FDRHPO North Country EMS Program Agency

“Proudly Serving Clinton, Essex, Franklin, Jefferson, Lewis, St. Lawrence, Warren and Washington Counties”
To: North Country and Mountain Lakes EMS Agencies
Date: June 13, 2023
From: Jonathan Cole, Director
RE: Alternative Medications Due to Medication Shortages

On behalf of the North Country and Mountain Lake’s REMAC Chairs, Dr. Delaney and Dr. Bombard, the
NCEMS Program Agency requested the NYS Bureau of EMS to move to alternate medications as outlined in
the NYS Medication Formulary in accordance with NYS BEMS Policy Statement 13-04. This is due to the
shortage of midazolam CIV (Versed) for seizure management and for patient chemical restraint for the agitated
patient. The following was approved for usage:

For Seizures – Midazolam CIV (Versed)

• Alternate A - Lorazepam CIV (Ativan)*
• Alternate B - Diazepam CIV (Valium)*
For Behavioral: Agitated Patient Chemical Restraint- Midazolam CIV (Versed)
• Alternate B - Haloperidol
• Alternate C - Ketamine
For the above medications, refer to the NYS Collaborative Protocols the attached education and for
appropriate and recommended dosing.

Additionally, the North Country and Mountain Lakes REMAC Chairs have approved the usage of the GVOKE
Hypopen due to the glucagon shortage. The GVOKE Hypopen is a timed glucagon auto-injector. The GVOKE
Hypopen aligns with the NYS Collaborative Protocol dosing and the same route of administration as glucagon
administration. The GVOKE Hypopen can be approved for usage by your Agency’s Medical Director.

If an EMS Agency elects to utilize the GVOKE Hypopen, the agency should carry the following:
• One- Adult 1mg GVOKE Hypopen
• One- Pediatric 0.5 mg GVOKE Hypopen
The NCEMS Program Agency also requested the addition of levalbuterol (Xopenex) to be added as an
alternative medication to albuterol due to the medication shortage. Levalbuterol (Xopenex) has been approved
by the Regional Medical Directors/REMAC Charis for the use in the following NYS Collaborative Protocols:
Anaphylaxis (Pediatric and Adult), Dif Breathing- Adult: Asthma/COPD/Wheezing, Dif Breathing- Adult:
Pulmonary Edema, and Dif Breathing- Pediatric: Asthma/Wheezing.
• A unit of levalbuterol/Xopenex 1.25mg in 3mL may be substituted for albuterol 2.5mg in 3mL; may
repeat every 20 minutes to a total of three (3) doses.
Please see the attached education on the usage of lorazepam (Ativan), diazepam (Valium), and levalbuterol
(Xopenex).

To utilize the alternative medications, please fill out the attached form, have it signed by your agency
medical director and return it to our office.

*The alternate controlled substance medications must be included in your agency’s current Controlled
Substance Agreement. Please be sure to update the agreement as necessary with NYS and any distributing
pharmacies.

Fort Drum Regional Health Planning Organization | 120 Washington Street, Suite 230, Watertown, NY 13601
Office: (315) 755-2020 opt 2 | Fax: (315) 755-0717 | fdrhpo.org/ems
Lorazepam (Ativan)
&
Diazepam
(Valium/Diastat)
Purpose Protocol Change and Education

A national shortage of midazolam (Versed) injectable solution (5mg/mL) has impacted medication supplies for healthcare
including emergency medical services.

According to The American Society of Health-System Pharmacists (ASHP), the major professional organization for hospital
pharmacists, began listing midazolam (Versed) injectable solution on its current Drug Shortages List. At this time, allocation
of medication is monitored or capped for distribution due to the increased demand. The obstacle in stocking this medication
among rescue agencies is the availability of the product at a given time including the availability of alternative medication
options such as lorazepam (Ativan) and diazepam (Valium/Diastat).

