Ultracet

[Tramadol/Acetaminophen]

Overdosage & Contraindications
CONTRAINDICATIONS

ULTRACET should not be administered to patients who have previously demonstrated hypersensitivity to tram-adol, acetaminophen, any other component of this prod-uct or opioids.

ULTRACET is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hyp-notics, narcotics, centrally acting analgesics, opioids or psychotropic drugs.

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ULTRACET may worsen central nervous system and respiratory depression in these patients.

OVERDOSAGE

ULTRACET is a combination product. The clinical pre-sentation of overdose may include the signs and symp-toms of tramadol toxicity, acetaminophen toxicity or both. The initial symptoms of tramadol overdosage may include respiratory depression and or seizures.

The initial symptoms seen within the first 24 hours following an acetaminophen overdose are: anorexia, nausea, vomiting, malaise, pallor and diaphoresis.

Tramadol

Serious potential consequences of overdosage are respiratory depression, lethargy, coma, seizure, cardiac arrest and death. (See WARNINGS.) Fatalities have been reported in post marketing in association with both intentional and unintentional overdose with tramadol.

Acetaminophen

Serious potential consequences of overdosage with acetaminophen are hepatic centrilobular necrosis, lead-ing to hepatic failure and death. Renal tubular necrosis, hypoglycemia and coagulation defects also may occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of he-patic toxicity may not be apparent until 48 to 72 hours post ingestion.

Treatment of Overdose

A single or multiple overdose with ULTRACET may be a potentially lethal polydrug overdose, and con-sultation with a regional poison control center is recommended.

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