Precautions and Warnings With Orally Disintegrating Tramadol

People with head injuries must use extreme caution when taking orally disintegrating tramadol. There are many other warnings and precautions for this drug, including being aware that it can increase your risk of seizures, irregular breathing, and dizziness. If you are allergic to morphine, hydrocodone, or other opioids, you should not take this medication.

What Should I Tell My Healthcare Provider?

This medication is no longer available, as it has been discontinued by the manufacturer. Other tramadol products are still available. 
You should talk with your healthcare provider prior to taking orally disintegrating tramadol (Rybix™ ODT) if you have:
  • A history of drug or alcohol dependence
  • Suicidal thoughts or behaviors
  • Seizures or epilepsy
  • Liver disease, such as cirrhosis, liver failure, or hepatitis
  • Kidney disease, such as kidney failure (renal failure)
  • A head injury or high intracranial pressure
  • Severe abdominal (stomach) pain
  • Lung disease of any sort
  • Phenylketonuria
  • Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
Make sure to tell your healthcare provider about any other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Orally Disintegrating Tramadol Precautions and Warnings

Warnings and precautions to be aware of prior to taking orally disintegrating tramadol include the following:
  • Orally disintegrating tramadol should not be prescribed to people with suicidal tendencies. This medication can be lethal in the case of overdose, especially if combined with alcohol.
  • This drug can cause seizures, especially in people who have a history of seizures, who are withdrawing from alcohol or narcotics, who have a head injury, or who take certain medications (see Tramadol and Seizures for more information).
  • Even though orally disintegrating tramadol is not a controlled substance in most states, it still has a significant potential for abuse. It is not a good choice for people who have a history of addiction to alcohol or drugs (see Tramadol Abuse). Do not take the drug more frequently, longer, or at a higher dose than prescribed. If you feel you may be developing a problem with orally disintegrating tramadol, please seek help from your healthcare provider.
  • Orally disintegrating tramadol can cause a dangerous group of symptoms known as serotonin syndrome. This is most common when orally disintegrating tramadol is combined with certain other medications (see Tramadol and Serotonin Syndrome for more information).
  • This product can cause slow and irregular breathing. In severe situations, this may be life-threatening. This may be especially dangerous in people with lung problems.
  • The medication can cause problems in people with head injuries or high intracranial pressure. Orally disintegrating tramadol should only be used with extreme caution in such circumstances.
  • Orally disintegrating tramadol can interfere with the diagnosis of many conditions that cause severe abdominal (stomach) pain.
  • This medication can cause dizziness and drowsiness, and may increase the risk of falls in elderly people.
  • This medication contains phenylalanine. This is important for people with phenylketonuria, who must closely monitor their phenylalanine intake.
  • Do not drive or operate heavy machinery until you know how orally disintegrating tramadol affects you. Your reflexes and reaction times may be significantly affected, even if you feel fine.
  • Orally disintegrating tramadol can potentially interact with several other medications (see Drug Interactions With Orally Disintegrating Tramadol).
  • Orally disintegrating tramadol is considered a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are not known (see Tramadol and Pregnancy).
  • Orally disintegrating tramadol passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Tramadol and Breastfeeding).
Alternative Therapies for Pain Management

Orally Disintegrating Tramadol Information

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