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Drug overview for ZURNAI (nalmefene hcl):
Generic name: NALMEFENE HCL (NAL-me-feen)
Drug class: Opioid Antagonists
Therapeutic class: Antidotes and other Reversal Agents
Nalmefene hydrochloride is a synthetic opiate antagonist.
Nalmefene hydrochloride is used for the treatment of respiratory depression induced by natural and synthetic opiates. The drug also is used in the management of known or suspected opiate overdosage.
Generic name: NALMEFENE HCL (NAL-me-feen)
Drug class: Opioid Antagonists
Therapeutic class: Antidotes and other Reversal Agents
Nalmefene hydrochloride is a synthetic opiate antagonist.
Nalmefene hydrochloride is used for the treatment of respiratory depression induced by natural and synthetic opiates. The drug also is used in the management of known or suspected opiate overdosage.
DRUG IMAGES
ZURNAI 1.5 MG/0.5 ML AUTOINJCT
The following indications for ZURNAI (nalmefene hcl) have been approved by the FDA:
Indications:
Opioid overdose
Opioid-induced respiratory depression
Professional Synonyms:
Opiate-induced respiratory depression
Opioid agonist overdose
Opioid-induced inadequate ventilation
Indications:
Opioid overdose
Opioid-induced respiratory depression
Professional Synonyms:
Opiate-induced respiratory depression
Opioid agonist overdose
Opioid-induced inadequate ventilation
The following dosing information is available for ZURNAI (nalmefene hcl):
The manufacturer states that safety and efficacy of nalmefene hydrochloride in children younger than 18 years of age have not been established. However, the drug can be used in the reversal of opiate effects in neonates when, in the opinion of the clinician, the potential benefits are expected to outweigh the risks.
Dosage of nalmefene hydrochloride is expressed in terms of the base.
When used to partially reverse opiate depression following the use of opiates during surgery, the usual initial dosage of nalmefene is 0.25 mcg/kg given at 2- to 5-minute intervals until the desired response is obtained. A cumulative total dosage exceeding 1 mcg/kg does not provide additional therapeutic effect.
Patients who are at increased cardiovascular risk should receive an initial dosage of 0.1 mcg/kg given at 2- to 5- minute intervals until desired response is obtained. The goal of postoperative nalmefene therapy is to reverse excessive opiate effects without completely reversing opiate analgesia, which could precipitate acute pain.
When used postoperatively, the manufacturer recommends that the commercially available injection containing 100 mcg/mL of the drug be used; in patients with increased cardiovascular risk, it may be desirable to further dilute the injection to a final ratio of 1:1 in 0.9% sodium chloride injection or sterile water for injection.
For the treatment of known opiate overdosage or as an aid in the diagnosis of suspected opiate overdosage, the usual initial adult dosage of nalmefene is 7.14 mcg/kg (0.5 mg/70 kg), followed by a second dose of 14.29 mcg/kg (1 mg/70 kg) 2-5 minutes later, if necessary.
For these uses, the manufacturer recommends that the commercially available injection containing 1 mg/mL of the drug be used. If no response is observed after a total dose of 21.43 mcg/kg (1.5 mg/70 kg) of the drug has been administered, additional doses of the drug are unlikely to provide therapeutic effect.
Patients suspected of opiate dependency should receive an initial dosage of 1.43 mcg/kg (100 mcg/70 kg); if no withdrawal is observed within 2 minutes, the recommended dosage for opiate overdosage can be given.
Nalmefene hydrochloride is the longest acting of the currently available parenteral opiate antagonists. However, if recurrence of respiratory depression occurs, dosage of nalmefene should be titrated incrementally again to response in order to avoid over-reversal of opiate effects.
Although hepatic and renal impairment may substantially reduce clearance of nalmefene, adjustment of dosage of the drug is not needed for single episodes of opiate antagonism. However, in patients with renal failure, the incremental doses should be administered slowly (e.g., over 60 seconds) to minimize hypertension and dizziness associated with rapid administration of the drug in such patients.
Dosage of nalmefene hydrochloride is expressed in terms of the base.
When used to partially reverse opiate depression following the use of opiates during surgery, the usual initial dosage of nalmefene is 0.25 mcg/kg given at 2- to 5-minute intervals until the desired response is obtained. A cumulative total dosage exceeding 1 mcg/kg does not provide additional therapeutic effect.
Patients who are at increased cardiovascular risk should receive an initial dosage of 0.1 mcg/kg given at 2- to 5- minute intervals until desired response is obtained. The goal of postoperative nalmefene therapy is to reverse excessive opiate effects without completely reversing opiate analgesia, which could precipitate acute pain.
When used postoperatively, the manufacturer recommends that the commercially available injection containing 100 mcg/mL of the drug be used; in patients with increased cardiovascular risk, it may be desirable to further dilute the injection to a final ratio of 1:1 in 0.9% sodium chloride injection or sterile water for injection.
