420

Review Article

DOI: 10.1111/j.1610-0387.2008.06938.x

Epinephrine inhalers in emergency sets of patients

with anaphylaxis
Christiane Schlegel1, Richard Fux2, Tilo Biedermann1
(1) Department of Dermatology, Tbingen University Clinic, Tbingen, Germany
(2) Institute of Pharmacology and Toxicology, Division of Clinical Pharmacology Tbingen University Clinic, Tbingen,
Germany

JDDG; 2009 7:420425

Submitted: 18.6.2008 | Accepted: 6.9.2008

Keywords

Summary

Emergency sets are prescribed to allow patients with anaphylaxis to treat

themselves before professional aid arrives. The need for epinephrine in this setting is well-accepted, but how it should be administered is still controversial.
Epinephrine preparations can be administered orally, subcutaneously, intramuscularly or as aerosols. Primatene Mist is one epinephrine inhaler, which is approved for asthma treatment in the USA, and InfectoKruppInhal is another one
approved to support the treatment of acute laryngo-tracheitis and of allergic
reactions with a nebulizer. Both are possible components of the emergency set
for patients with anaphylaxis. The following review article summarizes data currently available on the use of epinephrine preparations in first-aid treatment of
anaphylaxis. Studies have shown that the plasma concentrations needed for
hemodynamic stabilization cannot be reached with epinephrine inhalers. Since
most cases of hypotension in anaphylaxis cannot be effectively treated with
epinephrine inhalers, the prescriber should be aware of this before including
them in an emergency pack.

epinephrine
inhalation
subcutaneous
anaphylaxis
emergency set

Introduction
Epinephrine (adrenalin), along with
norepinephrine (noradrenalin) and dopamine, is one of the bodys own catecholamines. The effects of epinephrine
are mediated by adrenergic receptors
(adrenoceptors) on target cells. When
analyzing their expression it must be recalled that there is variation between the
species with regard to distribution of adrenoceptors, and thus the results from
animal experiments are not entirely applicable to humans [1]. Via reversible
agonist-receptor binding, epinephrine
stimulates adrenoceptors which are cou-

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pled with a G protein, and the activation

signal is transmitted intracytoplasmically
to various target proteins [24]. Such intracellular mediation systems include
adenylate cyclase, phosphoinositol bisphosphate and ion channels, which together trigger the biological epinephrine
response. Adrenergic receptors (adrenoceptors) are traditionally divided by
pharmacological sensitivity into - and
-receptor types, and their respective
subtypes [4].
Epinephrine acts physiologically and
metabolically to prepare for action.
The main effects of epinephrine, after

activation of the adrenoceptors, are listed

in Table 1.
When administered subcutaneously, intravenously, or endotracheally in severe
anaphylactic events (grade III or IV based
on Ring and Memer), epinephrine (Suprarenin) counteracts symptoms of
shock by increasing heart rate (1), contraction power of the heart (1), peripheral vessel resistance (1) and bronchodilation and hence oxygen intake (2) [5].
Emergency set
Patients with a history of immediate hypersensitivity should always carry an

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Epinephrine inhalers in emergency sets

Table 1: Effects of adrenaline after activation of the adrenoceptors.

Adrenoreceptor Effect after activation
Vasoconstriction
1

Relaxation of smooth muscle in the gastrointestinal tract

Salivary secretion
Inhibition of synaptic release of noradrenaline and
acetylcholine

