INTRODUCTION
Drotaverine
hydrochloride is an analogue of papaverine with smooth muscle relaxant
properties. It is a non-anticholinergic antispasmodic, which selectively
inhibits phosphodiesterase IV and is accompanied by a mild calcium
channel-blocking effect. Adverse effects with drotaverine hydrochloride, such
as hypotension, vertigo, nausea, and palpitation, are mostly mild. It can be
supposed that intravenous drotaverine hydrochloride might be a feasible
antimotility alternative to intravenous hyoscine-N-butylbromide. Drotaverine
is a cholinergic muscarinic antagonist, an antispasmodic, effective in
treatment of spasm or twitches of the smooth muscles and pain. Drotaverine is
primarily indicated in conditions like cervical spasm during labor, biliary
spasm, cholangitis, cholecystitis, cholecytolithiasis, cystitis,
nephrolithiasis, papilitis, smooth muscle spasm, stone formation,
ureterolithiasis, urinary spasm, urolithiasis, vesical tenesmus. It is also
used to relieve pain caused due to irritable bowel syndrome, headache and
menstrual cycle. However, Drotaverine is contraindicated in conditions like
cardiac, renal and hepatic insufficiency and 2nd & 3rd
degree AV block. Intravenous
drotaverine provides effective pain relief in more than two-thirds of patients
with renal colic, with no serious side-effects. [1]
Several studies have been done showing
use of drotaverine for acceleration of labor but is less effective in relieving
of labor pains in addition atonic postpartum hemorrhage was seen more common[1, 2].
Intramuscular administration of drotaverine
in dilatation phase of uncomplicated pregnancies was found to reduce the
duration of cervical dilatation, total duration of labor and incidence of
cervical tears, with no change in stage 2 and 3 of labor[3].
In another study Intramuscular drotaverine decreased the time to spontaneous
micturition and decreased the incidence of urinary bladder catheterization. [4]
As a
smooth muscle relaxant, drotaverine will exacerbate existing hypotension
symptoms in patients and cause such symptoms to appear where they are absent
for some individuals, according to Biotavia. This side effect is particularly
important to consider for those who have poor circulation or low blood pressure
prior to taking the medication. For these patients, drotaverine can cause
extreme hypotension leading to fainting and collapse.
The aim of this study is to evaluate
incidence of hypotension and allergic reaction with Drotaverine. It enhances
other spasmolytic effects (including M-cholinblockers), hypotension caused by
tri-cyclic anti-depressants, quinidine, procainamide. It reduces the morphine
spasmogenic activity, anti-parkinsonic properties of levodopa (tremor and
rigidity increase are observed). [5]
METHODOLOGY
A retrospective cross-sectional study
was designed by enrolling a total of 62 patients. Data collection form was used
for gathering information.
Inclusion
criteria: All the patients, irrespective of
gender, ethnicity, above 18 years of age, were enrolled in the study.
Exclusion
criteria: All the patients, below 18 years of
age were excluded from the study.
RESULTS
One out of 62 patients experienced
hypotension – an incidence of 0.016%
DISCUSSION:
Drotaverine is a very good therapeutic
option for anti-spasmodic activity. With hyoscine injection withdrawn from
international market, drotaverine is an excellent drug for spastic smooth
muscle pain. Risk of allergic reactions and hypotension has been a concern with
the use of this drug. Official literature mentions a <0.1% risk of
hypotension. This particular adverse effect is more significant with IV than
I/M route of administration. Furthermore, rapid injection increases the risk of
drotaverine adverse effects. There have been anecdotal reports of physicians
concerned on safety of drotaverine in vulnerable cases in public sector. SKMCH
received multiple reminders from Punjab drug control unit (PDCU) on concern
over drotaverine safety. We evaluated in-house data for the year 2017. The drug
is non-formulary at our institute; hence use is not very common. A total of 62
patients received parenteral drotaverine for the year 2017. 1 out of 62
(0.016%) suffered hypotension right after administration of IV injection. The
patient suffered a single episode of B.P 90/60 – a drop from 125/70 earlier. NS
(0.9%) was initiated immediately which normalized the B.P in next 40 minutes.
Medication review revealed regular use of dimenhydrinate 50mg IV q8hrs for 2
days. Hypotension with drotaverine is expectedly enhanced with regular use of
drugs with hypotensive potential e.g. anti-hypertensives, anti-cholinergics, tricyclic
antidepressants etc.
Allergic skin reaction with drotaverine
has been a concern in the anecdotal reports from public sector. There was no
case of allergy reported with the drug at SKMCH for the year, 2017.
Drotaverine appears a good therapeutic
option with acceptable adverse effect profile. Extra caution is recommended for
use with hypotensive potential drugs. Parenteral injections should not be
administered rapidly. I/M route is preferred over I/V in terms of safety
profile.
CONCLUSION
Parenteral drotaverine use is safe in
adults. However, patients on medications like anit-hypertensives,
anti-histamines and tri-cyclic anti-depressents should be observed cautiously
while using drotaverine injection for the risk of hypotension.
REFERENCES
1. Singh,
K., et al., Drotaverine hydrochloride for augmentation of labor. International
Journal of Gynecology & Obstetrics, 2004. 84(1): p. 17-22.
2. Thapa,
M., et al., Effectiveness of drotaverine hydrochloride in progression of
labour. Nepal Journal of Obstetrics and Gynaecology, 2007. 2(2): p. 9-11.
3. Sangeeta,
S. and B. Lagisetti, Effect of Drotaverine administration on cervical
dilatation in uncomplicated deliveries.
4. Tomaszewski,
D. and M. Balkota, Intramuscular administration of drotaverine hydrochloride
decreases both incidence of urinary retention and time to micturition in
orthopedic patients under spinal anesthesia: a single blinded randomized study.
BioMed research international, 2015.