Acute overdosage with tramadol can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, seizures, bradycardia, hypotension, cardiac arrest, and death.
Deaths due to overdose have been reported with abuse and misuse of tramadol (see WARNINGS, Misuse, Abuse, and Diversion).Review of case reports has indicated that the risk of fatal overdose is further increased when tramadol is abused concurrently with alcohol or other CNS depressants, including other opioids.
In the treatment of tramadol overdosage, primary attention should be given to the re-establishment of a patent airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.
While naloxone will reverse some, but not all, symptoms caused by overdosage with tramadol, the risk of seizures is also increased with naloxone administration. In animals, convulsions following the administration of toxic doses of ULTRAM® could be suppressed with barbiturates or benzodiazepines but were increased with naloxone. Naloxone administration did not change the lethality of an overdose in mice. Hemodialysis is not expected to be helpful in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period.
For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, the tolerability of ULTRAM® can be improved by initiating therapy with the following titration regimen: ULTRAM® should be started at 25 mg/day qAM and titrated in 25 mg increments as separate doses every 3 days to reach 100 mg/day (25 mg q.i.d.). Thereafter the total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day (50 mg q.i.d.). After titration, ULTRAM® 50 to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg/day.
For the subset of patients for whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial doses, ULTRAM® 50 mg to 100 mg can be administered as needed for pain relief every four to six hours, not to exceed 400 mg per day.
Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Studies with tramadol in adults have shown that starting at the lowest possible dose and titrating upward will result in fewer discontinuations and increased tolerability.
- In all patients with creatinine clearance less than 30 mL/min, it is recommended that the dosing interval of ULTRAM® be increased to 12 hours, with a maximum daily dose of 200 mg. Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis.
- The recommended dose for adult patients with cirrhosis is 50 mg every 12 hours.
- In general, dose selection for an elderly patient over 65 years old should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. For elderly patients over 75 years old, total dose should not exceed 300 mg/day.
ULTRAM® (tramadol hydrochloride) Tablets — 50 mg are white, capsule-shaped, coated tablet imprinted “ULTRAM” on one side and “06 59″ on the scored side.
Bottles of 100 tablets: NDC 50458-659-60
Dispense in a tight container. Store at 25°C (77°F); excursions permitted to 15 –30°C (59 – 86°F).
Janssen Ortho, LLC
Gurabo, Puerto, Rico 00778
PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Raritan, New Jersey 08869
© OMPJI 2003Revised September 2009
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|ULTRAM tramadol hydrochloride tablet, coated|
|Labeler — Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC (831276758)|
|Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC||831276758||relabel, repack|
Revised: 03/2012 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
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