• Zimhi is a prescription medicine used in adults and children 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.
• Zimhi is to be given right away and does not take the place of emergency medical care. Get emergency medical help right away after the first dose, even if the person wakes up.
• Zimhi is safe and effective in children for known or suspected opioid overdose.

Zimhi is used to temporarily reverse the effects of opioid medicines. The medicine in Zimhi has no effect in people who are not taking opioid medicines. Always carry Zimhi with you in case of an opioid emergency.

• Use Zimhi 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 rubbing firmly on the middle of their chest (sternum)
  • breathing problems including slow or shallow breathing in someone difficult to awaken or they look 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 Zimhi in an opioid emergency should know where Zimhi is stored and how to give Zimhi before an opioid emergency happens. Make sure everyone reads the information contained in the case and carton as soon as you receive Zimhi.
• Zimhi is intended to be given by people 12 years of age or older. Younger children or those with limited hand strength may find the Prefilled syringe difficult to use.
• Get emergency medical help right away after using the first dose. 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 Zimhi is given. If this happens, give additional injections using a new prefilled syringe every 2 to 3 minutes and watch the person closely until emergency help is received.

Read the Instructions for Use at the end of this Patient Information leaflet for detailed information about the right way to use Zimhi.

• Use Zimhi exactly as prescribed by your healthcare provider.
• Each Zimhi Prefilled syringe contains only 1 dose of medicine and cannot be reused.
• Zimhi should be injected into the muscle (intramuscular) or underneath the skin (subcutaneous) of the outer thigh. It can be injected through your clothing if needed.
• Caregivers should pinch the thigh muscle while injecting Zimhi into a child under the age of 1 year old.
• If an accidental needlestick injury occurs, get emergency medical help right away. Accidental needlestick injuries may put you at risk for blood borne diseases (such as HIV, HBV, and HCV) that can cause illness or death. In addition, report an accidental needlestick injury or problems with the Zimhi Prefilled syringe to Adamis Pharmacovigilance at (800) 230-3935.

- Administer Zimhi (naloxone hydrochloride) 5 mg/0.5 mL to adult or pediatric patients into the anterolateral aspect of the thigh, through clothing if necessary.

Use: Zimhi is indicated in adult and pediatric patients for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
Zimhi is intended for immediate administration as emergency therapy in settings where opioids may be present. Zimhi is not a substitute for emergency medical care.

Do not use Zimhi if you are allergic to naloxone hydrochloride or any of the ingredients. See the end of this page for a complete list of ingredients.

What should I tell my healthcare provider before using Zimhi?

Before using Zimhi, 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 Zimhi may cause withdrawal symptoms in your unborn baby. Your unborn baby should be examined by a healthcare provider right away after you use Zimhi.
• are breastfeeding or plan to breastfeed. It is not known if Zimhi 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.

Zimhi 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 Zimhi and may include:
  • body aches
  • runny nose
  • yawning
  • nervousness
  • nausea or vomiting
  • increased heart rate
  • fever
  • sneezing
  • weakness
  • restlessness or irritability
  • stomach cramping
  • sweating
  • goose bumps
  • shivering or trembling
  • diarrhea
  • increased blood pressure

The most common side effects include: nausea, dizziness, lightheadedness, and increased amounts of red blood cell breakdown products (bilirubin) in your blood.

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.

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.