thdrawal symptoms may occur if tramadol hydrochloride is discontinued abruptly. (SeeDRUG ABUSE AND DEPENDENCE.) These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Other symptoms that have been seen less frequently with tramadol hydrochloride discontinuation include: panic attacks, severe anxiety, and paresthesias. Clinical experience suggests that withdrawal symptoms may be avoided by tapering tramadol hydrochloride at the time of discontinuation.
Physical Dependence and Abuse
Tramadol hydrochloride may induce psychic and physical dependence of the morphine-type (μ-opioid) (seeDRUG ABUSE AND DEPENDENCE). Tramadol hydrochloride should not be used in opioid-dependent patients. Tramadol hydrochloride 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 tramadol hydrochloride 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 (seeOVERDOSAGE).
PRECAUTIONS
Acute Abdominal Conditions
The administration of tramadol hydrochloride may complicate the clinical assessment of patients with acute abdominal conditions.
Use in Renal and Hepatic Disease
Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. In patients with creatinine clearances of less than 30 mL/min, dosing reduction is recommended (seeDOSAGE AND ADMINISTRATION). Metabolism of tramadol and M1 is reduced in patients with advanced cirrhosis of the liver. In cirrhotic patients, dosing reduction is recommended (seeDOSAGE AND ADMINISTRATION).
With the prolonged half-life in these conditions, achievement of steady-state is delayed, so that it may take several days for elevated plasma concentrations to develop.
Information for Patients
Tramadol hydrochloride tablets may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
Tramadol hydrochloride tablets should not be taken with alcohol containing beverages.
Tramadol hydrochloride tablets should be used with caution when taking medications such as tranquilizers, hypnotics or other opiate containing analgesics.
The patient should be instructed to inform the physician if they are pregnant, think they might become pregnant, or are trying to become pregnant (seePRECAUTIONS, LABOR AND DELIVERY).
The patient should understand the single-dose and 24-hour dose limit and the time interval between doses, since exceeding these recommendations can result in respiratory depression, seizures and death.
Drug Interactions
In vitro studies indicate that tramadol is unlikely to inhibit the CYP3A4-mediated metabolism of other drugs when tramadol is administered concomitantly at therapeutic doses. Tramadol does not appear to induce its own metabolism in humans, since observed maximal plasma concentrations after multiple oral doses are higher than expected based on s |
