Ultracet
From Pharmacopedia
More actions
Opioid analgesic (tramadol, atypical), Non-opioid analgesic (acetaminophen), Schedule IV controlled substance, Fixed-dose combination, Serotonin-norepinephrine reuptake inhibitor (tramadol secondary action)
Tramadol / Acetaminophen
Ultracet, Tramacet
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Summary
Classes
Common uses
Moderate to moderately severe acute pain (short-term, ≤5 days per label)0
Pharmacy
Starting dose
2 tablets (75 mg tramadol / 650 mg acetaminophen) PO every 4-6 hours as needed; maximum 8 tablets/day for ≤5 days
Preparations
Tramadol/acetaminophen 37.5/325 mg tablets
US FDA Max
8 tablets/d (300 mg tramadol / 2600 mg acetaminophen); 5-day duration limit per label
Pharmacology
Routes
Oral
Onset
30-60 minutes
Duration
4-6 hours
Half-life
Tramadol ~5-7 hours (M1 metabolite ~9 hours); acetaminophen 1-3 hours[2]
Bioavailability
Tramadol ~75% (oral); acetaminophen 85-98%[2]
Pregnancy
Avoid; neonatal opioid withdrawal documented.[citation needed]
Legal status
Schedule IV controlled substance in US (tramadol was reclassified from non-controlled to Schedule IV in 2014 after recognition of dependence risk)
Purported mechanism
Tramadol is a weak μ-opioid receptor agonist whose major analgesic activity comes from CYP2D6-mediated bioactivation to O-desmethyltramadol (M1), with substantial additional contribution from serotonin and norepinephrine reuptake inhibition; the dual mechanism resembles SNRI antidepressants in some respects.0 Serotonin syndrome risk with SSRIs, SNRIs, MAOIs, and other serotonergic agents. Seizure risk especially at high doses, in patients with epilepsy, or with concurrent serotonergic medications. CYP2D6 PGx affects efficacy through M1 conversion[1].
References
- ↑ CPIC Guideline for CYP2D6, OPRM1, and COMT and Opioid Use, 2021. https://cpicpgx.org/guidelines/cpic-guideline-for-codeine-and-cyp2d6/
- ↑ 2.0 2.1 FDA Prescribing Information, Ultracet (tramadol HCl / acetaminophen), Janssen, current revision. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021123s032lbl.pdf