Naloxone (nasal)
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
Important Administration Instructions REZENOPY nasal spray is for intranasal use only. All approved naloxone hydrochloride products achieve plasma concentrations that have been shown to be efficacious in reversing the effects of opioid overdose. Comparing different products on a nominal mg-for-mg basis may be misleading [see Clinical Pharmacology ] .
Because treatment of suspected opioid overdose must be performed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of REZENOPY nasal spray and the Instructions for Use . Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for REZENOPY nasal spray.
Emphasize the following instructions to the patient or caregiver: Seek medical care immediately after use. Since the duration of action of most opioids exceeds that of naloxone hydrochloride 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 additional doses of REZENOPY nasal spray, 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 REZENOPY nasal spray. Additional doses of REZENOPY nasal spray may be required before emergency medical assistance becomes available. Do not attempt to reuse REZENOPY nasal spray.
Each REZENOPY nasal spray contains a single dose of naloxone. Re-administer REZENOPY nasal spray, using a new nasal spray, if the patient does not respond within 2 to 3 minutes or responds and then relapses into respiratory depression. Administer REZENOPY nasal spray in alternate nostrils with each dose. Administer REZENOPY nasal spray according to the printed instructions on the device label and the Instructions for Use .
Place the patient in the supine position on their back. Prior to administration, be sure the device nozzle is inserted in either nostril of the patient, support the back of the neck and tilt the patient’s head back. Do not prime or test the device prior to administration . To administer the dose firmly press the bottom of the device plunger.
Remove the device nozzle from the nostril after use. Turn patient on their side as shown in the Instructions for Use and call for emergency medical assistance immediately after administration of the first dose of REZENOPY nasal spray.
Contraindications
4 CONTRAINDICATIONS REZENOPY nasal spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients. Hypersensitivity to naloxone hydrochloride. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Life-sustaining therapy for opioid overdose should not be withheld (see Clinical Considerations). Available data from retrospective cohort studies on naloxone use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, no embryotoxic or teratogenic effects were observed in mice and rats administered naloxone hydrochloride during organogenesis at doses equivalent to 2-times and 4-times, respectively, a human dose of 20 mg/day (2 sprays of Rezenopy) (see Data) .
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk An opioid overdose is a medical emergency and can be fatal for the pregnant woman and fetus if left untreated. Treatment with Rezenopy for opioid overdose should not be withheld because of potential concerns regarding the effects of Rezenopy on the fetus.
Data Animal Data Naloxone hydrochloride was administered during organogenesis to mice and rats at doses 2-times and 4-times, respectively, a human dose of 20 mg (two REZENOPY nasal sprays) based on body surface area comparison. These studies demonstrated no embryotoxic or teratogenic effects due to naloxone hydrochloride.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.