Drug shortages have been in existence since the early 2000s. However, the effects of the 2020 pandemic have exacerbated
supply, demand and distribution of medication needs. Additionally, in February 2023, one of the five major pharmaceutical
companies, Akorn Pharmaceuticals filed for Chapter 7 bankruptcy ceasing laying off all employees and ceasing all
manufacturing operations immediately in the United States.
Objectives
At the completion of this session, the Critical Care EMT and Paramedics will be able to:
1. Describe mechanisms of drug action.
2. List and differentiate the phases of drug activity, including the pharmaceutical, pharmacokinetic, and
pharmacodynamic phases.
3. Describe the process called pharmacokinetics, pharmacodynamics, including theories of drug action, drug-response
relationship, factors altering drug responses, predictable drug responses, iatrogenic drug responses, and unpredictable
adverse drug responses.
4. Differentiate among drug interactions.
5. Discuss considerations for storing and securing medications.
6. List the component of the drug profile by classification.
7. Integrate pathophysiological principles of pharmacology with patient assessment.
8. Synthesize patient history information and assessment findings to form a field impression.
9. Synthesize a field impression to implement a pharmacologic management plan.
Drug Names

Brand: Generic:
Ativan lorazepam
 Drug Classification: Description: Mechanism of Action:

• A benzodiazepine with • Lorazepam (Ativan) is • Lorazepam (Ativan)

antianxiety, sedative a nearly white powder binds to benzodiazepine
and anticonvulsant almost insoluble in receptors on the
Drug effects.
• Controlled Substance
water. The injectable
solution contains
postsynaptic GABA-A
ligand-gated chloride
Classification, schedule IV. polyethylene glycol in
propylene glycol with
benzyl alcohol as
channel neuron at
several sites within the
central nervous system
Description & preservative. (CNS). It enhances the
inhibitory effects of
GABA, which increases
Mechanism of the conductance of
chloride ions in the
Action cell. GABA’s inhibitory
action in the amygdala
is beneficial in anxiety
disorders, while its
inhibitory activity in the
cerebral cortex is
beneficial in seizure
disorders.
Pharmacokinetics

Onset: Peak: Duration: The medication is

predominantly metabolized
▪Approximately ▪Approximately 10 ▪Average approximately through the liver and hepatic
1-3 minutes via IV minutes after IV 6-12 hours. functions and excreted
administration. administration. through the renal system.
▪Approximately 5 to ▪Approximately 1-3
greater than 30 minutes hours after IM
via IM administration. administration.
Indications and Usage

• Lorazepam (Ativan) injectable solution is indicated for the treatment of status

epilepticus/seizure management and is indicated as preanesthetic medication,
producing sedation (sleepiness or drowsiness) effective in rapid tranquilization
in the agitated patient. This medication is intended for use across all age
groups.

• Lorazepam (Ativan) is an approved NYS alternative medication for the use of

midazolam (Versed).
 Route of Administration

Lorazepam (Ativan) injectable solution is for intravenous (IV/IO) or

intramuscular (IM) use only.

NOT for intranasal (IN) administration

Recommended Dosage

• Adult:
• 2mg IM/IV/IO (slow push). May repeat x1 after 15 minutes.
• Pediatrics:
• 0.1mg/kg IM/IV/IO not to exceed 2mg. May repeat x1 after 15 minutes.
Contraindications
Lorazepam (Ativan) Injectable Solution is contraindicated in
patients with a known sensitivity to benzodiazepines or its
vehicle (polyethylene glycol, propylene glycol and benzyl
alcohol) and individuals with hepatic and/or renal failure.
Side Effects

Most Common:
• Respiratory Depression, Excessive Sedation.
Consider Adverse Reactions

• Box Warning: Concomitant use of benzodiazepines with opioids can lead to sedation, severe respiratory depression,
coma, and death. Avoid this combination.

• Anaphylaxis to lorazepam (Ativan): Do not administer lorazepam (Ativan) to individuals with a known allergy to
the medication or any component of the formulation or other benzodiazepines (cross sensitivity with other
benzodiazepines may exist).

• Neonates and Premature Infants: Lorazepam (Ativan) is contraindicated to use in neonates or premature infants
with severe respiratory impairment.

