• IMPORTANT SAFETY INFORMATION

    WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND CYTOCHROME P450 3A4 INTERACTION

    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 or 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 CYP3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects 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 (5.11), Drug Interactions (7.1), and Clinical Pharmacology (12.3)].

    Please read the Full Prescribing Information

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    IMPORTANT SAFETY INFORMATION

    WARNING: ADDICTION, ABUSE, and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; and NEONATAL OPIOID WITHDRAWAL SYNDROME

    Addiction, Abuse, and Misuse
    Butrans 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 Butrans, and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1) and Overdosage (10)].

    Life-Threatening Respiratory Depression
    Serious, life-threatening, or fatal respiratory depression may occur with use of Butrans. Monitor for respiratory depression, especially during initiation of Butrans or following a dose increase. Misuse or abuse of Butrans by chewing, swallowing, snorting or injecting buprenorphine extracted from the transdermal system will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death [see Warnings and Precautions (5.2)].

    Accidental Exposure
    Accidental exposure to even one dose of Butrans, especially by children, can result in a fatal overdose of buprenorphine [see Warnings and Precautions (5.2)].

    Neonatal Opioid Withdrawal Syndrome
    Prolonged use of Butrans 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)].


    CONTRAINDICATIONS


    • Butrans 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 paralytic ileus, hypersensitivity (eg, anaphylaxis) to buprenorphine.

    WARNINGS AND PRECAUTIONS


    • Addiction, Abuse, and Misuse

      Butrans contains buprenorphine, a Schedule III controlled substance. Butrans exposes users to the risks of opioid addiction, abuse, and misuse. As modified-release products such as Butrans deliver the opioid over an extended period of time, there is a greater risk for overdose and death, due to the larger amount of buprenorphine present. 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 Butrans, and monitor all patients during therapy for the development of these behaviors or conditions. Abuse or misuse of Butrans by placing it in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking, overdose and death.

    • Life-Threatening Respiratory Depression

      Serious, life-threatening, or fatal respiratory depression has been reported with modified-release opioids, even when used as recommended, and if not immediately recognized and treated, may lead to respiratory arrest and death. The risk of respiratory depression is greatest during the initiation of therapy or following a dose increase; therefore, closely monitor patients for respiratory depression. Proper dosing and titration of Butrans are essential. Overestimating the Butrans dose when converting patients from another opioid product can result in fatal overdose with the first dose. Accidental exposure to Butrans, especially in children, can result in respiratory depression and death due to an overdose of buprenorphine.

    • Neonatal Opioid Withdrawal Syndrome

      Prolonged use of Butrans during pregnancy can result in neonatal opioid withdrawal syndrome which may be life-threatening to the neonate if not recognized and treated, and requires management according to protocols developed by neonatology experts.

    • Interactions with Central Nervous System Depressants

      Hypotension, profound sedation, coma, respiratory depression, or death may result if Butrans is used concomitantly with other CNS depressants, including alcohol or illicit drugs that can cause CNS depression. Start with Butrans 5 mcg/hour patch, monitor patients for signs of sedation and respiratory depression, and consider using a lower dose of the concomitant CNS depressant.

    • Use in Elderly, Cachectic, and Debilitated Patients and Patients with Chronic Pulmonary Disease

      Closely monitor elderly, cachectic, and debilitated patients, and patients with chronic obstructive pulmonary disease because of the increased risk of life-threatening respiratory depression. Consider the use of alternative non-opioid analgesics in patients with chronic obstructive pulmonary disease if possible.

    • QTc Prolongation

      Avoid in patients with Long QT Syndrome, family history of Long QT Syndrome, or those taking Class IA or Class III antiarrhythmic medications.

    • Hypotensive Effects

      Butrans may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. Monitor patients during dose initiation or titration.

    • Use in Patients with Head Injury or Increased Intracranial Pressure

      Monitor patients taking Butrans who may be susceptible to the intracranial effects of CO2 retention for signs of sedation and respiratory depression. Avoid the use of Butrans in patients with impaired consciousness or coma.

