Combination of Hydrocodone and Acetaminophen.
Each component keeps its own pharmacology page; the combination itself adds no new mechanism.
FDA label
Read the full label on DailyMed ↗
BOXED WARNING Opioid addiction/abuse/misuse risk (assess before and during); life-threatening respiratory depression (esp. at initiation/dose increase); accidental ingestion of one dose can be fatal in children; concomitant benzodiazepines/CNS depressants → profound sedation, respiratory depression, coma, death; prolonged in-utero exposure → neonatal opioid withdrawal syndrome; CYP3A4 inhibitor use (or inducer discontinuation) can raise hydrocodone levels → fatal respiratory depression; acetaminophen hepatotoxicity — acute liver failure, mostly at >4,000 mg/day APAP or multiple APAP products; opioid REMS.
| FDA dosing | Population | Start | Target | Max |
| Pain severe enough to require an opioid, alternatives inadequate (5/325 mg) | Adults | 1–2 tabs q4–6h PRN | Lowest dose achieving adequate analgesia | 8 tabs/day |
| Same (7.5/325 mg or 10/325 mg) | Adults | 1 tab q4–6h PRN | Lowest dose achieving adequate analgesia | 6 tabs/day |
Renal Severe renal disease: follow therapy with serial renal function tests (label gives no dose adjustment)
Hepatic Severe hepatic disease: follow therapy with serial liver function tests (label gives no dose adjustment); APAP hepatotoxicity risk >4,000 mg/day
Total daily acetaminophen from ALL sources — hepatotoxicity mostly at >4,000 mg/day APAP
Instructions
- Use lowest effective dose for shortest duration; many acute pain conditions need no more than a few days
- Converting from other opioids: underestimate the 24-h dose (conservative conversion)
- Do not abruptly stop in physically dependent patients: taper ≤10–25% of total daily dose every 2–4 weeks; pause or slow taper if withdrawal emerges
- Discuss access to an opioid overdose reversal agent (naloxone/nalmefene) with all patients
- Store securely out of reach of children; dispose of unused tablets promptly (flush if no take-back available)
Available strengths
- tab 5/325, 7.5/325, 10/325 mg
Contraindications
- Significant respiratory depression
- Acute or severe bronchial asthma in unmonitored setting or without resuscitative equipment
- Known or suspected GI obstruction, including paralytic ileus
Cautions
- Life-threatening respiratory depression — greatest risk at initiation/dose increase; elderly, cachectic, debilitated, and chronic pulmonary disease patients at higher risk
- Concomitant benzodiazepines/CNS depressants/alcohol: reserve for inadequate alternatives
- Adrenal insufficiency (usually >1 month of use)
- Severe hypotension incl. orthostatic; caution with circulatory shock
- Serotonin syndrome with concomitant serotonergic drugs
- Opioid-induced hyperalgesia/allodynia
- May impair driving/machinery operation
Adverse reactions
- Most frequent: light-headedness, dizziness, sedation, nausea, vomiting
- Constipation; drowsiness, mental clouding, dysphoria, mood changes
- Urinary retention/ureteral spasm
- Hearing impairment or permanent loss (chronic overdose)
- SJS/TEN, rash, pruritus; thrombocytopenia, agranulocytosis
- Hypoglycemia; androgen deficiency (long-term); anaphylaxis
Pregnancy Prolonged use during pregnancy → neonatal opioid withdrawal syndrome (life-threatening if not recognized/treated; ensure neonatology management at delivery); can cause fetal harm
Lactation Advise nursing mothers to watch infant for increased sleepiness, breathing difficulty, or limpness and seek immediate care
Part D rank #26.