Vicodin 10 mg

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

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:

1. Discontinue Use – May be expired/unsafe

2. Switch to Norco 10/325mg

3. 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

• Benzodiazepiny

• CYP3A4 inhibitors