NALOXONE HYDROCHLORIDE
Naloxone hydrochloride nasal spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose. It is administered to patients exhibiting signs of respiratory or central nervous system depression in environments where opioids may be present. The medication serves as an immediate emergency therapy but is not a replacement for professional medical care. Use of the 2 mg strength is restricted to opioid-dependent patients at risk for severe withdrawal in specific low-risk household settings.
How NALOXONE HYDROCHLORIDE Works
Naloxone hydrochloride acts as an opioid antagonist by competing for the same receptor sites as opioid drugs. By binding to these receptors, it reverses the clinical effects of opioids, such as respiratory depression, sedation, and hypotension. It also antagonizes the psychotomimetic and dysphoric effects associated with agonist-antagonist medications. This competitive inhibition prevents opioids from activating the receptors, thereby neutralizing their impact on the central nervous system.
Details
- Status
- Prescription
- First Approved
- 1986-01-17
- Routes
- INJECTION, NASAL
- Dosage Forms
- INJECTABLE, SPRAY, SPRAY, METERED
Companies
NALOXONE HYDROCHLORIDE Approval History
What NALOXONE HYDROCHLORIDE Treats
3 indicationsNALOXONE HYDROCHLORIDE is approved for 3 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Opioid Overdose
- Respiratory Depression
- Central Nervous System Depression
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NALOXONE HYDROCHLORIDE FDA Label Details
ProIndications & Usage
Naloxone HCl Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. Naloxone HCl Nasal Spray is not a substitute for emergency medical care. Limitations of Use: Restrict prescription of naloxone hydrochloride nasal spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental o...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.