Thrombocyte aggregation
Vasoconstriction
Inhibition of insulin release

Heart: positive chronotropic, inotropic, bathmotropic, and

dromotropic effect
Bronchodilation

Vasodilation
Relaxation of visceral muscle

emergency anaphylaxis set with them in

the event that self-administration is necessary. According to different medical
associations recommendations vary on
the components that should be included in an anaphylaxis set. In Germany,
official guidelines state that an emergency kit for self-administration should
contain epinephrine in an autoinjector
(Figure 2), and if respiratory symptoms
are anticipated, also an epinephrine inhaler, a glucocorticoid and an antihistamine (H1-AH) (solution or readily dissolvable). The choice of antihistamine
for emergency kits is currently under discussion [6].
The contents of anaphylaxis sets vary
among hospitals and private practices
and are often based on the immediate
hypersensitivity symptoms of the individual patient. Yet, it is also known that
patients with a history of immediate hypersensitivity can experience a qualitatively different reaction upon re-exposure
than that experienced upon primary
contact with the allergen (such as hypotension rather than respiratory symptoms) [7].
Thus symptom-based prescription of
epinephrine-containing components (in
addition to glucocorticoids and antihistamines) for an emergency set is not a
simple matter.
Injectable forms of epinephrine
Epinephrine autoinjectors are a safe and
easy-to-use means of self-administering
epinephrine. Using the autoinjector, the

epinephrine is injected intramuscularly

in the anterolateral aspect of the thigh.
In Germany there are two different epinephrine autoinjectors on the market:
Anapen 150 (150 g epinephrine)/ Anapen 300 (300 g epinephrine), which is
supplied by Dr. Beckmann company, and
Fastjekt, 0.15 mg and 0.3 mg epinephrine/single dose by Allergopharma.
The injectors do not differ in price (each
costs about 79 ), but there are differences in their use. The Anapen 150 (junior) is suitable for use in children weighing 15 kg or more. The Anapen 300 is
appropriate for patients weighing 30 kg or
more. To use an Anapen first the black
safety cap must be removed from the
needle and then the black seal taken off
the red button. The pen is then placed on
the lateral aspect of the thigh, and slight
pressure applied. After pushing the button, the Anapen is held in place for about 10 seconds to administer the contents. The Fastjekt 150 may be used in
children up to 30 kg. The Fastjekt autoinjector is ready for use immediately after
removing the gray safety cap. Sudden movement and excessive pressure can cause it
to automatically inject. Thus the Fastjekt
makes administration of the epinephrine
easier. Yet the risk of accidentally injecting
a finger during an emergency also appears
greater (Figure 3), although exact data are
not available. There are reports in the literature on accidental injury with the
epinephrine autoinjector EpiPenTM which
is available in the United States [810].
Accidental injection with an epinephrine

The Authors Journal compilation Blackwell Verlag GmbH, Berlin JDDG 1610-0379/2009/0705

autoinjector can lead to necrosis of the distal phalanges from severe vasospasm. The
EpiPen, an epinephrine autoinjector, is
not approved in Germany. In general,
concomitant use of other sympathomimetic drugs (such as 2-receptor agonists
for broncholysis) warrants caution given
the risk of life-threatening disruption of
heart rhythm (lengthening of the QT interval) [11, 12].
The main requirement for use of an autoinjector is proper patient education.
Studies have shown, however, that despite patient education, many remain reluctant to use an autoinjector. Although
the majority of patients reportedly agree
on the necessity of carrying an epinephrine autoinjector in their emergency
kits, only a portion of them actually have
a functioning epinephrine autoinjector
on them, and many patients would not
use it in an emergency [1315].
There are as yet no studies available that
apply the criteria of evidence-based medicine to the effectiveness of various
therapeutic procedures in allergy emergencies [1518]. Epinephrine, given
subcutaneously, intramuscularly, or intravenously, is the initial treatment of
choice in anaphylaxis. H1 and H2 antihistamines (H1-AH), as well as glucocorticoids, are given as adjuvant therapies, although there are no randomized
controlled studies on their use.
Inhalable epinephrine formulations
Examples of inhalable epinephrine formulations are Primatene MistTM and InfectoKrupp Inhal. The Primatene Mist
inhaler is also available as spray foam,
with the added chlorofluorocarbons as foaming agents. InfectoKrupp Inhal is
available as a solution with a pump or
drop applicator for use in a nebulizer. A
pump/nebulizer/spray chamber system is
available separately. This allows it to be
used as a spray (Figure 1). InfectoKrupp
Inhal, made by Infectopharm, was approved for use as a nebulizer in November
2005 as adjuvant therapy in acute respiratory distress arising in acute stenosing
laryngo-tracheitis and allergic reactions.
10 ml of InfectoKrupp Inhal contain
40 mg of epinephrine; 1 puff contains
0.56 mg of epinephrine; the recommended standard dose, which is merely applicable to use in the nebulizer, is 714 puffs.
The larger the particle size, the greater is
the amount of purely oropharyngeal deposition of the drug: at a particle size

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Epinephrine inhalers in emergency sets

Figure 1: Inhalable epinephrine preparations.

