Tramadol HCl (Ultram) Drug Study

Generic Name: tramadol hydrochloride
Brand Names: Ultram, Zydol

Classifications

• Central nervous system (cns) agent;
• Analgesic;
• Narcotic (opiate) agonist

Pregnancy Category: C

Actions

• Centrally acting opiate receptor agonist that inhibits the uptake of norepinephrine and serotonin, suggesting both opioid and nonopioid mechanisms of pain relief. May produce opioid-like effects, but causes less respiratory depression than morphine.

Therapeutic Effects

• Effective agent for control of moderate to moderately severe pain.

Uses

• Management of moderate to moderately severe pain.

Contraindications

• Hypersensitivity to tramadol or other opioid analgesics; patients on MAO inhibitors; patients acutely intoxicated with alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic drugs; substance abuse; patients on obstetric preoperative medication; abrupt discontinuation; alcohol intoxication; pregnancy (category C); lactation; children 75 y.

Route & Dosage

Pain

• Adult: PO 50–100 mg q4–6h prn (max: 400 mg/d), may start with 25 mg/d if not well tolerated, and increase by 25 mg q3d up to 200 mg/d
• Geriatric: PO 50–100 mg q4–6h prn (max: 300 mg/d), may start with 25 mg/d if not well tolerated, and increase by 25 mg q3d up to 200 mg/d

Renal Impairment

• Clcr <30 mL/min: decrease to 50–100 mg q12h

Hepatic Impairment

• Cirrhosis decrease to 50–100 mg q12h

Administration

Oral

• Note: Dosage reduction is recommended for patients with renal insufficiency and hepatic impairment.
• Store at 15°–30° C (59°–86° F).

Adverse Effects ( 1%)

• CNS: Drowsiness, dizziness, vertigo, fatigue, headache, somnolence, restlessness, euphoria, confusion, anxiety, coordination disturbance, sleep disturbances, seizures.
• CV: Palpitations, vasodilation.
• GI: Nausea, constipation, vomiting, xerostomia, dyspepsia, diarrhea, abdominal pain, anorexia, flatulence.
• Body as a Whole: Sweating, anaphylactic reaction (even with first dose), withdrawal syndrome (anxiety, sweating, nausea, tremors, diarrhea, piloerection, panic attacks, paresthesia, hallucinations) with abrupt discontinuation.
• Skin: Rashes
• Special Senses: Visual disturbances.
• Urogenital: Urinary retention/frequency, menopausal symptoms.

Diagnostic Test Interference

• Increased creatinine, liver enzymes; decreased hemoglobin; proteinuria.

Interactions

• Drug: Carbamazepine significantly decreases tramadol levels (may need up to twice usual dose). Tramadol may increase adverse effects of mao inhibitors. tricyclic antidepressants, cyclobenzaprine, phenothiazines, selective serotonin-reuptake inhibitors (ssris), mao inhibitors may enhance seizure risk with tramadol. May increase CNS adverse effects when used with other cns depressants.
• Herbal: St. John’s wort may increase sedation.

Pharmacokinetics

• Absorption: Rapidly absorbed from GI tract; 75% reaches systemic circulation. Onset: 30–60 min. Peak: 2 h.
• Duration: 3–7 h.
• Distribution: Approximately 20% bound to plasma proteins; probably crosses blood–brain barrier; crosses placenta; 0.1% excreted into breast milk.
• Metabolism: Metabolized extensively in liver by cytochrome P450 system.
• Elimination: Excreted primarily in urine. Half-Life: 6–7 h.

Nursing Considerations

Assessment & Drug Effects

• Assess for level of pain relief and administer prn dose as needed but not to exceed the recommended total daily dose.
• Monitor vital signs and assess for orthostatic hypotension or signs of CNS depression.
• Discontinue drug and notify physician if S&S of hypersensitivity occur.
• Assess bowel and bladder function; report urinary frequency or retention.
• Use seizure precautions for patients who have a history of seizures or who are concurrently using drugs that lower the seizure threshold.
• Monitor ambulation and take appropriate safety precautions.

Patient & Family Education

• Exercise caution with potentially hazardous activities until response to drug is known.
• Understand potential adverse effects and report problems with bowel and bladder function, CNS impairment, and any other bothersome adverse effects to physician.
• Do not breast feed while taking this drug.