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CVS - Selling Naloxone Without Prescription!

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Partnership for Drug-Free Kids - Where Families Find Answers

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CVS Will Sell Naloxone Without Prescription in 14 States - Partnership for Drug-Free Kids - Where Families Find Answers

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CVS announced it will add 12 states to its program to sell the opioid overdose antidote naloxone without a prescription, bringing the total to 14. The company already sells naloxone without a prescription in Massachusetts and Rhode Island.

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President Barack Obama recently signed a law aimed at addressing the burgeoning opioid crisis in the US.

While the law was undoubtedly a step forward for a gridlocked Congress, it won't affect one of the crisis' most intractable problems - the skyrocketing price of naloxone, a drug that instantly reverses overdoses.

A report from the US Centers for Disease Control and Prevention in January revealed that drug overdose deaths reached a new high in 2014, totaling 47,055 people. Opioids were involved in 60% of those deaths.

Frequently referred to as an "antidote" for opioid overdoses, naloxone has seen drastic price increases in recent years, according to information provided by Truven Health Analytics, a healthcare-analytics company. A popular injectable version of the drug has gone from $0.92 a dose to more than $15 a dose over the last decade. An auto-injector version is up to more than $2,000 a dose.

On the market since 1971, naloxone works by blocking opioid drugs from interacting with the brain's receptors, counteracting the drugs' dangerous side effects, like slow respiration, coma, and death, during an overdose. The drug almost instantly pulls an overdose victim back to sobriety and has only minor side effects for opioid users - and almost none if mistakenly administered to patients not suffering an overdose.

The price increases, however, have made affording the drug difficult for community organizations, which provide naloxone for free to drug users, their family members, and other nonmedical personnel.

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These organizations along with pharmacies, public-health departments, and substance-use treatment facilities prevented more than 26,000 overdoses from 1996 to June 2014 by providing naloxone, according to a survey of 136 such organizations conducted by the Harm Reduction Coalition, a national advocacy group. That number is also likely lower than the actual number of overdoses prevented, according to the survey.

We're not talking about a limited commodity.

Many see the drug's price hikes as unwarranted and are frustrated with the lack of access.

"We're not talking about a limited commodity. Naloxone is a medicine that is almost as cheap as sterile sodium chloride - salt water," Dan Bigg, the executive director of the Chicago Recovery Alliance, an outreach organization that has been providing naloxone to drug users for nearly 20 years, told Business Insider.

In June, Sens. Claire McCaskill, a Democrat from Missouri, and Susan Collins, a Republican from Maine, sent a letter to the five pharmaceutical companies that produce naloxone - Amphastar, Pfizer, Adapt, Kaléo, and Mylan - asking for an explanation of the recent price changes.

"At the same time this epidemic is killing tens of thousands of Americans a year, we're seeing the price of naloxone go up by 1000% or more," McCaskill wrote. "Maybe there's a great reason for the price increases, but given the heart-breaking gravity of this epidemic and the need for this drug, I think we have to demand some answers."

How much it costs to save a life

All five pharmaceutical companies that produce naloxone have seen price hikes in recent years or, for the newer entrants such as Adapt, priced their product far above the industry average several years ago.

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As of January 2015, Amphastar's version of naloxone was up to $41 a dose, according to Fierce Pharma, a pharmaceutical-industry news site. That follows a price increase from $17 to $33 a dose in October 2014, according to data provided by Truven Health Analytics. In 2001, the price was just $12 a dose.

As of October 2014 - the most recent time for which prices are available - Hospira's version of naloxone was $15.80 a dose. That's up from $0.92 a dose in 2005, according to Truven Health Analytics. The price of Hospira's version of naloxone hit a peak of $21.90 a dose in January 2014. Pfizer purchased Hospira last year.

Meanwhile, Kaléo has raised the price of its naloxone product, Evzio, several times since last year. In November 2015, the price went up to $375, followed by an increase to $1,875 in February 2016. Since then, the price has been raised to $2,250 for each single-dose injector. Evzio, which is an auto-injector that works like an EpiPen and is specifically created for use by people without medical training, was introduced at $287.50 for each single-dose injector in July 2014, according to Truven.

Adapt's Narcan, a nasal-spray form of the drug released in February, costs $63 for each single-dose spray unit, though it does sell the product for approximately half that price to government agencies, community organizations, and patients without insurance, Matt Ruth, Adapt's chief commercial officer, told Business Insider.

Further exacerbating the price problem, according to Bigg, is that most organizations advocate providing overdose victims with multiple doses of naloxone because opioid drugs last longer than naloxone. Such a practice is necessary for safety, but means that these prices only give a partial picture of how difficult it currently is to fund such a program.

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The price increases, combined with the increase in demand, have caused sales of naloxone to jump from $21.3 million in 2011 to $81.9 million last year, according to numbers from prescription-tracking company IMS Health and cited by The Los Angeles Times.

Amphastar, one of the two producers of the lower-priced injectable naloxone, saw a revenue increase of 4% in the first quarter of 2016 compared with the first quarter of 2015, according to a press release. The company attributed that increase largely "to an increase in sales of naloxone to $10.3 million from $6.7 million."

All prices stem from purchasing directly from the manufacturer, not the list price, which is higher because of distributor markup. The list price is paid primarily by consumers purchasing naloxone without a prescription.

The source of the increases

According to Bigg, while price increases have been consistent for 20 years, the price hikes jumped in frequency and volume in 2008 after several manufacturers stopped producing the drug, leaving Hospira and Amphastar as the sole manufacturers of naloxone.

