Original Article

Effectiveness and Safety of Isoxsuprine Hydrochloride

as Tocolytic Agent in Arresting Active/Threatened
Preterm Labor and Its Role in Maintenance
Tocolysis—A Prospective, Open-Label Study
Purushottam B. Jaju, MD, OBG1

1 Department of Obstetrics and Gynecology, B.M. Patil Medical Address for correspondence Purushottam B. Jaju, MD, OBG,
College Hospital and Research Centre, Vijayapur, Karnataka, India Department of Obstetrics and Gynaecology, BLDEA’s, Sri B. M. Patil
Medical College Hospital, Vijayapura, Karnataka 586103, India
Am J Perinatol (e-mail: p.b.jaju@gmail.com).

Downloaded by: State University of New York at Stony Brook. Copyrighted material.
Abstract Objective The aim of the study is to obtain insights on the short and long-term safety
and effectiveness of isoxsuprine hydrochloride as a tocolytic agent in the management
of PTL.
Study Design In this prospective, single-center, noncomparative study, patients (with
preterm labor at gestational age of 24–37 weeks) were administered intravenous (IV)
infusion of 40-mg isoxsuprine hydrochloride until uterine quiescence, followed by
intramuscular (IM) injection of isoxsuprine hydrochloride 10 mg/4-hourly for first
24 hours and maintained with retard 40-mg sustained release capsule (two times a
day) till the time of delivery or 37 completed weeks of pregnancy.
Results All patients (n ¼ 50) achieved successful tocolysis in 24 hours and 48 hours
postadministration of isoxsuprine hydrochloride (IV/IM/oral). Mean (SD) gestation age
at the time of delivery was 39.8  2.1 weeks, with latency period of 58.5  18.7 days.
Pregnancy outcomes were normal in all the patients and no congenital anomaly/fetal
Keywords infection was reported. Mean (SD) fetal birth weight was 2.7  0.3 kg; mean (SD) Apgar
► isoxsuprine score at 1 and 5 minutes were 7.5  0.6 and 9.2  0.4, respectively. Maternal tachycardia
► latency period and vomiting (8.0% each) were the commonly reported adverse drug reactions, which were
► preterm labor resolved with dose adjustment.
► pregnancy Conclusion Isoxsuprine was found to be an effective and well-tolerated tocolytic
prolongation agent in arresting PTL, in turn resulting in the overall improvement in maternal and
► tocolytics perinatal outcomes.

Preterm labor, defined as the onset of labor between 24 and 37
completed weeks of gestation, presents the most significant
clinical challenge for obstetricians, globally.1,2 The incidence of
preterm labor varies between 8 and 10% of all pregnancies,
accounting for nearly 80% of the neonatal morbidity.3,4 Com-
pared with the developed world, the incidence of preterm labor
is greater in developing countries. Amongst the developing
countries, India has a very high incidence of 23.3% preterm
labor and 10 to 69% preterm delivery.5
Despite advances in obstetric and neonatal care, the
incidence of preterm birth continues to increase.6,7 It is
estimated that 15 million preterm births take place each
year, with over 1 million infant deaths due to complications
of preterm birth.7 The causes of preterm labor are unclear,
but the consequences are well defined. Gestational age is
inversely proportional to the risk of neonatal morbidity and
mortality. Lower the gestational age, higher the risk of
mortality and morbidity.8 Preterm birth is responsible for