    • Application Site Skin Reactions

      In rare cases, severe application site skin reactions with signs of marked inflammation including “burn,” “discharge,” and “vesicles” have occurred.

    • Anaphylactic/Allergic Reactions

      Cases of acute and chronic hypersensitivity to buprenorphine have been reported both in clinical trials and in the post-marketing experience.

    • Application of External Heat

      Avoid exposing the Butrans application site and surrounding area to direct external heat sources. There is a potential for temperature-dependent increases in buprenorphine released from the system resulting in possible overdose and death.

    • Use in Patients with Gastrointestinal Conditions

      Avoid the use of Butrans in patients with paralytic ileus and other GI obstructions. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

    ADVERSE REACTIONS


    • Most common adverse reactions (≥5%) reported by patients treated with Butrans in the clinical trials were nausea, headache, application site pruritus, dizziness, constipation, somnolence, vomiting, application site erythema, dry mouth, and application site rash.

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    INDICATIONS AND USAGE

    Intermezzo® (zolpidem tartrate) is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.

    Limitations of Use: Intermezzo is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.

    IMPORTANT SAFETY INFORMATION

    Intermezzo is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema.

    Co-administration with Intermezzo and other CNS depressants increases the risk of CNS depression. Intermezzo should not be taken with alcohol. The use of Intermezzo with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended.

    The risk of next-day driving impairment (and psychomotor impairment) is increased if Intermezzo is taken with less than 4 hours of bedtime remaining; if higher than recommended dose is taken; if co-administered with other CNS depressants; or co-administered with other drugs that increase the blood levels of zolpidem. A small negative effect on SDLP (standard deviation of lateral position, a measure of driving impairment) may remain in some patients 4 hours after taking Intermezzo, such that a potential negative effect on driving cannot be completely excluded.

    The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.

    Cases of angioedema involving the tongue, glottis, or larynx have been reported in patients after taking the first or subsequent doses of zolpidem. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. Angioedema, and additional symptoms suggesting anaphylaxis, may occur in patients taking zolpidem and may be fatal. Patients who develop angioedema or anaphylaxis should not be rechallenged.

    Abnormal thinking and behavior changes have been reported in patients treated with a sedative-hypnotic including zolpidem. Complex behaviors, including driving or eating while not fully awake, with amnesia for the event, as well as visual and auditory hallucinations and abnormal behaviors such as decreased inhibition, bizarre behavior, agitation, and depersonalization may occur. Although behaviors such as “sleep-driving” have occurred with zolpidem alone at therapeutic doses, the co-administration of zolpidem with alcohol and other CNS depressants increases the risk of such behaviors, as does the use of zolpidem at doses exceeding the maximum recommended dose. Discontinuation of Intermezzo should be strongly considered for patients reporting a “sleep-driving” episode.

    In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides) have been reported with the use of sedative-hypnotics. Intentional overdosage is more common in this group of patients; therefore, protective measures may be required and prescribe the least amount of Intermezzo that is feasible.

    Because persons with a history of addiction to or abuse of drugs or alcohol are at increased risk for misuse, abuse, and addiction of zolpidem, they should be monitored carefully when receiving Intermezzo. Zolpidem tartrate is a Schedule IV controlled substance. Post-marketing reports of abuse, dependence, and withdrawal resulting from use of oral zolpidem tartrate have been received. Zolpidem has produced withdrawal signs and symptoms following a rapid dose decrease or abrupt discontinuation.

    The most commonly observed adverse reactions (>1%) were headache (Intermezzo 3%, placebo 1%), nausea (1% for both patient groups), and fatigue (Intermezzo 1%, placebo 0%).

    Please read the Full Prescribing Information

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    IMPORTANT SAFETY INFORMATION

    WARNING: ADDICTION, ABUSE and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4 INTERACTION

    Addiction, Abuse, and Misuse
    OXYCONTIN®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 OXYCONTIN and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1)].

