Key facts
- Active ingredient
- Naloxone Hydrochloride
- Drug class
- Opioid Antagonist
- Form
- Spray/Inhaler
- Strength
- Naloxone Hydrochloride 10MG/SPRAY
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Scienture
- Half-life
- 30 to 81 minutes (mean 64 ± 12 minutes) (how long it stays in your system)
- What the pharmacy pays
- ~$4.41 per ml — not your price
- FDA application
- NDA215487
What is Rezenopy?
From the FDA label:Rezenopy (naloxone hydrochloride) nasal spray is a pre-filled, single dose intranasal spray. Chemically, naloxone hydrochloride is the hydrochloride salt of 17-Allyl-4,5α-epoxy- 3,14-dihydroxymorphinan-6-one hydrochloride with the following structure: Naloxone hydrochloride, an opioid antagonist, occurs as a white, to slightly off-white powder or almost white crystalline powder and contains two molecules of water of hydration. It is freely soluble in water, in dilute acids, and in strong alkali; slightly soluble in ethanol. pKa values (proton on Nitrogen) are respectively 7.94 at 20°C and 7.82 at 37°C. Each REZENOPY nasal spray delivers 10 mg naloxone hydrochloride (equivalent to 9 mg of naloxone) in a 0.11 mL aqueous solution. Inactive ingredients include glycerin, trisodium citrate dihydrate, hydrochloric acid and sodium hydroxide to adjust pH, and purified water. The pH range is 3.9 to 4.5. chem structure
How to use
REZENOPY nasal spray is for intranasal use only. ( 2.1 ) Seek emergency medical care immediately after use. ( 2.1 ) Administration of a single spray of REZENOPY nasal spray intranasally into one nostril in adult and pediatric patients. ( 2.2 ) If the patient does not respond within 2 to 3 minutes or responds and then relapses into respiratory depression, an additional dose of REZENOPY nasal spray may be given into the other nostril with a new device. ( 2.2 ) Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance. ( 2.2 ) 2.1 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 (12.3) ] . 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…
Side effects
The following serious adverse reactions are discussed elsewhere in the labeling: Precipitation of Severe Opioid Withdrawal [see Warnings and Precautions (5.3) ]. Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice. The following adverse reactions were observed in a REZENOPY nasal spray clinical study. In a pharmacokinetic study of 30 healthy adult volunteers exposed to one spray of REZENOPY nasal spray, adverse reactions of abdominal pain upper, nasopharyngitis and dysgeusia were observed. The following adverse reactions have been identified primarily during post-approval use of naloxone hydrochloride in the post-operative setting. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. Excessive doses of naloxone hydrochloride in post-operative patients have resulted in significant reversal of analgesia, and have caused…
Warnings
Important safety information
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 additional doses of REZENOPY nasal spray, as necessary, using a new nasal spray device while awaiting emergency medical assistance. ( 5.1 ) 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. ( 5.2 ) Precipitation of Severe Opioid Withdrawa l: Use in patients who are opioid dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life- threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal. ( 5.3 ) Risk of Cardiovascular (CV) Effects : Abrupt postoperative reversal of opioid depression may result in adverse CV effects. These events have primarily occurred in patients who had pre-existing CV disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride. ( 5.3 ) 5.1 Risk of Recurrent Respiratory and Central Nervous System Depression The duration of action of most opioids may exceed that of REZENOPY nasal spray resulting in a return of respiratory and/or central nervous system depression after an initial improvement in symptoms. Therefore, it is necessary to seek emergency medical assistance immediately after administration of the first dose of REZENOPY nasal spray and to keep the patient under continued surveillance. Administer additional doses of REZENOPY nasal spray if the patient does not adequately respond or responds and then relapses back into respiratory depression, as necessary [see Dosage and Administration (2.2) ] . Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance. 5.2 Risk of Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists Reversal of respiratory depression by partial agonists or mixed agonist/antagonists such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses of naloxone hydrochloride may be required to antagonize buprenorphine because the latter has a long duration of action due to its slow rate of binding and subsequent slow dissociation from the opioid receptor [see Dosage and Administration (2.2) ]. Buprenorphine antagonism is characterized by a gradual onset of the reversal effects and a decreased duration of action of the normally prolonged respiratory depression. 