Dental: Relief of moderate to moderately severe dental pain
Medical: Relief of moderate to moderately severe medical pain
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.
Central nervous system: Dizziness, headache, somnolence, stimulation,
Gastrointestinal: Nausea, diarrhea, constipation, vomiting, dyspepsia
Neuromuscular & skeletal: Weakness
<1%: Palpitations, seizures, respiratory depression, suicidal tendency,
anaphylactoid reactions, pruritus, hives, bronchospasm, angioedema
Symptoms of overdose include CNS and respiratory depression, gastrointestinal
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
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
Quinidine (and other inhibitors of CYP2D6) may increase the tramadol serum
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
|Mental Health: Effects
on Mental Status|
May cause dizziness, drowsiness, or restlessness
Effects on Psychiatric
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
|Dental Health: Local
No information available to require special precautions
Effects on Dental Treatment|
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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