Tramadol Hcl Er: US FDA label indications

Label details

Brand name

Tramadol Hcl Er

Generic name

Tramadol Hcl

Manufacturer

DIRECT RX

Route

Oral

Product type

Human Prescription Drug

Substance

Tramadol Hydrochloride

Application number

ANDA200503

Indications and usage (label excerpt)

INDICATIONS & USAGE SECTION Tramadol hydrochloride extended-release tablets are indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time

Warnings (label excerpt)

WARNINGS SECTION Seizure Risk Seizures have been reported in patients receiving tramadol within the recommended dosage range. Spontaneous postmarketing 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 re-uptake inhibitors (SSRI antidepressants or anorectics), Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or Other opioids. Administration of tramadol may enhance the seizure risk in patients taking: MAO inhibitors (see also WARNINGS - Use with MAO Inhibitors ), Neuroleptics, or Other 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, nalo…

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Trials whose interventions mention this drug

Canadian trials first. A match on the drug name does not mean the trial studied this specific product.