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Effectiveness and Safety of Isoxsuprine Hydrochloride
three-fourths of the cases of neonatal mortality and one-half
of the cases of neurologic impairment in children.6,9,10 The
risk of long-term neurodevelopmental and medical disabil-
ities is high among children born preterm.7,11
The delivery of a preterm neonate is a clinical challenge for
an obstetrician, that threatens the life and health of the
infant.12 Tocolytic therapy to arrest preterm labor is an impor-
tant intervention in obstetrics. Tocolytic agents inhibit uterine
contractions and relax the uterine myometrium by different
mechanisms leading to the arrest of preterm labor.13 They help
in delaying preterm delivery, thereby permitting time for
antenatal corticosteroid administration, which in turn helps
in fetal lung maturity.13,14
Different classes of drugs such as β-agonists, calcium
channel blockers, cyclooxygenase inhibitors, magnesium
sulfate, nitrates, and oxytocin receptor antagonists are
used as tocolytics in the management of preterm labor13;
however, β-agonist agent, isoxsuprine, and oxytocin receptor
antagonists, atosiban, are the only two drugs approved by the
Central Drugs Standard Control Organization for the man-
agement of preterm labor in India.15
Isoxsuprine hydrochloride, a β-adrenergic agonist, was
the first β-agonist used to inhibit preterm labor in 1961.16,17
It is one of the most widely used tocolytic agent in India.5 A
systematic review by Giorgino and Egan provides prelimi-
nary evidence that isoxsuprine hydrochloride administered
acutely (IV administration) and as maintenance therapy (IM
or oral administration) is effective in prolonging pregnancy
in women at risk of preterm delivery.18
This combined analysis of 25 publications containing indi-
vidual and double-blind studies data by Giorgino and Egan
revealed a beneficial effect of isoxsuprine in 89% cases at the
risk of preterm delivery, along with the evidence of favorable
tolerability.18 Several other clinical studies performed in
patients at risk of preterm labor5,18–24 have demonstrated
therapeutic efficacy, in addition to favorable tolerability of
isoxsuprine hydrochloride in arresting preterm labor.
However, side effects like tachycardia and hypotension are
observed in all class of tocolytic drugs, mainly dose-depen-
dent, and can be controlled with dose titration and appropria-
tion. However, a perfect tocolytic agent which is 100% effective
and has no fetomaternal side effects does not exist.25
Isoxsuprine hydrochloride is an economical and approved
drug, being used for over 6 decades in India.26 In view of the
observations concerning efficacy and safety of the drug, Feder-
ation of Obstetric and Gynaecological Societies of India has
conceived a treatment algorithm with revised dosage regime
for isoxsuprine hydrochloride. The present study was con-
ducted with the objective to understand the effectiveness
and safety of isoxsuprine hydrochloride as a tocolytic agent
at this updated/recommended dose regime in arresting
active/threatened preterm labor and to understand its role in
maintenance tocolysis.
Materials and Methods
This was a prospective, single center, open-label, noncom-
parative study (CTRI/2018/04/013262) evaluating effective-
American Journal of Perinatology
Jaju
ness and safety of isoxsuprine hydrochloride as a uterine
relaxant in preterm labor, and its effect on maternal and
neonatal outcomes. This pilot study was conducted with 50
patients, from April 2018 to September 2018, at the Depart-
ment of Obstetrics and Gynecology, B.M. Patil Medical
College, Vijayapur, Karnataka, India.
Patients with preterm labor at the gestational age of 24 to
37 weeks (threatened and active PTL), with two or more
uterine contractions per 20 minutes each lasting for at least
20 seconds, cervical dilatation <3 cm, cervical effacement
<50%, and intact membrane were included in this study.
Patients with antepartum hemorrhage, fetal malformations,
pregnancy with heart disease and diabetes mellitus, multiple
pregnancies, hydramnios, and premature rupture of mem-
branes were excluded from the study.
Patients were treated as per revised dosage regime and
administered an IV infusion of 40-mg isoxsuprine hydro-
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chloride (Duvadilan, Abbott India Ltd), diluted in 500 mL of
5% w/v dextrose, dip rate set at 8 drops/min (0.04 mg/min).
Drop rate was increased by 8 drops/min every 15 minutes
until uterine quiescence and was further continued till
subsequent 12 hours. Patients achieving uterine quiescence
were administered an IM injection of isoxsuprine hydrochlo-
ride, 10 mg/4 hourly for first 24 hours. Patients were then
prescribed isoxsuprine hydrochloride 40-mg sustained
release capsule twice daily (Duvadilan retard, Abbott India
Ltd) as a maintenance therapy for next 24 hours, which was
continued till the time of delivery or 37 completed weeks of
pregnancy, whichever was earlier.
The study was conducted in accordance with the
principles of Declaration of Helsinki and in compliance
with Good Clinical Practice guidelines. Written informed
consent was obtained from all study participants or legally
acceptable representative of the patient, before being
examined for eligibility criteria. The study protocol and
the informed consent form were reviewed and approved by
relevant Institutional Review Board before initiation of the
study.
Study End Points
The primary end point of the study was the percentage of
patients achieving successful tocolysis in the first 24 hours,
first with IV and then with IM administration of isoxsuprine
hydrochloride injection, followed by isoxsuprine hydrochlo-
ride retard 40-mg capsule in the subsequent 24 hours as
maintenance therapy. Treatment was considered successful
if the uterine quiescence was maintained for at least
48 hours.
The secondary end points included maternal latency
period, fetal Apgar score (1 minute and 5 minutes), fetal birth
weight, percentage of fetal neonatal intensive care unit
(NICU) admissions with reasons, and global assessment of
the effectiveness and tolerability by physician and patients,
post-treatment with isoxsuprine hydrochloride therapy.
Safety with isoxsuprine hydrochloride injection during acute
therapy and with isoxsuprine hydrochloride retard 40-mg
capsule during maintenance therapy was also summarized.
 Effectiveness and Safety of Isoxsuprine Hydrochloride Jaju

