September 5, 2015
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Ultram

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Ultram

Overdosage
Contraindications

OVERDOSE

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Symptoms

Symptoms of overdosage with ULTRAM® are 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 AND PRECAUTIONS, Drug Abuse, Addiction and Dependence). 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.

Treatment

A single or multiple overdose with ULTRAM® may be a potentially lethal polydrug overdose, and consultation with a regional poison control centre is recommended.

In treating an overdose of ULTRAM®, primary attention should be given to maintaining adequate ventilation along with general supportive treatment. 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. Seizures may be controlled with diazepam.

In animals, convulsions following the administration of toxic doses of tramadol could be suppressed with barbiturates or benzodiazepines but were increased with naloxone. Naloxone administration did not change the lethality of an overdose in mice.

Based on experience with tramadol, 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.

Emptying of the gastric contents is useful to remove any unabsorbed drug.

CONTRAINDICATIONS

  • ULTRAM® should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, opioids or to any component of this product.
  • ULTRAM® is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs. ULTRAM® may worsen central nervous system and respiratory depression in these patients.
  • The concomitant use of ULTRAM® and MAO inhibitors (or within 14 days following discontinuation of such therapy) is contraindicated.

Last reviewed on RxList: 3/18/2015
This monograph has been modified to include the generic and brand name in many instances.

Overdosage
Contraindications

Ultram - User Reviews

Ultram User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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