Nalmefene Hydrochloride Injection
Generic Name: nalmefene hydrochloride injection
Brand Names:
Nalmefene Hydrochloride
Nalmefene Hydrochloride Injection Rx only DESCRIPTION Nalmefene Hydrochloride Injection, an opioid antagonist, is a 6-methylene analogue of naltrexone. The chemical structure is shown below: Molecular Formula: C 21 H 25 NO 3 •HCl•H 2 O Molecular Weight: 393.91, CAS # 1228646-72-7 Chemical Name: 17-(Cyclopropylmethyl)-4,5α-epoxy-6-methylenemorphinan-3,14-diol, hydrochloride salt, monohydrate Nalmefene hydrochloride is a white to almost white crystalline powder which is freely soluble in water up...
Overview
Nalmefene Hydrochloride Injection Rx only DESCRIPTION Nalmefene Hydrochloride Injection, an opioid antagonist, is a 6-methylene analogue of naltrexone. The chemical structure is shown below: Molecular Formula: C 21 H 25 NO 3 •HCl•H 2 O Molecular Weight: 393.91, CAS # 1228646-72-7 Chemical Name: 17-(Cyclopropylmethyl)-4,5α-epoxy-6-methylenemorphinan-3,14-diol, hydrochloride salt, monohydrate Nalmefene hydrochloride is a white to almost white crystalline powder which is freely soluble in water up...
Uses
INDICATIONS AND USAGE 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.
Dosage
DOSAGE AND ADMINISTRATION Important Information - Dosage Forms Nalmefene Hydrochloride Injection is supplied in two concentrations that can be identified by their color coded container labels: a concentration suitable for postoperative use (100 µg/mL) in a blue labeled vial containing ONE (1) mL and a concentration suitable for the management of overdose (1 mg/mL, 10 times as concentrated, 20 times as much drug) in a green labeled vial containing TWO (2) mL. Proper steps should be taken to prevent use of the incorrect concentration. General Principles Nalmefene hydrochloride injection should be titrated to reverse the undesired effects of opioids.
Side Effects
ADVERSE REACTIONS 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. In a small number of subjects, at doses exceeding the recommended nalmefene hydrochloride injection dose, nalmefene produced symptoms suggestive of reversal of endogenous opioids, such as have been reported for other narcotic antagonist drugs.
Warnings
WARNINGS 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. CONTRAINDICATIONS Nalmefene Hydrochloride Injection is contraindicated in patients with a known hypersensitivity to the product.
Storage
HOW SUPPLIED Nalmefene Hydrochloride Injection is available in the following presentations: A single-dose vial containing 1 mL of 100 µg/mL nalmefene base (Blue Label) Box of 1 (NDC 82432-101-01) A single-dose vial containing 2 mL of 1 mg/mL nalmefene base (Green Label) Box of 1 (NDC 82432-102-02) Protect from light, store at 20°C-25°C (68°F to 77°F).
Frequently Asked Questions
What is Nalmefene Hydrochloride Injection used for?▼
INDICATIONS AND USAGE 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.
What are the side effects of Nalmefene Hydrochloride Injection?▼
ADVERSE REACTIONS 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. In a small number of subjects, at doses exceeding the recommended nalmefene hydrochloride injection dose, nalmefene produced symptoms suggestive of reversal of endogenous opioids, such as have been reported for other narcotic antagonist drugs.
What are the important warnings for Nalmefene Hydrochloride Injection?▼
WARNINGS 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. CONTRAINDICATIONS Nalmefene Hydrochloride Injection is contraindicated in patients with a known hypersensitivity to the product.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.