For the treatment of known opiate overdosage or as an aid in the diagnosis of suspected opiate overdosage, the usual initial adult dosage of nalmefene is 7.14 mcg/kg (0.5 mg/70 kg), followed by a second dose of 14.29 mcg/kg (1 mg/70 kg) 2-5 minutes later, if necessary.
For these uses, the manufacturer recommends that the commercially available injection containing 1 mg/mL of the drug be used. If no response is observed after a total dose of 21.43 mcg/kg (1.5 mg/70 kg) of the drug has been administered, additional doses of the drug are unlikely to provide therapeutic effect.
Patients suspected of opiate dependency should receive an initial dosage of 1.43 mcg/kg (100 mcg/70 kg); if no withdrawal is observed within 2 minutes, the recommended dosage for opiate overdosage can be given.
Nalmefene hydrochloride is the longest acting of the currently available parenteral opiate antagonists. However, if recurrence of respiratory depression occurs, dosage of nalmefene should be titrated incrementally again to response in order to avoid over-reversal of opiate effects.
Although hepatic and renal impairment may substantially reduce clearance of nalmefene, adjustment of dosage of the drug is not needed for single episodes of opiate antagonism. However, in patients with renal failure, the incremental doses should be administered slowly (e.g., over 60 seconds) to minimize hypertension and dizziness associated with rapid administration of the drug in such patients.
Nalmefene hydrochloride may be administered by IV, IM, or subcutaneous injection.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ZURNAI 1.5 MG/0.5 ML AUTOINJCT | Maintenance | Adults inject 1.5 mg by intramuscular route may repeat dose in 2-5 minutes if desired effect is not achieved |
No generic dosing information available.
The following drug interaction information is available for ZURNAI (nalmefene hcl):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ZURNAI (nalmefene hcl):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for ZURNAI (nalmefene hcl):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 14 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Hypertension Tachycardia |
Fever Hypotension Vasodilation of blood vessels |
| Rare/Very Rare |
|---|
|
Acute cognitive impairment Agitation Bradycardia Cardiac arrhythmia Hallucinations Myoclonus Pruritus of skin Pulmonary edema Urinary retention |
There are 15 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Nausea Vertigo Vomiting |
Chills Dizziness Earache Headache disorder Irritability Pain Palpitations Tinnitus |
| Rare/Very Rare |
|---|
|
Depression Diarrhea Drowsy Pharyngitis |
The following precautions are available for ZURNAI (nalmefene hcl):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ZURNAI (nalmefene hcl):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ZURNAI (nalmefene hcl)'s list of indications:
| Opioid overdose | |
| T40.0x1A | Poisoning by opium, accidental (unintentional), initial encounter |
| T40.0x2A | Poisoning by opium, intentional self-harm, initial encounter |
| T40.0x3A | Poisoning by opium, assault, initial encounter |
| T40.0x4A | Poisoning by opium, undetermined, initial encounter |
| T40.1x1A | Poisoning by heroin, accidental (unintentional), initial encounter |
| T40.1x2A | Poisoning by heroin, intentional self-harm, initial encounter |
| T40.1x3A | Poisoning by heroin, assault, initial encounter |
| T40.1x4A | Poisoning by heroin, undetermined, initial encounter |
| T40.2x1A | Poisoning by other opioids, accidental (unintentional), initial encounter |
| T40.2x2A | Poisoning by other opioids, intentional self-harm, initial encounter |
| T40.2x3A | Poisoning by other opioids, assault, initial encounter |
| T40.2x4A | Poisoning by other opioids, undetermined, initial encounter |
| T40.3x1A | Poisoning by methadone, accidental (unintentional), initial encounter |
| T40.3x2A | Poisoning by methadone, intentional self-harm, initial encounter |
| T40.3x3A | Poisoning by methadone, assault, initial encounter |
| T40.3x4A | Poisoning by methadone, undetermined, initial encounter |
| T40.411A | Poisoning by fentanyl or fentanyl analogs, accidental (unintentional), initial encounter |
| T40.412A | Poisoning by fentanyl or fentanyl analogs, intentional self-harm, initial encounter |
| T40.413A | Poisoning by fentanyl or fentanyl analogs, assault, initial encounter |
| T40.414A | Poisoning by fentanyl or fentanyl analogs, undetermined, initial encounter |
| T40.421A | Poisoning by tramadol, accidental (unintentional), initial encounter |
| T40.422A | Poisoning by tramadol, intentional self-harm, initial encounter |
| T40.423A | Poisoning by tramadol, assault, initial encounter |
| T40.424A | Poisoning by tramadol, undetermined, initial encounter |