< 8 m it is 0 %, while at a particle size of

16 m or more about 100 %. Particles
< 3 m can penetrate the alveoli, particles
15 m in size can reach small respiratory
passages, and particles > 8 m are deposited in the large respiratory passages [19].
Primatene Mist and InfectoKrupp Inhal in nebulizer form distribute particle sizes < 5 m. At this size (< 5 m), a certain
systemic effect may be presumed (circulatory effects). Given the small particle size
of the aerosol it generates, the InfectoKrupp Inhal, with a pump and drop applicator in a nebulizer, is suitable for both
treatment of acute stenosing laryngotracheitis and acute respiratory distress occurring in an allergic reaction. The required aerosol generation by the nebulizer,
however, makes it unsuitable for emergency use. The situation is different for
the pump spray by Infectopharm that

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allows the administration of epinephrine

in spray form. The resulting particle size is
> 10 m and thus deposited only in the
oropharynx. The InfectoKrupp Inhal as
a pump spray system is suitable as emergency medication only in acute stenosing
laryngo-tracheitis and not for treatment
of allergic bronchial asthma.
Primatene MistTM Inhaler (Wyeth) is
available in the United States as an overthe-counter-drug for the treatment of
bronchial asthma in patients aged 4 years
and up. Each puff contains 0.22 mg of
epinephrine. The recommended dose in
asthma bronchiale is 12 puffs. In
Germany it is available through the international pharmacy and costs about
35 (15 ml). A problem for prescribing
it in Germany is the ban on halon which
applies to all products containing CFCs
including medicinal products. An extra

declaration is required when prescribing

the Primatene Mist inhaler. It is important to explain that the drug is absolutely
necessary and that there are no existing
treatment alternatives.
In Germany Primatene Mist (inhaler)
was used for a rather long time (until InfectoKrupp Inhal was approved for use
in allergic reactions at the end of 2005)
as the only epinephrine preparation in
anaphylaxis sets, after a series of accidents involving epinephrine autoinjectors with unintended injection of the
fingers [810]. It is widely believed that
12 puffs from a Primatene Mist inhaler may also help stabilize circulation, in
addition to its known effects of bronchodilation and its topical effects on accompanying laryngeal edema. Studies on test
subjects have shown, however, that the
amount of epinephrine absorbed varies
[20]. Further studies on healthy adults
have shown low bioavailability of inhaled epinephrine; assuming correct inhalation technique, only 1015 % of the
inhaled aerosol actually reaches the
lungs, where it is absorbed into the circulation [2122]. Most of the inhaled epinephrine (8590 %) remains in the oropharynx and is broken down in the
gastrointestinal tract by catechol-O-methyltransferase and monoamino oxidase.
There have been a few studies comparing
plasma levels of epinephrine after inhalation versus subcutaneous administration
of epinephrine. Plasma concentrations of
epinephrine achieved by inhalation varied greatly, similar to subcutaneous administration, but fell even earlier into
pre-dose ranges. In addition, the high
dosage levels of inhaled epinephrine used
in test subjects had limiting gastrointestinal side effects [20, 23]. Another study
considered systemic absorption of epinephrine after local (eyedrops), inhalation (oral, nasal), buccal and subcutaneous administration based on plasma
levels and cardiovascular effects [24].
Neither epinephrine eyedrops (1 mg IsoptoEpinal) nor 30 puffs of epinephrine delivered to the buccal mucosa
showed any significant effect on plasma
epinephrine levels. After inhalation (10
puffs with an epinephrine Medihaler;
0.15 mg epinephrine per puff ) there were
no changes to plasma epinephrine levels.
After another 20 puffs of epinephrine
given over a period of 2 hours, plasma
epinephrine levels rose twofold; on the
whole, however, epinephrine absorption

