Hysingla ER

Drug Information
Handout
Hysingla ER
Hydrocodone bitartrate extended release
Indications and Usage
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Opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long– term opioid
treatment and for which alternative treatment options are inadequate.
Dosage and Administration
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Available in Extended– release tablets: 20mg, 30mg, 40mg, 60mg, 80mg, 100mg, 120mg
Administered once every 24 hours
Take tablets whole, DO NOT chew, crush, and take with adequate water
Conversion from Oral Hydrocodone Formulations to Hysingla ER:
 Patients receiving other oral hydrocodone– containing formulations may be converted by administering the patient’s
total daily oral hydrocodone dose as Hysingla ER once daily. ALWAYS round doses down.
Conversion from other oral opiods to Hysingla ER:
 Discontinue all other around-the-clock opioid drugs when Hysingla therapy is initiated. The table below can be used to
determine potential dosing.
 This is NOT a table of equianalgesic doses.
 The conversion factors in this table are ONLY for the conversion FROM one of the listed oral opioids to Hysingla.
 The tablet CANNOT be used to convert FROM Hysingla to another opioid. Doing so will result in an over– estimation of
the dose of the new opioid and may result in overdose.
To calculate the estimated total hydrocodone daily dose using table 1:
For patients on a single opioid, sum the current total dialy dose of the opioid and then multiply the total daily dose by the
approximate oral conversion factor to calculate the approximate oral hydrocodone daily dose.
For patients on a regimen of more than one opioid, calculate the approximate oral hydrocodone dose for each opioid and
sum the totals to obtain the approximate oral hydrorcodone daily dose.
For patients on a regimen of fixed ratio– opioid/ non-opioid analgesic products, use only the opioid component of these
products in the conversion.
Reduce the calculated daily oral hydrocodone dose by 25%. ALWAYS round down.
Conversion of Methadone to Hysingla ER:
 Close monitoring is of particular importance when converting from methadone.
 The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure.
Methadone has a long half– life and can accumulate in the plasma.
Conversion from Transdermal Fentanyl to Hysingla ER:
 18 hours following the removal of the transdermal patch, Hysingla treatment can be initiated.
 For each 25mcg/hr fentanyl, a dose of Hysingla ER 20mg every y24 hours represents a conservative initial dose.
Adjust the dose of Hysingla in increments of 10mg to 20mg every 3 to 5 days as needed to achieve adequate analgesia
Patients who experience breakthrough pain may require a dose increase of Hysingla, or may need rescue medication with
an appropriate dose of an immediate-release analgesic.
DO NOT abruptly discontinue Hysingla. When the patient no longer requires therapy, use a gradual downward titration. The
dose should be reduced every 2-4 days. The next dose should be at least 50% of the prior dose. After reaching Hysingla
20mg dose for 2-4 days, Hysingla can be discontinued.
Drug Information
Page 2
Warnings and Precautions
CONTRAINDICATIONS:
 Significant respiratory depression
 Acute or severe bronchial asthma
 Known or suspected paralytic ileus and GI obstruction
 Hypersensitivity to any component of Hysingla ER or the active ingredient, hydrocodone bitartrate
WARNINGS AND PRECAUTIONS
 Misuse, abuse, diversion
 Interactions with CNS depressants
 Elderly, cache tic, debilitated patients and those with chronic pulmonary disease
 Patients with head injury or increased intracranial pressure
 Risk of choking/ GI obstruction
 Concomitant use of CYP3A4 inhibitors may increase opioid effects
 Impaired mental/ physical abilities
 QTc prolongation has been observed. Avoid use with patient with congenital long QTc syndrome. Observation should be
considered with patients with other cardiac irregularities.
Drug Interactions
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CYP3A4 inhibitors
CNS depressants
Mixed agonists/ antagonists
MAO inhibitors or tricyclic antidepressants
Special Populations
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Hepatic Impairment:
 No dose adjustments in starting dose with Hysingla is required in patients with mild or moderate hepatic impairment.
 Patients with severe hepatic impairment may have higher plasma concentrations than those with normal function.
Initiate therapy with 1/2 the initial dose of Hysingla in these patients and monitor closely for respiratory depression
and sedation.
Renal Impairment
 No dose adjustments in starting dose with Hysingla is required in patients with mild renal impairment.
 Patients with moderate to severe renal impairment, and end– stage renal disease may have higher plasma concentrations than those with normal function. Initiate therapy with 1/2 the initial dose of Hysingla in these patients and monitor closely for respiratory depression and sedation.
Geriatric
 Plasma concentrations are similar between patients >65 years old compared to younger patients.
 Hydrocodone can cause confusion and over– sedation in the elderly.
 Further, because of their greater frequency of decreased hepatic, renal, or cardiac function, concomitant disease and
concomitant use of CNS active medications, start elderly patients on low doses of Hysingla and monitor closely for
adverse events such as respiratory depression, sedation, and confusion.
Adverse Reactions (Most common, >20%)
The only predominant Adverse reaction was Nausea (16%) all other adverse reactions were <10% and are common reactions
that are seen in most other opioid medications.