5.3 Precipitation of Severe Opioid Withdrawal The use of REZENOPY nasal spray in patients who are opioid dependent may precipitate opioid withdrawal characterized by the following signs and symptoms: 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 the following signs and symptoms: convulsions, excessive crying, and hyperactive reflexes. Monitor the patient for the development of the signs and symptoms of opioid withdrawal. Abrupt postoperative reversal of opioid depression after using naloxone hydrochloride 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 pre-existing cardiovascular disorders or received other drugs that may have similar adverse cardiovascular effects. Although a direct cause and effect relationship has not been established, after use of naloxone hydrochloride, monitor patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects for hypotension, ventricular tachycardia or fibrillation, and pulmonary edema in an appropriate healthcare setting. It has been suggested that the pathogenesis of pulmonary edema associated with the use of naloxone hydrochloride is similar to neurogenic pulmonary edema, i.e., a centrally mediated massive catecholamine response leading to a dramatic shift of blood volume into the pulmonary vascular bed resulting in increased hydrostatic pressures. 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 [see Use in Specific Population (8.4) ].
Who should not take Rezenopy
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 )
How long does Naloxone Hydrochloride stay in your body?
The elimination half-life of naloxone hydrochloride is 30 to 81 minutes (mean 64 ± 12 minutes) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the serum elimination half-life in adults with normal organ function; naloxone is metabolized in the liver by glucuronide conjugation (major metabolite naloxone-3-glucuronide, which is inactive) and excreted in urine. The half-life is much longer in neonates (mean 3.1 ± 0.5 hours). Because naloxone's half-life is short — often shorter than that of the opioids it reverses — its effects can wear off before the opioid does, so repeat dosing may be needed. Half-life is a pharmacokinetic elimination measure, not a drug-test detection window.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: NALOXONE HYDROCHLORIDE injection — DailyMed FDA label.
Drug class
How this class works, per Opioid Antagonists - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Rezenopy ranks — best-rated opioid antagonist for:
Dosage forms
Spray/Inhaler
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Rezenopy treat?
- Rezenopy (Naloxone Hydrochloride) may be used to treat opioid-related disorders, respiration disorders, septic shock, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Rezenopy work?
- Rezenopy is a opioid antagonist. Opioid antagonists attach to the same brain and body receptors that opioids use, but without switching them on. By occupying those receptors, they block opioids from binding and can rapidly reverse an overdose or curb opioid cravings.
- How much does Rezenopy cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $4.41 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Rezenopy?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Rezenopy. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Rezenopy?
- Rezenopy is marketed by Scienture. You can see Scienture's full profile, rating, and other products on pharmaranks.
- Is Rezenopy a brand-name or generic drug?
- Rezenopy is a brand-name product with the active ingredient Naloxone Hydrochloride. Lower-cost generic equivalents containing Naloxone Hydrochloride are available — ask your pharmacist.
- Is Rezenopy available over the counter?
- No. Rezenopy is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Rezenopy come in?
- Rezenopy is currently marketed as spray/inhaler, per the FDA's National Drug Code Directory.
- What class of drug is Rezenopy?
- Rezenopy is classified as opioid antagonist, per the FDA's Established Pharmacologic Class.
- Is Rezenopy FDA-registered?
- Rezenopy is on record with the U.S. FDA under application number NDA215487. You can verify this on its official FDA label.
- Is Rezenopy safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Rezenopy. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Rezenopy?
- Rezenopy's side effects are taken directly from its FDA label. From the label: The following serious adverse reactions are discussed elsewhere in the labeling: Precipitation of Severe Opioid Withdrawal [see Warnings and Precautions (5.3) ]. Because clinical studies are conducted under widely varying conditions,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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