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  • Learn about formulary coverage and how your patients can save on their Butrans prescriptions.

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    IMPORTANT SAFETY INFORMATION

    WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE

    Abuse Potential
    Butrans contains buprenorphine, an opioid agonist and Schedule III controlled substance with an abuse liability similar to other Schedule III opioids, legal or illicit [see Warnings and Precautions (5.1)]. Assess each patient’s risk for opioid abuse or addiction prior to prescribing Butrans. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (eg, major depressive disorder). Routinely monitor all patients receiving Butrans for signs of misuse, abuse, and addiction during treatment [see Drug Abuse and Dependence (9)].

    Life-Threatening Respiratory Depression
    Respiratory depression, including fatal cases, may occur with use of Butrans, even when the drug has been used as recommended and not misused or abused [see Warnings and Precautions (5.2)]. Proper dosing and titration are essential and Butrans should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of Butrans or following a dose increase.

    Accidental Exposure
    Accidental exposure to Butrans, especially in children, can result in a fatal overdose of buprenorphine [see Warnings and Precautions (5.3)].


    ADMINISTRATION OF BUTRANS


    • Butrans is for transdermal use (on intact skin) only. Each Butrans Transdermal System is intended to be worn for 7 days

    • Instruct patients not to use Butrans if the pouch seal is broken or the patch is cut, damaged, or changed in any way and not to cut Butrans

    • Instruct patients to apply immediately after removal from the individually sealed pouch

    • Apply Butrans to the upper outer arm, upper chest, upper back or the side of the chest. These 4 sites (each present on both sides of the body) provide 8 possible application sites. Rotate Butrans among the 8 described skin sites. After Butrans removal, wait a minimum of 21 days before reapplying to the same skin site

    • Apply Butrans to a hairless or nearly hairless skin site. If none are available, the hair at the site should be clipped, not shaven. Do not apply Butrans to irritated skin. If the application site must be cleaned, clean the site with water only. Do not use soaps, alcohol, oils, lotions, or abrasive devices. Allow the skin to dry before applying Butrans

    • If problems with adhesion of Butrans occur, the edges may be taped with first aid tape. If Butrans falls off during the 7 days dosing interval, dispose of the transdermal system properly and place a new Butrans Transdermal System on at a different skin site

    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


    • Abuse Potential

      Buprenorphine can be abused in a manner similar to other opioid agonists, legal or illicit. Assess risk for opioid abuse or addiction prior to prescribing. Routinely monitor all patients for signs of misuse, abuse, and addiction. Addiction can occur even under appropriate medical use. Misuse or abuse of Butrans by chewing, swallowing, snorting or injecting buprenorphine extracted from the transdermal system will result in the uncontrolled delivery of the opioid and pose a significant risk that could result in overdose and death

    • Life-Threatening Respiratory Depression

      Respiratory depression is the primary risk of Butrans and may lead to respiratory arrest and death. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Butrans, the risk is greatest during the initiation of therapy or following a dose increase. 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

      Accidental exposure to Butrans, especially in children, can result in a fatal overdose

    • Elderly, Cachectic, and Debilitated Patients

      Respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics. Monitor such patients closely, particularly when initiating and titrating Butrans and when Butrans is given concomitantly with other drugs that depress respiration

    • Use in Patients with Chronic Pulmonary Disease

      Monitor patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression for respiratory depression, particularly when initiating therapy and titrating with Butrans. Even usual therapeutic doses of Butrans may decrease respiratory drive to the point of apnea

    • Interactions with Alcohol, CNS Depressants, and Illicit Drugs

      Hypotension, profound sedation, coma or respiratory depression may result if Butrans is added to a regimen that includes other CNS depressants, alcohol, or illicit drugs

    • 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 after initiating or titrating

    • Use in Patients with Head Injury or Increased Intracranial Pressure

      Monitor patients who may be susceptible to the intracranial effects of CO2 retention for signs of sedation and respiratory depression, particularly when initiating therapy with Butrans. Opioids may also obscure the clinical course in a patient with a head injury

    • 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

    • Avoidance of Withdrawal

      When discontinuing Butrans, gradually taper the dose. Do not abruptly discontinue Butrans

    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

    Please read the Full Prescribing Information

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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: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE

    Abuse Potential
    OxyContin® contains oxycodone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit [see Warnings and Precautions (5.1)]. Assess each patient’s risk for opioid abuse or addiction prior to prescribing OxyContin. The risk for opioid abuse is 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 depressive disorder). Routinely monitor all patients receiving OxyContin for signs of misuse, abuse, and addiction during treatment [see Drug Abuse and Dependence (9)].

    Life-Threatening Respiratory Depression
    Respiratory depression, including fatal cases, may occur with use of OxyContin, even when the drug has been used as recommended and not misused or abused [see Warnings and Precautions (5.2)]. Proper dosing and titration are essential and OxyContin should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of OxyContin or following a dose increase. Instruct patients to swallow OxyContin tablets intact. Crushing, dissolving, or chewing the tablet can cause rapid release and absorption of a potentially fatal dose of oxycodone.

    Accidental Exposure
    Accidental ingestion of OxyContin, especially in children, can result in fatal overdose of oxycodone [see Warnings and Precautions (5.3)].


    • OxyContin is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, known or suspected paralytic ileus and gastrointestinal obstruction, and hypersensitivity (e.g., anaphylaxis) to oxycodone

    • OxyContin contains oxycodone, an opioid agonist and Schedule II controlled substance. Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. Assess each patient’s risk for opioid abuse or addiction prior to prescribing OxyContin and routinely monitor all patients during therapy because of a risk for addiction, even under appropriate medical use

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

    • Respiratory depression is the chief hazard of opioid agonists, including OxyContin and, if not immediately recognized and treated, may lead to respiratory arrest. The risk of respiratory depression is greatest during initiation of therapy or following a dose increase. Proper dosing and titration are essential and OxyContin should only be prescribed by healthcare professionals knowledgeable in the use of potent opioids

    • OxyContin 60 mg and 80 mg tablets are for use in opioid-tolerant patients only. Ingestion of these strengths may cause fatal respiratory depression when administered to patients not already tolerant to high doses of opioids

    • Accidental ingestion, especially in children, can result in a fatal overdose of oxycodone

    • Elderly, cachectic, and debilitated patients, and patients with chronic obstructive pulmonary disease should be monitored closely because of increased risk of respiratory depression

    • Hypotension, profound sedation, coma, or respiratory depression may result if OxyContin is used concomitantly with other CNS depressants, including alcohol and/or illicit drugs that can cause CNS depression. Start with a lower OxyContin dose and consider dose reduction of the concomitant CNS depressant because of additive effects. Monitor patients for signs of sedation and respiratory depression

    • OxyContin may cause severe hypotension. Monitor patients at increased risk of hypotension during dose initiation and titration. Avoid use of OxyContin in patients with circulatory shock

    • In patients with head injury or increased intracranial pressure, monitor for signs of sedation and respiratory depression. Avoid use of OxyContin in patients with impaired consciousness or coma susceptible to intracranial effects of CO2 retention

    • 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 analgesics, as they may reduce the analgesic effect and/or precipitate withdrawal. Do not abruptly discontinue OxyContin

    • OxyContin may impair the mental and 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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