Mylan and Kaléo introduced naloxone products in 2014, and Adapt followed suit at the beginning of this year.

Only Mylan, Amphastar, and Hospira, however, make injectable versions - by far the cheapest forms of the drug. Adapt and Kaléo make the more expensive nasal spray and auto-injector, respectively.

Bigg says the limited number of producers has kept the price high and increasing.

But some think the price hikes are a response to a big uptick in demand and point to new laws and programs designed to equip police officers and first responders with naloxone, as well as increase access for the general public.

"Naloxone used to be an item purchased by emergency rooms and ambulances ... Now that harm-reduction organizations have pushed for laws requiring everyone to carry it, the demand has gone up exponentially," Tessie Castillo, the advocacy and communication coordinator at the North Carolina Harm Reduction Coalition, told Business Insider. Pharmaceutical companies "know that they can make more money because of the demand, so they try to."

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Over the last couple of years, more than 30 states have acted to increase naloxone access, prescriptions, and use. In 2014, then US Attorney General Eric Holder urged federal law-enforcement agencies to train and equip personnel with naloxone. Such laws and policies were pushed by organizations like Castillo's.

Daniel Raymond, the policy director of the Harm Reduction Coalition, told Business Insider that his organization has noticed increases in the price of naloxone in recent months, but he said he's skeptical that pharmaceutical companies were "profiteering" off the opioid crisis.

Instead, he attributed the increase to broader dynamics "playing out across the pharmaceutical spectrum."

"If naloxone was the only pharmaceutical product that was seeing price increases, I would be very suspicious," Raymond said. "But because this is playing out across the sector ... it's part of a larger trend that the whole healthcare industry and policymakers are struggling to get a handle on."

A Food and Drug Administration analysis of the naloxone market in 2015 attributed the price increase to a general trend across the pharmaceutical industry for generic injectable medicines.

Big Pharma's response

While a statement from Pfizer, on behalf of Hospira, did not respond directly to questions about recent price increases, the company emphasized that it believes it has priced naloxone "responsibly," taking into consideration both "sensitivity to the need for the product" and "the investments necessary to produce high-quality generic drugs as well as ensure appropriate distribution through licensed medical professionals."

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The company further touted its commitment to the naloxone market after other manufacturers ceased production.

Amphastar raised the price of its naloxone product because of rising manufacturing costs and investments made in developing its own intranasal naloxone product, Bill Peters, the company's chief financial officer, told The Los Angeles Times.

Kaléo points to the ease of use of its product, the Evzio auto-injector, as justification for its high price. Evzio's auto-injection system provides " voice and visual instruction" to aid administration in an emergency.

"The price of Evzio is reflective of its innovation, years of extensive research to ensure the device is easy to use and reliable and to ensure the broadest access to this potentially life-saving product," Kaléo spokesman Lora Grassilli said in a statement. She added that Evzio is the first FDA-approved naloxone product specifically created for those without medical training.

Ruth, the chief commercial officer for Adapt, told Business Insider that Adapt researched the market prior to setting the price of its Narcan nasal spray in February, which he says has been "well received so far." Ruth further pointed to Adapt's awareness and access initiatives as reasons for Narcan's higher price point.

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"Those initiatives aren't free," Ruth said. "We are looking to do this as efficiently as possible and charge an affordable and responsible rate for patients and organizations alike. We believe we've done that."

Both products are increasingly being pushed as the naloxone product of choice for police officers and the general public alike.

While Bigg and Castillo acknowledged that Evzio and Narcan are easier to use than a syringe and vial, both were skeptical that such advancements in delivery justified their considerably higher price tag.

The Chicago Recovery Alliance staff has been using syringes and vials since its inception, according to Bigg, who said that in 7,500 reports on overdose reversals, they've never had someone tell them that they couldn't or didn't understand how to use the syringe.

"We've had no problems with syringes. The syringes are really self-explanatory," Castillo said.

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Amphastar has responded to the criticism over naloxone pricing through "increased discounting and rebates." In an Amphastar press release on 2016's first-quarter financials, the company noted that naloxone pricing was down compared with the previous quarter.

Increasing access to many - but not all

Many large organizations like the Chicago Recovery Alliance and government agencies have been insulated to some extent from the rising prices, thanks to special discounts and donations from naloxone producers as well as grants to pay for such products.

Kaléo, for example, has donated 150,000 Evzio auto-injectors to first-responders, public-health departments, and nonprofits since the product's approval in April 2014.

In January, Adapt announced a program in partnership with the Clinton Foundation providing a free carton of Narcan to any high school in the US that asks for it. Adapt has also donated 50,000 doses of Narcan to various organizations.

Bigg and Castillo said that their organizations, which provide naloxone to those in need for free, would not be able to exist without such generosity on the part of pharmaceutical companies. According to Bigg, many police departments have money to pay for naloxone because of asset seizures, which confiscate the alleged proceeds or instruments related to crime. Many federal, state, and local government agencies have also been given grants to pay for naloxone.

While these measures have generally increased the availability of naloxone, Castillo says the result is that those hardest hit by the high prices are smaller harm-reduction organizations or community programs that don't have the clout of larger government agencies or the renown of a large nonprofit like the Harm Reduction Coalition. Castillo says that she has spoken to "lots and lots" of organizations and programs that have closed in recent years or failed to get started because of naloxone's high price tag.

"The companies have been pretty good about providing us with deals and discounts, but that's just to us. That is not a normal experience for most organizations that are trying to buy naloxone," Castillo said.

