Naloxone Mylan 0.4mg /1ml

Naloxone 0.4mg

Dosing & Uses
Adult 

Dosage Forms & Strengths

injectable solution

  • 0.4mg/mL
  • 1mg/mL

IM/SC auto-injector

  • 0.4mg/0.4mL (2 auto-injectors/package)

Opioid Overdose

Indicated for the complete or partial reversal of opioid depression (including respiratory depression) induced by natural and synthetic opioids

0.4-2 mg IV/IM/SC; repeat q2-3min PRN; not to exceed 10 mg (0.01 mg/kg)

Consider other causes of respiratory depression if desired response not achieved after administering 10 mg cumulative total

Endotracheal (this is the least desirable route of administration and supported only by anecdotal evidence): 2-2.5 times (0.8-5 mg) initial IV dose

For chronic opioid abuse, use smallest doses (0.1-0.2 mg) to avoid acute withdrawal; titrate to reversal of respiratory depression

Following reversal, additional dose(s) may need to be administered at later interval (ie, 20 to 60 min) depending on type and duration of opioid

Continuous IV infusion (Off-label)

  • For use in patients exposed to long acting opioids (eg, methadone), sustained release products
  • Calculate dose/hr based on effective intermittent dose used and duration of adequate response seen
  • Alternatively, use two-thirds of initial effective naloxone bolus on an hourly basis (0.25-6.25 mg/hr); administer one-half of initial bolus dose 15 min after initiating continuous IV infusion to prevent drop in naloxone levels

Inhalation via Nebulization (Off-label)

  • 2 mg as inhalation via nebulization; may repeat
  • Switch to IV or IM administration when possible
  • Nebulization method is not included in the AHA recommendations for initial management of opioid-associated life-threatening emergency

Evzio Auto-Injector

  • Indicated for immediate administration as emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression
  • 0.4 mg or 2 mg IM/SC into anterolateral aspect of the thigh (through clothing if necessary)
  • Seek emergency medical care immediately after use
  • Additional doses may be administered q2-3min until EMS arrives

Dosing considerations (Evzio)

  • Take-home, single-use auto-injector with visual and voice instruction for guidance
  • May be prescribed to a family member or caregiver
  • Compact size for portability with retractable needle system
  • Intended for immediate administration as emergency therapy in settings where opioids may be present
  • Not a substitute for emergency medical care
  • Also see Administration

Reversal of Respiratory Depression with Therapeutic Opioid Doses

0.04-0.4 mg IV/IM/SC initially; may repeat until desired response achieved; if desired response not observed after 0.8 mg total, consider other causes of respiratory depression

Postoperative Opioid Depression

0.1-0.2 mg IV q2-3min to desired degree of reversal (eg, adequate ventilation and alertness without significant pain)

May repeat within 1-2hr intervals depending on amount, type (eg, short or long acting) and timing of last dose administered; supplemental IM doses have produced longer lasting effects

Pediatric

Dosage Forms & Strengths

injectable solution

  • 0.4mg/mL
  • 1mg/mL

IM/SC auto-injector

  • 0.4mg/0.4mL (2 auto-injectors/package)

Opioid Reversal

Postanesthesia (acute) opioid reversal

  • Neonates: 0.01 mg/kg IV into umbilical vein/IM/SC; give subsequent dose of 0.1 mg/kg if needed
  • Children: 0.01 mg/kg IV once; may repeat with 0.1 mg/kg

Reversal of respiratory depression with therapeutic opioid dosing

  • Manufacturer dosing: 0.005-0.01 mg; repeat q2-3min PRN based on response
  • AAP dosing: 0.001-0.015 mg/kg/dose IV; titrate to effect

Acute opioid overdose

  • ≤20 kg or <5 years: 0.1 mg/kg/dose IV/IM/SC/ET; if needed, repeat q2-3min PRN; not to exceed 2 mg/dose
  • >20 kg or ≥5 years: 2 mg IV/IM/SC/ET; if needed, repeat q2-3min PRN
  • Consider endotracheal administration when IV/intraosseous route not available; optimal endotracheal dose unknown; 2-3 times the IV dose recommended

Opioid Overdose (Evzio Auto-Injector)

Indicated for immediate administration as emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression

0.4 mg or 2 mg IM/SC into anterolateral aspect of the thigh (through clothing if necessary); if child is <1 yr, pinch the thigh muscle while administering the dose

Seek emergency medical care immediately after use

Additional doses may be administered q2-3min until EMS arrives

Dosing considerations (Evzio)

  • Take-home, single-use auto-injector with visual and voice instruction for guidance
  • May be prescribed to a family member or caregiver
  • Compact size for portability with retractable needle system
  • Intended for immediate administration as emergency therapy in settings where opioids may be present
  • Not a substitute for emergency medical care
  • Also see Administration

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Naloxone Mylan 0.4mg /1ml only for the indication prescribed.