YOUR PATIENTS' HYDROCODONE NEEDS VARY THEIR ER HYDROCODONE DOESN'T HAVE TO

Privacy Policy

The privacy of Site users' personal information is important to Purdue. This Privacy Policy describes information that may be collected about Site users; how Site user information is used; how Purdue protects it; and what choices Site users have on how that information is used.

  1. This Privacy Policy covers the following types of information:

    This Privacy Policy covers Purdue's treatment of personally identifiable information that Purdue collects when you are on this Web site, and when you use Purdue's services or click on Purdue's online advertisements on the Internet to access a Purdue Site. This Privacy Policy does not apply to the practices of companies that Purdue does not own or control, or to people that Purdue does not employ or manage. Information collection and use will be handled in the following manner set forth in this Privacy Policy.

  2. PERSONAL INFORMATION WE COLLECT

    Information we collect from visitors

    Visitors to Purdue Sites can access the Site's home page, and browse some areas of the site, without disclosing any personally identifiable information. We do track information provided to us by your browser, including the Site you came from (known as the referring URL), any Purdue online advertisements located on third party websites that you may have clicked on to access one of the Purdue Sites, the type of browser you use, the time and date of access, and other information that does not personally identify you. On some of our sites, you must register to access portions of the site.

    In addition, we gather information about you that is automatically collected by our Web server, such as your IP address and domain name. Purdue may use Web server and browser information to individually customize its offerings and presentations if you submit your personal information.

    Information we collect when you register

    Visitors registering for services on our Web sites are asked to provide identifying information, such as name, gender, and contact information. On the registration screen, we label which information is required for registration, and which information is optional and may be given at your discretion. Purdue Sites obtain visitors' consent before collecting personally identifiable information.

    Information from outside sources

    We may also collect information about physicians or other health care professionals who register on Purdue Sites from other sources in order to verify their licensure status and identity. In some cases, we ask customers for information after they register, such as credit card information. Where necessary (for example, to process an order for a purchase), our Web sites may contact financial or credit organizations to confirm customer credit card information.

    From time to time we may augment our existing user databases with legally obtained information from third parties. Some of this information may be personally identifiable, such as national change of address information. We do this to better target our information offerings and promotional campaigns and to provide pertinent offers in which we think you would be interested.

    Other information

    • We may also collect information that you voluntarily provide to us through responses to surveys, search functions, questionnaires, feedback, forms and the like.

    • On some of our Sites, we offer health assessment tools that ask you to provide self-assessment information.

    • We may also ask you to provide additional information such as your e-mail address if you want to obtain additional services or information or to resolve complaints or concerns.

  3. Purdue will take reasonable steps to safeguard any information you share with us. Purdue stores the information you provide about yourself in a database in order to provide you with the information you request. The information is stored for the lifetime of the database unless you request that it be removed.

  4. Purdue will limit the collection and use of your information that Purdue requires to deliver superior service to you, which includes advising you about Purdue's products, newsletters, services and other opportunities, and to administer Purdue's business.

  5. This Site is not intended or designed to attract children under the age of 13. We do not knowingly collect personally identifiable data from site visitors under the age of 13.

  6. Purdue will permit only authorized employees, consultants, third party vendors or other agents, who are trained in the proper handling of customer information, to have access to that information. Employees who violate Purdue's Privacy Policy will be subject to Purdue's normal disciplinary process.

  7. Except as described above, Purdue will not otherwise use or disclose any of your personally identifiable information, except to the extent reasonably necessary: (i) to correct technical problems and malfunctions, to technically process your information and to determine the effectiveness of our projects; (ii) to protect the security and integrity of our website; (iii) to protect our rights and property and the rights and property of others; (iv) to take precautions against liability; (v) to the extent required by law or to respond to judicial process; or (vi) to the enforcement agencies or for an investigation on a matter related to public safety, as applicable.