• Paradoxical Reactions: As with all benzodiazepines, paradoxical reactions such as stimulation, mania, irritability,
restlessness, agitation, aggression, psychosis, hostility, rage, or hallucinations may occur in rare instances and in an
unpredictable fashion. In these instances, further use of the drug in these patients should be considered with caution
Special Populations
• Pregnancy: Category D. Lorazepam (Ativan) may cause fetal damage when administered to
pregnant women. Lorazepam (Ativan) Injectable Solution should not be used during pregnancy
except in serious or life-threatening conditions where safer drugs cannot be used or are
ineffective. Status epilepticus may represent such a serious and life-threatening condition.
• An increased risk of congenital malformations associated with the use of minor tranquilizers
(chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy has
been suggested in several studies.
• Nursing Mothers: Lorazepam has been detected in human breast milk. Therefore, lorazepam
should not be administered to nursing mothers because, like other benzodiazepines, the
possibility exists that lorazepam may sedate or otherwise adversely affect the infant.
Protocols Containing the Use and
Administration of midazolam (Versed)

• NYS Bureau of EMS and Trauma Systems Collaborative Protocols

• Seizures- Adult
• Seizures- Pediatrics
• Behavioral: Agitated Patient- Adult
• Behavioral: Agitated Patient- Adolescent
• Behavioral: Agitated Patient- Pediatric
Drug Names

Brand: Generic:
Valium, Diastat diazepam
 Drug Classification: Description: Mechanism of Action:

• A benzodiazepine with • It’s a colorless • Diazepam (Valium) binds

antianxiety, sedative crystalline compound, to benzodiazepine
and anticonvulsant insoluble in water. Used receptors on the
Drug effects.
• Controlled Substance
for anxiety, acute
alcohol withdrawal,
postsynaptic GABA-A
ligand-gated chloride
channel neuron at several
skeletal muscle spasm,
Classification, schedule IV.
and seizure disorders
Increased risk of
sites within the central
nervous system (CNS). It
enhances the inhibitory
Description & profound sedation,
respiratory depression,
effects of GABA, which
increases the conductance
coma, and death with
Mechanism of concomitant opioid use.
of chloride ions in the
cell. GABAs inhibitory
act sat the level of the
Action limbic, thalamic, and
hypothalamic regions of
the CNS and can produce
any level of CNS
depression required
including sedation,
hypnosis, skeletal muscle
relaxation, and
anticonvulsant activity.
Pharmacokinetics

Onset: Peak: Duration: The medication is

predominantly metabolized
▪Approximately ▪Approximately 10
▪Average approximately through the liver and hepatic
1-3 minutes via IV minutes after IV functions and excreted
administration. administration. 6-12 hours. through the renal system.
▪Approximately 5 to ▪Approximately 1-3
greater than 30 minutes hours after IM
via IM administration. administration.
Indications and Usage
• Diazepam (Valium/Diastat) Injectable Solution is indicated for the treatment of
status epilepticus/seizure management. Diazepam (Valium/Diastat) may be
useful in the symptomatic relief of acute agitation, tremor, impending or acute
delirium tremens and hallucinosis. This medication is intended for use across
all age groups.

• Diazepam (Valium/Diastat) is an approved NYS alternative medication for the

use of midazolam (Versed).
 Route of Administration

Diazepam (Valium/Diastat) injectable solution is for intravenous (IV/IO) or

intramuscular (IM) use only.

NOT for intranasal (IN) administration

Recommended Dosage:

• Adult:
• 5mg IM/IV/IO (slow push). May repeat x1 after 15 minutes.
• Pediatrics:
• 0.2mg/kg IM/IV/IO not to exceed 5mg. May repeat x1 after 15 minutes.
Contraindications
Diazepam (Valium/Diastat) Injectable Solution is
contraindicated in patients with a known sensitivity to
diazepam.
Side Effects

Most Common:
• Respiratory Depression, Excessive Sedation.
Consider Adverse Reactions

• Box Warning: Concomitant use of benzodiazepines with opioids can lead to sedation, severe respiratory depression,
coma, and death. Avoid this combination.

• Anaphylaxis to diazepam (Valium/Diastat): Do not administer diazepam (Valium) to individuals with a known
allergy to the medication or any component of the formulation or other benzodiazepines (cross sensitivity with other
benzodiazepines may exist).

• Neonates and Premature Infants: Diazepam (Valium, Diastat) is contraindicated to use in neonates or premature
infants with severe respiratory impairment.

• Paradoxical Reactions: As with all benzodiazepines, paradoxical reactions such as stimulation, mania, irritability,
restlessness, agitation, aggression, psychosis, hostility, rage, or hallucinations may occur in rare instances and in an
unpredictable fashion. In these instances, further use of the drug in these patients should be considered with caution.
Drug Interactions
• General: Diazepam (Valium, Diastat) Injection, like other injectable benzodiazepines, produces additive depression
of the central nervous system when administered with other CNS depressants such as ethyl alcohol, phenothiazines,
barbiturates, MAO inhibitors, and other antidepressants.