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That system has left organizations like Castillo's at the mercy of pharmaceutical companies' generosity. When a pharmaceutical company changes policy - such as earlier this year when Kaléo suspended its charitable donations for the year because of "overwhelming demand" - it can be devastating.

Many of the companies have programs to ensure either lower prices or no cost for patients. Kaléo has a " patient-assistance program" that provides Evzio to people with commercial insurance at no cost. The program allows uninsured people with financial difficulties to request Evzio at no cost.

Adapt's "public-interest pricing" charges approximately half of its list price to community organizations, police departments, public-health organizations, and those without insurance.

Numerous solutions to the price problem have been suggested. Bigg believes that making naloxone available over the counter, as is now allowed in numerous states, would encourage more manufacturers to enter the marketplace and drive down the price - an effort applauded by many doctors and pharmacists. In addition, he thinks that once the FDA approves more naloxone products currently in development, the price should come down as well.

Castillo called for more consistent and transparent pricing, discounts, and donations for all organizations - government and community - that provide naloxone.

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Raymond suggested that one factor unique to naloxone makes it difficult to rein in the price increases.

The primary buyers "are all purchasing individually in small amounts so they don't have the leverage to bargain for discounts," Raymond said. He suggested a solution in the form of a bulk-purchasing program that could aggregate demand and push suppliers to drop their prices.

The demand for naloxone isn't likely to go down anytime soon.

The law Obama signed on July 22, the Comprehensive Addiction and Recovery Act, includes measures to make naloxone more readily available to the public, as well as to police officers and first responders.

Another bill, which Congress is scheduled to vote on in the coming weeks, would push doctors to co-prescribe naloxone with every opioid prescription they write.

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The price of the 'antidote' to the overdose crisis is skyrocketing

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President Barack Obama recently signed a law aimed at addressing the burgeoning opioid crisis in the US. While the law was undoubtedly a step forward for a gridlocked Congress, it won't affect one of the crisis' most intractable problems - the skyrocketing price of naloxone, a drug that instantly reverses overdoses.

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SAMHSA's efforts to expand the use of Naloxone: 

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SAMHSA's efforts to expand the use of Naloxone: 

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What Is Naloxone?

Naloxone is a medication approved by the Food and Drug Administration (FDA) to prevent overdose by opioids such as heroin, morphine, and oxycodone. It blocks opioid receptor sites, reversing the toxic effects of the overdose. Naloxone is administered when a patient is showing signs of opioid overdose. The medication can be given by intranasal spray, intramuscular (into the muscle), subcutaneous (under the skin), or intravenous injection.

Naloxone is also added to buprenorphine to decrease the likelihood of diversion and misuse of the combination drug product. Learn more about buprenorphine.

A doctor can prescribe naloxone to patients who are in medication-assisted treatment (MAT), especially if the patient is taking medications used in MAT or considered a risk for opioid overdose. Candidates for naloxone are those who:

Take high doses of opioids for long-term management of chronic pain

Receive rotating opioid medication regimens

Have been discharged from emergency medical care following opioid poisoning or intoxication

Take certain extended-release or long-acting opioid medications

Are completing mandatory opioid detoxification or abstinence programs

Pregnant women can be safely given naloxone in limited doses under the supervision of a doctor.

A doctor or pharmacist can show patients, their family members, or caregivers how to administer naloxone. Intravenous injection every two to three minutes is recommended in emergencies.

Patients given an automatic injection device or nasal spray should keep the item available at all times. Medication should be replaced when the expiration date passes.

Naloxone is effective if opioids are misused in combination with other sedatives or stimulants. It is not effective in treating overdoses of benzodiazepines or stimulant overdoses involving cocaine and amphetamines.

Side Effects of Naloxone

Patients who experience an allergic reaction from naloxone, such as hives or swelling in the face, lips, or throat, should seek medical help immediately. They should not drive or perform other potentially unsafe tasks.

Use of naloxone may cause symptoms of opioid withdrawal, including:

Feeling nervous, restless, or irritable

Body aches

Dizziness or weakness

Diarrhea, stomach pain, or nausea

Fever, chills, or goose bumps

Sneezing or runny nose in the absence of a cold

Opioid Overdose

Opioid overdose can happen:

When a patient misunderstands the directions for use, accidentally takes an extra dose, or deliberately misuses a prescription opioid or an illicit drug like heroin

If a person takes opioid medications prescribed for someone else

If a person mixes opioids with other medications, alcohol, or over-the-counter drugs

Opioid overdose is life-threatening and requires immediate emergency attention. Recognizing the signs of opioid overdose is essential to saving lives. Learn more about opioid overdose.

SAMHSA's Efforts to Expand the Use of Naloxone

In an effort to save more lives from opioid overdose, SAMHSA published the Opioid Overdose Prevention Toolkit - 2014. The Toolkit equips communities and local governments with material to develop policies and practices to help prevent opioid-related overdoses and deaths. It also serves as a foundation for educating and training:

Communities

Prescribers of opioid pain medications

First responders

Patients who are prescribed opioid medications

Individuals and family members who have experienced an opioid overdose

SAMHSA is also working with its federal partners and state and local law enforcement to expand the safe administration of naloxone by first responders.

SAMHSA is working with emergency medical service professionals to:

Identify any state or local laws that permit or restrict naloxone use by certain types of first responders

Advocate for their use of naloxone in emergency situations

The SAMHSA publication Expansion of Naloxone in the Prevention of Opioid Overdose - 2014 (PDF | 479 KB) explains this effort further.

Publications and Resources

Training on Providing Naloxone

Naloxone is a regulated medication and must be administered properly. SAMHSA's Division of Pharmacologic Therapies (DPT) provides opioid prescribing courses for physicians, webinars, workshops, and summits, and publications and research.