  8. Cookies, log files, and pixel-tags (Web beacons) are technologies used by the Purdue Sites to identify a user as the user moves through Purdue Sites, or as the user clicks on a Purdue online advertisement located on a third party website. Your browser allows us to place some information (session based IDs and/or persistent cookies) on your computer's hard drive that identifies the computer you are using. We may use cookies to personalize our Web sites and to track your usage across other Purdue Sites. Your Web browser can be set to allow you to control whether you will accept cookies, reject cookies, or to notify you each time a cookie is sent to you. If your browser is set to reject cookies, Web sites that are cookie-enabled will not recognize you when you return to the Web site, and some Web site functionality may be lost. The Help section of your browser will tell you how to prevent your browser from accepting cookies. On occasion, we contract with third parties to place cookies on your computer's hard drive. Although cookies do not normally contain personally identifiable information, if you have provided us information about you, we may associate your registration information with cookies or other tracking utilities our Web site places on your computer's hard drive. Associating a cookie with your registration data allows us to offer increased personalization and functionality. Without cookies, this functionality would not be possible. Some of our business partners may use cookies on our sites (for example, links to business partners). We do not want our business partners to use cookies to track our customers' activities once they leave our sites. However, we may not have total control over how our business partners may use cookies on our Web sites. In addition, we may use other tracking systems like pixel-tags. Pixel tags, sometimes called Web beacons, are similar in function to a cookie. But because of their insignificant size, it is not visible; though, they are used to pass certain information to our servers to personalize our Web sites and to track your usage across other Purdue Web sites where Purdue online advertisements are located. In addition, we may also use pixel tags in our HTML based e-mails.

  9. As a resource to Site visitors, Purdue may provide links to other websites. Site users should carefully review the privacy policies and practices of these websites, as Purdue cannot control or be responsible for the privacy practices of other Web sites.

  10. At any time, you can contact Purdue to remove your name from our marketing list.

  11. For the purpose of determining the effectiveness of our Site and other online marketing programs, Purdue may hire certain third party organizations that collect, analyze and report on non-personally identifiable data or provide website and/or program support services. To the extent possible, Purdue will require these organizations to conform to Purdue's Privacy Policy.

  12. THIRD PARTIES. Purdue may share some kinds of information with third parties as described below:

    • Companies and people who work for us: Purdue contracts with other companies and individuals to help Purdue provide services. For example, Purdue may host some of our Sites on another company's computers, hire technical consultants to maintain our Web-based health sites, or work with companies to remove repetitive information from customer lists, analyze data, provide marketing assistance, and provide customer service. In addition, if you are a health care professional, Purdue may validate your licensure status and other information against available databases that list licensed health care professionals. In order to perform their jobs, these other companies may have limited access to some of the personal information Purdue maintains about our users. Other companies may collect information on our behalf through their sites. This occasionally incorporates the use of frames on the site that will not show the URL you are visiting in the browser address window. We require such companies to comply with the terms of our privacy policies, to limit their access to any personal information to the minimum necessary to perform their obligations, and not to use the information they may access for purposes other than fulfilling their responsibilities to us. We use our best efforts to limit other companies' use of personally identifiable or health care information.

    • Promotional and informational offers: Sometimes Purdue sends offers to selected groups of customers. To accomplish this Purdue may use third parties working on behalf of Purdue. Purdue provides a variety of mechanisms for you to tell us you do not want to receive such promotional-informational offers. For example, Purdue may provide an opt-in box for customers to receive information that is sent by a third-party fulfillment house. You can elect not to receive promotional or informational material from us by following the instructions to opt-out as mentioned or included in each of our programs that Purdue sends to you.

    • Legal requirements: We may release account and other personal information when Purdue believes that its release is required to comply with the law, regulations, rules or local ordinances. We may release personal health information if, in our judgment after review by an attorney, the release is compelled by law or regulation, or if the release may be necessary to prevent the death or serious injury of an individual.

