Generic Name: Tramadol

Brand name: Ultram, Ultram ER, Amadol, Tramadolor

Class of drug: Narcotic (opioid) analgesic.

Mechanism of action: Most likely produces analgesia by binding to opioid receptors. Also inhibits reuptake of norepinephrine and serotonin.

Indications/dosage/route: Oral only.

• Moderate to moderately severe pain

Adults: 50-100 mg q4-6h prn. Maximum: 400 mg/d.

Adjustment of dosage

• Kidney disease: Creatinine clearance <30 mL/min: 50-100 mg q12h. Maximum: 200 mg/d.
• Liver disease (cirrhosis): 50 mg q12h.
• Elderly: Maximum daily dose of 300 mg in patients >75 years.
• Pediatric: Safety and efficacy of tramadol have not been estab-
• lished in children <16 years.

Food: May take with food.

Pregnancy: Category C.

Lactation: Appears in breast milk. Best to avoid.

Contraindications: Hypersensitivity to tramadol or opioids; acute intoxication with alcohol; other analgesics, opioids, hypnotics, or psychotropic agents.

Warnings/precautions

• Use with caution in patients with increased cranial pressure, head injury, alcohol and drug withdrawal, respiratory depression, acute abdominal conditions, history of physical dependence on opioids, and in those concomitantly using (SSRIs), tricyclic antidepressants, neuroleptics, drugs decreasing seizure threshold, kidney or liver disease, elderly.
• Tramadol has been associated with seizures. There is an increased risk in patients with conditions that predispose to seizures, eg, head injury.
• Tramadol is not recommended for patients who have exhibited dependence on opioids or have received opioids previously for more than 1 week.
• Prolonged use of tramadol may result in physical or psychologic dependence although this is not as intense as with opioids.
• Do not give tramadol to patients with abdominal pain without adequate evaluation to rule out structural or pathophysiologic causes.
• Tramadol should be discontinued gradually after long-term use to avoid withdrawal symptoms.
• Patients who have exhibited a previous allergic reaction to opioids may experience seizures if given tramadol.
• It is recommended that tramadol be given on a regular basis rather than prn.

Advice to patient

• Avoid driving and other activities requiring mental alertness or that are potentially dangerous until response to drug is known.
• Change position slowly, in particular from recumbent to upright, to minimize orthostatic hypotension. Sit at the edge of the bed for several minutes before standing, and lie down if feeling faint or dizzy. Avoid hot showers or baths and standing for long periods. Male patients with orthostatic hypotension may be safer urinating while seated on the toilet rather than standing.
• Avoid alcohol.
• If experiencing constipation, increase intake of fluids and consume high-fiber foods (bran, whole-grain bread, raw vegetables and fruits).

Adverse reactions

• Common: dizziness, vertigo, headache, nausea, constipation, somnolence.
• Serious: CNS stimulation, seizures, anaphylaxis.

Clinically important drug interactions

• Drugs that increase effects/toxicity of tramadol: alcohol, antihistamines, opioids, sedatives, hypnotics, other psychotropic drugs, MAO inhibitors, tricyclic antidepressants, SSRIs, carbamazepine, quinidine.
• Tramadol increases effects/toxicity of digoxin, warafarin, MAO inhibitors.

Parameters to monitor: BP and respiratory rate before and periodically after drug administration.

Editorial comments

• This agent has proven to be highly beneficial for patients with chronic pain in whom other opioids and/or NSAIDs are to be avoided. It produces less respiratory depression than narcotic agents. In some clinical trials, tramadol was comparable or superior to adult dosages of codeine with/without acetaminophen.
• Abuse and dependence on tramadol have been reported; avoid overuse. Use caution if administering to individuals with a prior history of opioid dependence or abuse of other drugs.