Ultram

[Tramadol]

100 mg SD i. v. M1 c c c 16.9 (18)
1
Use in Ambulatory Patients ULTRAM may impair the mental and or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly.

Use With MAO Inhibitors and Serotonin Re-uptake Inhibitors

Use ULTRAM with great caution in patients taking monoamine oxidase inhibitors. Animal studies have shown increased deaths with combined administration. Concomitant use of ULTRAM with MAO inhibitors or SSRI's increases the risk of adverse events, including seizure and serotonin syndrome.

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Withdrawal

Withdrawal symptoms may occur if ULTRAM is discontinued abruptly. (See DRUG ABUSE AND DEPENDENCE.) These symptoms may
include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Clinical experience suggests that withdrawal symptoms may be relieved by tapering the medication.

Physical Dependence and Abuse

ULTRAM may induce psychic and physical dependence of the morphine-type (µ-opioid) (see DRUG ABUSE AND DEPENDENCE).

ULTRAM should not be used in opioid-dependent patients.

ULTRAM has been shown to reinitiate physical dependence in some patients that have been previously dependent on other opioids. Dependence and abuse, including drug-seeking behavior 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 ULTRAM (tramadol hydrochloride tablets) 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).

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