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IMPORTANT SAFETY INFORMATION
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CONTRAINDICATION
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Nalmefene Hydrochloride injection is contraindicated in patients with a known hypersensitivity to the product.
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WARNINGS AND PRECAUTIONS
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Use of Nalmefene Hydrochloride injection in Emergencies
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Nalmefene Hydrochloride injection, like all drugs in this class, is not the primary treatment for ventilatory failure. In most emergency settings, treatment with Nalmefene Hydrochloride injection should follow, not precede, the establishment of a patent airway, ventilatory assistance, administration of oxygen, and establishment of circulatory access.
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Risk of Recurrent Respiratory Depression
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Accidental overdose with long acting opioids [such as methadone and levo-alpha-acetylmethadol (LAAM)] may result in prolonged respiratory depression. Respiratory depression in both the postoperative and overdose setting may be complex and involve the effects of anesthetic agents, neuromuscular blockers, and other drugs. While Nalmefene Hydrochloride injection has a longer duration of action than naloxone in fully reversing doses, the physician should be aware that a recurrence of respiratory depression is possible, even after an apparently adequate initial response to Nalmefene Hydrochloride injection treatment.
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Patients treated with Nalmefene Hydrochloride injection should be observed until, in the opinion of the
physician, there is no reasonable risk of recurrent respiratory depression.
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Cardiovascular Risks with Narcotic Antagonists
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Pulmonary edema, cardiovascular instability, hypotension, hypertension, ventricular tachycardia, and ventricular fibrillation have been reported in connection with opioid reversal in both postoperative and emergency department settings. In many cases, these effects appear to be the result of abrupt reversal of opioid effects.
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Although Nalmefene Hydrochloride injection has been used safely in patients with pre-existing cardiac disease, all drugs of this class should be used with caution in patients at high cardiovascular risk or who have received potentially cardiotoxic drugs.
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Risk of Precipitated Withdrawal
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Nalmefene Hydrochloride injection, like other opioid antagonists, is known to produce acute withdrawal symptoms and, therefore, should be used with extreme caution in patients with known physical dependence on opioids or following surgery involving high doses of opioids. Imprudent use or excessive doses of opioid antagonists in the postoperative setting has been associated with hypertension, tachycardia, and excessive mortality in patients at high risk for cardiovascular complications.
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Incomplete Reversal of Buprenorphine
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Preclinical studies have shown that nalmefene at doses up to 10 mg/kg (437 times the maximum recommended human dose) produced incomplete reversal of buprenorphine-induced analgesia in animal models. This appears to be a consequence of a high affinity and slow displacement of buprenorphine from the opioid receptors. Hence, Nalmefene Hydrochloride injection may not completely reverse buprenorphineinduced respiratory depression.
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Use in Pediatric Patients
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Safety and effectiveness of nalmefene hydrochloride injection in pediatric patients have not been established.
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ADVERSE REACTIONS
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The most common adverse reactions (>1%) reported in clinical trials with nalmefene injection were nausea (18%), vomiting (9%), tachycardia (5%), hypertension (5%), postoperative pain (4%), fever (3%), and dizziness (3%).
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To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1‐888‐726‐7535 or FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch. |
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References: 1. Nalmefene HCl Injection Full Prescribing Information. Purdue Pharma L.P.; 2022. 2. Cassel JA, Daubert JD, DeHaven
RN. [3H]Alvimopan binding to the μ opioid receptor: comparative binding kinetics of opioid antagonists. Eur J Pharmacol.
2005;520(1-3):29-36. doi:10.1016/j.ejphar.2005.08.008. 3. Emmerson PJ, Liu M-R, Woods JH, Medzihradsky F. Binding affinity and
selectivity of opioids at mu, delta and kappa receptors in monkey brain membranes. J Pharmacol Exp Ther. 1994;271(3):1630-1637.
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Sincerely,
[KAM/NAE name]
[KAM/NAE email]
[KAM/NAE phone number]
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