By using this Site and the contents and services available to you on our Website, you consent to our collection and use of your information as described above. Purdue will continuously assess its practices to ensure that your privacy is respected. Purdue may amend this Privacy Policy from time to time. If Purdue makes any substantial changes in the way Purdue uses your personal information Purdue will notify you by posting a prominent announcement on Purdue's Website.

See also Purdue's Terms & Conditions for additional information.

Purdue Pharma L.P. Privacy Policy updated: November 15, 2012

Social Security Number Protection Policy

Purdue is committed to the responsible protection of your Social Security number ("SSN"). This notice applies to any SSN that Purdue collects in the course of our business. Purdue protects the confidentiality of SSNs, including by maintaining manual and/or electronic security procedures to guard against unauthorized access to SSNs. Purdue also limits access to SSNs, including by only granting access to SSNs to Purdue employees who use that information to perform their job-related duties. In addition, Purdue discloses SSNs to third parties only where necessary for business purposes and not otherwise prohibited by law.

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 DEPRESSANTS

Addiction, 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.
Contraindications
  • 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.
Warnings and Precautions Addiction, Abuse, and Misuse
  • 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.
Life-Threatening Respiratory Depression
  • 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.
Neonatal Opioid Withdrawal Syndrome
  • 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.
Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers
  • 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.
Risks from Concomitant Use of Benzodiazepines or Other CNS Depressants
  • 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.
Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or Elderly, Cachectic, or Debilitated Patients
  • 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.
Adrenal Insufficiency
  • 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.
Severe Hypotension
  • 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 Interval Prolongation
  • 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.
Risk of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness
  • 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.
Gastrointestinal Obstruction, Dysphagia, and Choking
  • 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.
Risks of Use in Patients with Gastrointestinal Conditions
  • 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.
Increased Risk of Seizures in Patients with Seizure Disorders
  • 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.
Withdrawal
  • 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.
Risks of Driving and Operating Machinery
  • 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.
ADVERSE REACTIONS
  • 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.

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Indications and Usage

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.
Important Safety Information

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 DEPRESSANTS

Addiction, 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.
Contraindications
  • 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.
Warnings and Precautions Addiction, Abuse, and Misuse
  • 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.
Life-Threatening Respiratory Depression
  • 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.
Neonatal Opioid Withdrawal Syndrome
  • 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.
Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers
  • 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.
Risks from Concomitant Use of Benzodiazepines or Other CNS Depressants
  • 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.
Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or Elderly, Cachectic, or Debilitated Patients
  • 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.
Adrenal Insufficiency
  • 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.
Severe Hypotension
  • 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 Interval Prolongation
  • 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.
Risk of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness
  • 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.
Gastrointestinal Obstruction, Dysphagia, and Choking
  • 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.
Risks of Use in Patients with Gastrointestinal Conditions
  • 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.
Increased Risk of Seizures in Patients with Seizure Disorders
  • 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.
Withdrawal
  • 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.
Risks of Driving and Operating Machinery
  • 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.
ADVERSE REACTIONS
  • 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.

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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 DEPRESSANTS

Addiction, 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.
Contraindications
  • 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.
Warnings and Precautions Addiction, Abuse, and Misuse
  • 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.
Life-Threatening Respiratory Depression
  • 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.
Neonatal Opioid Withdrawal Syndrome
  • 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.
Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers
  • 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.
Risks from Concomitant Use of Benzodiazepines or Other CNS Depressants
  • 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.
Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or Elderly, Cachectic, or Debilitated Patients
  • 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.
Adrenal Insufficiency
  • 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.
Severe Hypotension
  • 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 Interval Prolongation
  • 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.
Risk of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness
  • 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.
Gastrointestinal Obstruction, Dysphagia, and Choking
  • 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.
Risks of Use in Patients with Gastrointestinal Conditions
  • 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.
Increased Risk of Seizures in Patients with Seizure Disorders
  • 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.
Withdrawal
  • 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.
Risks of Driving and Operating Machinery
  • 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.
ADVERSE REACTIONS
  • 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.