| T40.491A | Poisoning by other synthetic narcotics, accidental (unintentional), initial encounter |
| T40.492A | Poisoning by other synthetic narcotics, intentional self-harm, initial encounter |
| T40.493A | Poisoning by other synthetic narcotics, assault, initial encounter |
| T40.494A | Poisoning by other synthetic narcotics, undetermined, initial encounter |
| T40.601A | Poisoning by unspecified narcotics, accidental (unintentional), initial encounter |
| T40.602A | Poisoning by unspecified narcotics, intentional self-harm, initial encounter |
| T40.603A | Poisoning by unspecified narcotics, assault, initial encounter |
| T40.604A | Poisoning by unspecified narcotics, undetermined, initial encounter |
| T40.691A | Poisoning by other narcotics, accidental (unintentional), initial encounter |
| T40.692A | Poisoning by other narcotics, intentional self-harm, initial encounter |
| T40.693A | Poisoning by other narcotics, assault, initial encounter |
| T40.694A | Poisoning by other narcotics, undetermined, initial encounter |
| T50.7x1A | Poisoning by analeptics and opioid receptor antagonists, accidental (unintentional), initial encounter |
| T50.7x2A | Poisoning by analeptics and opioid receptor antagonists, intentional self-harm, initial encounter |
| T50.7x3A | Poisoning by analeptics and opioid receptor antagonists, assault, initial encounter |
| T50.7x4A | Poisoning by analeptics and opioid receptor antagonists, undetermined, initial encounter |
| Opioid-induced respiratory depression | |
| T40.0x1A | Poisoning by opium, accidental (unintentional), initial encounter |
| T40.0x2A | Poisoning by opium, intentional self-harm, initial encounter |
| T40.0x3A | Poisoning by opium, assault, initial encounter |
| T40.0x4A | Poisoning by opium, undetermined, initial encounter |
| T40.1x1A | Poisoning by heroin, accidental (unintentional), initial encounter |
| T40.1x2A | Poisoning by heroin, intentional self-harm, initial encounter |
| T40.1x3A | Poisoning by heroin, assault, initial encounter |
| T40.1x4A | Poisoning by heroin, undetermined, initial encounter |
| T40.2x1A | Poisoning by other opioids, accidental (unintentional), initial encounter |
| T40.2x2A | Poisoning by other opioids, intentional self-harm, initial encounter |
| T40.2x3A | Poisoning by other opioids, assault, initial encounter |
| T40.2x4A | Poisoning by other opioids, undetermined, initial encounter |
| T40.3x1A | Poisoning by methadone, accidental (unintentional), initial encounter |
| T40.3x2A | Poisoning by methadone, intentional self-harm, initial encounter |
| T40.3x3A | Poisoning by methadone, assault, initial encounter |
| T40.3x4A | Poisoning by methadone, undetermined, initial encounter |
| T40.411A | Poisoning by fentanyl or fentanyl analogs, accidental (unintentional), initial encounter |
| T40.412A | Poisoning by fentanyl or fentanyl analogs, intentional self-harm, initial encounter |
| T40.413A | Poisoning by fentanyl or fentanyl analogs, assault, initial encounter |
| T40.414A | Poisoning by fentanyl or fentanyl analogs, undetermined, initial encounter |
| T40.421A | Poisoning by tramadol, accidental (unintentional), initial encounter |
| T40.422A | Poisoning by tramadol, intentional self-harm, initial encounter |
| T40.423A | Poisoning by tramadol, assault, initial encounter |
| T40.424A | Poisoning by tramadol, undetermined, initial encounter |
| T40.491A | Poisoning by other synthetic narcotics, accidental (unintentional), initial encounter |
| T40.492A | Poisoning by other synthetic narcotics, intentional self-harm, initial encounter |
| T40.493A | Poisoning by other synthetic narcotics, assault, initial encounter |
| T40.494A | Poisoning by other synthetic narcotics, undetermined, initial encounter |
| T40.5x1A | Poisoning by cocaine, accidental (unintentional), initial encounter |
| T40.5x2A | Poisoning by cocaine, intentional self-harm, initial encounter |
| T40.5x3A | Poisoning by cocaine, assault, initial encounter |
| T40.5x4A | Poisoning by cocaine, undetermined, initial encounter |
| T40.601A | Poisoning by unspecified narcotics, accidental (unintentional), initial encounter |
| T40.602A | Poisoning by unspecified narcotics, intentional self-harm, initial encounter |
| T40.603A | Poisoning by unspecified narcotics, assault, initial encounter |
| T40.604A | Poisoning by unspecified narcotics, undetermined, initial encounter |
| T40.691A | Poisoning by other narcotics, accidental (unintentional), initial encounter |
| T40.692A | Poisoning by other narcotics, intentional self-harm, initial encounter |
| T40.693A | Poisoning by other narcotics, assault, initial encounter |
| T40.694A | Poisoning by other narcotics, undetermined, initial encounter |
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