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Ultracet

[Tramadol/Acetaminophen]

Use With Other Acetaminophen-containing Products

Due to the potential for acetaminophen hepatotoxicity at doses higher than the recommended dose, ULTRACET should not be used concomitantly with other acetaminophen-containing products.

Withdrawal

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Withdrawal symptoms may occur if ULTRACET is dis-continued abruptly. (See DRUG ABUSE AND DEPEN-DENCE.) These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diar-rhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Clinical experience suggests that withdrawal symptoms may be relieved by tapering the medication.

Physical Dependence and Abuse

Tramadol may induce psychic and physical dependence of the morphine-type (µ-opioid). (See DRUG ABUSE AND DEPENDENCE.) Tramadol should not be used in opi-oid-dependent patients. Tramadol has been shown to reinitiate physical dependence in some patients that have been previously dependent on other opioids. Dependence and abuse, including drug-seeking be-havior and taking illicit actions to obtain the drug are not limited to those patients with prior history of opioid dependence.

Risk of Overdosage

Serious potential consequences of overdosage with tramadol are central nervous system depression, respiratory depression and death. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment.
(See OVERDOSAGE.)

Serious potential consequences of overdosage with acetaminophen are hepatic (centrilobular) necrosis, lead-ing to hepatic failure and death. Emergency help should be sought immediately and treatment initiated immedi-ately if overdose is suspected, even if symptoms are not apparent.

PRECAUTIONS

General

The recommended dose of ULTRACET should not be exceeded.

Do not coadminister ULTRACET with other tramadol or acetaminophen-containing products. (See WARN-INGS, Use With Other Acetaminophen-containing Products and Risk of Overdosage.)

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