" Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for use of niacin and fenofibric acid with statins to treat high cholesterol.
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EVZIO is intended for immediate administration as emergency therapy in settings where opioids may be present.
EVZIO is not a substitute for emergency medical care.
DOSAGE AND ADMINISTRATION
Important Administration Instructions
- EVZIO is for intramuscular and subcutaneous use only.
- Because treatment of suspected opioid overdose must be performed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of EVZIO and the Instructions for Use.
- Seek emergency medical care immediately after use. Since the duration of action of most opioids exceeds that of naloxone hydrochloride, and the suspected opioid overdose may occur outside of supervised medical settings, seek immediate emergency medical assistance, keep the patient under continued surveillance, and administer repeated doses of EVZIO as necessary. Always seek emergency medical assistance in the event of a suspected, potentially life-threatening opioid emergency after administration of the first dose of EVZIO.
- Additional doses of EVZIO may be required until emergency medical assistance becomes available.
- Do not attempt to reuse EVZIO. Each EVZIO contains a single dose of naloxone.
- Visually inspect EVZIO through the viewing window for particulate matter and discoloration prior to administration. Do not administer unless the solution is clear and the glass container is undamaged.
The Instructions for Use should be read by the patient or caregiver at the time they receive a prescription for EVZIO. Provide the following instructions to the patient or caregiver:
- EVZIO must be administered according to the printed instructions on the device label or the electronic voice instructions (EVZIO contains a speaker that provides voice instructions to guide the user through each step of the injection). If the EVZIO electronic voice instruction system does not operate properly, EVZIO will still deliver the intended dose of naloxone hydrochloride when used according to the printed instructions on its label.
- Once the red safety guard is removed, EVZIO must be used immediately or disposed of properly. Do not attempt to replace the red safety guard once it is removed.
Upon actuation, EVZIO automatically inserts the needle intramuscularly or subcutaneously, delivers 0.4 mg naloxone hydrochloride injection, and retracts the needle fully into its housing. Post injection, the black base locks in place, a red indicator appears in the viewing window, and electronic visual and audible instructions signal that EVZIO has delivered the intended dose of naloxone hydrochloride and instructs the user to seek emergency medical attention.
Administer the initial dose of EVZIO to adult or pediatric patients intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary, and seek emergency medical assistance. Administer EVZIO as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death. The requirement for repeat doses of EVZIO depends upon the amount, type, and route of administration of the opioid being antagonized.
If the desired response is not obtained after 2 or 3 minutes, another EVZIO dose may be administered. If there is still no response and additional doses are available, additional EVZIO doses may be administered every 2 to 3 minutes until emergency medical assistance arrives. 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 or require higher doses of naloxone.
Dosing in Adults and Pediatric Patients over Age One
Instruct patients or their caregivers to administer EVZIO according to the Instructions for Use, intramuscularly or subcutaneously.
Dosing in Pediatric Patients under Age One
In pediatric patients under the age of one, the caregiver should pinch the thigh muscle while administering EVZIO.
Dosage Forms And Strengths
Injection: 0.4 mg/0.4 mL naloxone hydrochloride solution in a pre-filled auto-injector. Each EVZIO delivers 0.4 mg naloxone hydrochloride injection (0.4 mL).
Carton containing two EVZIO (naloxone hydrochloride injection, USP) 0.4 mg auto-injectors and a single Trainer for EVZIO -NDC 60842-030-01
Storage And Handling
Store EVZIO in the outer case provided.
Store at controlled room temperature 15°C to 25°C (59°F to 77°F) excursions permitted between 4°C and 40°C (between 39°F and 104°F).
Before using, check to make sure the solution in the auto-injector is not discolored. Replace EVZIO if the solution is discolored or contains a precipitate.
Manufactured for: kaleo, Inc. Richmond, VA 23219. Issued: 4/2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/14/2014
Additional Evzio Information
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.
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