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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 assoc. risks; reserve ER forms for pts w/ inadequate tx alternatives; not indicated for prn analgesic use; proper dosing and titration essential to decr. resp. depression risk
Addiction, Abuse, and Misuse
opioid agonist Schedule II controlled substance w/ 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 pts for misuse, abuse, and addiction
Respiratory Depression
serious, life-threatening, or fatal cases may occur even w/ recommended use, esp. during tx start or after dose incr; to decr. risk, initiate and titrate dose appropriately; instruct pts 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, esp. by children, can result in fatal hydrocodone overdose
Risks from Concomitant Use w/ Benzodiazepines, CNS Depressants
concomitant opioid use w/ benzodiazepines or other CNS depressants, incl. alcohol, may result in profound sedation, resp. depression, coma, and death; reserve concomitant use for pts w/ inadequate alternative tx options
Neonatal Opioid Withdrawal Syndrome
extended use in pregnant pts can lead to potentially life-threatening neonatal opioid withdrawal syndrome; advise pregnant pts of risks and ensure tx by neonatology experts avail. at delivery if extended opioid use required
Opioid Analgesic REMS
providers are strongly encouraged to complete risk evaluation and mitigation strategy (REMS)-compliant education program, counsel pts and/or caregivers w/ each Rx on serious risks, safe use, and importance of reading medication guide
CYP450 3A4 Interaction
concomitant use w/ CYP450 3A4 inhibitors or D/C of concomitant CYP450 3A4 inducers may incr. hydrocodone conc. which may incr. or prolong adverse effects incl. potentially fatal resp. depression; monitor pts 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 naloxone if risk of opioid overdose or accidental ingestion
pain, severe chronic
- [opioid-naive or opioid-nontolerant pts]
- 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 pts 65 yo and older; do not cut/crush/chew/dissolve tab; doses of 80 mg/day or greater for use in opioid-tolerant pts only; taper total daily dose by no more than 10-25% q2-4wk to D/C if long-term use
- [opioid-tolerant pts]
- 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 pts 65 yo and older; do not cut/crush/chew/dissolve tab; taper total daily dose by no more than 10-25% q2-4wk to D/C if long-term use
renal dosing
- [opioid-naive or opioid-nontolerant pts]
- renal impairment: no adjustment
- HD/PD: not defined
- [opioid-tolerant pts]
- mod-severe impairment: decr. usual start dose by 50%
- HD/PD: not defined
hepatic dosing
- [opioid-naive or opioid-nontolerant pts]
- hepatic impairment: no adjustment
- [opioid-tolerant pts]
- severe impairment: decr. usual start dose by 50%
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.