• General: Apnea, coma, bradycardia, arrhythmia, heart arrest, and death have been reported with the concomitant use
of haloperidol and lorazepam.

• Diphenhydramine: (Moderate) Coadministration can potentiate the CNS effects (e.g., increased sedation or
respiratory depression) of either agent. Use caution with this combination.

• Amiodarone: (Moderate) Monitor for an increase in diazepam-related adverse reactions, including sedation and
respiratory depression, if coadministration with amiodarone is necessary.

• Atropine, Ketamine: (Moderate) Concomitant administration of benzodiazepines with CNS-depressant drugs, such
as diphenoxylate/difenoxin, can potentiate the CNS effects of either agent.

• Nitroglycerin: (Minor) Nitroglycerin can cause hypotension. This action may be additive with other agents that can
cause hypotension such as benzodiazepines. Patients should be monitored more closely for hypotension if
nitroglycerin is used concurrently with benzodiazepines.
Special Populations
• Pregnancy: Category D. Diazepam (Valium, Diastat) may cause fetal damage when
administered to pregnant women. Diazepam (Valium, Diastat) Injectable Solution should not be
used during pregnancy except in serious or life-threatening conditions where safer drugs cannot
be used or are ineffective. Status epilepticus may represent such a serious and life-threatening
condition.
• Nursing Mothers: Diazepam (Valium, Diastat) has been detected in human breast milk.
Therefore, diazepam (Valium, Diastat) should not be administered to nursing mothers because,
like other benzodiazepines, the possibility exists that lorazepam may sedate or otherwise
adversely affect the infant, except in serious or life-threatening conditions where safer drugs
cannot be used or are ineffective.
Protocols Containing the Use and
Administration of midazolam (Versed)

• NYS Bureau of EMS and Trauma Systems Collaborative Protocols

• Seizures- Adult
• Seizures- Pediatrics
• Behavioral: Agitated Patient- Adult
• Behavioral: Agitated Patient- Adolescent
• Behavioral: Agitated Patient- Pediatric
In Summary…
lorazepam (Ativan) & diazepam (Valium)
• Safe for Pediatric and Adult Patients
• Not recommended for neonate use
• Indications and Use

Similarities:
• Administration: IV/IO and IM
• Pharmacokinetics
• Controlled Substances: Class IV
• Side Effects: Respiratory Depression, Excessive Sedation
• Contraindications: Do not use if there is a known sensitivity to the medication
• Nursing Mothers & Pregnancy: Category D

Differences: • Dosage for Pediatric and Adult Patients

• Diazepam (Valium) drug interactions
Resources
• FDA Drug Shortages. (n.d.). FDA. https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
• https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020837s041lbl.pdf
• https://www.google.com/imgres?imgurl=https%3A%2F%2Fcdn.boundtree.com%2Femp%2Fproducts%2F0409-3213-
12_515Wx515H_8811391942686&tbnid=IHhkggIexbuCXM&vet=12ahUKEwjT0LrogLnAhVsGFkFHfvnDTMQMygBegUIARDLAQ..i&i
mgrefurl=https%3A%2F%2Fwww.buyemp.com%2Fproduct%2Fdiazepam-5mg-ml-10ml-fliptop-vial%2F0409-3213-
12&docid=d6M5CD1KRjc01M&w=152&h=334&q=diazepam&hl=en&ved=2ahUKEwjT0LrogLn-
AhVsGFkFHfvnDTMQMygBegUIARDLAQ
• Dhaliwal, J. S. (2022, September 3). Diazepam. StatPearls - NCBI Bookshelf. https://www.ncbi.nlm.nih.gov/books/NBK537022/
• Diazepam Injection (diazepam) dose, indications, adverse effects, interactions. . . from PDR.net. (n.d.). https://www.pdr.net/drug-
summary/Diazepam-Injection-diazepam-719#:~:text=1%20to%202%20mg%20IV,to%204%20hours%20as%20needed.&text=Adults-
,2%20to%2010%20mg%20PO%202%20to%204%20times%20per,for%20the%20debilitated%20adult%20patient.&text=2%20to%202.5%20
mg%20PO%201%20to%202%20times%20daily,to%20response%20and%20patient%20tolerability.
• diazepam injection, USP - CARPUJECT Dosage and Administration | Pfizer Medical Information - US. (n.d.). Pfizer MI.
https://www.pfizermedicalinformation.com/en-us/diazepam-0/dosage-admin
• Drug Shortage Detail: Midazolam Injection. (n.d.). https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-
detail.aspx?id=576&loginreturnUrl=SSOCheckOnly
• FDA Drug Shortages. (n.d.). FDA.
https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Midazolam%20Injection&st=c&tab=tabs-1
• Ghiasi, N. (2023, January 31). Lorazepam. StatPearls - NCBI Bookshelf.
https://www.ncbi.nlm.nih.gov/books/NBK532890/#:~:text=Mechanism%20of%20Action,-
Lorazepam%20binds%20to&text=It%20enhances%20the%20inhibitory%20effects,chloride%20ions%20in%20the%20cell.
Levalbuterol
HCl
Inhalation
Solution
XOPENEX®
 Purpose:
Temporary Medication Alternative and Education
A national shortage of albuterol sulfate inhalation solution (2.5mg/3mL) has impacted medication
supplies for healthcare including emergency medical services.