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What Is Naloxone? Naloxone is a medication approved by the Food and Drug Administration (FDA) to prevent overdose by opioids such as heroin, morphine, and oxycodone. It blocks opioid receptor sites, reversing the toxic effects of the overdose. Naloxone is administered when a patient is showing signs of opioid overdose.

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What is Naloxone??

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Generic name: naloxone [ nah-LOX-one ]
Brand names: Narcan, Kloxxado, Zimhi
Dosage form: Injectable solution (Zimhi 5 mg/0.5 mL), Nasal spray (Narcan 4 mg, Kloxxado 8 mg)
Drug class: Antidotes

Medically reviewed by Melisa Puckey, BPharm. Last updated on Mar 29, 2023.

What is naloxone?

Naloxone is an FDA approved medicine used to quickly reverse an opioid overdose. Naloxone is a opioid antagonist that works by attaching to opioid receptors and therefore reverses and blocks the effects of other opioids.

Naloxone should be used as soon as possible to treat a known or suspected opioid overdose emergency if there are signs of slowed breathing, severe sleepiness or the person is not able to respond (loss of consciousness). Once naloxone has been given the patient must receive emergency medical care straight away, even if they wake up.

Naloxone is not a controlled substance, according to the US Drug Enforcement Administration (DEA).

Naloxone is available as a nasal spray ( Narcan 4mg, Kloxxado 8mg) or an injection ( Zimhi 5 mg/0.5 mL).

Narcan nasal spray became approved by the FDA on March 29, 2023 as is an over-the-counter (OTC) medicine that is available without a prescription. Other naloxone products are still prescription medicines, but in many states, these naloxone products are available from a pharmacist without a prescription from your doctor, under state Naloxone Access Laws or alternate arrangements.

Opioids are sometimes called a narcotic. Examples of opioids are buprenorphine, codeine, fentanyl, oxycodone (Oxycontin), heroin, hydrocodone (Vicodin, Lortab), hydromorphone, meperidine, morphine, methadone, oxymorphone, and tramadol.

What is Naloxone used for?

Naloxone is used to treat a known or suspected opioid overdose emergency in children or adults. Signs of an opioid overdose may include:

slowed breathing, or no breathing;

very small or pinpoint pupils in the eyes;

slow heartbeats; or

extreme drowsiness, especially if you cannot wake the person from sleep.

Even if you are not sure an opioid overdose has occurred, if the person is not breathing or is unresponsive, give the naloxone right away and then seek emergency medical care.

Naloxone has different uses when used in multi-ingredient medications including buprenorphine with naloxone ( Suboxone, Zubsolv, Bunavail) which is used to treat opioid addiction, and naloxone with oxycodone (Targiniq ER) which is used for pain.

Warnings

In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast feeding. Make sure any doctor caring for you afterward knows that you have received naloxone.
A person caring for you can give the naloxone if you stop breathing or don't wake up. Make sure any person caring for you knows where you keep naloxone and how to use it.

Your caregiver must get emergency help after giving you naloxone. You may need another injection every 2 to 3 minutes until emergency help arrives.

Drinking alcohol can increase certain side effects of naloxone.

Naloxone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

If you are using any narcotic pain medication, the pain-relieving effects of the narcotic will be reversed while you are also receiving this medicine.

Before taking this medicine

You should not be treated with this medicine if you are allergic to naloxone or any ingredients in naloxone injection or naloxone nasal spray.

If possible before you receive naloxone, tell your doctor if:

you have heart problems; or

you are pregnant or breastfeeding.

Using naloxone while you are pregnant may cause opioid withdrawal effects in your unborn baby. However, having an opioid overdose can be fatal to both mother and baby. It is much more important to treat an overdose in the mother. You must get emergency medical help after using this medicine. Be sure all emergency medical caregivers know that you are pregnant.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

In an emergency, you may not be able to tell caregivers if you are pregnant or breastfeeding. Make sure any doctor caring for your pregnancy or your baby knows you received naloxone.

How is naloxone given?

Use naloxone exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

If you are a caregiver or family member, read all instructions when you first get this medicine so you will know how to use it in an emergency. Ask your doctor or pharmacist if you have any questions.

Naloxone injection instructions

Each naloxone injection contains only one dose of medicine and cannot be reused.

Place the patient on their back and when you are ready to inject, pull off cap to expose needle.

Do not put your finger on top of the device. For a child under the age of 1 years old, pinch the thigh muscle while administering the dose.

Hold naloxone injection by finger grips only and slowly insert the needle into the thigh.

After needle is in thigh you should push the plunger all the way down until it clicks and then hold for 2 seconds.

Right after the injection, using one hand with fingers behind the needle, slide the safety guard over the needle. You should not use two hands to activate the safety guard. Put the used syringe into the blue case and close the case.

Naloxone nasal spray instructions

Each naloxone nasal spray contains only one dose of medicine and cannot be reused.

Lay the person on their back. Support their neck with your hand and allow the head to tilt back before giving the nasal spray.

Remove the nasal spray from the box. Peel back the tab to open the nasal spray blister.

Hold the nasal spray with your thumb on the bottom of the plunger and your first and middle fingers on either side of the nozzle. Do not apply any pressure until you are ready to give the dose.

Gently insert the tip of the nozzle into one nostril until your fingers on either side of the nozzle are against the bottom of the person's nose.

Press the plunger firmly to give the dose of nasal spray, then after giving the dose, remove the nasal spray from the nostril.

