(Levodropropzine Cough Syrup 30 mg/5 ml)

Description:
Levodropropizine, the (-)-(S)-isomer of dropropizine, is a cough suppressant with
peripheral action. It decreases the excitability of tracheobronchial receptors thus suppressing
the cough reflex.

Chemical Structure:
Mechanism of Action
Levodropropizine is a non-opioid agent whose peripheral antitussive action may result
from its modulation of sensory neuropeptide levels within the respiratory tract. In particular,
levodropropizine exerts its antitussive effect through an inhibitory action at the level of the
airway sensory nerves and it has been shown to be able to inhibit in vitro the release of
neuropeptides from C-fibers. In addition, in anaesthetized cats, it markedly reduces the
activation of C-fibres and abolishes the associated reflexes. The activity of levodropropizine
on airway sensory units other than the C-fibres has not been investigated.

Indications and Dosage

Oral
Cough:
Adult: 60 mg up to tid at intervals of at least 6 hours. Dosage recommendations may
vary among countries or individual products (refer to specific product guidelines).
Child: 2-12 years 1 mg/kg/dose up to tid at intervals of at least 6 hours. Max: 3 mg/kg
daily. >12 years Same as adult dose. Dosage recommendations may vary among
countries or individual products (refer to specific product guidelines).

Administration
Should be taken on an empty stomach. Take between meals.

Contraindications
Excessive mucous discharge or limited mucociliary function (e.g. Kartagener syndrome
or bronchial ciliary dyskinesia). Severe hepatic impairment.

Special Precautions
Severe renal impairment, Children.

Hepatic Impairment
Severe: Contraindicated.

Adverse Reactions
Significant: Rarely, drowsiness, altered consciousness.
Cardiac disorders: Palpitations.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal distress, heartburn.
General disorders and administration site conditions: Fatigue.
Nervous system disorders: Dizziness, headache, numbness.
Patient Counselling Information
This drug may cause drowsiness or altered consciousness, if affected, do not drive or
operate machinery.

Pharmacokinetics:
Absorption: Rapidly absorbed from the gastrointestinal tract. Bioavailability: >75%. Time to
peak plasma concentration: 0.75 hours (range: 0.25-2 hours).

Distribution:
Plasma protein binding: 11-14%.
 STUDY ON LEVODROPROPIZINE COMPARING TO OTHER
ANTISTUSSIVE AGENTS

Levodropropizine for treating cough in adult and children:

A meta-analysis of published studies
Alessandro Zanasi, Luigi Lanata, Giovanni Fontana, Federico Saibene, Peter Dicpinigaitis, and
Francesco De Blasio
Author information Article notes Copyright and License information Disclaimer

ABSTRACT
Background
Cough is one of the most common symptoms for which patients seek medical
attention from primary care physicians and lung specialists. About 40% of the population at
any one time report cough.
Cough is associated with significantly impaired health-related quality of life.
Levodropropizine is an effective and very well tolerated peripheral antitussive drug. We want
to compare it to central cough suppressants efficacy (opioids and non-opioids) that may be
associated with side effects limiting their use.

Methods
After a comprehensive literature search, a meta-analysis of 7 clinical studies of
levodropropizine vs. control, including a total of 1,178 patients, was performed with the aim
to evaluate the overall comparative efficacy of levodropropizine in the pediatric and adult
population.
Three electronic databases and reference list were used to search for studies that
assessed the efficacy of levodropropizine for treating cough in children and adults using as
standardized efficacy parameters the cough frequency and severity, and number of night
awakenings as outcome parameters.

Results
The meta-analysis of all standardized efficacy parameters showed a highly statistically
significant difference in the overall antitussive efficacy in favor of levodropropizine vs. control
treatments (p = 0.0015).
The heterogeneity test for the efficacy outcome was not statistically significant
(p = 0.0534).
Seven studies met out inclusion criteria. A meta-analysis of the eligible ones showed a
statistically significant difference in the overall anti-tussive effect of levodropropizine versus
control (p = 0.0015).
Conclusions
This analysis indicates that levodropropizine is an effective antitussive drug in children
and adults, with statistically significant better overall efficacy outcomes vs. central antitussive
drugs (codeine, cloperastine, dextromethorphan) in terms of reducing cough intensity and
frequency, and nocturnal awakenings. This result further reinforces the favorable benefit/risk
profile of levodropropizine in the management of cough. The efficacy of levodropropizine in
the treatment of cough in children and adults is higher than that of the common centrally-
acting anti-tussive.