In March 2020, The American Society of Health-System Pharmacists (ASHP), the major professional
organization for hospital pharmacists, began listing albuterol sulfate metered-dose inhalers (MDIs) on its
Drug Shortages List. Allocation of medication became much more closely monitored or even capped for
administration and distribution requiring alternative medication supplies to be utilized.

In February 2023, one of the five major pharmaceutical companies, Akorn Pharmaceuticals filed for
Chapter 7 bankruptcy ceasing laying off all employees and ceasing all manufacturing operations
immediately in the United States.
Objectives
At the completion of this session, the advanced EMT will be able to:
1. Describe mechanisms of drug action.
2. List and differentiate the phases of drug activity, including the pharmaceutical, pharmacokinetic, and
pharmacodynamic phases.
3. Describe the process called pharmacokinetics, pharmacodynamics, including theories of drug action, drug-response
relationship, factors altering drug responses, predictable drug responses, iatrogenic drug responses, and unpredictable
adverse drug responses.
4. Differentiate among drug interactions.
5. Discuss considerations for storing and securing medications.
6. List the component of the drug profile by classification.
7. Integrate pathophysiological principles of pharmacology with patient assessment.
8. Synthesize patient history information and assessment findings to form a field impression.
9. Synthesize a field impression to implement a pharmacologic management plan.
Drug Names

Generic:
Brand: XOPENEX®
levalbuterol,
Inhalation
levalbuterol HCl,
Solution
levalbutamol
Drug Classification, Description & Mechanism of Action
Drug Classification: Description:
• Short Acting Beta2 • XOPENEX® Inhalation
Adrenergic Agonist Solution (levalbuterol) is a
sterile, clear, colorless,
preservative-free solution of
the hydrochloride salt of
levalbuterol, the (R)-
enantiomer of the drug
substance racemic albuterol
Mechanism of Action:
• XOPENEX® (levalbuterol)
relaxes the smooth muscles
of all airways, from the
trachea to the terminal
bronchioles. XOPENEX®
(levalbuterol) acts as a
functional antagonist to
relax the airway irrespective
of the spasmogen involved,
thus protecting against all
bronchoconstrictor
challenges.
Pharmacokinetics

Onset: 10-17 minutes Peak: 1.5 Hours Duration: Average 5 A portion of the medication
Hours is inhaled through the
respiratory tract and
absorbed through the
circulatory system. The
medication is predominantly
metabolized through the
gastrointestinal tract and
excreted through the renal
system.
Indications and Usage

XOPENEX® (levalbuterol HCl) Inhalation Solution is indicated for the

treatment or prevention of bronchospasm in adults, adolescents, and children 1
year of age and older with reversible obstructive airway disease with the presence
of wheezing. Do not exceed recommended dose.
 Route of Administration
Inhalation Solution for oral inhalation use only. Administer by nebulization using
with a standard jet nebulizer (with a face mask or mouthpiece) connected to an
oxygen supply.
Recommended Dosage

• Recommended Dosage: Single unit dose vial of 1.25mg in 3mL

• 1.5mg in 3mL XOPENEX® (levalbuterol HCl) is equivalent to 2.5mg in 3mL albuterol