After giving a dose of naloxone

You need to get emergency medical help as soon as you have given the injection or nasal spray.

Tell the healthcare provider that you have given a dose of naloxone.

Turn the patient on their side to place them in the recovery position after giving them the naloxone.

If symptoms continue or return after using the naloxone, an additional dose may be needed.

If you are giving additional doses, use a new naloxone nasal spray or new naloxone injection every 2 to 3 minutes and continue to closely watch the person until emergency help has arrived.

You may need to perform CPR (cardiopulmonary resuscitation) on the person while you are waiting for emergency help to arrive.

Using naloxone does not take the place of emergency medical care.

Narcan Nasal Spray training video

Dosing information

Usual Adult Dose for Opioid Overdose

Initial dose:

0.4 mg to 2 mg IV; alternatively, may give IM or subcutaneously

If the desired response is not obtained, doses should be repeated at 2 to 3 minute intervals

If no response is observed with a total dose of 10 mg, the diagnosis of opioid-induced or partial opioid-induced toxicity should be questioned

Auto-injector:

Administer 0.4 mg (1 actuation) IM or subcutaneously into the anterolateral aspect of the thigh (through clothing if necessary)

If the desired response is not achieved, a second dose may be administered after 2 or 3 minutes; additional doses may be administered every 2 to 3 minutes until emergency medical assistance arrives

Nasal Spray:

Administer 1 spray intranasally into 1 nostril

If the desired response is not achieved after 2 or 3 minutes, give a second dose intranasally into alternate nostril; additional doses may be administered every 2 to 3 minutes in alternating nostrils until emergency medical assistance arrives

Comments:

IV route is recommended in emergency situations since it has the most rapid onset of action.

The duration of action of some opioids exceed that of this drug, therefore, repeat doses may be needed; the need for repeat doses will depend on the amount, type, and route of administration of the opioid being antagonized.

Usual Adult Dose for Reversal of Opioid Sedation

Initial dose:

0.1 to 0.2 mg IV at 2 to 3 minute intervals to the desired degree of reversal

Supplemental doses administered IM have been shown to produce a longer-lasting effect

Intravenous Infusion:

A concentration of 0.004 mg/mL may be administered by IV infusion; titrate in accordance with patient's response

Comments:

For the partial reversal of opioid depression following the use of opioids during surgery, smaller doses of naloxone are usually sufficient; larger than necessary doses may result in significant reversal of analgesia and increases in blood pressure.

Usual Pediatric Dose for Opioid Overdose

Neonates:

Initial dose: 0.01 mg/kg IV, IM, or subcutaneously; repeat dose every 2 to 3 minutes as needed

Children:

Initial dose: 0.01 mg/kg IV; if desired response is not obtained, may give 0.1 mg/kg IV

If IV route is not available may give IM or subcutaneously in divided doses.

Administer 0.4 mg (1 actuation) IM or subcutaneously into the anterolateral aspect of the thigh (through clothing if necessary); if desired response is not achieved, a second dose may be administered after 2 or 3 minutes; additional doses may be administered every 2 to 3 minutes until emergency medical assistance arrives

Under 1 year of age: Thigh muscle should be pinched while administering injection

Comments:

Neonatal opioid withdrawal syndrome may be life-threatening and should be treated according to protocols developed by neonatology experts.

To avoid precipitating opioid withdrawal symptoms, consider use of a naloxone product that can be dosed according to weight and titrated to effect.

The duration of action of some opioids will exceed that of this drug, therefore, repeat doses may be needed; the need for repeat doses will depend on the amount, type, and route of administration of the opioid being antagonized.

Patients should remain under continued surveillance; if a patients responds and relapses back into respiratory depression, additional doses should be given.

Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.

Usual Pediatric Dose for Reversal of Opioid Sedation

Neonates:

Initial dose: 0.01 mg/kg IV, IM or subcutaneously at 2 to 3 minute intervals to the desired degree of reversal

Children:

0.005 mg to 0.01 mg IV at 2 to 3 minute intervals to the desired degree of reversal

Intravenous Infusion:

A concentration of 0.004 mg/mL may be administered by IV infusion; titrate in accordance with patient's response

Comments:

For the partial reversal of opioid depression following the use of opioids during surgery, smaller doses of naloxone are usually sufficient; larger than necessary doses may result in significant reversal of analgesia and increases in blood pressure.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using naloxone?

Avoid leaving a person alone after giving him or her a naloxone dose. An overdose can impair a person's thinking or reactions.

Naloxone side effects

Get emergency medical help if you have signs of an allergic reaction to naloxone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Because naloxone reverses opioid effects, the administration may cause sudden withdrawal symptoms such as:

nausea, vomiting, diarrhea, stomach pain;

fever, sweating, body aches, weakness;

tremors or shivering, fast heart rate, pounding heartbeats, increased blood pressure;

goose bumps, shivering;

runny nose, yawning; or

feeling nervous, restless, or irritable.

Sudden withdrawal symptoms in a baby younger than 4 weeks old may be life-threatening if not treated the right way. Symptoms include crying, stiffness, overactive reflexes, and seizures. Call your doctor or get emergency medical help if you are unsure how to properly give this medicine to a baby.

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 FDA at 1-800-FDA-1088.

What other drugs will affect naloxone?

Other drugs may interact with naloxone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Ingredients

Kloxxado nasal spray
Active ingredient: naloxone hydrochloride
Inactive ingredients: dehydrated alcohol (20% (w/w)), edetate disodium dihydrate, propylene glycol, purified water, and sodium hydroxide and hydrochloric acid to adjust pH. The pH range is from 4.0 to 5.5.

