KLOXXADO 8 mg/.1mL
Naloxone HCL · SPRAY · Hikma Specialty USA Inc.
KLOXXADO is a spray containing naloxone hcl at 8 mg/.1mL, taken nasal. Manufactured by Hikma Specialty USA Inc..
Key Facts
- Brand Name
- KLOXXADO
- Generic Name
- Naloxone HCL
- NDC Code (Product)
59467-679- Manufacturer
- Hikma Specialty USA Inc.
- Strength
- 8 mg/.1mL
- Dosage Form
- SPRAY
- Route
- NASAL
- Marketing Status
- Application #
- NDA212045
- Marketing Start
- 08/03/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE KLOXXADO is 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 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. (1) 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. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • KLOXXADO is for intranasal use only. ( 2.1 ) • Seek emergency medical care immediately after use. ( 2.1 ) • All approved naloxone hydrochloride products achieve plasma concen- trations effective at reversing the effects of opioid overdose. Comparing products on a nominal mg-for-mg basis may be misleading. ( 2.1 ) • Administer a single spray of KLOXXADO to adult or pediatric patients intranasally into one nostril. ( 2.2 ) • Administer additional doses of KLOXXADO, using a new nasal spray with each dose, if the patient does not respond or responds and then relapses into respiratory depression. Additional doses of KLOXXADO may be given every 2 to 3 minutes until emergency medical assistance arrives. ( 2.2 ) • Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance. ( 2.2 ) 2.1 Important Dosage and Administration Instructions • KLOXXADO is for intranasal use only. • One spray delivers the entire contents of the drug product. • All approved naloxone hydrochloride products achieve plasma concentrations that have been shown to be efficacious in reversing the effects of opioid overdose. Comparing different…
Contraindications
4 CONTRAINDICATIONS KLOXXADO is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients in KLOXXADO. Hypersensitivity to naloxone hydrochloride or to any of the other ingredients. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: • Recurrent Respiratory and Central Nervous System Depression [see Warnings and Precautions ( 5.1 )] • Precipitation of Severe Opioid Withdrawal [see Warnings and Precautions ( 5.3 )] The following adverse reactions were reported with KLOXXADO in two adult subjects each: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Specialty USA Inc. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice. KLOXXADO nasal spray, 4 mg No adverse events were reported in a pharmacokinetic study of 72 healthy adult volunteers exposed to one spray of 4 mg KLOXXADO nasal spray in one nostril. KLOXXADO nasal spray, 8 mg In two pharmacokinetic studies a total of 47 healthy adult volunteers were exposed to …
Frequently Asked Questions
What is KLOXXADO used for?
KLOXXADO contains Naloxone HCL. It is a spray taken nasal. Consult your doctor for specific uses.
Is KLOXXADO a controlled substance?
KLOXXADO is not classified as a controlled substance by the DEA.
What is the generic name for KLOXXADO?
The generic name for KLOXXADO is Naloxone HCL. There are 2 other brand versions of Naloxone HCL.
What is the NDC code for KLOXXADO 8 mg/.1mL?
The NDC (National Drug Code) for KLOXXADO 8 mg/.1mL is 59467-679, listed by Hikma Specialty USA Inc..