• Do Not Exceed Recommended Dose: Fatalities have been reported in association with
excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of
death is unknown, but cardiac arrest following an unexpected development of a severe acute
asthmatic crisis and subsequent hypoxia is suspected.
Dosage & Administration
Ages 1-Adult

• According to the Physician's Desk Reference:

• A unit dose of Xopanex® (levalbuterol HCl) 1.25mg in 3mL may be substituted for
albuterol 2.5mg in 3mL; may repeat every 20 minutes to a total of three doses
Contraindications
XOPENEX® (levalbuterol HCl) Inhalation Solution is
contraindicated in patients with a history of hypersensitivity to
levalbuterol or racemic albuterol. Reactions have included
urticaria, angioedema, rash, bronchospasm, anaphylaxis, and
oropharyngeal edema.
Side Effects

Most Common:
• Increased Heartbeat

More Common:
• Anxiety, Body Aches or Pain, Chills, Congestion, Cough, Dryness or Soreness of the Throat,
Fever, General Aches and Pains, Hoarseness, Increased Cough, Leg Cramps, Loss of Appetite,
Migraines or Other Headaches, Nervousness, Runny or Stuffy Nose.
Precautions

• The drug compatibility (physical and chemical), efficacy, and safety of

XOPENEX® (levalbuterol HCl) Inhalation Solution when mixed with other
drugs in a nebulizer have not been established.
• XOPENEX® (levalbuterol HCl) Inhalation Solution, like other
sympathomimetic agents, can cause adverse reactions such as hypertension,
angina, vertigo, central nervous system stimulation, sleeplessness, headache,
and drying or irritation of the oropharynx.
Consider Adverse Reactions (1 of 2)

 Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of
inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac
arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is
suspected.

 Cardiovascular Effects:
 XOPENEX® (levalbuterol HCl) Inhalation Solution, like other beta-adrenergic agonists, can produce clinically significant
cardiovascular effects in some patients, as measured by heart rate, blood pressure, and symptoms.
 Effects are uncommon after administration of XOPENEX® (levalbuterol HCl) Inhalation Solution at recommended doses, if
they occur, the drug may need to be discontinued.
 Beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the t-wave, prolongation of
the QTc interval, and ST segment depression. The clinical significance of these findings is unknown.
 XOPENEX® (levalbuterol HCl) Inhalation Solution, like all sympathomimetic amines, should be used with caution in patients
with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Consider Adverse Reactions (2 of 2)

 Paradoxical Bronchospasm:
 XOPENEX® Inhalation Solution can produce paradoxical bronchospasm, which may be life threatening.
 If paradoxical bronchospasm occurs, XOPENEX® (levalbuterol HCl) Inhalation Solution should be discontinued immediately.
 It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the
first use of a new vial.

 Coexisting Conditions:
 XOPENEX® (levalbuterol HCl) Inhalation Solution, like all sympathomimetic amines, should be used with caution in patients
with cardiovascular disorders, especially coronary insufficiency, hypertension, and cardiac arrhythmias; in patients with
convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic
amines.
 Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be
expected to occur in some patients after the use of any beta-adrenergic bronchodilator. Changes in blood glucose may occur.
Special Populations
• Pregnancy: Teratogenic Effects: Pregnancy Category C. There are no adequate and
well-controlled studies of XOPENEX® (levalbuterol HCl) Inhalation Solution in
pregnant women. Because animal reproduction studies are not always predictive of
human response, XOPENEX® (levalbuterol HCl) Inhalation Solution should be used
during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Protocols Containing the Use and
Administration of Albuterol