Narcan nasal spray
Active ingredient: naloxone hydrochloride
nactive ingredients: benzalkonium chloride (preservative), disodium ethylenediaminetetraacetate (stabilizer), sodium chloride, hydrochloric acid to adjust pH and sterile water.
Narcan is not made with natural rubber latex.

Zimhi injection
Active ingredient: naloxone hydrochloride
Inactive ingredients: sodium chloride, hydrochloric acid to adjust pH, and water for injection.
Zimhi is not made with natural rubber latex.

Storage
Kloxxado

Store at room temperature 68ºF to 77ºF (20°C to 25°C).

Do not freeze. Do not expose to temperatures below 41°F (5°C) or above 104°F (40°C).

Keep Kloxxado nasal spray in its box until ready to use. Protect from light.

Narcan

Store below 77°F (25°C) with excursions permitted up to 104°F (40°C).

Do not freeze Narcan or expose it to excessive heat above 104°F (40°C).

Keep Narcan in its box until ready to use. Protect from light.

Replace Narcan before the expiration date on the box.

Keep this medicine and all medicines out of the reach of children.

Zimhi

Store between 68°F to 77°F (20°C to 25°C). Do not expose to extreme cold or heat. For example, do not store in your vehicle's glove box and do not store in the refrigerator or freezer.

Store the Zimhi syringe in its closed plastic case to protect from light.

Check Your Stored Zimhi Often - The solution should be clear when viewed through the window on the device. If the solution is discolored (yellowish or brown color), cloudy or contains particles, replace Zimhi with a new one.

Manufacturers

Kloxxado is distributed by Hikma Specialty USA Inc. Columbus, OH 43228

Narcan is distributed by Emergent Devices Inc., Plymouth Meeting, PA 19462 USA.

Zimhi is a trademark of Adamis Pharmaceuticals Corporation. Manufactured for Adamis Pharmaceuticals, San Diego, CA 92130, USA. Distributed By USWM LLC, Louisville, KY 40241.

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Naloxone: Opioid Overdose, Instructions, Side Effects - Drugs.com

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Generic name: naloxone [ nah-LOX-one ] Brand names: Narcan, Kloxxado, Zimhi Dosage form: Injectable solution (Zimhi 5 mg/0.5 mL), Nasal spray (Narcan 4 mg, Kloxxado 8 mg) Drug class: Antidotes Medically reviewed by Melisa Puckey, BPharm. Last updated on Mar 29, 2023. Naloxone is an FDA approved medicine used to quickly reverse an opioid overdose.

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When Jack O'Connor was 19, he was so desperate to beat his addictions to alcohol and opioids that he took a really rash step. He joined the Marines.

"This will fix me," O'Connor thought as he went to boot camp. "It better fix me or I'm screwed."

After 13 weeks of sobriety and exercise and discipline, O'Connor completed basic training, but he started using again immediately.

"Same thing," he says. "Percocet, like, off the street. Pills."

Percocet is the brand name for acetaminophen and oxycodone. Oxycodone is a powerful opioid. It's one of the most commonly prescribed painkillers, and is a key factor in one of the country's most pressing public health problems - an opioid addiction epidemic. It is a crisis that started, in part, from the overprescription of painkillers like Percocet, and then shifted to heroin as people addicted to prescription drugs looked for a cheaper high.

O'Connor is one of an estimated 2.5 million Americans addicted to opioids and heroin, according to the National Institute on Drug Abuse. Over three years, he detoxed from prescription painkillers - and heroin - more than 20 times. Each time, he started using again. So why is it so hard for opioid addicts to quit? You can boil it down to two crucial bits of science: the powerful nature of opioids and the neuroscience behind how addiction hijacks the brain.

"The first recording of opioid use was 5,000 years ago," says Dr. Seddon Savage, an addiction and pain specialist at Dartmouth College. It was "a picture of the opium poppy and the words ' the joy plant.' "
'It Ruined Me That Time. But I Loved It'
Jack O'Connor says he ended his freshman year of college as an alcoholic. He went home that summer desperate to replace alcohol with something else. And it was not hard to do. In 2012, 259 million opioid pain medication prescriptions were written - that's enough painkillers for every American to have a bottle of the pills. O'Connor got his hands on some 30-milligram Percocet.

"I ended up sniffing a whole one, and I blacked out, puking everywhere," says O'Connor. "I don't remember anything. It ruined me that time. But I loved it."

Opioids got him higher faster than any drug he had tried. And even though different drugs produce different highs, they all involve the same pathway in the brain.

Opioids increase the amount of dopamine in a part of the brain called the limbic reward system. Dopamine causes intense feelings of pleasure, which drives users to seek out the drug again and again.

They trigger the release of dopamine, which is a neurotransmitter that causes intense pleasure in parts of the brain that include the limbic system, according to Savage. It links brain areas that control and regulate emotions such as the pleasures of eating, drinking and sex. "This is a very ancient part of the human brain that's necessary for survival," says Savage. "All drugs that people use to get high tickle this part of the brain."

People can become psychologically and physically dependent on opioids very quickly. Breaking the physical dependence involves a several-day nightmare called detox, when the body gets used to being without the drug.

"It is an amazing thing to see someone basically vibrating in their chair, feeling nauseated, looking like hell," says Jeffrey Ferguson, a detox specialist at Serenity Place in Manchester, N.H.

Jack O'Connor put himself through detox 20 times, but that didn't stop his addiction. O'Connor's limbic reward system had hijacked other systems in his brain - systems that drive judgment, planning and organization - driving them all to seek that pleasure of getting high. This process can go on during years of sobriety, according to Savage.

