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Patients should be instructed that:

  • RYZOLT™ (tramadol hydrochloride extended-release tablets) is for oral use only and should be swallowed whole with a sufficient quantity of liquid and not split, chewed, dissolved or crushed.
  • RYZOLT™ (tramadol hydrochloride extended-release tablets) may cause seizures and/or serotonin syndrome with concomitant use of serotonergic agents (including SSRIs, SNRIs and triptans) or drugs that significantly reduce the metabolic clearance of tramadol.
  • RYZOLT™ (tramadol hydrochloride extended-release tablets) should be taken once daily, at approximately the same time every day and that exceeding these instructions can result in respiratory depression, seizures or death.
  • RYZOLT™ (tramadol hydrochloride extended-release tablets) should not be taken in doses exceeding the maximum recommended daily dose as exceeding these recommendations can result in respiratory depression, seizures or even death (See DOSAGE AND ADMINISTRATION)
  • RYZOLT™ (tramadol hydrochloride extended-release tablets) may impair the mental and physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Patients using this drug should be cautioned accordingly.
  • RYZOLT™ (tramadol hydrochloride extended-release tablets) should not be taken with alcohol-containing beverages.
  • RYZOLT™ (tramadol hydrochloride extended-release tablets) should be used with caution when taking medications such as tranquilizers, hypnotics or other opiate containing analgesics.
  • Female patients should be instructed to inform the physician if they are pregnant, think they might become pregnant, or are trying to become pregnant (See PRECAUTIONS - Pregnancy and Labor and Delivery).
  • Clinical experience suggests that signs and symptoms of withdrawal may be reduced by tapering medication when discontinuing tramadol therapy.
  • Patients should be informed to keep RYZOLT™ (tramadol hydrochloride extended-release tablets) out of reach of children.

Last reviewed on RxList: 3/2/2009
This monograph has been modified to include the generic and brand name in many instances.

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