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Epinephrine inhalers in emergency sets

Figure 2: Injectable epinephrine preparations.

was a less complete and shorter compared

with subcutaneous administration. After
subcutaneous epinephrine administration (0.5 mg), plasma epinephrine levels
increased within 5 minutes significantly
and led to an increase in heart rate and systolic blood pressure with a maximum effect after 15 minutes, a lasting effect of
almost 90 minutes and a decrease within
2 hours. Changes in plasma epinephrine
levels were directly correlated with corresponding cardiovascular effects (increased heart rate, systolic blood pressure)
and finger tremor [24].
Another study included 12 healthy
men and women [23, 25]. Epinephrine was administered either subcutaneously (0.5 mg) or by inhalation
consisting of 10 or 20 inhalations
(epinephrine Medihaler; 0.15 mg epi-

nephrine per inhalation). In subjects

with subcutaneous administration, serum epinephrine levels varied as did
the time of maximum concentration
(between 5 and 120 minutes). The inhaled epinephrine was rapidly and
dose-dependently absorbed; yet the
dosage level was much higher than
that used to treat bronchial asthma.
For treatment of bronchial asthma, 1
to 2 puffs are recommended, with a
single puff containing 0.22 mg epinephrine. Inhalation (spray) led to variable plasma levels of epinephrine;
there was less fluctuation, however,
than in subcutaneous administration,
and maximum plasma concentrations
were achieved more rapidly (in 5 to
10 minutes). At 20 spurts or more,
patients experienced dose-limiting

The Authors Journal compilation Blackwell Verlag GmbH, Berlin JDDG 1610-0379/2009/0705

Figure 3: Fastjekt after simulated injection of

the thumb of an assistant with a bent needle
(left). Correct use of the Fastjekt injector
(right).

nausea and vomiting, as signs of the

local (gastrointestinal) effects of epinephrine [23].
Results of a study on administering epinephrine to children with anaphylaxis
are notable. This prospective randomized, single-blind controlled study with
19 asymptomatic children (614 years of

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age) who were given 1020 inhalations

of epinephrine (0.25 mg per inhalation)
based on body weight, found that plasma
levels of epinephrine did not differ from
pre-dose concentrations or endogenous epinephrine concentrations after
inhalation of placebo. After the inhalations the verum group experienced cough
and nausea [26].
To summarize, it may be said that there
are no reliable data on the use of epinephrine aerosols in anaphylactic patients with circulatory symptoms with
regard to systemic bioavailability and
effectiveness. Studies on healthy subjects have shown that, with careful inhalation technique (to ensure uniform
laminar flow), 1545 puffs (about
0.20 mg each) would be needed in order to achieve effective plasma levels of
epinephrine that are comparable to a
one-time dose of 0.30 mg subcutaneous epinephrine. The administration
of 12 or 4 puffs is thus inadequate in
pharmacological terms to stabilize
circulation.
Discussion
The need for epinephrine in anaphylactic emergencies is undisputed. Epinephrine has also been referred to as the
most undermedicated drug. Controversy exists, however, on whether and in
what form epinephrine preparations
should be given, especially for use in
emergency sets as self-medication.
Epinephrine preparations exist as injectable solutions, inhalations, eyedrops,
and tablets. Based on current knowledge,
intramuscular [27] administration of
epinephrine is preferable to inhalation
for systemic treatment of an anaphylactic
reaction with circulatory compromise.
Intramuscular administration of epinephrine is superior to subcutaneous
administration. One study comparing
subcutaneous and intramuscular administration of epinephrine in children
showed that there was considerable variability in terms of the time at which
maximum plasma concentrations were
reached (8 minutes in intramuscular administration versus 34 minutes in subcutaneous administration). Maximum
plasma concentrations after intramuscular administration were higher than after
subcutaneous administration [25]. Relative contraindications for epinephrine
autoinjectors include severe impairment
of kidney function, arterial hypertension,

