Hysingla Er

Hysingla Er Manufacturers

• Purdue Pharma Lp
  

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  Hysingla Er | Purdue Pharma Lp

  

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  2.1 Initial Dosing

  HYSINGLA ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experienceand risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with HYSINGLA ER [see Warnings and Precautions (5.2)].

  HYSINGLA ER is administered orally once daily (every 24 hours).

  HYSINGLA ER tablets must be taken whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17)]. Crushing, chewing, or dissolving HYSINGLA ER tablets will result in uncontrolled delivery of hydrocodone and can lead to overdose or death [see Warnings and Precautions (5.1)].

  Use of HYSINGLA ER as the First Opioid Analgesic
  Initiate therapy with HYSINGLA ER 20 mg orally every 24 hours.

  Use of HYSINGLA ER in Patients who are not Opioid Tolerant
  The starting dose for patients who are not opioid tolerant is HYSINGLA ER 20 mg orally every 24 hours. Opioid tolerant patients are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, or an equianalgesic dose of another opioid.

  Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression [see Warnings and Precautions (5.2)].

  Daily doses of HYSINGLA ER greater than or equal to 80 mg are only for use in opioid tolerant patients.

  Conversion from Oral Hydrocodone Formulations to HYSINGLA ER
  Patients receiving other oral hydrocodone-containing formulations may be converted to HYSINGLA ER by administering the patient's total daily oral hydrocodone dose as HYSINGLA ER once daily.

  Conversion from Other Oral Opioids to HYSINGLA ER
  Discontinue all other around-the-clock opioid drugs when HYSINGLA ER therapy is initiated.

  Although tables of oral and parenteral equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and formulations. As such, it is preferable to underestimate a patient’s 24-hour oral hydrocodone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral hydrocodone requirements and manage an adverse reaction.

  To obtain the initial HYSINGLA ER dose, first use Table 1 to convert the prior oral opioids to a total hydrocodone daily dose and then reduce the calculated daily hydrocodone dose by 25% to account for interpatient variability in relative potency of different opioids.

  Consider the following when using the information found in Table 1.

  
  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 opioid analgesics to HYSINGLA ER. The table cannot be used to convert from HYSINGLA ER to another opioid. Doing so will result in an over-estimation of the dose of the new opioid and may result in fatal overdose Table 1. Conversion factors to HYSINGLA ER (Not Equianalgesic Doses) Opioid Oral dose (mg) Approximate oral conversion factor Codeine 133 0.15 Hydromorphone 5 4 Methadone 13.3 1.5 Morphine 40 0.5 Oxycodone 20 1 Oxymorphone 10 2 Tramadol 200 0.1

  To calculate the estimated total hydrocodone daily dose using Table 1:

  For patients on a single opioid, sum the current total daily 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 hydrocodone 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 the dose down, if necessary, to the nearest HYSINGLA ER tablet strength available and initiate therapy with that dose. If the converted HYSINGLA ER dose using Table 1 is less than 20 mg, initiate therapy with HYSINGLA ER 20 mg.

  Example conversion from a single opioid to HYSINGLA ER:
  For example, a total daily dose of oxycodone 50 mg would be converted to hydrocodone 50 mg based on the table above, and then multiplied by 0.75 (ie, take a 25 % reduction) resulting in a dose of 37.5 mg hydrocodone. Round this down to the nearest dose strength available, HYSINGLA ER 30 mg, to initiate therapy.

  Close observation and frequent titration are warranted until pain management is stable on the new opioid. Monitor patients for signs and symptoms of opioid withdrawal or for signs of over-sedation/toxicity after converting patients to HYSINGLA ER.

  The dose of HYSINGLA ER can be gradually adjusted every three to five days, using increments of 10 to 20 mg, until adequate pain relief and acceptable tolerability have been achieved.

  Conversion from Methadone to HYSINGLA ER
  Close monitoring is of particular importance when converting from methadone to other opioid agonists. 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
  Eighteen hours following the removal of the transdermal fentanyl patch, HYSINGLA ER treatment can be initiated. For each 25 mcg/hr fentanyl transdermal patch, a dose of HYSINGLA ER 20 mg every 24 hours represents a conservative initial dose. Follow the patient closely during conversion from transdermal fentanyl to HYSINGLA ER, as there is limited experience with this conversion.

  Conversion from Transdermal Buprenorphine to HYSINGLA ER
  All patients receiving transdermal buprenorphine (≤ 20 mcg/hr) should initiate therapy with HYSINGLA ER 20 mg every 24 hours. Follow the patient closely during conversion from transdermal buprenorphine to HYSINGLA ER, as there is limited experience with this conversion.

  2.2 Titration and Maintenance of Therapy

  Individually titrate HYSINGLA ER to a dose that provides adequate analgesia and minimizes adverse reactions. Continually re-evaluate patients receiving HYSINGLA ER to assess the maintenance of pain control and the relative incidence of adverse reactions as well as monitoring for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for the use of opioid analgesics.

  Adjust the dose of HYSINGLA ER in increments of 10 mg to 20 mg every 3 to 5 days as needed to achieve adequate analgesia.

  Patients who experience breakthrough pain may require a dose increase of HYSINGLA ER, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the HYSINGLA ER dose.

  If unacceptable opioid-related adverse reactions are observed, the next daily dose may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

  2.3 Administration of HYSINGLA ER

  HYSINGLA ER is administered once daily (every 24 hours).

  HYSINGLA ER must be taken whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17)].

  Crushing, chewing, or dissolving HYSINGLA ER tablets will result in uncontrolled delivery of hydrocodone and can lead to overdose or death [see Warnings and Precautions (5.1)].

  Multiple tablets of lower dose strengths that provide the desired total daily dose can be taken as a once daily dose.

  2.4 Patients with Hepatic Impairment

  Patients with severe hepatic impairment may have higher plasma concentrations than those with normal function. Initiate therapy with ½ the initial dose of HYSINGLA ER in these patients and monitor closely for respiratory depression and sedation [see Clinical Pharmacology (12.3)].

  2.5 Patients with 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 ½ the initial dose of HYSINGLA ER in these patients and monitor closely for respiratory depression and sedation [see Clinical Pharmacology (12.3)].

  2.6 Discontinuation of HYSINGLA ER

  Do not abruptly discontinue HYSINGLA ER. When the patient no longer requires opioid therapy, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically dependent patient. The dose may be reduced every 2-4 days. The next dose should be at least 50% of the prior dose. After reaching HYSINGLA ER 20 mg dose for 2-4 days, HYSINGLA ER can be discontinued.

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