Hydrocodone 10/325mg

Hydrocodone Bitartrate/Acetaminophen 10mg/325mg – Moderate-to-Severe Short-Term Pain Relief
(Most Commonly Prescribed Opioid-Acetaminophen Combination in the U.S.)

Therapeutic Profile

• Schedule II Controlled Substance (DEA)
• Onset: 20-30 minutes
• Duration: 4-6 hours
• Metabolism: Liver (CYP2D6/3A4 for hydrocodone)

Clinical Indications

✔ Acute musculoskeletal pain (e.g., fractures, severe sprains)
✔ Postoperative pain (dental, minor surgical procedures)
✔ Short-term management (<5 days recommended)
✔ Breakthrough pain in opioid-tolerant patients

Dosing Protocol

For OPIOID-NAÏVE Patients:

• Start with 1/2 tablet (5mg hydrocodone) q4-6h PRN

• Max initial dose: 6 tablets/24h (60mg hydrocodone/1,950mg APAP)

For OPIOID-TOLERANT Patients:

• May require 1 tablet q4h (max 8 tablets/24h = 2,600mg APAP)

Critical Limits:

• APAP Ceiling: ≤3,000mg/day (chronic) or ≤4,000mg/day (acute)

• Never Exceed: 3,250mg APAP/24h (FDA limit)

Product Identification

• White Oval Tablets (generic)

• Common Imprints:
  • “10/325”
  • “M366”
  • “IP 110”

• Brand Versions:
  • Norco® (discontinued but still referenced)
  • Vicodin® (original 5/500mg formulation discontinued)

Black Box Warnings

⚠️ ACETAMINOPHEN HEPATOTOXICITY (leading cause of ALF in U.S.)
⚠️ OPIOID ADDICTION/OVERDOSE RISK
⚠️ LIFE-THREATENING RESPIRATORY DEPRESSION

Safety & Monitoring Requirements

• Naloxone Co-Prescription mandatory in most states
• PDMP Check before each prescription
• Renal/Hepatic Adjustment:

• Reduce dose/frequency in impairment
  • Avoid With:

• Alcohol

• Benzodiazepines

• CYP3A4 inhibitors (e.g., macrolides, azoles)

Prescribing Best Practices

1. Always start lowest effective dose

2. Limit initial prescriptions to ≤3 day supply

3. Use with non-opioid adjuvants (NSAIDs, ice, PT)

4. Document “lowest necessary quantity” justification

Clinical Alert:
“10/325mg contains 2x the opioid of standard starter doses (5/325mg). Reserve for patients with confirmed opioid tolerance or severe acute pain.”