Background
Cough is one of the most common symptoms for which patients seek medical
attention from primary care physicians and lung specialists. In epidemiologic studies, up to
40% of people at any one time report cough.
Clinically, the etiology of cough can be broadly classified into acute and chronic as
deduced from the length of time it persists, acute cough lasting from 1 to 3 weeks and chronic
cough lasting more than 8 weeks. The most frequent causes of acute cough are viral or
bacterial upper respiratory tract infections (URTIs), while those of chronic cough are asthma,
gastro-esophageal reflux disease (GERD), chronic rhinitis, chronic bronchitis, chronic
obstructive pulmonary disease (COPD), ACE-inhibitors treatment.
Regardless of whether it is acute or chronic, cough is associated with significantly
impaired health-related quality of life, as sleep disturbance, nausea, chest pain and lethargy
frequently occur.
The general approach managing any cough begins with a search for the cause of cough
and treatment of the underlying cause. However, to recognize the origin of cough is not
always an easy task and, even when identified, cough is refractory to specific therapy in a
significant number of patients. Furthermore, empiric treatment with antitussive agents is
often needed, in particular when associated with deterioration in the quality of life.
The etiology of cough in children differs from that in adults: viral URTI, protracted
bacterial bronchitis and asthma are frequently the cause of cough in children. So, the
empirical approach commonly used in adults is unsuitable for children. Clinical evaluation of
cough in children should also include an assessment of environmental factors, particularly
tobacco smoke, parental concerns and expectations.
Two types of antitussive drugs are mainly available for the management of cough:
centrally acting (opioids and non-opioids) cough suppressants and peripheral antitussives.
Codeine, dextromethorphan and cloperastine are among the most common central agents
that inhibit cough primarily by their effect on the cough center. Levodropropizine is a non-
opioid agent whose peripheral antitussive action may result from its modulation of sensory
neuropeptide levels within the respiratory tract. In particular, levodropropizine exerts its
antitussive effect through an inhibitory action at the level of the airway sensory nerves and it
has been shown to be able to inhibit in vitro the release of neuropeptides from C-fibers. In
addition, in anaesthetized cats, it markedly reduces the activation of C-fibres and abolishes
the associated reflexes. The activity of levodropropizine on airway sensory units other than
the C-fibres has not been investigated.
Centrally acting cough suppressants, although largely used, may achieve antitussive
activity at the expense of unpleasant or intolerable side effects in adults and serious adverse
events in children: side effects like drowsiness, dependency, loss of awareness, insomnia and
difficulty in breathing.
Furthermore, the efficacy of most antitussive drugs, particularly those for URTI, has
been challenged recently; in fact, the American College of Chest Physicians (ACCP) advises
against the use of antitussive drugs in URTI.
Thus, the aim of the present study was to make a meta-analysis of clinical studies of
levodropropizine vs. control drugs to evaluate the overall comparative efficacy of
levodropropizine in the pediatric and adult population.

Methods
Literature search and study selection
A comprehensive systematic literature search was carried out on the main scientific
electronic databases (PubMed/MEDLINE, EMBASE, and Cochrane Library) from their
inception throughout May 2014, to identify original clinical studies of levodropropizine for
the treatment of cough in the pediatric and adult settings. We sought additional articles from
reference lists of review articles.
The inclusion criteria used to select studies were established a priori. Only studies with
a controlled design (vs. both active control and placebo), including pediatric and adult
patients and assessing efficacy endpoints related to cough outcomes, were selected.
Out of all the studies identified by means of our systematic literature search a total of 7
published clinical studies conducted with levodropropizine in adults or children met the
eligibility criteria and were selected for our meta-analysis.
These studies included a total population of 1,178 patients: four studies included 789
children and three studies included a total of 389 adults.
Levodropropizine was compared with central antitussive in five studies [8–12] and
against a placebo in two studies [13, 14].

