|
|
| Drug Name: | Tramadol Hydrochloride |
| Manufacturer: | TEVA PHARMACEUTICALS USA |
| Other Info: | |
| Clinical Trials: | |
Tramadol hydrochloride tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids.
Tramadol hydrochloride tablets are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs.
Tramadol may worsen central nervous system and respiratory depression in these patients.Seizures have been reported in patients receiving tramadol within the recommended dosage range.
Spontaneous post-marketing reports indicate that seizure risk is increased with doses of tramadol above the recommended range.
Concomitant use of tramadol increases the seizure risk in patients taking:Selective serotonin reuptake inhibitors (SSRI antidepressants or anorectics),Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), orOther opioids.Administration of tramadol may enhance the seizure risk in patients taking:MAO inhibitors (see also WARNINGS, Use with MAO Inhibitors),Neuroleptics, orOther drugs that reduce the seizure threshold.Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections).
In tramadol overdose, naloxone administration may increase the risk of seizure.
NIH - Clinical Trials