"Addiction recruits memory systems, motivational systems, impairs inhibitory systems and continues to stimulate the drive to use," she says.

O'Connor says all his decisions began to serve his addiction. When he was using, everything was about getting the next drink or drug.

Over his years of addiction, O'Connor lied to his family and stole from his job - all while also trying to get sober. A little over a year ago, he put himself through a five-day detox clinic and managed to get through five more days in the real world sober. Then he couldn't take it. One day he started obsessively searching his credit cards for drug residue. He found a bag of heroin in his wallet.

"Somebody's telling me I need to get high," he thought at the time.

And that's what he did.
'I Don't Need It Anymore'

Feelings like joy and shame also play a role in drug dependence, and make it hard to quit. Practical issues are a challenge, too. "Finding the job, saving money, finding a place to live," says Ferguson. "Maybe they have some felony convictions. It's a lot."

And the country is facing a shortage of addiction treatment facilities and specialists; the shortage ranges wildly from one state to another. Treatment for opioid addiction includes a variety of services: medication, talk therapy, job support, all stretched out over years. Detox isn't enough.

"For people who don't get intensive treatment, people who are just detoxified [from opioids]," says Savage, "relapse rates can be above 90 percent."

O'Connor is now 23 and he's finally sober - Jan. 11 is his one-year sobriety date. In that time he's been in a nonmedical residential treatment program in Dover, N.H., where he lives and works. He has support - a girlfriend, his family, the Marines. And in the same way that he once replaced his coping skills with drugs, he has rebuilt his coping skills around quitting drugs.

"I don't need it anymore," he says. "I literally, physically and emotionally don't need it." And as much as O'Connor loved the feeling of getting high on heroin, now there is something he loves more: "I love the way I feel sober," he says.

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Anatomy Of Addiction: How Heroin And Opioids Hijack The Brain

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When Jack O'Connor was 19, he was so desperate to beat his addictions to alcohol and opioids that he took a really rash step. He joined the Marines. "This will fix me," O'Connor thought as he went to boot camp. "It better fix me or I'm screwed."

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PORTLAND, Me. - A woman in her 30s was sitting in a car in a parking lot here last month, shooting up heroin, when she overdosed. Even after the men she was with injected her with naloxone, the drug that reverses opioid overdoses, she remained unconscious. They called 911.

Firefighters arrived and administered oxygen to improve her breathing, but her skin had grown gray and her lips had turned blue. As she lay on the asphalt, the paramedics slipped a needle into her arm and injected another dose of naloxone.

In a moment, her eyes popped open. Her pupils were pinpricks. She was woozy and disoriented, but eventually got her bearings as paramedics put her on a stretcher and whisked her to a hospital.

Every day across the country, hundreds, if not thousands, of people who overdose on opioids are being revived with naloxone. Hailed as a miracle drug by many, it carries no health risk; it cannot be abused and, if given mistakenly to someone who has not overdosed on opioids, does no harm. More likely, it saves a life.

As a virulent opioid epidemic continues to ravage the country, with 78 people in the United States dying of overdoses every day, naloxone's use has increasingly moved out of medical settings, where it has been available since the 1970s, and into the homes and hands of the general public.

But naloxone, also known by the brand name Narcan, has also had unintended consequences. Critics say that it gives drug users a safety net, allowing them to take more risks as they seek higher highs. Indeed, many users overdose more than once, some multiple times, and each time, naloxone brings them back.

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Naloxone, also known as Narcan, temporarily blocks opiate receptors. Credit Tristan Spinski for The New York Times

Advocates argue that the drug gives people a chance to get into treatment and turn their lives around and that there is no evidence naloxone increases the use of opiates. And, they say, few addicts knowingly risk needing to be revived, since naloxone ruins their high and can make them violently ill.

With drug overdoses now killing more people than car crashes in most states, lawmakers in all but three - Kansas, Montana and Wyoming - have passed laws making naloxone easier to obtain. Its near-universal availability reflects the relatively humane response to the opioid epidemic, which is based largely in the nation's white, middle-class suburbs and rural areas - a markedly different response from that of previous, urban-based drug epidemics, which prompted a "war on drugs" that led to mass incarceration, particularly of blacks and Hispanics.

This more compassionate response has been on display this week at the Democratic National Convention in Philadelphia. Speakers there have talked about addiction and the need for more accessible treatment, and a call by Senator Jeanne Shaheen of New Hampshire for all emergency responders to carry naloxone drew applause from the delegates.

Nonprofit organizations began distributing naloxone to drug users in the mid-1990s, but most of the state laws making it more accessible have been enacted only in the last few years. Between this and so-called good Samaritan laws that provide immunity to people who call 911 to report an overdose, the chances are much greater now that someone who overdoses will be saved and given medical attention instead of left for dead or sent to jail.

The federal government still requires a prescription for naloxone, but that is under review by the Food and Drug Administration, which has also approved a Narcan nasal spray that is easier to administer and is growing increasingly popular.

There is no question that the nation's death toll from heroin and prescription opioids would be significantly higher without naloxone. Prince, the pop superstar, is just one of those who were saved by it. After he overdosed on Percocet, an opiate painkiller, on his airplane in April, the plane made an emergency landing, and he was revived on the tarmac with naloxone - only to overdose on fentanyl six days later and die when no one was around to administer naloxone.

In 2014, in Maine alone, 208 people died from overdoses. That year, emergency responders saved 829 lives with naloxone. But that was just a fraction of those saved here, as most uses go unreported. In 83 percent of cases, according to a national survey last year by the Centers for Disease Control and Prevention, naloxone is given by other drug users, the people most likely to be on the scene, not by emergency responders.