Data analysis
Due to the small number of clinical trials in the pediatric and adult population and the
different clinical endpoints, the efficacy outcomes of the selected studies were standardized
in order to compare the overall efficacy of levodropropizine versus control groups. Thus, the
meta-analysis was performed after standardization of the overall efficacy variables assessed
as endpoints in the eligible studies (i.e. reduction in cough frequency and severity, and
number of night awakenings). For all the studies, original Absolute Mean Delta was calculated
as the mean differences between baseline and final values of efficacy parameters in both
groups, with the respective (approximate) standard deviations (SD) and the number of cases
(N) studied in single treatment groups [15]. Standardized Mean Delta was calculated by
means of the original Absolute Mean Delta (with their SD and N) and indicates a fraction or
multiple of unitary standard deviations, expressed as standardized units [16, 17].

Characteristics of included studies

The study of De Blasio et al. [10] was an observational one, carried out in 433 children
(mean age 6 years) whose aim was to evaluate the efficacy of antitussive drugs in reducing
the severity of acute cough associated with a URTI. A subgroup of 161 children received
antitussive treatment with levodropropizine (N = 101) or central cough suppressants (codeine
or cloperastine, N = 60).
In a double blind , two parallel groups, randomized study carried out by Kim et al. [11],
the efficacy of levodropropizine was compared to the central antitussive dextromethorphan
in 77 children (mean age 3 years) with acute or chronic bronchitis with non-recurrent or
slightly recurrent cough treated for 2–3 days (oral t.i.d. administration). In a double blind,
double-dummy, two parallel groups, randomized study Banderali et al. [8] evaluated the
efficacy of levodropropizine compared to dropropizine, administered orally t.i.d. for 3 days,
in the management of non-productive cough in 267 pediatric patients (2–14 years old).
The efficacy of levodropropizine vs. placebo in single oral dose for 4 weeks on
nocturnal cough was investigated by Fiocchi et al. in a small double blind randomized study
in 12 children with asthma [14]. In a double blind, two parallel groups , randomized study
[12], Luporini et al. evaluated the efficacy of levodropropizine compared to dihydrocodeine
(oral t.i.d. administration for 7 days) in the treatment of non-productive cough in 140 adults
with primary lung cancer or metastatic cancer of the lungs. The double blind, double-dummy,
parallel groups, randomized trial of Catena et al. [9], evaluated the therapeutic efficacy of
levodropropizine compared to dextromethorphan, administered orally t.i.d. for 5 days in 209
adults with moderate non-productive cough. The efficacy of levodropropizine vs. placebo
(oral t.i.d administration for 3 days) on cough severity in 40 adult patients with bronchitis was
evaluated in a double blind, randomized , clinical trial carried out by Allegra et al. [13]. The
main characteristics of published studies evaluating the antitussive efficacy of
levodropropizine vs. control in children and adults are summarized in Tables 1 and 2, 3,
respectively.
TABLE 1: Characteristics of clinical studies comparing levodropropizine to controls in children

INTERVENTION
STUDY DESIGN PARTICIPANTS CONDITION OUTCOMES
VS COMPARATOR
Children N = 433
Levodropropizine Acute cough Cough severity
De Blasio Observational (161 valid for
vs. cloperastine associated reduced by all
2012 study analysis) Mean
/codeine with a URTI antitussives
age: 6,1 yrs.
Acute or
RCT double- chronic Improvement in
blind, two Children N = 77 Levodropropizine bronchitis cough frequency
parallel groups (75 valid for vs. with non- and severity
Kim 2002
Oral analysis) Mean dextromethorpha recurrent or significantly higher
administration age: 3 yrs. n slightly with
t.i.d. for 3 days recurrent levodropropizine
cough
RCT double-
blind, double- Significant
dummy, Children N = 267 decrease in cough
Levodropropizine Non-
Banderali prospective, two (258 valid for frequency and
vs. productive
1995 parallel groups, analysis) Age: 2– night awakenings
dropropizine cough
Oral 14 yrs. with both
administration treatment
t.i.d. for 3 days
RCT double- Significant
blind, Oral reduction in
Fiocchi Children N = 12 Levodropropizine Asthmatic
administration in nocturnal
1991 Age: 2–8 yrs. vs. placebo cough
single dose for 4 awakening with
weeks levodropropizine