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Epinephrine inhalers in emergency sets

thyrotoxicosis,
pheochromocytoma,
narrow angle glaucoma, abnormal urinary excretion, and cor pulmonale,
heart rhythm disorders (tachycardia),
and coronary heart disease. The preference for inhalable epinephrine preparations results from reluctance on the part
of patients and doctors to use or prescribe autoinjectors [13, 14], potential
cardiac side effects of parenteral administration [28], and injury due to improper
injection [810].
In addition, studies have shown that 69 %
of parents of children with a history of
food-induced anaphylactic reactions were
not able to use an autoinjector (EpiPen)
[29]. This means that compliance is worse
for autoinjectors than for epinephrine inhalers [13, 14, 29]. Thus it may become
a matter of the use of an inhaler versus
non-treatment. Also, there is a recognized need for epinephrine inhalers as
emergency treatment for asthmatic reactions [30].
With regard to study methods, in all studies mentioned here on inhalation of
epinephrine, healthy subjects used careful inhalation technique. The subjects
were thoroughly instructed in the use of
the aerosol, and there was no prior physical exertion [20, 26]. There are no
comparative studies available on inhaled
versus subcutaneous/intramuscular/oral
epinephrine administration in patients
actually undergoing an anaphylactic
event [27]. Given that during an anaphylactic reaction patients often have
difficulty breathing (due to bronchospasm or laryngeal edema) [27], bioavailability would presumably be more limited than in healthy people. In order to
reach systemically effective plasma concentrations of epinephrine, 2040 inhalations are recommended. At such high
concentrations, considerable gastrointestinal effects such as nausea and vomiting can occur. In 2 out of 8 patients, [23]
20 inhalations (0.15 mg epinephrine per
inhalation) caused mild nausea, in another 2 patients severe nausea, and in one
patient vomiting occurred. One person
with severe nausea complained of symptoms lasting for hours, while in the remainder of patients symptoms subsided
within 80 minutes. It is not conceivable
that in an emergency situation a continued laminar flow of the inhaled preparation could be achieved.
Epinephrine inhalers may be recommended for swelling of the upper airways and

adequate inhalers also for broncho construction, but not for circulatory shock.
In a child with asthma, urticaria, and
food allergy, such a preparation is worth
discussing, but not in a patient with a
wasp venom allergy and circulatory
collapse. When prescribing Primatene
Mist (inhaler) and InfectoKrupp
Inhal for emergency sets for patients
with immediate hypersensitivity, doctors
should thus keep in mind that in most
instances, hemodynamic stabilization
cannot be achieved. There is an indication for Primatene Mist in patients
with bronchial asthma and laryngeal
edema (off-label use), because inhalation
of epinephrine has been shown to be effective in laryngeal edema and bronchospasm [31, 32].
For treatment of patients with anaphylaxis, the required plasma epinephrine
concentrations for 1-receptor-mediated
circulatory effects are not reliably achieved
with aerosols. They depend on various influences, mainly inhalation technique, and
at high doses (up to 40 puffs) are accompanied by severe gastrointestinal side
effects and the risk of hyperventilation.
To treat anaphylaxis with circulatory
compromise, emergency sets for patients
with a history of immediate hypersensitivity should include an epinephrine injector (Fastjekt or Anapen). Prior to
using the autoinjector, it is essential that
the patient be thoroughly and repeatedly
educated in its use in order to ensure
compliance and correct use [15].
<<<
Conflict of interest
None.

Correspondence to
Prof. Dr. med. Tilo Biedermann
Universitts-Hautklinik
Liebermeisterstrae 25
Tel.: +49-7071-29-80836
Fax: +49-7071-29-4117
D-72076 Tbingen
E-mail: tilo.biedermann@med.
uni-tuebingen.de

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