YOUR PATIENTS' HYDROCODONE NEEDS VARY THEIR ER HYDROCODONE DOESN'T HAVE TO
COPYRIGHT AND TRADEMARK NOTICE
RESTRICTION ON USING THE CONTENT OF THIS WEBSITE
Purdue makes no representation regarding the availability, the accuracy, or the completeness of the content of this Site. The Site contains information about products that may or may not be available in a particular country or region of the world, may be available under different trademarks in different countries and, where applicable, may be approved by government regulatory authority for sale or use with different indications and restrictions in different countries.
This Site may contain, from time to time, information related to various health, medical and fitness conditions and their treatment. For non-healthcare providers, such information is not intended to be a substitute for the advice provided by a physician or other medical professional. You should not use the information contained herein for diagnosing a health or fitness problem or disease. In any event, users of this Site should always consult a doctor and/or other medical professional with respect to health concerns.
While Purdue uses reasonable efforts to include accurate and up-to-date information in its Site, Purdue makes no warranties or representations as to its accuracy. Purdue assumes no liability or responsibility for any errors or omissions in the content of its Site. This Site may provide links or references to other Web sites not affiliated with Purdue. Such links to other Sites are provided only as a convenience to users of this Site. Purdue has not reviewed all of the Sites that may be linked to its Site, and is not responsible for the content of any other Site linked to this Site. Linking to any pages off this Site is at your own risk. Purdue shall not be liable for any damages or injury arising from users' access to such Sites.
INDEMNIFICATION BY SITE USER
LIMITATION OF LIABILITY
Purdue provides the contents of its Site for informational purposes and for your general interest and entertainment only. By using the Site you hereby agree not to rely on any of the information contained herein. UNDER NO CIRCUMSTANCES SHALL PURDUE BE LIABLE FOR YOUR RELIANCE ON ANY SUCH INFORMATION NOR SHALL PURDUE BE LIABLE FOR DAMAGES OF ANY KIND, INCLUDING, WITHOUT LIMITATION, ANY DIRECT, INCIDENTAL, SPECIAL CONSEQUENTIAL, INDIRECT OR PUNITIVE DAMAGES THAT RESULT FROM THE USE OF, OR THE INABILITY TO USE, THE MATERIALS IN THIS SITE OR THE MATERIALS IN ANY SITE WHICH MAY BE LINKED TO THIS SITE, EVEN IF PURDUE OR A PURDUE AUTHORIZED REPRESENTATIVE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. APPLICABLE LAW MAY NOT ALLOW THE LIMITATION OR EXCLUSION OF LIABILITY OR INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU. IN NO EVENT SHALL PURDUE'S TOTAL LIABILITY TO YOU FOR ALL DAMAGES, LOSSES, AND CAUSES OF ACTION WHETHER THE CAUSE OF ACTION IS IN CONTRACT, TORT (INCLUDING, BUT NOT LIMITED TO, NEGLIGENCE) OR OTHERWISE EXCEED THE AMOUNT PAID BY YOU, IF ANY, FOR ACCESSING THIS SITE.
DISCLAIMER OF WARRANTIES
THE MATERIALS IN THIS SITE ARE PROVIDED "AS IS" AND WITHOUT WARRANTIES OF ANY KIND EITHER EXPRESS OR IMPLIED. TO THE FULLEST EXTENT PERMISSIBLE PURSUANT TO APPLICABLE LAW, PURDUE DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. PURDUE DOES NOT WARRANT THAT THE FUNCTIONS CONTAINED IN THE MATERIALS WILL BE UNINTERRUPTED OR ERROR-FREE, THAT DEFECTS WILL BE CORRECTED, OR THAT THIS SITE OR THE SERVER THAT MAKES IT AVAILABLE ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS. PURDUE DOES NOT WARRANT OR MAKE ANY REPRESENTATIONS REGARDING THE USE OR THE RESULTS OF THE USE OF THE MATERIALS IN THESE SITES IN TERMS OF THEIR CORRECTNESS, ACCURACY, RELIABILITY, OR OTHERWISE. YOU (AND NOT PURDUE) ASSUME THE ENTIRE COST OF ALL NECESSARY SERVICING, REPAIR OR CORRECTION. APPLICABLE LAW MAY NOT ALLOW THE EXCLUSION OF IMPLIED WARRANTIES, SO THE ABOVE EXCLUSION MAY NOT APPLY TO YOU.
JURISDICTIONAL ISSUES/EXPORT RESTRICTIONS
This Site may link to other Sites produced by companies related to Purdue, some of which are outside the U.S. Those Sites may have information that is appropriate only to the particular originating country or region where the Site is based. You should not construe anything on the Site as a promotion or solicitation for any product or for the use of any product that is not authorized by the laws and regulations of the country where you are located. Purdue makes no representation that materials in the Site are appropriate or available for use in other locations. Those who choose to access this Site from other locations do so on their own initiative and are responsible for compliance with local laws, if and to the extent local laws are applicable.