Statistical Analysis Table 2 Gestational and neonatal outcomes

The data was analyzed using SPSS 23.0 software and descrip-
tive statistics, independent samples t-test, and nonparamet- Variable(s) N ¼ 50
ric test as required. p-value less than 0.05 was assumed to be Gestation outcomes
significant. Gestation age delivery (weeks) (mean  SD) 39.8  2.1
Latency period (days) (mean  SD) 58.5  18.7
Results Neonatal outcomes

A total of 50 patients with a mean (SD) age of 24.4  3.3 years
were enrolled in the study. The mean (SD) gestation age was
31.5  2.6 weeks at the baseline. Majority of the patients were
multigravida (29 [58.0%]). The demographic and baseline
characteristics of the patients are summarized in ►Table 1.
All the patients (50 [100.0%]) achieved successful tocolysis
in the first 24 hours postadministration of isoxsuprine hy-
drochloride injection (IV administration followed by IM
injection). Further, tocolysis was maintained in all the
Fetal birth weight (kg) (mean  SD) 2.7  0.3
APGAR score at 1 minute (median [range]) 7.0 (2.0)
APGAR score at 5 minutes (median [range]) 9.0 (1.0)
7.0 (2.0) and 9.0 (1.0), respectively. Only one infant (1 [2.0%])
required NICU admission on day 4 postbirth due to hyper-
bilirubinemia, who was in NICU for 3 days. Gestational and
neonatal outcomes are summarized in ►Table 2, and preg-

patients (50 [100.0%]) for the subsequent 24 hours with
isoxsuprine hydrochloride retard 40-mg capsule therapy.
The mean (SD) gestation age at the time of delivery was
39.8  2.1 weeks. The duration of the latency period ranged
between 13 and 97 days, with a mean (SD) latency period of
58.5  18.7 days. Pregnancy outcomes were normal in all the
patients with the majority (47 [94.0%]) being vaginal deliv-
eries. No congenital anomaly or fetal infection was reported.
More number of patients completed gestation period of
37 weeks as compared with the deliveries before 37 weeks
(90 vs. 10%; 95% CI 0.03–0.22)
The mean (SD) fetal birth weight was 2.7  0.3 kg. The
median (range) Apgar score at 1 minute and 5 minutes were
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nancy outcomes in ►Table 3.
Gestation and neonatal outcomes at the time of delivery
were further analyzed by dividing study cohort into two
groups, patients with gestation age of <32 weeks (group 1)
and >32 weeks (group 2), at baseline. The mean (SD)
gestation ages at the time of delivery were 39.1  1.9 and
40.5  2.1 weeks in groups 1 and 2, respectively, a value
which was significantly higher by 1.4 weeks (95% CI 0.2–2.5;
p < 0.05) in group 2. The mean (SD) latency period was
67.7  16.8 days in group 1 and 47.7  14.8 days in group 2.
The latency period was significantly higher in group 1 by
20 days (95% CI 11.0–29.1; p < 0.001) compared with group
2. Results are summarized in ►Table 4.

