Kloxxado FDA Approval History
Last updated by Judith Stewart, BPharm on May 2, 2021.
FDA Approved: Yes (First approved April 30, 2021)
Brand name: Kloxxado
Generic name: naloxone hydrochloride
Dosage form: Nasal Spray
Company: Hikma Pharmaceuticals USA Inc.
Treatment for: Opioid Overdose
Kloxxado (naloxone hydrochloride) nasal spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.
- Kloxxado is intended for immediate administration as emergency therapy in settings where opioids may be present. Kloxxado is not a substitute for emergency medical care.
- Kloxxado (naloxone hydrochloride 8 mg per spray) contains twice as much naloxone as Narcan Nasal Spray (naloxone hydrochloride 4 mg per spray).
- Kloxxado is administered intranasally into one nostril. Additional doses may be given if the patient remains unresponsive while waiting for emergency medical assistance to arrive.
- Adverse reactions include abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.
Development Timeline for Kloxxado
|Apr 30, 2021||Approval FDA Approves Kloxxado (naloxone hydrochloride) Nasal Spray for Emergency Treatment of Opioid Overdose|
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