SHOP BY NEED
Vicodin® (Hydrocodone Bitartrate/Acetaminophen) 10mg/300mg – Discontinued Opioid-Analgesic Combination
*(Note: Vicodin brand is no longer manufactured. Current equivalent = Norco 10/325mg)*
⚠️ Critical Safety Update
-
Original Formulation: 10mg hydrocodone + 300mg APAP
-
Status: Discontinued (replaced by lower APAP formulations)
-
Current Standard: Norco 10/325mg
Therapeutic Profile
• Schedule II Controlled Substance (High abuse potential)
• Composition:
-
Hydrocodone 10mg (μ-opioid agonist)
-
Acetaminophen 300mg (non-opioid analgesic)
• Onset: 20-30 minutes
• Duration: 4-6 hours
Why Reformulated?
-
FDA 2011 Mandate: All opioid/APAP combos limited to ≤325mg APAP
-
Liver Toxicity Risk:
-
8 tablets = 2,400mg APAP (near daily max)
-
No safety margin for additional APAP use
-
Modern Alternatives
Product | Hydrocodone | APAP | Status |
---|---|---|---|
Norco 10/325mg | 10mg | 325mg | Available |
Hysingla ER | 10-120mg | 0mg | APAP-free |
Zamicet | 10mg | 300mg | Liquid form |
Dosing Protocol (Historical)
-
Adults: 1 tab q4-6h PRN pain
-
Max Daily APAP: ≤3,000mg (chronic)
-
Never Exceed: 4,000mg APAP/24h
Black Box Warnings
⚠️ ACETAMINOPHEN HEPATOTOXICITY
⚠️ OPIOID ADDICTION/OVERDOSE RISK
⚠️ LIFE-THREATENING RESPIRATORY DEPRESSION
If You Have Old Vicodin 10/300:
-
Discontinue Use – May be expired/unsafe
-
Switch to Norco 10/325mg
-
Monitor LFTs if long-term use
Safety Essentials for Current Prescribing
• Naloxone Co-Prescription required
• PDMP Checks before each Rx
• 7-Day Limit for acute pain
• Avoid With:
-
Alcohol
-
Benzodiazepines
-
CYP3A4 inhibitors