Drug Interactions between Targiniq ER and tramadol

GENERALLY AVOID: Concomitant use of tramadol with other central nervous system (CNS) depressants including other opioids may result in profound sedation, respiratory depression, coma, and death. The risk of hypotension and seizures may also be increased. In patients who have been previously dependent on or chronically using opioids, tramadol can reinitiate physical dependence or precipitate withdrawal symptoms.

MANAGEMENT: Concomitant use of tramadol with other opioids should generally be avoided. If coadministration is necessary, the dosage and duration of each drug should be limited to the minimum required to achieve desired clinical effect. Patients should be monitored closely for development of seizures, respiratory depression and sedation, and advised to avoid driving or operating hazardous machinery until they know how these medications affect them. Cough medications containing opioids (e.g., codeine, hydrocodone) should not be prescribed to patients on tramadol. In addition, tramadol should not be used in opioid-dependent patients, and use in patients who are chronically on opioids is also not recommended. Tramadol is contraindicated in patients with acute opioid intoxication.

MONITOR: This warning does not apply to the naloxone component in non-injectable formulations of naloxone-containing combination medicines. Naloxone injection is an antagonist that will reverse the actions of opiates. This reversal can occur when the opiate drug is being used clinically and when it is being abused. Physically dependent patients may experience withdrawal symptoms. Abrupt postoperative opioid reversal has resulted in hypotension, ventricular tachycardia and fibrillation, pulmonary edema, cardiac arrest, encephalopathy, and death.

MANAGEMENT: Patients receiving naloxone injection should be monitored for changes in vital signs, nausea, vomiting, diarrhea, aches, fever, runny nose, sneezing, nervousness, irritability, shivering, abdominal cramps.

MONITOR: Concomitant use of pure opioid antagonists, such as naloxone and naltrexone may reduce the therapeutic effects and/or precipitate withdrawal symptoms in patients treated with tramadol or tapentadol. The partial analgesic activity of tramadol or tapentadol due to mu-opioid receptor agonist activity can be antagonized by the mu-opioid receptor antagonists naloxone and naltrexone. It should be noted that tramadol and tapentadol have low affinity binding for the mu-opioid receptor compared with other opiates. For example, tapentadol has 18 times less binding affinity than morphine to the mu-opioid receptor. However, these opioid antagonists may still precipitate withdrawal symptoms in patients who are physically dependent on tramadol or tapentadol. Furthermore, the opioid antagonist naloxone has been recommended for clinically significant respiratory or circulatory depression secondary to tramadol or tapentadol overdose. However, the risk of seizures may be increased when naloxone is used to treat a tramadol overdose.

MANAGEMENT: Caution and clinical monitoring are recommended when pure opioid antagonists, such as naloxone and naltrexone are used concomitantly with tramadol or tapentadol. A non-opioid therapeutic alternative or a dosage adjustment for tramadol or tapentadol may be considered if concomitant use of an opioid antagonist is unavoidable. Patients with a suspected tramadol overdose should be closely monitored for seizure activity if an opioid antagonist is used to treat the overdose.