TABLE 2: Characteristics of clinical studies comparing levodropropizine to controls in adults

INTERVENTION
STUDY DESIGN PARTICIPANTS CONDITION OUTCOMES
VS COMPARATOR
RCT ,double- Higher reduction in
Allegra blind Oral Adults N = 40 Levodropropizine Bronchitis cough severity
1988 administration Age: >13 yrs vs. placebo cough with
t.i.d. for 3 days levodropropizine
Significant
RCT , double- reduction in cough
blind, double- frequency with
Levodropropizine Moderate
dummy, two both treatments;
Catena Adults N = 209 vs. non-
parallel groups Levodropropizine
1997 Age: 18–75 yrs dextromethorpha productive
Oral significantly more
n cough
administration effective in
t.i.d. for 5 days reducing nocturnal
awakenings
RCT, double- Significant
blind, two reduction in cough
Levodropropizine
Luporini parallel gropus Adults Lung cancer severity and
vs.
1998 Oral N = 140 > 18 yrs cough nocturnal
dihydrocodeine
administration awakenings with
t.i.d. for 7 days both treatments
Results
Table 3 shows the original Absolute Mean Delta (with SD and N) calculated for each efficacy
parameter (cough frequency, cough severity, and night awakenings) assessed in each of the
eligible clinical studies, both in levodropropizine and control groups in pediatric and adult
patients.

Table 3: Absolute and standardized mean delta (levodropropizine vs. controls)

LEVODROPROPIZINE CONTROLS C.I.95% P
STUDIES,
Mean Mean STANDARDIZED
PARAMETERS SD N SD N Lower Upper
Delta Delta MEAN DELTA
Banderali,
-8.4 17.3 130 -7.7 13.7 126 -0.045 -0.291 0.202 0.7216
frequency
Dong Soo,
-1.3 1.14 38 -0.7 1.12 37 -0.525 -0.996 -0.055 0.0290
frequency
Banderali,
nocturnal -1.0 2.55 132 -1 2.46 126 0.000 -0.246 0.246 1.0000
awakenings
Fiocchi,
nocturnal -1.06 0.81 12 -0.46 0.74 12 -0.747 -1.639 0.146 0.0966
awakenings
Dong Soo,
-1.2 1.0 38 -0.7 0.99 37 -0.495 -0.967 -0.028 0.0382
severity
De Blasio,
-1.58 0.96 101 -1.1 1.13 60 -0.465 -0.792 -0.139 0.0055
severity
Catena,
-8.3 7.5 110 -8.2 7.75 99 -0.013 -0.287 0.260 0.9250
frequency
Catena,
nocturnal -2.7 1.8 80 -2.12 1.8 79 -0.321 -0.637 -0.005 0.0466
awakenings
Luporini,
nocturnal -1 1.5 34 -1 1.4 29 0.0 -0.508 0.508 1.0000
awakenings
Allegra,
-1.55 1 20 -0.8 1.11 20 -0.696 -1.362 -0.030 0.0410
severity
Luporini,
-1.2 2.92 58 -1.2 3.2 65 0.0 -0.358 0.358 1.000
severity

The results of the standardization of different efficacy variables, in order to make them
comparable, are also shown in Table 3 as Standardized Mean Delta (with 95% C.I. and p
between treatment groups).
The results of the meta-analysis of all standardized parameters, representing overall
antitussive efficacy, showed a highly statistically significant difference in efficacy in favor of
levodropropizine versus control treatments (including central cough suppressants), with p of
0.0015 (Table 4). The size of antitussive effect of levodropropizine vs. control treatments in
the paediatric and adult setting is shown in the overall efficacy meta-analysis chart (Figure 1).
Table 4
Meta-analysis of overall antitussive efficacy (levodropropizine vs. controls)
Levodropropizine versus Controls Standardized Mean Delta C.I. 95 % p

Lower Upper

−0.176 −0.282 −0.069 0.0015

Open in a separate window

Figure 1

Meta-analysis of the efficacy of levodropropizine vs. controls in pediatric and

adult studies.

