No

Analgesic, Non-narcotic

Dental: Relief of moderate to moderately severe dental pain

Medical: Relief of moderate to moderately severe medical pain

C

Previous hypersensitivity to tramadol, opioids, or any components; opioid-dependent patients; acute intoxication with alcohol, hypnotics, centrally-acting analgesics, opioids, or psychotropic drugs

Should be used only with extreme caution in patients receiving MAO inhibitors. Use with caution and reduce dosage when administered to patients receiving other CNS depressants. An increased risk of seizures may occur in patients receiving serotonin reuptake inhibitors (SSRIs or anorectics), tricyclic antidepressants, other cyclic compounds, (including cyclobenzaprine, promethazine), neuroleptics, MAO inhibitors, or drugs which may lower seizure threshold. Patients with a history of seizures, or with a risk of seizures (head trauma, metabolic disorders, CNS infection, or malignancy, or during alcohol/drug withdrawal) are also at increased risk.

>1%:

Central nervous system: Dizziness, headache, somnolence, stimulation, restlessness

Gastrointestinal: Nausea, diarrhea, constipation, vomiting, dyspepsia

Neuromuscular & skeletal: Weakness

Miscellaneous: Diaphoresis

<1%: Palpitations, seizures, respiratory depression, suicidal tendency, anaphylactoid reactions, pruritus, hives, bronchospasm, angioedema

Symptoms of overdose include CNS and respiratory depression, gastrointestinal cramping, constipation

Naloxone 2 mg I.V. (0.01 mg/kg children) with repeat administration as needed up to 18 mg

Naloxone may increase the risk of seizures in tramadol overdose

CYP2D6 enzyme substrate

Increased toxicity:

Amphetamines may increase the risk of seizures with tramadol.

Cimetidine increases the half-life of tramadol by 20% to 25%.

SSRIs may increase the risk of seizures with tramadol.

Tricyclic antidepressants may increase the risk of seizures.

MAOIs may increases the risk of seizures.

Naloxone may increase the risk of seizures in tramadol overdose.

Neuroleptic agents may increase the risk of tramadol-associated seizures and may have additive CNS depressant effects.

Opioids may increase the risk of seizures, and may have additive CNS depressant effects.

Quinidine (and other inhibitors of CYP2D6) may increase the tramadol serum concentrations.

Binds to m-opiate receptors in the CNS causing inhibition of ascending pain pathways, altering the perception of and response to pain; also inhibits the reuptake of norepinephrine and serotonin, which also modifies the ascending pain pathway

Onset of action: ~1 hour

Absorption: Oral: ~75%

Serum half-life, elimination: 6 hours

Time to peak serum concentration: 2 hours

Adults: Oral: 50-100 mg every 4-6 hours, not to exceed 400 mg/day

Monitor patient for pain, respiratory rate, and look for signs of tolerance and, therefore, abuse potential; monitor blood pressure and pulse rate, especially in patients on higher doses

100-300 ng/mL; however, serum level monitoring is not required

May cause dizziness, drowsiness, or restlessness

Contraindicated with opioid-dependent patients, MAOIs, psychotropics; carbamazepine may decrease the effects of tramadol; concurrent use with MAOIs and TCAs may produce seizures; tramadol has MAOI activity and should be used cautiously with other antidepressants

No information available to require special precautions

No effects or complications reported

If self-administered, use exactly as directed (do not increase dose or frequency); may cause physical and/or psychological dependence. Take with food or milk. While using this medication, do not use alcohol and other prescription or OTC medications (especially pain medications, sedatives, antihistamines, or cough preparations) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). You may experience drowsiness, dizziness, or blurred vision (use caution when driving or engaging in tasks requiring alertness until response to drug is known); nausea, vomiting, or loss of appetite (small frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); constipation (increased exercise, fluids, or dietary fruit and fiber may help). Report severe unresolved constipation; difficulty breathing or shortness of breath; excessive sedation or increased insomnia and restlessness; changes in urinary pattern or menstrual pattern; muscle weakness or tremors; or chest pain or palpitations. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Do not breast-feed.

Avoid driving or operating machinery until the effect of drug wears off; tramadol has not been fully evaluated for its abuse potential, report cravings to your physician immediately

Tablet, as hydrochloride: 50 mg, 100 mg

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