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Hysingla ER
hydrocodone
Black Box Warnings .
Appropriate Use
should only be prescribed by healthcare professionals knowledgeable about ER opioid use and how to mitigate associated risks; reserve ER forms for patients with inadequate tx alternatives; not indicated for prn analgesic use; proper dosing and titration essential to decr. respiratory depression risk
Addiction, Abuse, and Misuse
opioid agonist Schedule II controlled substance 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; instruct patients to swallow ER tabs whole; crushing, chewing, or dissolving ER tabs can cause rapid release and absorption of potentially fatal hydrocodone dose
Accidental Ingestion
accidental consumption 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. hydrocodone concentration which may incr. or prolong adverse effects including potentially fatal respiratory depression; monitor patients receiving any concomitant CYP450 3A4 inhibitor or inducer
Adult Dosing .
Dosage forms: ER TAB: 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg, 120 mg
Dosage Form Details
- [formulation clarification]
- Info: abuse-deterrent formulation to reduce potential abuse or misuse
Special Note
- [prescribing info]
- Info: consider prescribing opioid overdose reversal agent (e.g., naloxone, nalmefene), especially if risk of opioid overdose or accidental ingestion
pain, severe chronic
- [opioid-nontolerant patients]
- Dose: individualize dose PO q24h; Start: 20 mg PO q24h, may incr. by 10-20 mg/day PO q3-5 days; Info: use lowest effective dose, shortest effective tx duration; titrate slowly in patients 65 yo and older; do not cut/crush/chew/dissolve tab; doses of 80 mg/day or greater for use in opioid-tolerant patients only; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [opioid-tolerant patients]
- Dose: individualize dose PO q24h; Start: individualize based on current opioid intake, see pkg insert for conversion; Info: use lowest effective dose, shortest effective tx duration; titrate slowly in patients 65 yo and older; do not cut/crush/chew/dissolve tab; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
renal dosing
- [opioid-nontolerant patients]
- renal impairment: no adjustment
- HD/PD: not defined
- [opioid-tolerant patients]
- moderate-severe impairment: decr. usual start dose by 50%
- HD/PD: not defined
hepatic dosing
- [opioid-nontolerant patients]
- hepatic impairment: no adjustment
- [opioid-tolerant patients]
- severe impairment: decr. usual start dose by 50%
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.