    Life-Threatening Respiratory Depression
    Serious, life-threatening, or fatal respiratory depression may occur with use of OXYCONTIN. Monitor for respiratory depression, especially during initiation of OXYCONTIN or following a dose increase. Instruct patients to swallow OXYCONTIN tablets whole; crushing, chewing, or dissolving OXYCONTIN tablets can cause rapid release and absorption of a potentially fatal dose of oxycodone [see Warnings and Precautions (5.2)].

    Accidental Ingestion
    Accidental ingestion of even one dose of OXYCONTIN, especially by children, can result in a fatal overdose of oxycodone [see Warnings and Precautions (5.2)].

    Neonatal Opioid Withdrawal Syndrome
    Prolonged use of OXYCONTIN 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 OXYCONTIN with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving OXYCONTIN and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.14) and Clinical Pharmacology (12.3)].


    • OxyContin 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 paralytic ileus and gastrointestinal obstruction, hypersensitivity (e.g., anaphylaxis) to oxycodone.

    • OxyContin contains oxycodone, a Schedule II controlled substance. OxyContin exposes users to the risks of opioid addiction, abuse, and misuse. As modified-release products such as OxyContin deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of oxycodone present. 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 OxyContin and monitor all patients during therapy for the development of these behaviors or conditions.

    • Instruct patients to swallow the OxyContin tablets intact. Crushing, chewing, snorting, or injecting the dissolved product could result in overdose and death.

    • Serious, life-threatening, or fatal respiratory depression has been reported with modified-release opioids, even when used as recommended, and if not immediately recognized and treated, may lead to respiratory arrest and death. The risk of respiratory depression is greatest during initiation of therapy or following a dose increase; therefore, closely monitor patients for respiratory depression. Proper dosing and titration of OxyContin are essential. Overestimating the OxyContin dose when converting patients from another opioid product can result in fatal overdose with the first dose.

    • Accidental ingestion of even one dose of OxyContin, especially by children, can result in respiratory depression and death due to an overdose of oxycodone.

    • Prolonged use of OxyContin during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening to the neonate if not recognized and treated, and requires management according to protocols developed by neonatology experts.

    • Hypotension, profound sedation, coma, respiratory depression, or death may result if OxyContin is used concomitantly with other CNS depressants, including alcohol or illicit drugs that can cause CNS depression. Start with 1/3 to 1/2 the usual dose of OxyContin, monitor patients for signs of sedation and respiratory depression, and consider using a lower dose of the concomitant CNS depressant.

    • Closely monitor elderly, cachectic, and debilitated patients, and patients with chronic obstructive pulmonary disease because of increased risk of life-threatening respiratory depression. Consider the use of alternative non-opioid analgesics in patients with chronic pulmonary disease if possible.

    • OxyContin may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. Monitor patients during dose initiation and titration. Avoid use of OxyContin in patients with circulatory shock.

    • Monitor patients taking OxyContin who may be susceptible to the intracranial effects of CO2 retention for signs of sedation and respiratory depression. Avoid the use of OxyContin in patients with impaired consciousness or coma.

    • OxyContin is contraindicated in patients with GI obstruction, including paralytic ileus. Use caution when prescribing OxyContin for patients who have difficulty swallowing, or have underlying GI disorders that may predispose them to obstruction. Consider use of an alternative analgesic in these patients.

    • OxyContin may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

    • OxyContin may aggravate convulsions in patients with convulsive disorders and may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure disorders for worsened seizure control.

    • Avoid the use of mixed agonist/antagonist or partial agonist analgesics in patients who have received or are receiving OxyContin, as they may reduce the analgesic effect and/or precipitate withdrawal. Do not abruptly discontinue OxyContin.

    • OxyContin may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.

    • Concomitant use of CYP3A4 inhibitors may prolong opioid effects. Use with CYP3A4 inducers may cause lack of efficacy or development of withdrawal symptoms. If co-administration is necessary, evaluate patients frequently and consider dose adjustments until stable drug effects are achieved.

    Please read the Full Prescribing Information

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