Kloxxado
Generic name: naloxone hydrochloride
Dosage form: nasal spray
Drug class: Antidotes
Medically reviewed by A Ras MD.
What is Kloxxado?
Kloxxado 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.
Description
KLOXXADO (naloxone hydrochloride) nasal spray is an opioid antagonist supplied in a pre-filled intranasal device designed to deliver a single dose of 8 mg of naloxone hydrochloride (equivalent to 7.2 mg naloxone) in 0.1mL.
Chemically, naloxone hydrochloride is the hydrochloride salt of 17-allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride with molecular weight of 363.84 g/mol.
Its molecular formula is C19H21NO4.HCl, and it has the following chemical structure, as shown below.
Naloxone hydrochloride occurs as a white to slightly off-white powder, and is soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and in chloroform.
The inactive ingredients in KLOXXADO include: 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.
Mechanism of Action
Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites. Administration of naloxone hydrochloride reverses the effects of opioids, including respiratory depression, sedation and hypotension. It can also reverse the psychotomimetic and dysphoric effects of agonist-antagonists such as pentazocine.
What is the most important information I should know about Kloxxado?
Kloxxado nasal spray is used to temporarily reverse the effects of opioid medicines. The medicine in Kloxxado nasal spray has no effect in people who are not taking opioid medicines. Always carry Kloxxado nasal spray with you in case of an opioid emergency.
- Use Kloxxado nasal spray right away if you or your caregiver think signs or symptoms of an opioid emergency are present, even if you are not sure, because an opioid emergency can cause severe injury or death. Signs and symptoms of an opioid emergency may include:
- unusual sleepiness and you are not able to awaken the person with a loud voice or by rubbing firmly on the middle of their chest (sternum)
- breathing problems including slow or shallow breathing in someone difficult to awaken or who looks like they are not breathing
- the black circle in the center of the colored part of the eye (pupil) is very small, sometimes called “pinpoint pupils”, in someone difficult to awaken
- Family members, caregivers, or other people who may have to use Kloxxado nasal spray in an opioid emergency should know where Kloxxado nasal spray is stored and how to give Kloxxado nasal spray before an opioid emergency happens.
- Get emergency medical help right away after giving the first dose of Kloxxado nasal spray. Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help.
- The signs and symptoms of an opioid emergency can return after Kloxxado nasal spray is given. If this happens, give another dose after 2 to 3 minutes using a new Kloxxado nasal spray and watch the person closely until emergency help is received.
Who should not use Kloxxado?
Do not use Kloxxado nasal spray:
- if you are allergic to naloxone hydrochloride or any of the ingredients in Kloxxado nasal spray. See the end of this guide for a complete list of ingredients in Kloxxado nasal spray.
What should I tell my healthcare provider before using Kloxxado?
Before using Kloxxado nasal spray, tell your healthcare provider about all of your medical conditions, including if you:
- have heart problems
- are pregnant or plan to become pregnant. Use of Kloxxado nasal spray may cause withdrawal symptoms in your unborn baby. Your unborn baby should be examined by a healthcare provider right away after you use Kloxxado nasal spray.
- are breastfeeding or plan to breastfeed. It is not known if Kloxxado nasal spray passes into your breast milk.
Tell your healthcare provider about the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use Kloxxado?
Read the Instructions for Use at the end of this Patient Information leaflet for detailed information about the right way to use Kloxxado nasal spray.
- Use Kloxxado nasal spray exactly as prescribed by your healthcare provider.
- Each Kloxxado nasal spray contains only 1 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 Kloxxado nasal spray.
- Kloxxado nasal spray should be given into one nostril.
- If additional doses are needed, give Kloxxado nasal spray in the other nostril.
What are the possible 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:
- body aches
- diarrhea
- increased heart rate
- fever
- runny nose
- sneezing
- goosebumps
- sweating
- yawning
- nausea or vomiting
- nervousness
- restlessness or irritability
- shivering or trembling
- stomach cramping
- weakness
- increased blood pressure
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, weakness, dizziness, headache, 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.
General information about the safe and effective use of Kloxxado
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Kloxxado nasal spray for a condition for which it was not prescribed. You can ask your pharmacist or healthcare provider for information about Kloxxado nasal spray that is written for health professionals.
How should I store 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.
- Replace Kloxxado nasal spray before the expiration date on the box.
Keep Kloxxado nasal spray and all medicines out of the reach of children.
What are the ingredients in Kloxxado?
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.
Kloxxado nasal spray is not made with natural rubber latex.
For more information, visit WWW.HIKMA.COM or call Hikma Specialty USA Inc. at 1-800-962-8364.
Instructions for use
Kloxxado (Kloks-AH-doh)
(naloxone hydrochloride)
nasal spray
You and your family members or caregivers should read the Instructions for Use that comes with Kloxxado nasal spray before using it. Talk to your healthcare provider if you and your family members or caregivers have any questions about the use of Kloxxado nasal spray.
Use Kloxxado nasal spray for known or suspected opioid overdose in adults and children.
Important: For use in the nose only.
- Do not remove or test the Kloxxado nasal spray until ready to use.
- Each Kloxxado nasal spray has 1 dose and cannot be reused.
- You do not need to prime Kloxxado nasal spray.
| How to use Kloxxado nasal spray:
Step 1. Lay the person on their back to receive a dose of Kloxxado nasal spray. Step 2. Remove Kloxxado nasal spray from the box. Note: Kloxxado freezes at temperatures below 5°F (-15°C). If this happens, the device will not spray. Get emergency medical help right away if this happens. Do not wait for Kloxxado to thaw. Kloxxado may still be used if it has been thawed after being previously frozen. Step 3. Hold the Kloxxado nasal spray with your thumb on the bottom of the plunger and your first and middle fingers on either side of the nozzle.
Step 4. Tilt the person’s head back and provide support under the neck with your hand. 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. Step 5. Press the plunger firmly to give the dose of Kloxxado nasal spray. Step 6. Remove the Kloxxado nasal spray from the nostril after giving the dose. What to do after Kloxxado nasal spray has been used: Step 7. Get emergency help right away.
If additional Kloxxado nasal sprays are available, Steps 2 through 6 may be repeated every 2 to 3 minutes until the person responds or emergency medical help is received. Step 8. Put the used Kloxxado nasal spray back into its box. Step 9. Throw away (dispose of) the used Kloxxado nasal spray in a place that is away from children. |
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How should I store Kloxxado nasal spray?
- 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.
- Replace Kloxxado nasal spray before the expiration date on the box.
- Keep Kloxxado nasal spray and all medicines out of the reach of children.
Label
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
- KLOXXADOTM (naloxone HCl) nasal spray, 8 mg – Folding Carton
- NDC # 59467-679-01
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
