Pharmacological Class:
Opioid antagonist.

Active Ingredient(s):
Naloxone HCl 0.4mg/0.4mL; soln in a prefilled auto-injector for IM or SC inj; latex-free.

Company
kaleo, Inc.

Indication(s):
Emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or CNS depression.

Pharmacology:
Naloxone HCl antagonizes opioid effects by competing for the same receptor sites. It reverses the effects of opioids, including respiratory depression, sedation, and hypotension. Also, naloxone HCl can reverse the psychotomimetic and dysphoric effects of agonist-antagonists such as pentazocine.

When naloxone HCl is administered intravenously, the onset of action is generally apparent within two minutes. The time to onset of action is shorter for intravenous compared to subcutaneous or intramuscular routes of administration. The duration of action is dependent upon the dose and route of administration of naloxone HCl.

Legal Classification:
Rx

Adults & Children:
<1 year: Pinch thigh muscle while administering; monitor inj site for residual needle parts and/or infection. ≥1 year: Inject IM or SC into the anterolateral aspect of the thigh (through clothing, if necessary) according to label instructions. All: may give additional doses every 2–3 minutes until desired response or emergency medical assistance available. Repeated doses depending on amount, type, and route of administration of the opioid being antagonized may be required.

Warnings/Precautions:
Not a substitute for emergency medical care. Monitor patients with satisfactory response due to long duration of some narcotics. Have other resuscitative measures available. Known or suspected opioid dependence; abrupt reversal may precipitate acute withdrawal syndrome. Post-op use in pre-existing cardiac disorders; monitor. Neonates. Elderly. Pregnancy (Category B). Nursing mothers.

Interaction(s)
Caution with cardiotoxic drugs. Incomplete reversal of mixed agonists/antagonists (eg, buprenorphine, pentazocine); may require higher naloxone dose.

Adverse Reaction(s)
Post-op reversal of opioid depression: nausea, vomiting, sweating, tremulousness, tachycardia, hypotension, hypertension, seizures, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Also, excessive naloxone doses in post-op: reversal of analgesia, agitation.

How Supplied:
Prefilled auto-injectors—2 (w. Trainer)

LAST UPDATED:
7/18/2014