Software from this Site is further subject to United States export controls. No software from this Site may be downloaded or otherwise exported or re-exported (i) into (or to a national or resident of) Cuba, Iraq, Libya, North Korea, Iran, Syria or any other country subject to United States export control restrictions; or (ii) to anyone on the U.S. Treasury Department's list of Specially Designated Nationals or the U.S. Commerce Department's Table of Denial Orders. By downloading or using the Software, you represent and warrant that you are not located in, under the control of, or a national or resident of any such country or on any such list.
CAREER AND/OR BUSINESS OPPORTUNITIES
The Site displays information about job postings ("Current Openings") for informational purposes only. This information is subject to change without notice, and in displaying such information Purdue makes no representation or warranty that the information contained on the Site will be timely or free of errors and omissions.
It is the intent of Purdue to leave you with absolute control over the decision to forward your personal information or resume to the company. It is your choice to give Purdue your personal information via the Internet, Fax or Mail.
Although accessible by others, the intent of Purdue in displaying Current Openings on this Site is to display employment opportunities within the United States of America. You should not construe anything on the Site as a promotion or solicitation for employment not authorized by the laws and regulations of the country where you are located.
Links Out — This Site may provide links or references to other Web sites not affiliated with Purdue. Purdue has not reviewed the content of Web sites that may be linked to its Site, makes no representations about the content of the Web sites, and is not responsible for the content of any other Web site linked to this Site. Linking to any pages off this Site is at your own risk. Purdue shall not be liable for any damages or injury arising from users' access to such Web sites.
Links In — Unless otherwise set forth in a written agreement between you and Purdue, you must adhere to Purdue's linking policy as follows: i) any link to a Purdue Site must be a text only link clearly marked with the name of the specific Purdue Web site, ii) the appearance, position and other aspects of the link may not be such as to damage or dilute the goodwill associated with Purdue's name or trademarks, iii) the link must point to one of the specific Purdue Web site URLs homepage and not to other pages within the Web site, iv) the appearance, position and other attributes of the link may not create the false appearance that your organization or entity is sponsored by, associated with, or affiliated with Purdue or the Site, v) when selected by the user, the link must display the Web site on full screen and not within a "frame" on the linking Website, and vi) the linked Web site must comply with all applicable U.S. laws, rules, and regulations. Purdue shall not be liable for any damages or injury arising from such Links In any Purdue Site.
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES AND OTHER CNS DEPRESSANTSAddiction, Abuse, and Misuse
Hysingla ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Hysingla ER, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)].Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of Hysingla ER. Monitor for respiratory depression, especially during initiation of Hysingla ER or following a dose increase. Instruct patients to swallow Hysingla ER tablets whole; crushing, chewing, or dissolving Hysingla ER tablets can cause rapid release and absorption of a potentially fatal dose of hydrocodone [see Warnings and Precautions (5.2)].Accidental Ingestion
Accidental ingestion of even one dose of Hysingla ER, especially by children, can result in a fatal overdose of hydrocodone [see Warnings and Precautions (5.2)].Neonatal Opioid Withdrawal Syndrome
Prolonged use of Hysingla ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.3)].Cytochrome P450 3A4 Interaction
The concomitant use of Hysingla ER with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Monitor patients receiving Hysingla ER and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.4), Drug Interactions (7), and Clinical Pharmacology (12.3)].Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.5), Drug Interactions (7)].
- Reserve concomitant prescribing of Hysingla ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
- Limit dosages and durations to the minimum required.
- Follow patients for signs and symptoms of respiratory depression and sedation.
Indications and usage
Hysingla® ER (hydrocodone bitartrate) is 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.Limitations of Use
- Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Hysingla ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- Hysingla ER is not indicated as an as-needed (prn) analgesic.
- Hysingla ER is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; hypersensitivity to hydrocodone or any component of Hysingla ER.
- Hysingla ER contains hydrocodone, a Schedule II controlled substance. Hysingla ER exposes users to the risks of opioid addiction, abuse, and misuse. Because extended-release products such as Hysingla ER deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydrocodone present.
- Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Hysingla ER. Addiction can occur at recommended doses and if the drug is misused or abused.
- Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing Hysingla ER, and monitor all patients receiving Hysingla ER for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as Hysingla ER, but use in such patients necessitates intensive counseling about the risks and proper use of Hysingla ER along with intensive monitoring for signs of addiction, abuse, and misuse.
- Abuse or misuse of Hysingla ER by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the hydrocodone and can result in overdose and death.
- Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing Hysingla ER. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug.
- Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended, and if not immediately recognized and treated, may lead to respiratory arrest and death.
- While serious, life‐threatening, or fatal respiratory depression can occur at any time during the use of Hysingla ER, the risk is greatest during the initiation of therapy or following a dosage increase. Closely monitor patients for respiratory depression especially within the first 24–72 hours of initiating therapy with and following dosage increases of Hysingla ER.
- To reduce the risk of respiratory depression, proper dosing and titration of Hysingla ER are essential. Overestimating the Hysingla ER dosage when converting patients from another opioid product can result in fatal overdose with the first dose.
- Accidental ingestion of even one dose of Hysingla ER, especially by children, can result in respiratory depression and death due to an overdose of hydrocodone.
- Prolonged use of Hysingla ER during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
- Concomitant use with a CYP3A4 inhibitor, such as macrolide antibiotics, azole-antifungal agents, and protease inhibitors, particularly when an inhibitor is added after a stable dose of Hysingla ER is achieved, and discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, may increase plasma concentrations of hydrocodone and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression. Monitor patients closely at frequent intervals and consider dosage reduction of Hysingla ER until stable drug effects are achieved. Concomitant use of Hysingla ER with CYP3A4 inducers or discontinuation of an CYP3A4 inhibitor could decrease hydrocodone plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to hydrocodone. Monitor patients closely at frequent intervals and consider increasing the opioid dosage if needed to maintain adequate analgesia or if symptoms of opioid withdrawal occur.
- Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Hysingla ER with benzodiazepines or CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
- If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Follow patients closely for signs and symptoms of respiratory depression and sedation.
- Advise both patients and caregivers about the risks of respiratory depression and sedation when Hysingla ER is used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs.
- The use of Hysingla ER in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated. Hysingla ER-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of Hysingla ER.
- Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients.
- Monitor such patients closely, particularly when initiating and titrating Hysingla ER and when Hysingla ER is given concomitantly with other drugs that depress respiration. Alternatively, consider the use of non-opioid analgesics in these patients.
- Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers.
- Hysingla ER may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or after concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics). Monitor these patients for signs of hypotension after initiating or titrating the dosage of Hysingla ER. In patients with circulatory shock, Hysingla ER may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of Hysingla ER in patients with circulatory shock.
- QTc prolongation has been observed with Hysingla ER following doses of 160 mg. This observation should be considered in making decisions regarding patient monitoring when prescribing Hysingla ER in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or who are taking medications known to prolong QTc interval.
- Hysingla ER should be avoided in patients with congenital long QT syndrome. In patients who develop QTc prolongation, consider reducing the dose by 33–50%, or changing to an alternate analgesic.
- In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), Hysingla ER may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor those patients for signs of sedation and respiratory depression, particularly when initiating therapy with Hysingla ER. Opioids may obscure the clinical course in a patient with a head injury. Avoid the use of Hysingla ER in patients with impaired consciousness or coma.
- In the clinical studies with specific instructions to take Hysingla ER with water to swallow the tablets, 11 out of 2476 subjects reported difficulty swallowing Hysingla ER. These reports included esophageal obstruction, dysphagia, and choking, one of which had required medical intervention to remove the tablet. Instruct patients not to pre-soak, lick or otherwise wet Hysingla ER tablets prior to placing in the mouth, and to take one tablet at a time with enough water to ensure complete swallowing immediately after placing in the mouth.
- Patients with underlying gastrointestinal disorders such as esophageal cancer or colon cancer with a small gastrointestinal lumen are at greater risk of developing these complications. Consider use of an alternative analgesic in patients who have difficulty swallowing and patients at risk for underlying gastrointestinal disorders resulting in a small gastrointestinal lumen.
- Hysingla ER is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus. The hydrocodone in Hysingla ER may cause spasm of the sphincter of Oddi. Opioids may cause increases in the serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis.
- The hydrocodone in Hysingla ER may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during Hysingla ER therapy.
- Avoid the use of mixed agonist/antagonist analgesics (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including Hysingla ER. In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms. When discontinuing Hysingla ER, gradually taper the dosage. Do not abruptly discontinue Hysingla ER.
- Hysingla ER may impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Peak blood levels of hydrocodone may occur 14–16 hours (range 6–30 hours) after initial dosing of Hysingla ER. Blood levels of hydrocodone, in some patients, may be high at the end of 24 hours after repeated-dose administration. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Hysingla ER and know how they will react to the medication.
- The most common adverse reactions (≥5%) reported by patients treated with Hysingla ER in the chronic pain clinical trials were constipation, nausea, vomiting, fatigue, upper respiratory tract infection, dizziness, headache, and somnolence.
Intended for healthcare professionals of the United States of America only.