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Monitor patients with biliary tract disease, including acute pancreatitis, for worsening of symptoms. Serotonergic Drugs: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome.
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Muscle Relaxants: Hydrocodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Diuretics: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
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Program Terms, Conditions, and Eligibility Criteria
Zohydro ER [package insert]. Data on file.
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Persion Pharmaceuticals LLC. An analysis of rescue medication utilization from a 3-month, randomized, double-blind, placebo-controlled study in patients with chronic low back pain treated with single-entity, twice-daily, extended-release hydrocodone. Pain Med. Single-entity hydrocodone extended-release capsules in opioid-tolerant subjects with moderate-to-severe chronic low back pain: a randomized double-blind, placebo-controlled study.
Centers for Disease Control and Prevention. Calculating total daily dose of opioids for safer dosage. Accessed January 9, Vicodin [package insert]. 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.
Healthcare providers are strongly encouraged to do all of the following: Complete a REMS-compliant education program offered by an accredited provider of continuing education CE or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain. Respiratory depression, if not immediately.
Rx Only. DEA order form required. Dosing Conversion Calculator Titration Discontinuation. Efficacy vs Placebo Hour Effectiveness. This site is intended for US healthcare professionals only. Tolerability Chart Important Safety Information. HCPs Patients Pharmacists. When opioid-experienced patients with chronic pain need more than short-term solutions Start Fast. Maintenance 1 Periodically reassess the continued need for opioid analgesics. Periodically reassess the continued need for opioid analgesics.
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Speak with our specialists to find the nearest pharmacies stocking Xtampza ER. Eligibility required. Xtampza 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 Xtampza ER and monitor all patients regularly for the development of these behaviors or conditions.
programmingjunkie.com/4281.php Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to. Serious, life-threatening, or fatal respiratory depression may occur with use of Xtampza ER. Monitor for respiratory depression, especially during initiation of Xtampza ER or following a dose increase.
Accidental ingestion of even one dose of Xtampza ER , especially by children, can result in a fatal overdose of oxycodone.
Dosing & Uses
Prolonged use of Xtampza 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. The concomitant use of Xtampza ER with all cytochrome P 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 P 3A4 inducer may result in an increase in oxycodone plasma concentration.