High-Dose Naloxone giving hope to help combat opioid overdose trend


LOUISVILLE — Wednesday, August 31 was International Overdose Awareness Day, and ZIMHI™ (naloxone HCL injection), a higher-dose naloxone product approved for use in the treatment of opioid overdose, is helping bring attention to the growing opioid epidemic in the United States and why “Every Moment Matters” when it comes to treating an overdose.

According to the Centers for Disease Control and Prevention (CDC), more than 100,000 people died of drug overdoses in 2021, and nearly two-thirds of those deaths involved fentanyl or other synthetic opioids. Communities are at significant risk from counterfeit fentanyl-laced pills, 40% of which contain a potentially lethal dose, according to the Drug Enforcement Administration (DEA).

“Studies show that approximately 50% of opioid overdose reversals require more than one dose of naloxone, which is where our higher-dose product is better positioned to help,” said Breck Jones Sr., CEO of US WorldMeds.1 “With the highly potent synthetic opioids today, ZIMHI, administered through a pre-filled syringe, is a rapid solution for first responders, hospitals, treatment centers and caregivers to assist in the fight to save lives. Every moment matters when someone is experiencing an overdose and we expect this product to have a significant impact across the United States.” 

ZIMHI, a 5 mg/0.5 mL product, was FDA-approved in October 2021. U.S. WorldMeds is working to educate communities nationwide on the effectiveness of intramuscular naloxone administration, as intranasal delivery may not be the optimal solution for all patients experiencing an opioid overdose. When experiencing an opioid overdose, studies show brain damage may begin within 1-2 minutes, death of brain cells within 5 minutes and death of the patient could happen within 10 minutes, which is why every moment matters when it comes to the treatment of opioid overdoses. ZIMHI is given in four simple steps2:

• Press the needle into a person’s outer thigh after twisting off the needle cap.

• Push the plunger until it clicks to inject and hold for two seconds before removing the needle.

• Pull the safety guard over the needle using one hand, with your fingers behind the needle.

• Place the used syringe back into its blue case and close it.

Get emergency medical help right away after using the first dose of ZIMHI. Rescue breathing or CPR may be given while waiting for emergency medical help.

ZIMHI may cause serious side effects, including sudden opioid withdrawal symptoms, which may include body aches, fever, sweating, runny nose, sneezing, goose bumps, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, stomach cramping, increased blood pressure or increased heart rate. Other common side effects of ZIMHI include dizziness and injection site redness.

The product is welcome news for people like Capt. Callie Crow, a paramedic from Poolville, Texas, who lost her son Drew to an overdose in June 2020.

“A police officer got there fast, and EMS just seven minutes later,” said Crow. “That officer had naloxone on his belt, an emergency treatment for an opioid overdose.” However, Crow said the treatment wasn’t used on her son. “I had a lot of time to think and process, and one of the things that bothered me the most was why didn’t the officer deliver the naloxone? Haunting me even further was the fact that Drew had a box of naloxone on his desk that he had gotten from the university the week before, yet his wife didn’t know what it was. So, my son had a total of four potentially life-saving doses within feet of him when he died.”

Captain Crow is now working to educate communities in Texas about her son’s story, how essential it is to have a naloxone product that will help in the fight against opioid overdoses, and why training is crucial for first responders, organizations, caregivers and family members. 

“With ZIMHI, my crusade continues – to educate people about the product, and answer the real question when it comes to opioid addiction: What still has to be done? The reality is there is no more hiding from this issue, and we need to do away with the stigma attached to addiction.”

As we approach National Recovery Month in September, US WorldMeds is hoping to educate people so that during the chaos of an opioid overdose emergency, they have the tools to help save lives, giving more people stories of recovery, rather than loss. 

“None of us are immune to this epidemic, as we all know someone who has struggled with or is currently struggling with this issue, whether we realize it or not,” said Jones Sr. “We are excited to offer a product that could help save lives and to see the impact ZIMHI can have against this epidemic.”

For more information on ZIMHI, visit zimhi.com/public-service/ or contact [email protected]

INDICATION

ZIMHI is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. 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.

IMPORTANT SAFETY INFORMATION

Do not use ZIMHI if you are allergic to naloxone hydrochloride or any of the ingredients in ZIMHI.

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.

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.

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.

Get emergency medical help right away after using the first dose of ZIMHI. Rescue breathing or CPR may be given while waiting for emergency medical help.

The signs and symptoms of an opioid emergency can return within several minutes after ZIMHI is given. If this happens, give additional injections using a new ZIMHI prefilled syringe every 2 to 3 minutes and continue to closely watch the person until emergency help is received.

ZIMHI may cause serious side effects, including sudden opioid withdrawal symptoms, which may include: body aches, fever, sweating, runny nose, sneezing, goose bumps, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, stomach cramping, increased blood pressure, or increased heart rate.

Other common side effects of ZIMHI include dizziness and injection site redness.

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 of ZIMHI. Call your doctor for medical advice about side effects.

To report SUSPECTED ADVERSE REACTIONS, contact Adamis Pharmaceuticals Corporation at 1 (800) 230-3935 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

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