Table 1 Demographic and baseline characteristics of patients

Table 3 Pregnancy outcomes
Variable(s) N ¼ 50
Age (years) (mean  SD) 24.4  3.3 Variable(s) N ¼ 50
Weight (kg) (mean  SD) 57.3  6.0 Pregnancy outcome, n (%)
Height (cm) (mean  SD) 151.0  3.5 Normal 50 (100%)
Uterine contractions 3.9  0.6 Type of delivery, n (%)
(in 20 minutes) (mean  SD)
LSCS 3 (6.0%)
Gestation age at baseline 31.5  2.6
(weeks) (mean  SD) Vaginal 47 (94.0%)

Cervical dilatation (mean  SD) 1.8  0.5 NICU admission, n (%)

Cervical effacement (mean  SD) 26.4  17.0 Yes 1a (2.0%)

Gravidity, n (%) No 49 (98.0%)

Multigravida 29 (58.0%) Congenital anomaly, n (%)

Primigravida 21 (42.0%) No 50 (100%)

Education, n (%) Any fetal infection, n (%)

Graduate/PG 18 (36.0%) No 50 (100%)

Secondary/SSC 16 (32.0%) APGAR score at 1 minute, n (%)

Elementary education 13 (26.0%) Excellent condition (score between 7 and 10) 50 (100%)

Uneducated 03 (6.0%) APGAR score at 5 minutes, n (%)

Occupation, n (%) Excellent condition (score between 7 and 10) 50 (100%)

Housewife 29 (58.0%) Abbreviations: NICU, neonatal intensive care unit; LSCS, lower segment
cesarean section.
Working 21 (42.0%) a
Day 4 hyperbilirubinemia, baby admitted in NICU for 3 days.

