Naloxone Intranasal

Naloxone intranasal is used for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system (CNS) depression.

Naloxone intranasal is available under the following different brand names: Narcan Nasal Spray.

Dosage Forms and Strengths

Intranasal Solution

• 4mg/actuation

Dosage Considerations – Should be Given as Follows:

Opioid Overdose

• Indicated for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system (CNS) depression.
• Initial dosing: 1 spray delivered by intranasal administration; delivers 4 mg of naloxone HCl

Repeat dosing

• Seek emergency medical assistance as soon as possible after administering the first dose
• The requirement for repeat doses depends on the amount, type, and route of administration of the opioid being antagonized
• Administer in alternate nostrils with each dose
• If the patient responds and relapses back into respiratory depression before emergency assistance arrives, administer an additional dose of naloxone intranasal using a new spray and continue surveillance of the patient
• If the desired response is not obtained after 2-3 minutes, administer an additional dose using a new spray
• If there is still no response and additional doses are available, administer additional doses every 2-3 minutes using a new spray with each dose until emergency medical assistance arrives
• Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance

Dosage Modifications

Partial opioid agonists or mixed agonist/antagonists

• Reversal of respiratory depression by partial agonists or mixed agonist/antagonists (e.g., buprenorphine, pentazocine) may be incomplete and require higher doses of naloxone or repeated administration

Dosing Considerations

• Intended for immediate administration as emergency therapy in settings where opioids may be present
• Not a substitute for emergency medical care
• Geriatric patients have a greater frequency of decreased hepatic, renal, or cardiac function and concomitant disease or other drug therapy; therefore, the systemic exposure of naloxone can be higher in these patients

Side effects of naloxone intranasal include:

• Precipitation of severe opioid withdrawal
• Increased blood pressure
• Musculoskeletal pain
• Headache
• Nasal dryness
• Nasal swelling
• Nasal congestion
• Nasal inflammation

Postmarketing side effects of naloxone intranasal reported include:

• Aggressive behavior upon abrupt reversal of an opioid overdose
• Constipation
• Toothache
• Muscle spasms
• Nose pain
• Excessively dry skin

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Naloxone intranasal has no listed severe interactions with other drugs.
• Naloxone intranasal has no listed serious interactions with other drugs.
• Naloxone intranasal has no listed moderate interactions with other drugs.
• Naloxone intranasal has no listed mild interactions with other drugs.
   

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings
 

This medication contains naloxone intranasal. Do not take Narcan Nasal Spray if you are allergic to naloxone intranasal or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Naloxone Intranasal?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Naloxone Intranasal?”

Cautions

• Risk of recurrent respiratory and CNS depression
• There is limited data to inform if 2 mg dose will avoid precipitation of severe opioid withdrawal in the setting of opioid dependence; however, the 2 mg dose may not provide adequate and timely reversal in persons who may be exposed to an overdose of potent or very high dose of opioids
• The risk of recurrent respiratory and CNS depression exists because the duration of action of most opioids may exceed that of naloxone nasal spray
• Seek immediate emergency medical assistance following the first dose
• Administer additional doses and additional supportive and/or resuscitative measures while waiting for help
• Reversing partial opioid agonists or mixed opioid agonist/antagonists
• Incomplete reversal of respiratory depression may be observed when attempting to reverse partial opioid agonists or mixed opioid agonist/antagonists
• Larger or repeat doses may be required to antagonize buprenorphine because the latter has a long duration of action owing to its slow rate of binding and subsequent slow dissociation from the opioid receptor

Precipitation of severe opioid withdrawal

• Use in opioid-dependent patients may precipitate opioid withdrawal characterized by body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may include convulsions, excessive crying, and hyperactive reflexes
• Abrupt postoperative reversal of opioid depression may result in nausea, vomiting, sweating, tremulousness, tachycardia, hypotension, hypertension, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest; death, coma, and encephalopathy have been reported as sequelae of these events; these events have primarily occurred in patients who had preexisting cardiovascular disorders or received other drugs that may have similar adverse cardiovascular effects
• There may be clinical settings, particularly the postpartum period in neonates with known or suspected exposure to maternal opioid use, where it is preferable to avoid the abrupt precipitation of opioid withdrawal symptoms; in these settings, consider the use of an alternative naloxone-containing product that can be titrated to effect and, where applicable, dosed according to weight

Pregnancy and Lactation

The limited available data on naloxone intranasal use in pregnant women are not sufficient to inform a drug-associated risk regarding teratogenicity. Naloxone crosses the placenta and may precipitate withdrawal in the fetus, as well as in the opioid-dependent mother. The fetus should be evaluated for signs of distress after naloxone is used. Careful monitoring is needed until the fetus and mother are stabilized.

It is unknown if naloxone intranasal is distributed in human breast milk. Studies in nursing mothers have shown that naloxone does not affect prolactin or oxytocin hormone levels. Naloxone is minimally orally bioavailable. Consult your doctor before breastfeeding.