Generic drug: naloxone hydrochloride
Brand name: Kloxxado
What is Kloxxado (naloxone hydrochloride), and how does it work?
- Kloxxado (naloxone hydrochloride) nasal spray is a prescription medicine used for the treatment of an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond.
- Kloxxado nasal spray is to be given right away and does not take the place of emergency medical care.
- Get emergency medical help right away after giving the first dose of Kloxxado nasal spray, even if the person wakes up.
- Kloxxado nasal spray is safe and effective in children for known or suspected opioid overdose.
What are the side effects of Kloxxado?
Kloxxado nasal spray may cause serious side effects, including:
- Sudden opioid withdrawal symptoms. In someone who has been using opioids regularly, opioid withdrawal symptoms can happen suddenly after receiving Kloxxado nasal spray and may include:
In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include: seizures, crying more than usual, and increased reflexes.
The most common side effects of Kloxxado in adults include:
- stomach-area (abdomen) pain,
- nose (nasal) discomfort and
- a feeling like you are going to faint.
These are not all of the possible side effects of Kloxxado nasal spray.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Kloxxado?
Important Dosage And Administration Instructions
- Kloxxado is for intranasal use only.
- The device is ready to use. Do not prime or test prior to administration.
- Do not attempt to reuse Kloxxado. Each Kloxxado contains a single dose of naloxone and cannot be reused.
- Because suspected opioid overdose is usually managed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of Kloxxado and the Instructions for Use.
Instruct the patient or caregiver to read the Instructions for Use on the product packaging at the time they receive a prescription for Kloxxado. Emphasize the following instructions to the patient or caregiver.
- Administer Kloxxado as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death.
- Always seek immediate emergency medical assistance after the first dose of Kloxxado has been administered in the event of a suspected, potentially life-threatening opioid emergency because the duration of action of most opioids exceeds that of naloxone hydrochloride. Keep the patient under continued surveillance and administer repeated doses of Kloxxado, as necessary, until emergency personnel arrive.
- Administer Kloxxado according to the printed instructions on the carton and the Instructions for Use
on the product packaging.
- 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 and remove the device nozzle from the nostril after use. Place the patient in recovery position by turning him/her onto their side as shown in the Instructions for Use and call for emergency medical assistance immediately after the first dose of Kloxxado.
- Administer additional doses of Kloxxado, using a new nasal spray, every 2 to 3 minutes as needed if the patient does not respond or responds and then relapses into respiratory depression. Administer Kloxxado in alternate nostrils with each dose. [see the Dosing In Adult And Pediatric Patients section below].
Dosing In Adult And Pediatric Patients
The recommended initial dose of Kloxxado in adult and pediatric patients is one spray delivered by intranasal administration into one nostril, which delivers 8 mg of naloxone hydrochloride to adult or pediatric patients.
- Seek emergency medical assistance as soon as possible, after administering the first dose of Kloxxado.
- If the desired response is not obtained after 2 or 3 minutes, administer an additional dose using a new Kloxxado in alternate nostril. If there is still no response and additional doses are available, administer additional doses of Kloxxado every 2 to 3 minutes, alternating nostrils and using a new Kloxxado, until emergency medical assistance arrives. The requirement for repeat doses of Kloxxado depends upon the amount, type, and route of administration of the opioid being antagonized.
- If the patient responds to Kloxxado and subsequently relapses back into respiratory depression before emergency assistance arrives, administer an additional dose using a new Kloxxado, in the opposite nostril, and continue surveillance of the patient.
- Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
- Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete and require repeated administration of Kloxxado using a new nasal spray.
Is Kloxxado safe to use while pregnant or breastfeeding?
- 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 adverse maternal or fetal outcomes.
- Naloxone may precipitate opioid withdrawal in the pregnant woman and fetus.
- There is no information regarding the presence of naloxone in human milk, the effects of naloxone on the breastfed infant or on milk production.
- Studies in nursing mothers have shown that naloxone does not affect prolactin or oxytocin hormone levels.
- Naloxone is minimally orally available and is unlikely to affect the breastfed infant.
Latest Medications News
Daily Health News
Kloxxado (naloxone hydrochloride) nasal spray is a prescription medicine used for the treatment of an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond. Kloxxado nasal spray is to be given right away and does not take the place of emergency medical care. Serious side effects of Kloxxado nasal spray include sudden opioid withdrawal symptoms, with signs such as body aches, diarrhea, increased heart rate, fever, runny nose, and more.