• NYS Bureau of EMS and Trauma Systems Collaborative Protocols

• Dif Breathing- Adult: Asthma/ COPD/ Wheezing
• Dif Breathing- Pediatric: Asthma/Wheezing
• Anaphylaxis- Adult
• Anaphylaxis- Pediatric
• Hyperkalemia- Adult
• Crush Injuries- Adult
Resources
• FDA Drug Shortages. (n.d.). FDA. https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
• Hendeles, L., & Prabhakaran, S. (2020). Nationwide Shortage of Albuterol Inhalers and Off-Label Use in COVID-
19 Patients. Pediatric Allergy Immunology and Pulmonology, 33(4), 216–219.
https://doi.org/10.1089/ped.2020.1300
• Levalbuterol (Inhalation Route) Side Effects - Mayo Clinic. (n.d.). https://www.mayoclinic.org/drugs-
supplements/levalbuterol-inhalation-route/side-effects/drg-
20067232?p=1#:~:text=Levalbuterol%20is%20used%20to%20prevent,medicines%20known%20as%20adrenergic%
20bronchodilators.
• PharmD, K. M. (2019, October 18). Xopenex (levalbuterol). https://www.medicalnewstoday.com/articles/326815
• Sunovion Pharmaceuticals Inc. to Divest Xopenex® (levalbuterol HCI) Inhalation Solution (IS) to Akorn, Inc. (n.d.).
https://news.sunovion.com/press-releases/press-releases-details/2014/Sunovion-Pharmaceuticals-Inc-to-Divest-
Xopenex-levalbuterol-HCI-Inhalation-Solution-IS-to-Akorn-Inc/default.aspx
• Xopenex Inhalation Solution (levalbuterol hydrochloride) dose, indications, adverse effects, interactions. . . from
PDR.net. (n.d.). https://www.pdr.net/drug-summary/Xopenex-Inhalation-Solution-levalbuterol-hydrochloride-
2089.3447
• https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020837s041lbl.pdf
• Image: https://www.buyemp.com/product/levalbuterol-inhalation-solution-usp-1-25mg-0-5ml-individually-
wrapped/6993-93
• A unit dose of levalbuterol/Xopanex® 1.25mg in 3mL may be substituted for albuterol
2.5mg in 3mL; may repeat every 20 minutes to a total of three doses.
• A unit dose of levalbuterol/Xopanex® 1.25mg in 3mL may be substituted for albuterol
2.5mg in 3mL; may repeat every 20 minutes to a total of three doses.
• A unit dose of levalbuterol/Xopanex® 1.25mg in 3mL may be substituted for albuterol
2.5mg in 3mL; may repeat every 20 minutes to a total of three doses.
• A unit dose of levalbuterol/Xopanex® 1.25mg in 3mL may be substituted for albuterol
2.5mg in 3mL; may repeat every 20 minutes to a total of three doses.
• A unit dose of levalbuterol/Xopanex® 1.25mg in 3mL may be substituted for albuterol
2.5mg in 3mL; may repeat every 20 minutes to a total of three doses.
• Lorazepam (Ativan): Adult: 2mg IM/IV/IO (slow push). May repeat x1 after 15 minutes may be
substituted for midazolam (Versed).
• Diazepam (Valium/Diastat): Adult: 5mg IM/IV/IO (slow push). May repeat x1 after 15 minutes.
may be substituted for midazolam (Versed).
• Lorazepam (Ativan): Pediatrics: 0.1mg/kg IM/IV/IO not to exceed 2mg. May repeat x1 after 15
minutes may be substituted for midazolam (Versed).
• Diazepam (Valium/Diastat): Pediatrics: 0.2mg/kg IM/IV/IO not to exceed 5mg. May repeat x1 after
15 minutes may be substituted for midazolam (Versed).
 FDRHPO North Country EMS Program Agency
“Proudly Serving Clinton, Essex, Franklin, Jefferson, Lewis, St. Lawrence, Warren and Washington Coun�es”

Agency Name:___________________________________
Medical Director:_________________________________

Please indicate below the alternative medications being utilized

at your agency:
Lorazepam (Ativan)
Diazepam (Valium)
GVOKE Hypopen
Levalbuterol (Xopenex)

By signing below, you acknowledge the following:

1. Your agency has updated its Controlled Substance Agreement and/or Policy to include
the controlled substances you are carrying (Lorazepam and/or Diazepam Only).
2. Your agency has reviewed the accompanied training in order to begin utilizing the
alternative medications listed above, apart from the GVOKE Hypopen.

Agency Director Of Operations Agency Medical Director

__________________________ ____________________________
Print Print
__________________________ ____________________________
Signature/Date Signature/Date
______________________________________________________________________________
Office Use Only: Date Received and Approved __/__/__

Fort Drum Regional Health Planning Organization | 120 Washington Street, Suite 230, Watertown, NY 13601
Office: (315) 755-2020 opt 2 | Fax: (315) 755-0717 | fdrhpo.org/ems