SHOP BY NEED
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:
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Start with 1/2 tablet (5mg hydrocodone) q4-6h PRN
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Max initial dose: 6 tablets/24h (60mg hydrocodone/1,950mg APAP)
For OPIOID-TOLERANT Patients:
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May require 1 tablet q4h (max 8 tablets/24h = 2,600mg APAP)
Critical Limits:
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APAP Ceiling: ≤3,000mg/day (chronic) or ≤4,000mg/day (acute)
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Never Exceed: 3,250mg APAP/24h (FDA limit)
Product Identification
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White Oval Tablets (generic)
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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:
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Reduce dose/frequency in impairment
• Avoid With: -
Alcohol
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Benzodiazepines
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CYP3A4 inhibitors (e.g., macrolides, azoles)
Prescribing Best Practices
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Always start lowest effective dose
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Limit initial prescriptions to ≤3 day supply
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Use with non-opioid adjuvants (NSAIDs, ice, PT)
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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.”