Tapentadol
Tapentadol is a centrally acting analgesic with a dual mechanism of action. It acts as an agonist at the mu-opioid receptor and as a norepinephrine reuptake inhibitor. It is classified as a Schedule II controlled substance due to risks of addiction, abuse, misuse, and respiratory depression.
Dosage by Body Weight
For adults, the typical immediate-release starting dose is 50 mg to 100 mg every 4 to 6 hours as needed for pain. On the first day of dosing, a second dose may be administered as soon as 1 hour after the first dose if adequate pain relief is not attained. Daily doses exceeding 700 mg on the first day and 600 mg on subsequent days are not recommended. Extended-release formulations are dosed twice daily for chronic pain management. Tapentadol is not recommended for pediatric patients under 18 years of age.
- Body Weight
- Below 5 kg
- Dose
- Not recommended
- Frequency
- Not applicable
- Tracking Notes
- Safety and effectiveness have not been established in pediatric patients. Severe risk of life-threatening respiratory depression.
- Body Weight
- 5-7 kg
- Dose
- Not recommended
- Frequency
- Not applicable
- Tracking Notes
- Contraindicated in pediatric populations of this weight class. Avoid use.
- Body Weight
- 8-10 kg
- Dose
- Not recommended
- Frequency
- Not applicable
- Tracking Notes
- Opioids are not routinely used for pediatric pain management unless under strict, specialist inpatient supervision.
- Body Weight
- 11-15 kg
- Dose
- Not recommended
- Frequency
- Not applicable
- Tracking Notes
- Do not administer Tapentadol to children of this weight range without direct specialist prescription and supervision.
- Body Weight
- 16-20 kg
- Dose
- Not recommended
- Frequency
- Not applicable
- Tracking Notes
- Clinical data regarding safety and efficacy in patients under 18 years of age are insufficient.
| Body Weight | Dose | Frequency | Tracking Notes |
|---|---|---|---|
| Below 5 kg | Not recommended | Not applicable | Safety and effectiveness have not been established in pediatric patients. Severe risk of life-threatening respiratory depression. |
| 5-7 kg | Not recommended | Not applicable | Contraindicated in pediatric populations of this weight class. Avoid use. |
| 8-10 kg | Not recommended | Not applicable | Opioids are not routinely used for pediatric pain management unless under strict, specialist inpatient supervision. |
| 11-15 kg | Not recommended | Not applicable | Do not administer Tapentadol to children of this weight range without direct specialist prescription and supervision. |
| 16-20 kg | Not recommended | Not applicable | Clinical data regarding safety and efficacy in patients under 18 years of age are insufficient. |
Formulation
Purpose
Used for the management of acute moderate to severe pain in adults, and daily, around-the-clock, long-term treatment for severe chronic pain, including neuropathic pain associated with diabetic peripheral neuropathy.
Generic Name
TapentadolBranded Drug Names
Tapentadol is listed as a generic drug name. Common branded medicines that may contain the same active ingredient include:
Scheduled Drug
Yes. This medicine should be supplied or used only according to applicable prescription and regulatory requirements.