Concerning the estimated efficacy outcomes, levodropropizine was

superior or equal to controls in all 7 clinical studies, also reaching a
statistically significant difference (p < 0,05) in 4 studies.

In our meta-analysis, the test of heterogeneity for the efficacy outcome

was not statistically significant (p = 0.0534).
Discussion
Cough remains a serious unmet clinical problem [2]. It is a symptom of a range of diseases
such as asthma, chronic obstructive pulmonary disease, GERD, or other conditions of
unknown origin [2].
Managing the symptom of cough, regardless of whether the etiology is known, is also a
challenge to even the most experienced health care provider [1].
The American College of Chest Physicians (ACCP) guidelines also recommend the use of
peripheral cough suppressants such as levodropropizine in adult patients with cough due to
acute or chronic bronchitis for the short-term symptomatic relief. These guidelines state that
levodropropizine related to therapy of acute or chronic bronchitis has got the highest level of
benefit, while the central antitussive drugs such as codeine and dextromethorphan show a
lower level of benefit [18].
Recently, the European Medicines Agency (EMA) started a review of codeine-containing
medicines when used for cough and cold in children. In fact, codeine is converted into
morphine by CYP2D6 enzyme. It is well-known that some patients defined as ‘CYP2D6 ultra-
rapid metabolizers’ convert codeine to morphine at a faster rate, resulting in higher levels of
morphine in their blood leading to toxic effects such as breathing difficulties. EMA is still
evaluating the available evidence on the benefit-risk balance of codeine-containing medicines
when they are used for cough and cold in children [19]. FDA and MHRA recommended against
the use of OTC products for cough and colds, as central antitussives in infants and young
children and the American Academy of Paediatrics has advised against using
dextromethorphan and codeine for treating cough in the pediatric population [20].
The major efficacy of levodropropizine in comparison to central antitussives has been recently
demonstrated in a meta-analysis considering only children with cough of various origin (10).
This standardized meta-analysis of 7 published clinical studies, despite some limitations
mainly linked to the small number of trials included in the analysis and the different efficacy
variables assessed, provides an overview of the major comparative studies on
levodropropizine in terms of efficacy both in the pediatric and adult setting, demonstrating a
higher efficacy of levodropropizine.

Conclusions
Levodropropizine is an effective antitussive drug both in children and adults, showing
statistically significant better outcomes vs. central antitussive drugs in terms of overall
efficacy in reducing cough intensity, frequency and night awakenings.
These positive results are particularly important considering that levodropropizine is a very
well tolerated peripheral antitussive drug, while centrally-acting cough suppressants may be
associated with serious side effects that limit their use, thus further reinforcing the favorable
benefit/risk profile of levodropropizine in the management of cough.
Go to:
Acknowledgements
The authors would like to thank B Chinea, D Ferrari (Ibis Informatica srl) for their statistical
support.

Footnotes
Competing interests
Lanata and Saibene are employees of Dompé SpA, Medical Department. Dompé SpA is a
company that manufactures and commercializes levodropropizine. Dicpinigaitis has served as
a consultant to Dompe. De Blasio has been member of an International Advisory Group
supported by an unrestricted educational grant of Dompé SpA. Moreover, he received speech
honoraria from Dompé SpA at National as well International meetings. Giovanni Fontana
received research grants or fees from Menarini, Edmond Pharma, Dompé Vertona Pharma,
AMD.
Authors' contributions
All authors carried out the literature review. All authors carried out the draft paper. All
authors read and approved the final manuscript.
Go to:
Contributor Information
Alessandro Zanasi, Email: [email protected].
Luigi Lanata, Email: [email protected].
Giovanni Fontana, Email: [email protected].
Federico Saibene, Email: [email protected].
Peter Dicpinigaitis, Email: moc.liamg@nipcidp.
Francesco De Blasio, Email: moc.liamg@aihcraecid.

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Excretion: Via urine (35% as unchanged drug and metabolites). Elimination half-life: 2.3 ± 0.5
hours.

Storage
Store below 30°C. Protect from light.

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