Hydrocodone 5-325 mg

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

1. Start low (1 tab q6h) for opioid-naïve patients

2. Limit initial Rx to ≤3–7 day supply

3. Combine with non-opioids (NSAIDs, ice, PT)

4. 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)