Renal Dose Adjustment (Based on CrCl)
- 10-30 mL/min: Increase dosing interval to q12 hrs
- < 10 mL/min: Contraindicated
Hepatic Dose Adjustment
- Moderate hepatic impairment: Increase dosing interval to q12 hrs
- Severe hepatic impairment: Contraindicated
See Supplemental Patient Information
- Respiratory depression have occurred, take extreme care in patients treated with exceeding doses, on concomitant use of other CNS drugs, including alcohol, and history of respiratory depression
- May obscure acute abdominal conditions
- Taper when discontinuing, abrupt discontinuation may induce withdrawal
- Convulsions have occurred even at recommended doses, avoid concomitant use with drugs lowering seizures threshold
- Has a potential for abuse, on prolong use tolerance, psychic and physical dependence have occurred
- Not suitable as a substitute in opioid-dependent patients
- Cannot suppress morphine withdrawal symptoms
- Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving tramadol
- Patients may experience impaired mental/physical abilities
- Serotonin syndrome may occur, particularly with concomitant use of serotonergic drugs
Cautions: Use cautiously in
- Alcohol use
- Renal impairment
- Opioid-dependent patients
- Head injury
- Shock
- Reduced level of consciousness of uncertain origin
- Disorders of the respiratory centre or function
- Increased intracranial pressure
- Sensitivity to opiates
- Respiratory depression
- History of seizures
- Co-administration of MAO inhibitors
- Co-administration of CNS depressants
- Acute abdomen
- Geriatrics
Supplemental Patient Information
- Advise patients to avoid engaging in activities requiring mental alertness, operating vehicles and hazardous machinery
Pregnancy Category:C
Breastfeeding: Safety unknown for IV form; low levels are excreted in milk, unlikely to produce adverse effects in breastfeed infants, monitor premature infants for increased sleepiness, difficulty breastfeeding, breathing difficulties,limpness, and contact a physician immediately on occurrence of these events. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 2 December 2010). May induce changes in the respiratory rate in neonates; chronic use during pregnancy may lead to neonatal withdrawal symptoms. Manufacturer do not recommend use during breastfeeding.
