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A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.Hoecker JL (expert opinion). Mayo Clinic, Rochester, Minn. Oct. 21, 2015. Overview Symptoms causes Diagnosis treatment Diagnosis Treatment Clinical trials Preparing for your appointment Self-management.
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Pharmacologic Effect. Application: Alcohol addiction (with the consent of the patient and in combination with psychotherapy and social practices prevention of the pharmacological effects of exogenous opioids to maintain opioids-free state in patients with opioid addiction after previously held detoxification (as part of psychological and.
Race Pooled analysis of CONTRAVE data suggested no clinically meaningful differences in the pharmacokinetic parameters of bupropion or naltrexone based on race. Elderly The pharmacokinetics of CONTRAVE have not been evaluated in the geriatric population.Hepatic Impairment Pharmacokinetic data are not available with CONTRAVE in patients.
Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of modified-release opioids, even when used as recommended. Respiratory depression from opioid use, if not immediately recognized and treated, may lead to respiratory arrest and death.The morphine in EMBEDA may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms. Opioids may cause increases in the serum amylase. 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.
Monitor these patients for signs of hypotension after initiating or titrating the dose of EMBEDA. In patients with circulatory shock, EMBEDA may cause vasodilation that can further reduce cardiac output and blood pressure.Contraindications. EMBEDA 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, or hypersensitivity (e.g., anaphylaxis) to morphine or naltrexone.
Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient's clinical status. Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.Use in Patients with Convulsive or Seizure Disorders. The morphine in EMBEDA may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings. Avoidance of Withdrawal Avoid the use of mixed agonist/antagonist (i.e., pentazocine, nalbuphine, and butorphanol) or.
Interaction with Central Nervous System Depressants. Patients must not consume alcoholic beverages or prescription or non-prescription products containing alcohol while on EMBEDA therapy. The co-ingestion of alcohol with EMBEDA may result in increased plasma levels and a potentially fatal overdose of morphine.Addiction, Abuse, and Misuse EMBEDA contains morphine a Schedule II controlled substance. As an opioid, EMBEDA exposes users to the risks of addiction, abuse, and misuse. As modified-release products such as EMBEDA deliver the opioid over an extended period of time, there is a greater.
Neonatal Opioid Withdrawal Syndrome Prolonged use of EMBEDA 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.Closely monitor patients for respiratory depression when initiating therapy with EMBEDA and following dose increases. Accidental Ingestion. Accidental ingestion of even one dose of EMBEDA, especially by children, can result in a respiratory depression and death due to an overdose of morphine.
Use in Elderly, Cachectic, and Debilitated Patients. Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics, or altered clearance compared to younger, healthier patients.While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of EMBEDA, the risk is greatest during the initiation of therapy or following a dose increase.
Monitor such patients closely, particularly when initiating and titrating EMBEDA and when EMBEDA 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.In these patients mixed agonists/antagonists and partial agonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms. Consuming EMBEDA capsules that have been altered by crushing, chewing or dissolving the pellets can release sufficient naltrexone to precipitate withdrawal in opioid-dependent individuals.
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed EMBEDA and in those who obtain the drug illicitly. Addiction can occur at recommended doses and if the drug is misused or abused.Interaction with Alcohol Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking EMBEDA. The co-ingestion of alcohol with EMBEDA may result in increased plasma levels and a potentially fatal overdose of morphine.
Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and.Neonatal Opioid Withdrawal Syndrome Prolonged use of EMBEDA during pregnancy can result in withdrawal signs 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.
Avoid the use of EMBEDA in patients with impaired consciousness or coma. Use in Patients with Gastrointestinal Conditions. EMBEDA is contraindicated in patients with paralytic ileus. Avoid the use of EMBEDA in patients with other GI obstruction.Crushing, chewing or dissolving EMBEDA can cause rapid release and absorption of a potentially fatal dose of morphine. Accidental Ingestion. Accidental ingestion of even one dose of EMBEDA, especially by children, can result in a fatal overdose of morphine.