Apadaz

Appropriate Use

should only be prescribed by healthcare professionals knowledgeable about opioid use and how to mitigate associated risks; reserve opioid analgesics for patients with inadequate tx alternatives; proper dosing and titration essential to decr. respiratory depression risk

Medication Error Risk

ensure accuracy when prescribing, dispensing, and administering hydrocodone/acetaminophen oral solution; dosing errors due to confusion between mg and mL or different concentrations can result in accidental overdose and death

Addiction, Abuse, and Misuse

Schedule II controlled substance combination containing an opioid agonist with risk of addiction, abuse, and misuse, which can lead to overdose and death; assess opioid abuse or addiction risk prior to prescribing; regularly reassess all patients for misuse, abuse, and addiction

Respiratory Depression

serious, life-threatening, or fatal cases may occur even with recommended use, especially during tx start or after dose incr; to decr. risk, initiate and titrate dose appropriately

Accidental Ingestion

accidental ingestion of even one dose, especially by children, can result in fatal hydrocodone overdose

Risks from Concomitant Use with Benzodiazepines, CNS Depressants

concomitant opioid use with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death; reserve concomitant use for patients with inadequate alternative tx options

Neonatal Opioid Withdrawal Syndrome

advise pregnant patients with extended opioid use of risk of potentially life-threatening neonatal opioid withdrawal syndrome; ensure tx by neonatology experts available at delivery

Opioid Analgesic REMS

providers are strongly encouraged to complete risk evaluation and mitigation strategy (REMS)-compliant education program, counsel patients and/or caregivers with each Rx on serious risks, safe use, and importance of reading medication guide

CYP450 3A4 Interaction

concomitant use with CYP450 3A4 inhibitors or D/C of concomitant CYP450 3A4 inducers may incr. opioid concentration which may incr. or prolong adverse effects including potentially fatal respiratory depression; monitor patients receiving any concomitant CYP450 3A4 inhibitor or inducer

Hepatotoxicity

acetaminophen associated with acute liver failure including cases of liver transplant and death; most liver injury associated with acetaminophen doses >4000 mg per day and >1 acetaminophen-containing product