FDA-Recommended IV Dosage of Tramadol Per Kilogram
The FDA does not provide a specific per-kilogram IV dosage recommendation for tramadol, as IV tramadol is not currently FDA-approved in the United States.
Available Tramadol Formulations and Dosing
Tramadol is currently available in the following formulations with FDA-approved dosing:
- Oral immediate-release (IR): 50-100 mg every 4-6 hours, maximum 400 mg/day 1
- Oral extended-release (ER): Maximum 300 mg/day 1
For pediatric patients, though not FDA-approved for this population, clinical guidelines suggest:
- 1-1.5 mg/kg every 4-6 hours, with maximum daily dose of 8 mg/kg/day not exceeding 400 mg per day 2
Pharmacological Properties
Tramadol is an atypical opioid with dual mechanism of action:
- Weak mu-opioid receptor agonist
- Inhibits norepinephrine and serotonin reuptake 1
- Considered approximately one-tenth as potent as morphine 1
Important Considerations
Contraindications
- Should not be administered to patients taking monoamine oxidase inhibitors
- Should be used with caution or avoided in patients taking serotonergic medications (TCAs, SSRIs) due to risk of serotonin syndrome 1, 2
Adverse Effects
- Dose-dependent adverse effects include nausea, vomiting, dizziness, and sedation 3
- Risk of seizures, particularly at higher doses 4
- Respiratory depression can occur, especially with higher doses 4
Dosage Adjustments
- Lower doses recommended for:
- Older adults (75 years and older)
- Patients with hepatic or renal dysfunction 1
- To reduce risk of seizures
Clinical Implications
While IV tramadol is used in some countries, it is important to note that the FDA has not approved an IV formulation in the United States. If IV administration is being considered in a clinical setting where it is available:
- Start with lower doses and titrate carefully
- Monitor closely for respiratory depression and seizures
- Consider alternative analgesics with established IV dosing guidelines if appropriate
For practitioners in settings where IV tramadol is available, consulting local regulatory guidelines and institutional protocols is essential, as FDA guidance does not provide specific per-kilogram IV dosing recommendations.