Nalmefene Hydrochloride

Nalmefene Hydrochloride Injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. Nalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose.

Nalmefene Hydrochloride Injection is contraindicated in patients with a known hypersensitivity to the product.

Use of Nalmefene Hydrochloride Injection in Emergencies 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. Risk of Recurrent Respiratory Depression 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.

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.

Adverse event information was obtained following administration of nalmefene hydrochloride injection to 152 normal volunteers and in controlled clinical trials to 1127 patients for the treatment of opioid overdose or for postoperative opioid reversal. Nalmefene was well tolerated and showed no serious toxicity during experimental administration to healthy individuals, even when given at 15 times the highest recommended dose.