Hydrocodone Bitartrate/Acetaminophen 5mg-325mg – Moderate Pain Relief with Opioid + APAP
Therapeutic Profile
-
Schedule II Controlled Substance (High potential for abuse/dependence)
-
Composition:
-
Hydrocodone 5mg (semi-synthetic opioid)
-
Acetaminophen 325mg (analgesic/antipyretic)
-
-
Onset: 20–30 minutes
-
Duration: 4–6 hours
-
Metabolism: Liver (CYP2D6/3A4 for hydrocodone)
FDA-Approved Indications
✔ Acute pain management (e.g., dental procedures, injuries)
✔ Short-term relief (typically ≤5 days)
✔ Moderate to moderately severe pain when non-opioids are insufficient
Dosing Guidelines
-
Adults (opioid-naïve):
-
1–2 tablets every 4–6 hours as needed
-
Max daily APAP: ≤3,000mg (chronic) or ≤4,000mg (acute)
-
Max daily hydrocodone: ≤40mg (8 tablets)
-
-
Elderly/Renal Impairment:
-
Start with 1 tablet q6h
-
Avoid in severe hepatic impairment
-
Abuse-Deterrent Features
-
Generic formulations (no FDA-mandated AD properties)
-
Common imprints: “M365” (white oval), “IP 109” (white round)
Black Box Warnings
⚠️ ACETAMINOPHEN TOXICITY (Risk of liver failure)
⚠️ OPIOID ADDICTION/OVERDOSE (Respiratory depression risk)
⚠️ NEONATAL WITHDRAWAL (With prolonged pregnancy use)
Safety & Monitoring
-
Naloxone co-prescription strongly recommended
-
PDMP checks required before prescribing
-
Avoid with:
-
Alcohol
-
Benzodiazepines
-
Other CNS depressants
-
Product Identification
-
Tablet Appearance:
-
White, oval/round (varies by manufacturer)
-
Common imprints: “M365,” “IP 109,” “5/325”
-
-
Packaging:
-
Bottles of 30/60/90/120 tablets
-
Unit-dose available for hospitals
-
Prescribing Best Practices
-
Start low (1 tab q6h) for opioid-naïve patients
-
Limit initial Rx to ≤3–7 day supply
-
Combine with non-opioids (NSAIDs, ice, PT)
-
Document MEDD calculations
Why Choose 5/325mg?
→ Safer starting dose vs. 7.5/10mg hydrocodone
→ Lower APAP load than legacy 5/500mg formulations
→ Flexible dosing (tablets are often scored)
Available Brands/Generics:
-
Norco 5/325mg (brand discontinued, but name persists)
-
Generic equivalents (multiple manufacturers)
