in a well designed study. Patients receiving tramadol SR capsules were significantly less likely than those receiving tramadol IR capsules to report nausea.

▴ Starting treatment with tramadol SR capsules at a dosage of 50mg twice daily with subsequent dose escalation resulted in improved tolerability in patients with moderate to severe chronic pain.

▴ The lowest tramadol SR capsule dosage of 50mg twice daily (administered to 35% of patients with moderate to severe non-oncological pain) significantly improved pain intensity and frequency in 83.4% and 70.4% of patients, respectively, in a postmarketing observational study evaluating tramadol SR capsules 50–200mg twice daily (n = 3888).

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Notes

  1. Trade names include Tradonal® Retard, Zamadol® SR caps, Zamudol® LP, Tradonal® SR, Tramadol HCl Meda and Travex®. The use of trade names is for product identification purposes only and does not imply endorsement.

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  1. Adis International Limited, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, Auckland, New Zealand

    Gillian M. Keating

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  1. Gillian M. Keating
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Correspondence to Gillian M. Keating.

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Keating, G.M. Tramadol Sustained-Release Capsules. Drugs 66, 223–230 (2006). https://doi.org/10.2165/00003495-200666020-00006

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  • DOI: https://doi.org/10.2165/00003495-200666020-00006

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