Naloxone nasal prep

Naloxone nasal prep is used for: Opioid Overdose

Opioid Overdose Indicated for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or CNS depression Initial dosing: 1 spray delivered by intranasal administration; delivers 4 mg of naloxone HCl

Opioid Overdose Indicated for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or CNS depression Initial dosing: 1 spray delivered by intranasal administration; delivers 4 mg of naloxone HCl

Intranasal Administration Because treatment of suspected opioid overdose must be performed by someone other than the patient, instruct the prescription recipient to inform those around him or her about the presence of naloxone intranasal and the Instructions for Use Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for naloxone intranasal Emphasize the following instructions Administer as quickly as possible because prolonged respiratory depression may result in damage to the CNS or death Since the duration of action of most opioids exceeds that of naloxone and the suspected opioid overdose may occur outside of supervised medical settings, seek immediate emergency medical assistance, keep the patient under continued surveillance until emergency personnel arrive, and administer repeated doses of naloxone intranasal, as necessary Always seek emergency medical assistance in the event of a suspected, potentially life-threatening opioid emergency after administration of the first dose of naloxone intranasal Additional doses may be required until emergency medical assistance becomes available Do not attempt to reuse naloxone intranasal; each spray contains a single dose of naloxone and cannot be reused Readminister using a new nasal spray every 2-3 minutes if the patient does not respond or responds and then relapses into respiratory depression Administer in alternate nostrils with each dose Administer according to the printed instructions on the device label and the Instructions for Use Place the patient in the supine position Prior to administration, be sure the device nozzle is inserted in either nostril of the patient, and provide support to the back of the neck to allow the head to tilt back Do not prime or test the device prior to administration To administer the dose, press firmly on the device plunger Remove the device nozzle from the nostril after use Turn patient on his or her side as shown in the Instructions for Use and call for emergency medical assistance immediately after administration of the first dose

Hypersensitivity

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 setting of opioid dependence; however, the 2 mg dose may not provide adequate and timely reversal in persons who may be exposed to overdose of potent or very high dose of opioids 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 (see Dosing and Administration sections) 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 (see Dosage Modifications) Precipitation of severe opioid withdrawal Use in patients who are opioid dependent 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 use of an alternative naloxone-containing product that can be titrated to effect and, where applicable, dosed according to weight

Pregnancy The limited available data on naloxone use in pregnant women are not sufficient to inform a drug-associated risk regarding teratogenicity Fetal/neonatal adverse reactions 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 Animal studies No embryotoxic or teratogenic effects were observed in mice and rats treated during the period of organogenesis at doses equivalent to 6-12 times a human dose of 8 mg/day Lactation Unknown if 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

Side effects of Naloxone nasal prep : Frequency Not Defined Precipitation of severe opioid withdrawal Increased blood pressure Musculoskeletal pain Headache Nasal dryness Nasal edema Nasal congestion Nasal inflammation

Competitive opioid antagonist that antagonizes opioid effects by competing for the same receptor sites It reverses the effects of opioids, including respiratory depression, sedation, and hypotension