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Hydrocodone ER (q24h)

HYSINGLA ER

What it isExtended-release full mu-opioid agonist; around-the-clock chronic pain when alternatives are inadequate.

Why this oneIt is an abuse-deterrent once-daily tablet; manipulation resistance cannot prevent oral misuse or addiction.

What limits itRespiratory depression, dependence, and fatal overdose remain possible; benzodiazepines and other depressants magnify risk.

FDA-approved for

FDA label

BOXED WARNING Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion (fatal in children); neonatal opioid withdrawal syndrome; risks from concomitant benzodiazepines/CNS depressants; CYP3A4 interactions; opioid REMS
FDA dosingPopulationStartTargetMax
Severe and persistent pain requiring an opioid analgesic (not for as-needed use)Adults (opioid-naive)20 mg QDIndividualized≥80 mg only for opioid-tolerant patients

Titration May titrate every 3 to 5 days (increments of 10-20 mg)

Renal No adjustment for mild; moderate/severe impairment and ESRD: initiate at one-half the starting dose and titrate carefully

Hepatic No adjustment for mild/moderate; severe impairment: initiate at one-half the starting dose

Opioid-tolerant defined as ≥60 mg oral hydrocodone/day (or equivalent) for ≥1 week

Instructions

Contraindications

Cautions

Adverse reactions

Pregnancy May cause neonatal opioid withdrawal syndrome with prolonged use; insufficient data on birth-defect risk

Lactation Hydrocodone present in human milk; breastfeeding not recommended during treatment

⚠ BOXED WARNINGS

Classes and tags

Clinical profile

Direct muscarinic antagonism0 / 4

Mechanism of action: Hydrocodone ER (q24h) ballicule

Hydrocodone ER (q24h) ballicule: receptor binding, kinetics and half-life diagram

Open Hydrocodone ER (q24h) in the interactive console ↗

Memory aids: mascots and interaction avatars

Hydrocodone ER (q24h) VICODIN / NORCO mascot mnemonic cartoon
“Viking Hydrant code”
Viking for Vicodin (combo with acetaminophen)
Hydrocodone ER (q24h) CYP2D6 substrate avatar
CYP2D6 substrate
Hydrocodone ER (q24h) CYP3A4 substrate avatar
CYP3A4 substrate

Open Hydrocodone ER (q24h) in the interactive console ↗