Naloxone Hydrochloride

What it is and how it works

Mechanism of Action Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites. Naloxone hydrochloride reverses the effects of opioids, including respiratory depression, sedation, and hypotension. It can also reverse the psychotomimetic and dysphoric effects of agonist-antagonists such as pentazocine.

Indications

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 or intentional opioid exposure by household contacts. Naloxone HCl 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. 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.

Dosage and administration (summary)

• Naloxone HCl Nasal Spray is for intranasal use only. • Seek emergency medical care immediately after use. • Administration of a single spray of Naloxone HCl Nasal Spray intranasally into one nostril. • Administer additional doses of Naloxone HCl Nasal Spray, 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 Naloxone HCl Nasal Spray may be given every 2 to 3 minutes until emergency medical assistance arrives. • Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.

Contraindications

Naloxone HCl Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients. Hypersensitivity to naloxone hydrochloride.

Warnings and precautions

• Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep patient under continued surveillance and administer repeat doses of naloxone using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance. • Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.

Pregnancy

Pregnancy Risk Summary The limited available data on naloxone use in pregnant women are not sufficient to inform a drug-associated risk. However, there are clinical considerations .

Storage and supply

Product: 50090-6710 NDC: 50090-6710-0 .1 mL in a VIAL, SINGLE-DOSE / 2 in a CARTON

Source: Naloxone Hydrochloride (Naloxone Hydrochloride) — US FDA prescribing information, 2023-10-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.