Rextovy

Rextovy (naloxone hydrochloride) is an over-the-counter (OTC) naloxone nasal spray used to reverse a known or suspected opioid overdose in adults and children. It delivers a 4 mg dose of naloxone directly into the nostril and begins working within minutes. Each device is single-use only. Rextovy was approved for OTC use by the FDA on June 16, 2026, and can be purchased without a prescription at pharmacies, convenience stores, and online.

Rextovy works by competing with opioids for the same receptors in the brain. When given during an overdose, it rapidly displaces the opioid from those receptors, restoring normal breathing and consciousness. It has no effect on people who have not taken opioids.

Rextovy is an emergency treatment, not a substitute for medical care. Call 911 as soon as you use it.

Rextovy is made by Amphastar Pharmaceuticals and is one of several OTC naloxone nasal spray products available in the U.S. Other options include Narcan (4 mg) and Kloxxado (8 mg). All contain naloxone but are manufactured by different companies.

Rextovy is for nasal use only. Each device is pre-filled with one 4 mg dose and is ready to use straight from the box. Do not prime or test it first, and do not attempt to reuse it.

• Lay the person on their back
• Tilt their head back by supporting the back of the neck
• Insert the device nozzle into one nostril
• Press the green plunger firmly all the way down
• Remove the device from the nostril
• Call 911 right away, even if they start to wake up
• If they respond normally, roll them onto their side (recovery position)
• If there is no improvement after 2 minutes, use a second device in the other nostril
• Keep repeating every 2 to 3 minutes in alternating nostrils until paramedics arrive

Each household where Rextovy is kept should have more than one device available, since multiple doses are often needed.

Overdose symptoms can return after the first dose

Naloxone wears off faster than most opioids. That means a person who appears to have recovered after one dose of Rextovy may relapse into respiratory depression within 30 to 90 minutes. This is one of the most important things to understand about naloxone: it buys time, but it does not end the overdose. Stay with the person, keep giving doses every 2 to 3 minutes if symptoms return, and always wait for emergency services to arrive before leaving.

Rextovy may be less effective for a buprenorphine overdose

Buprenorphine binds tightly to opioid receptors and is harder to displace than other opioids. If the overdose involves buprenorphine or another partial opioid agonist such as pentazocine, you may need to give more doses of Rextovy, and the response will be slower and shorter-lasting than with a full opioid like heroin or fentanyl.

Rextovy can trigger opioid withdrawal

In someone who has been regularly using opioids, Rextovy may cause sudden withdrawal. This is uncomfortable but is not life-threatening in adults. Symptoms can include sweating, rapid heartbeat, agitation, nausea, vomiting, diarrhea, muscle aches, and high blood pressure.

In newborns who have been exposed to opioids in the womb, withdrawal triggered by naloxone can be serious and may include seizures, inconsolable crying, and exaggerated reflexes. Seek emergency medical care immediately if a newborn shows these symptoms.

Heart-related risks

In people with underlying heart conditions, especially those who have recently had surgery under anesthesia, the sudden reversal of opioid effects can place significant stress on the cardiovascular system. In rare cases, this has led to rapid or irregular heartbeat, severe changes in blood pressure, fluid buildup in the lungs, and cardiac arrest. These events are uncommon in out-of-hospital overdose settings but are worth knowing about.

The only reason not to use Rextovy is a known allergy to naloxone hydrochloride or any of its inactive ingredients. There are no other contraindications.

If you are uncertain whether someone is overdosing, use it anyway. Rextovy has no harmful effect on people who have not taken opioids, and withholding it out of uncertainty can be fatal.

Tell your healthcare provider about Rextovy prescriptions, especially if the person who may need it:

• Has a history of heart disease or cardiovascular problems
• Is pregnant
• Is breastfeeding
• Takes medicines that could interact with naloxone

Family members and caregivers should be shown how to use Rextovy before an emergency happens, not during one.

Pregnancy

If a pregnant woman is experiencing an opioid overdose, Rextovy should be used without hesitation. The danger of untreated overdose, to both the mother and the unborn baby, far outweighs any risk from naloxone. After Rextovy is given, the fetus should be assessed by a healthcare provider as soon as possible, since naloxone may trigger withdrawal in an opioid-exposed unborn baby.

Breastfeeding

Naloxone is broken down quickly in the digestive system and is not meaningfully absorbed when swallowed, which means very little, if any, passes to a breastfed infant through milk. There is no evidence that naloxone affects milk supply or infant wellbeing. Talk to your healthcare provider if you have concerns.

Common Rextovy side effects

• Tingling or numbness in the mouth
• Headache

Serious side effects

• Sudden opioid withdrawal (see Warnings above)
• High or low blood pressure
• Rapid or irregular heartbeat
• Fluid in the lungs (pulmonary edema)
• Cardiac arrest (rare, primarily in surgical settings)

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Rextovy does not follow a daily dosing schedule. It is given on an as-needed basis during an overdose.

Use a new device for every dose. Doses cannot be split or adjusted, as each device delivers the full 4 mg.

In case of overdose of Rextovy itself: call Poison Control at 1-800-222-1222. If the person has collapsed, is having a seizure, or cannot be woken, call 911 immediately.

Knowing what to look for can save a life. Signs of opioid overdose include:

• Unresponsive: you cannot wake the person by calling their name or rubbing firmly on their chest
• Slow, shallow, or stopped breathing: fewer than one breath every 5 seconds, or no breathing at all
• Pinpoint pupils: the black circle in the center of the eye is very small, even in dim light
• Blue or grayish lips or fingernails: a sign the body is not getting enough oxygen
• Gurgling or choking sounds: sometimes called the "death rattle"
• Cold and clammy skin

If you see these signs and opioids may be involved, use Rextovy immediately and call 911. Do not wait to be certain as acting quickly is what matters.

Because Rextovy is used in emergencies, detailed medication reconciliation is not always possible ahead of time. However, there are a few important interactions to be aware of:

• Other opioids: Naloxone reverses all opioid effects simultaneously. In someone who takes opioids for chronic pain, Rextovy will also remove their pain relief. This is expected and not a reason to avoid using it in a true overdose.
• Buprenorphine (Suboxone, Subutex) or pentazocine: These partial opioid agonists are harder to reverse. More doses and longer monitoring time are needed.

Other drugs may interact with this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

• Store at room temperature between 68 degrees F to 77 degrees F (20 degrees C to 25 degrees C)
• Short-term storage between 39 degrees F to 104 degrees F (4 degrees C to 40 degrees C) is acceptable
• Do not freeze: a frozen device will not spray
• Keep in the original box, away from direct light
• Check the expiration date regularly and replace before it expires
• Keep out of reach of children

Rextovy should be somewhere accessible, such as a medicine cabinet, a bag, or a bedside drawer, not locked away. In a true overdose, seconds matter.

If the device accidentally freezes: do not wait for it to thaw in an active emergency. Call 911 immediately. If it was frozen but is not currently needed, leave it at room temperature for 15 minutes as it can still be used after thawing.

Active ingredient: naloxone hydrochloride

Inactive ingredients: sodium chloride, sodium hydroxide (to adjust pH), and water for injection USP

Rextovy is not made with natural rubber latex.

Rextovy is distributed by International Medication Systems, Limited, So. El Monte, CA 91733, U.S.A., an Amphastar Pharmaceuticals Company. For more information, visit www.amphastar.com or call 1-800-423-4136.