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Melissa Tucci, 44, has been revived from heroin overdoses seven times using naloxone. Credit Tristan Spinski for The New York Times

But in Maine this spring, Gov. Paul LePage, a Republican, questioned the effectiveness of naloxone and vetoed legislation that would have increased access to it.

"Naloxone does not truly save lives; it merely extends them until the next overdose," Mr. LePage wrote in his veto message in April. "Creating a situation where an addict has a heroin needle in one hand and a shot of naloxone in the other produces a sense of normalcy and security around heroin use that serves only to perpetuate the cycle of addiction."

Yet most users loathe naloxone's effects. By blocking opiate receptors, it plunges them into withdrawal and makes them "dope sick," craving more heroin or pills.

"I hate it," said Melissa Tucci, 44, a heroin user here who has been revived seven times. "When I start withdrawing, I vomit, you get diarrhea, you sweat profusely, your nose will run, you sneeze and have runny eyes, and you ache so bad you can't even walk."

She said she has overdosed so often not because she relied on naloxone to save her, but rather because she underestimated how potent the heroin was. And she said she keeps using heroin to avoid the agony of withdrawal.

The Maine Legislature easily overrode the governor's veto. According to the Network for Public Health Law, Maine is now one of 34 states with what is called a standing order, essentially a prescription that makes naloxone available to the general public.

Still, Mr. LePage gave voice to the troubling reality that some people repeatedly overdose, and can seem stubbornly resistant to help.

Sarah Connolly at her home in Falmouth, Me., last month. Ms. Connolly, 26, overdosed seven years ago in the bathroom of a Burger King in Michigan and was revived with naloxone. Credit Tristan Spinski for The New York Times

"They're usually very angry when we bring them around," said Deputy Chief John Everett of the Portland Fire Department. "One kid yelled at me, 'You think this will make me stop doing drugs?' I said, 'No, the only thing that will make you stop doing drugs is a body bag.'"

On the other hand, Sarah Connolly, 26, said she was alive because of naloxone. Seven years ago she was revived after overdosing in the bathroom of a Burger King in Michigan. "Most of my veins were so deteriorated from using that they had to give it to me in my hand," she said recently at a training session here on how to administer naloxone. She said that after overdosing, she left an emergency room against medical advice and went out to find more heroin.

She continued to use heroin, but stopped cold when she became pregnant. Now she is unrecognizable from her days of addiction. She moved to Maine, married her son's father, is pregnant with their second child, and is studying to be a high school English teacher.

"I have a real sense of purpose now," she said. "I believe I'm a miracle because I had a second chance."

Gov. Tom Wolf of Pennsylvania, a Democrat, said in a recent interview that the only responsible approach to the epidemic ravaging his state was to make naloxone widely available and provide more treatment. Pennsylvania is one of the states with a standing order for naloxone.

"This is a disease, not a moral failing," Mr. Wolf said.

Dr. Alexander Y. Walley, an addiction medicine specialist at Boston Medical Center, said arguing that naloxone encourages riskier drug use was like saying that seatbelts encourage riskier driving.

"A person with an opioid use disorder is by definition using despite harmful consequences," Dr. Walley said. That aside, he said, "receiving naloxone not only reverses the overdose, it also reverses the euphoria and withdrawal relief that the opioid user is seeking. Thus, it is only used as a last resort."

Oliver Bradeen, a substance use disorder liaison for the Police Department in Portland, Me., who responds to most emergency overdose calls. Credit Tristan Spinski for The New York Times

Dr. Mark Publicker, an addiction medicine specialist in Portland, said that repeated overdoses were often the result of increasingly potent heroin, especially when combined with drugs like fentanyl and sedatives, producing a lethal cocktail.

"While your psychological tolerance becomes greater, your cardiorespiratory tolerance doesn't," he said. "You keep pushing the limit because your reward threshold has become impossibly high."

Naloxone can start to wear off 20 to 30 minutes after it is administered and dissipate entirely after 90 minutes. The withdrawal from the opiate can be so brutal that it often drives people to use heroin again right away.

"I had a woman who overdosed three times in one day," said Zoe Odlin-Platz, a community health promotion specialist at the India Street needle exchange here. After the third overdose, she said, the woman broached the possibility of seeking treatment.

The bigger problem, advocates say, is the dearth of available treatment, particularly for people without insurance. Nevertheless, Portland paramedics make every effort to take revived drug users to a hospital, and hope that in those moments after being revived, they might decide to seek help.

"People are vulnerable at that point, and I ask them if they want to talk," said Oliver Bradeen, a substance use disorder liaison for the Portland Police Department, who responds to most emergency overdose calls. And, he said, "sometimes the universe comes together and it works out."

But sometimes it doesn't.

Bruce Carleton, a veteran paramedic with the Portland Fire Department, was among those who responded last month when the woman in the parking lot overdosed. He talked her into going to the hospital, but when he went by her room later on, her bed was empty.

A version of this article appears in print on , on Page A14 of the New York edition with the headline: A Lifesaver for Heroin Users, but No Cure for an Epidemic. Order Reprints | Today's Paper | Subscribe

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Naloxone Saves Lives, but Is No Cure in Heroin Epidemic

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PORTLAND, Me. - A woman in her 30s was sitting in a car in a parking lot here last month, shooting up heroin, when she overdosed. Even after the men she was with injected her with naloxone, the drug that reverses opioid overdoses, she remained unconscious. They called 911.