American Journal of Perinatology

Effectiveness and Safety of Isoxsuprine Hydrochloride
Table 4 Gestation and neonatal outcomes-grouped by gestation age at baseline
Variable(s) Group 1a
(n ¼ 27)
Gestation age at delivery (weeks) (mean  SD) 39.1  1.9
Latency period (d) (mean  SD) 67.7  16.8
Fetal birth weight (kg) (mean  SD) 2.6  0.4
APGAR score at 1 minute (median [range]) 7.0 (2.0)
APGAR score at 5 minutes (median [range]) 9.0 (1.0)
a
Patients with gestation age of <32 weeks at baseline.
b
Patients with gestation age of >32 weeks at baseline.
c
Analyzed using independent sample t-test.
d
Analyzed using Mann-Whitney U-test.
The mean (SD) fetal birth weight was 2.6  0.4 kg in
group 1 and 2.7  0.3 kg in group 2. The median (range) Apgar
scores at 1 and 5 minutes were 7.0 (2.0) and 9.0 (1.0) in group
1 and 2, respectively (►Table 4).
Furthermore, physicians ranked efficacy of isoxsuprine
hydrochloride as excellent in 47 (94.0%) patients, and toler-
ability as excellent in 41 (82.0%) patients, based on global
assessment. Likewise, the efficacy of the drug was ranked as
excellent by 48 (96.0%) patients, and tolerability as excellent
by 44 (88.0%) patients.
Safety
Most commonly reported adverse drug reactions (ADR) were
maternal tachycardia (04 [8.0%]) and vomiting (04 [8.0%]),
followed by fetal tachycardia (02 [4.0%]) and nausea (02
[4.0%]). However, ADRs were resolved with dose adjustment.
No incidence of ADR was observed during treatment with
isoxsuprine hydrochloride retard 40-mg capsule.
Discussion
Preterm birth represents the single largest cause of mortality
and morbidity for newborns. Treatment with tocolytics has
been associated with successful pregnancy prolongation for
48 hours, permitting administration of antenatal corticoste-
roids, reducing neonatal morbidity and mortality.27
The present study evaluated effectiveness and safety of
isoxsuprine hydrochloride administered acutely (IV adminis-
tration followed by IM injection) and as maintenance therapy
(oral isoxsuprine hydrochloride capsule—40 mg) in arresting
preterm labor, and its effect on maternal and neonatal
outcomes.
All the patients in this study achieved successful tocolysis
in the first 24 hours postparenteral administration of iso-
xsuprine hydrochloride (IV followed by IM administration)
and right through the maintenance therapy during the
subsequent 24 hours. Successful tocolysis rate achieved
with isoxsuprine hydrochloride in our study is almost similar
to tocolysis rate of 84%,28 88.0%,23 and 85.0%24 reported by
Roy et al,28 Rohtagi,23 and Singh et al,24 respectively, but
considerably higher than that reported by Raymajhi and
Pratap (70%)29 and Nagendrappa et al (75%).19
American Journal of Perinatology
Jaju
Group 2b Sig. p-Value
(n ¼ 23) (two-tailed)
40.5  2.1 0.020 p < 0.05c
47.7  14.8 0.000 p < 0.001c
2.7  0.3 0.155 p > 0.05c
7.0 (2.0) 0.653 p > 0.05d
9.0 (1.0) 0.752 p > 0.05d
The mean (SD) gestation age at the baseline was
31.5  2.6 weeks in our study, which was similar to results
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reported by other studies.12,19,28,30,31 The mean (SD) ges-
tation age at the time of delivery in our study was 39.8  2.1
weeks and mean (SD) latency period (prolongation of
pregnancy) was 58.5  18.7 days, which was comparatively
higher than the mean time gain of 28.41 days as reported by
Singh et al24 and 36.77 days as reported by Jaju et al.22 Also, in
our study, prolongation of pregnancy was significantly more
in patients with gestation age of <32 weeks at baseline,
compared with a patient with gestation age of >32 weeks
(67.7 days vs. 47.7 days; p < 0.001). The mean prolongation of
pregnancy by 58.5 days in our study shows that isoxsuprine
hydrochloride therapy provided sufficient time for cortico-
steroid to act, thereby minimizing the incidence of neonatal
complications.
Pregnancy outcome was normal for all the patients (50
[100.0%]) in our study, which was slightly higher than that
reported by Rohtagi.23 Most of the deliveries in our study
were vaginal (47 [94.0%]), in comparison to 60%28 and 73.9%
12
vaginal deliveries reported by Roy et al28 and Mahajan and
Marwah,12 respectively. There was no congenital anomaly or
fetal infection reported in our study.
The data from our study revealed the innocuous effect of
isoxsuprine hydrochloride on the fetus. Overall, the health of
all the newborns (50 [100.0%]) was in excellent condition. The
mean (SD) fetal birth weight in our study was 2.7  0.3 kg,
which was comparable to the birth weight of 2.5 kg30 and
2.8 kg28 reported by Sirohiwal et al30 and Roy et al,28 respec-
tively. The mean (SD) Apgars score were 7.5  0.6 at 1 minute
and 9.2  0.4 at 5 minutes. The number of infants requiring
NICU admission in this study (1 [2.0%]) were significantly
lower than (11 [24.0%])28 NICU admissions reported by Roy
et al.28 There were no incidences of fetal death (stillbirth) or
early neonatal death in comparison to incidences of perinatal
mortality (2 [6.66%]) reported by Raymajhi and Pratap.29
The ADRs observed in our study with isoxsuprine hydro-
chloride, in the acute and maintenance phase, were less as
compared to the ADRs reported by the others.12,19,28,31 Most
commonly reported ADRs in our study were maternal tachy-
cardia and vomiting. The incidence of ADR was observed with
parenteral administration of isoxsuprine; no ADRs were
reported during maintenance therapy with isoxsuprine oral
 Effectiveness and Safety of Isoxsuprine Hydrochloride
retard 40-mg capsules. No incidence of serious ADR was
reported in our study. All the ADRs reported in our study
were mild in nature, which reflects that isoxsuprine hydro-
chloride injection (IV followed by IM administration) and
maintenance therapy (oral) were well-tolerated.
Overall, the drug proved to be effective in arresting preterm
labor, with a successful (100%) tocolysis effect during 24 and
48 hours of administration. Furthermore, a considerable in-
crease in gestation period was observed with maintenance
therapy, without causing any side effects. Results from our
study present evidence of effectiveness and safety of isoxsu-
prine hydrochloride administered parenterally (IV administra-
tion followed by IM injection) and as maintenance therapy (oral
isoxsuprine hydrochloride capsule) in arresting preterm labor,
leading to overall improvement in maternal and neonatal
outcomes.
However, small sample size, nonstatistically powered and
absence of control and/or comparator group are some of the
limitations of this study. Further, large scale randomized
controlled studies are warranted to substantiate the results.
Conclusion
Isoxsuprine was found to be an effective and well-tolerated
tocolytic agent in arresting preterm labor and during main-
tenance tocolysis, resulting in an improvement in maternal
and perinatal outcomes.
Note
This data was presented (oral presentation) at the 26th
World Congress on Controversies in Obstetrics, Gynecology
& Infertility (COGI), London, UK—November 23 to 25, 2018
Funding
This investigator-initiated study was funded by Abbott
India Limited.
Conflict of Interest
None declared.
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American Journal of Perinatology