Multimedia: Slideshows, Images & Quizzes
Mental Health: Marijuana Addiction and Abuse
Cannabis use disorder is when you're addicted to marijuana. Learn more about this condition and how to treat it.
Sugar Addiction Facts: Cravings, Hidden Sugar, and More in Pictures
Learn about sugar addiction to see why we often crave sweets and binge on carbs. Learn how sugar affects the brain and get tips...
How to Quit Smoking: 13 Tips to End Addiction
Quitting smoking is a great way to improve your health. Learn tips and techniques to quit smoking and kick the cigarette habit...
Opioid Dependence Quiz: Test Your IQ of Opioid Misuse Disorder
What are opioids? Take this quiz to learn about opioids (opiates, narcotic pain killers) as well as addiction and dependence that...
Strange Addictions: Sugar, Porn, Ice Cubes and More
Are you addicted? People aren’t only addicted to drugs, alcohol, and cigarettes. Patterns of addiction can be found in less...
Mental Health: Celebrities Who Are Open About Addiction
Addiction affects people from all walks of life. See celebrities who’ve battled drug and alcohol use disorders and shared their...
Related Disease Conditions
The term sex addiction describes the behavior of someone who has an unusually strong sex drive or sexual obsession. Sex and thoughts of sex dominate a sex addict's thinking, making it difficult to work or engage in healthy personal relationships. Sex addicts may engage in exhibitionism, voyeurism, prostitution, compulsive masturbation, or cybersex. Treatment for sex addiction includes individual counseling, marital and/or family therapy, support groups, 12-step recovery programs, and in some cases, medications.
Hookahs vs. Cigarette Smoking (Addiction and Health Dangers)
A hookah is a water pipe that's used to smoke flavored tobacco like watermelon, licorice, coconut, chocolate, cherry, mint, apple, and cappuccino. The use of this type of tobacco smoking began in ancient India and Persia centuries ago. You can find hookah cafes all over the world, for example, the U.S., France, Russia, Britain, and the Middle East. New forms of electronic hookah are now available. Some people who smoke tobacco think that hookahs are less dangerous to their health because the smoke is filtered through water, but the smoke from hookahs contain the same cancer-causing chemicals that cigarette smoke does. Smoking tobacco via cigarettes or hookah are both dangerous to your health.
Cocaine and Crack Addiction
Cocaine is an addictive stimulant that is smoked, snorted, and injected. Crack is cocaine that comes in a rock crystal that is heated to form vapors, which are then smoked. Cocaine has various effects on the body, including dilating pupils, constricting blood vessels, increasing body temperature, heart rate, and blood pressure.
Ingredients of the drug bath salts include mephedrone, methylone, MDPV, or MDPK. Feeling high and sexually stimulated are symptoms of bath salt abuse. The primary goals for the treatment of addiction symptoms are abstinence, relapse prevention, and rehabilitation.
Compulsive gambling is a disorder that affects millions in the U.S. Symptoms and signs include a preoccupation with gambling, lying to family or loved ones to hide gambling, committing crimes to finance gambling, and risking importance relationships and employment due to gambling. Treatment may incorporate participation in Gamblers' Anonymous, psychotherapy, and medications like carbamazepine, topiramate, lithium, naltrexone, antidepressants, clomipramine, and fluvoxamine.
Treatment & Diagnosis
Medications & Supplements
- guaifenesin/decongestant/narcotic antitussive/antihistamine - oral
- butalbital/acetaminophen/caffeine (Alagesic LQ, Capacet, Dolgic Plus, Esgic, Fioricet, and Others)
- Benzodiazepines vs. Narcotics (Opioids)
- expectorant/decongestant/narcotic antitussive/acetaminophen-oral
- Codeine Side Effects, Warnings, and Interactions
- decongestant/narcotic antitussive - oral, Alahist DHC, Symtan
- Types of Addiction and Substance Abuse Medications
- narcotic antitussive/antihistamine - oral
- narcotic analgesic/aspirin/caffeine - oral
- Targeted Therapy: What Is Oncogenic Addiction in Cancer Cells?
- Olinvyk (oliceridine)
- What Are Opioid Equivalents and Conversions?
- decongestant/narcotic antitussive/acetaminoph/antihistamine - oral
- decongestant/narcotic antitussive/antihistamine - oral
- Pain Medications (Narcotics)
Prevention & Wellness
Health Solutions From Our Sponsors
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.