Tramadol Contraindications and Precautions
- abrupt discontinuation
- ethanol intoxication
- opiate agonist hypersensitivity
- breast-feeding
- children
- driving or operating machinery
- elderly
- GI disease
- head trauma
- hepatic disease
- increased intracranial pressure
- labor
- pregnancy
- renal impairment
- respiratory depression
- seizure disorder
- substance abuse
Tramadol Contraindications and Precautions
The use of tramadol is contraindicated in cases of acute ethanol intoxication and intoxication with other agents such as opiate agonists, hypnotics, centrally acting analgesics, or psychotropic drugs.
Data obtained by the manufacturer during postmarketing surveillance has revealed reports of anaphylactoid reactions following the initial tramadol dose, particularly in patients with a history of codeine hypersensitivity. Manufacturer labeling recommends that any patient who is hypersensitive to tramadol or any of the components in the commercial formulation should not receive tramadol. Also, patients who have demonstrated a prior opiate agonist hypersensitivity reaction to codeine or other opiate agonists should not receive tramadol because there is an increased risk of developing anaphylactoid reactions to tramadol.
Administer tramadol with caution in patients at risk for respiratory depression. Respiratory depression is possible with large doses of tramadol, especially when given concurrently with ethanol and anesthetic agents. Concurrent administration with other respiratory depressants exacerbates this risk (see Tramadol Interactions). If respiratory depression occurs, treat as an overdose; however, administer naloxone cautiously in these situations due to an increased risk of seizures.
Tramadol should be used with caution in patients who are at risk of seizures including those who have a pre-existing seizure disorder, are receiving medications which reduce the seizure threshold (see Tramadol Interactions), who have certain medical conditions (i.e., increased intracranial pressure, CNS infection, head trauma), or who are experiencing ethanol or illicit drug withdrawal. In tramadol overdose, naloxone administration may increase the risk of seizure. In addition, administration of tramadol to patients with increased intracranial pressure or head trauma may obscure the existence, extent, or course of intracranial pathology because tramadol induces pupillary changes (miosis).
Tramadol should be used with caution in patients with GI disease. It may be difficult to assess the condition of patients with acute abdominal conditions if they are taking tramadol.
Tramadol is not recommended in patients with a substance abuse problem associated with opiate agonists. Tramadol has been shown to reinitiate physical dependence in some patients that have been physically dependent on other opiate agonists. Patients who have recently taken substantial amounts of opiate agonists may experience withdrawal symptoms after treatment with tramadol. Tramadol is not recommended in patients with a tendency towards opiate agonist substance abuse; in patients who have been physically dependent on opiate agonists; or in patients chronically taking opiate agonists. Psychologic dependence similar to that of codeine or dextropropoxyphene is possible with tramadol. However, because some of tramadol’s activity comes from the active metabolite, µ-opioid activity may be delayed, thus possibly reducing the potential for abuse.
To prevent withdrawal symptoms, avoid abrupt discontinuation of tramadol. Withdrawal symptoms may include anxiety, sweating, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, panic attacks, severe anxiety, paresthesias, and hallucinations (rarely). Clinical experience suggests that withdrawal symptoms may be relieved by tapering the dosage of tramadol.
Tramadol should be administered with caution to patients with renal impairment. Impaired renal function affects the rate and extent of excretion for both tramadol and its active metabolite M1. Dosage reductions are recommended if creatinine clearance falls below 30 ml/min (see Dosage). It may take several days for elevated plasma concentrations and toxicity to develop.
Dosage reductions and an increased dosage interval are recommended for patients with hepatic disease (see Dosage). Tramadol undergoes hepatic metabolism and liver cirrhosis reduces hepatic clearance. It may take several days for elevated plasma concentrations and toxicity to develop.
Tramadol is classified as FDA pregnancy category C. Studies have not assessed tramadol use during human pregnancy; it should only be given if the need clearly outweighs the risk. High dosage levels in animal studies show tramadol as embryotoxic and fetotoxic. No teratogenic effects have been noted in animal studies and fetal problems only occur at high doses, where maternal toxicity is more severe. Tramadol crosses the placenta and the effects on postnatal growth, development and functional maturation of the fetus are unknown. Tramadol should not be given to women prior to, or during labor unless the benefits outweigh the risk. Tramadol has been used outside the US for the management of pain associated with labor. The effect of tramadol on respiratory depression in the neonate has been studied and was not significantly different from that following the administration of morphine or meperidine.
Alternative analgesics are recommended for use in women who are breast-feeding their infants. Studies have not been undertaken to determine the extent of excretion of tramadol into breast milk. Following a 100 mg IV dose of tramadol, small amounts were detected in breast milk.
Elderly patients greater than age 75 experience slightly elevated serum concentrations of tramadol and a prolonged elimination half-life. Elderly patients vary in their tolerance of tramadol. In general, a lower starting dose, slower dose titration, and a lower maximum daily dose are recommended in these patients.
In the US, the safety and efficacy of tramadol in children < 16 years of age have not been established. In Germany, dosage recommendations, which are similar to adults, exist for children greater than 12 years of age.
Patients should be warned against driving or operating machinery until they know how tramadol may affect them.
[ Last revised: 7/23/2004 3:39:00 PM ]
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