{Generic Name}® Drotaverine 40mg

{Generic Name}® is an antispasmodic drug that works by inhibiting phosphodiesterase-4

(PDE4).5 It is a benzylisoquinoline derivative that is structurally related to papaverine, although it
displays more potent antispasmodic activities than papaverine. Drotaverine has been used in
the symptomatic treatment of various spastic conditions, such as gastrointestinal diseases,
biliary dyskinesia, and vasomotor diseases associated with smooth muscle spasms.1 It also has
been investigated in dysmenorrhea, abortion, 3 and augmentation of labour.4 More recently,
drotaverine gained attention in the treatment of benign prostatic hyperplasia, parainfluenza, and
avian influenza viruses.5

Drotaverine hydrochloride was used effectively and safely to shorten the duration of the first stage of
labor among nulliparous women with active spontaneous labor. 2

Methods

In a randomized, double-blind, placebo-controlled trial, 422 young nulliparous women admitted to Ain-
shams University Maternity Hospital, Cairo, Egypt, in spontaneous labor were initially enrolled between
May and December 2012. Drotaverine hydrochloride (40 mg) or placebo was given at the start of the
active phase of labor and then repeated every 2 hours (maximum 3 doses). All participants were
consistently managed in accordance with the local institutional intrapartum protocol. The primary
outcome was the rate of cervical dilation.
Results

After excluding women who delivered by cesarean, data were analyzed from 320 women. There was a
significant difference in post-treatment labor pain scores, duration of the active phase of labor, and rate
of cervical dilatation between the 2 groups (P < 0.001 for all). There was no difference in maternal
adverse effects.

Comparative evaluation of efficacy and safety of drotaverine versus mebeverine in irritable bowel
syndrome: A randomized double-blind controlled study. 6

Drotaverine was significantly superior in efficacy as compared to Mebeverine in alleviating pain severity
(starting from day 3), frequency and stools-elated symptoms of IBS.

References:

1. Bolaji OO, Onyeji CO, Ogundaini AO, Olugbade TA, Ogunbona FA:
Pharmacokinetics and bioavailability of drotaverine in humans. Eur J Drug Metab
Pharmacokinet. 1996 Jul-Sep;21(3):217-21.

2. Int J Gynaecol Obstet. 2014 Feb;124(2):112-7. doi:10.1016/j.ijgo.2013.08.013. Epub

2013 Nov 7.

3. Tomaszewski D, Balkota M: 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 Res Int. 2015;2015:926953. doi:
10.1155/2015/926953. Epub 2015 Jun 21.
4. Madhu C, Mahavarkar S, Bhave S: A randomised controlled study comparing
Drotaverine hydrochloride and Valethamate bromide in the augmentation of
labour. Arch Gynecol Obstet. 2010 Jul;282(1):11-5. doi: 10.1007/s00404-009-
1188-8. Epub 2009 Jul 31.
5. Pavel IZ, Heller L, Sommerwerk S, Loesche A, Al-Harrasi A, Csuk R: Drotaverine - a
Concealed Cytostatic! Arch Pharm (Weinheim). 2017 Jan;350(1). doi:
10.1002/ardp.201600289. Epub 2016 Nov 23.
6. Saudi J Gastroenterol . 2021 Feb 24. doi: 10.4103/sjg.SJG_266_20.