tramadol hydrochloride

tramadol hydrochloride Warning - High-alert drug!

Dromadol (UK), Larapam (UK), Mabron (UK), Tramake (UK), Ultram, Ultram ER, Zamadol (UK), Zydol (UK)

Pharmacologic class: Opioid agonist

Therapeutic class: Analgesic

Pregnancy risk category C

Action

Inhibits reuptake of serotonin and norepinephrine in CNS

Availability

Tablets: 50 mg

Tablets (extended-release): 100mg, 200mg, 300mg

⊘Indications and dosages

➣ Moderate to moderately severe pain

Adults: In rapid titration, 50 to 100 mg P.O. q 4 to 6 hours p.r.n. (not to exceed 400 mg/day, or 300 mg/day in patients older than age 75). In gradual titration, initially 25 mg P.O. daily; increase by 25 mg/day q 3 days to 100 mg/day, then increase by 50 mg/day q 3 days, up to 200 mg/day p.r.n. Alternately, 100 mg P.O (extended-release) up to a maximum of 300 mg daily.

Dosage adjustment

• Renal or hepatic impairment

Contraindications

• Hypersensitivity to drug, its components, or opioids
• Acute intoxication with alcohol, sedative-hypnotics, centrally acting analgesics, opioid analgesics, or psychotropic agents
• Physical opioid dependence

Precautions

Use cautiously in:
• seizure disorder or risk factors for seizures, renal or hepatic impairment, increased intracranial pressure, head trauma, acute abdomen
• history of opioid dependence or recent use of large opioid doses
• elderly patients
• pregnant or breastfeeding patients
• children younger than age 16 (safety not established).

Administration

• Give as prescribed, preferably before pain becomes severe.

Route	Onset	Peak	Duration
P.O.	1 hr	2-3 hr	4-6 hr
PO (ER)	Unknown	Unknown	Unknown

Adverse reactions

CNS: dizziness, vertigo, headache, drowsiness, anxiety, stimulation, confusion, incoordination, euphoria, nervousness, sleep disorder, asthenia, hypertonia, seizures

CV: vasodilation

EENT: visual disturbances

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, flatulence, dry mouth, anorexia

GU: urinary retention and frequency, proteinuria, menopausal symptoms

Respiratory: respiratory depression (with large doses, concomitant anesthetic use, or alcohol ingestion)

Skin: pruritus, sweating

Other: physical or psychological drug dependence, drug tolerance

Interactions

Drug-drug. Anesthetics, antihistamines, CNS depressants, other opioids, psychotropic agents, sedative-hypnotics: increased risk of CNS depression

Carbamazepine: increased tramadol metabolism and decreased efficacy

MAO inhibitors: increased risk of serotonin syndrome and seizures

Drug-diagnostic tests. Creatinine, hepatic enzymes: increased levels

Hemoglobin: decreased level

Drug-herbs. Chamomile, hops, kava, skullcap, valerian: increased CNS depression

Drug-behaviors. Alcohol use: increased CNS depression

Patient monitoring

• Assess patient's response to drug 30 minutes after administration.
• Monitor respiratory status. Withhold drug and contact prescriber if respirations become shallow or slower than 12 breaths/minute.
• Monitor for physical and psychological drug dependence. Report signs to prescriber.

Patient teaching

• Tell patient drug works best when taken before pain becomes severe.
• Inform patient (and significant other as appropriate) that drug may cause respiratory depression if used with alcohol. Recommend abstinence.
☞ Instruct patient to immediately report seizure.
• Tell patient drug interacts with many common over-the-counter drugs and herbal remedies. Instruct him to consult prescriber before taking these products.
• Inform patient that drug can cause physical and psychological dependence. Urge him to take it only as prescribed and needed.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.