Medicine 2: Drotaverine

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Medicine 2: Drotaverine

What is it?

Drotaverine is a medicine that helps relax muscles and reduce cramps. It works by blocking a certain enzyme (PDE4) in the body. Drotaverine is commonly used to treat pain and discomfort caused by conditions like stomach cramps, bile duct problems, and other issues involving tight or spasming muscles.¹

How does it work?

Drotaverine inhibits the PDE4 isoenzyme, leading to smooth muscle relaxation. However, in the airway and uterine smooth muscle, it might bind to L-type calcium channels, causing further smooth muscle relaxation. This relaxation can help reduce the spasms and contractions that cause menstrual pain.²

What is the efficacy?

Method: This double-blind, double-dummy, randomized, comparative, multicentric study enrolled 200 women (100 women in each arm) in the age range of 18–35 years with primary dysmenorrhea at four centers. The patients were randomly allocated to either aceclofenac 100mg–drotaverine 80mg b.i.d or aceclofenac 100mg alone b.i.d for a maximum of 3 days.

Results: Both treatments showed significant improvement in baseline values in all efficacy parameters. The total number of doses consumed by patients treated with combination therapy was less than with monotherapy (150 vs 168 doses). The combination was significantly superior to monotherapy with respect to patient's and investigator's global evaluation of the efficacy (p=0.002 and p=0.001, respectively). Both treatments were well tolerated.

Conclusion: This study establishes the efficacy of the aceclofenac–drotaverine combination in patients with primary dysmenorrhea. The fixed-dose combination of aceclofenac and drotaverine should therefore be considered as a suitable, effective, and well-tolerated treatment option for primary dysmenorrhea.³

Side-effects:

Short-term effects: Nausea, constipation, diarrhea.

Long-term effects: Hypertension and palpitations.

References

1. National Center for Biotechnology Information. PubChem Compound Summary for CID 1712095, Drotaverine [Internet]. Bethesda (MD): National Library of Medicine (US); [cited 2025 May 20]. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Drotaverine

1. Traserra S, Barber C, Alcalá-González LG, Landolfi S, Lange R, Malagelada C, et al. Evaluation of the mechanism of action of paracetamol, drotaverine, and peppermint oil and their effects in combination with hyoscine butylbromide on colonic motility: human ex-vivo study. Front Pharmacol. 2024 Jul 10;15:1384070. doi: 10.3389/fphar.2024.1384070.

1. Pareek A, Chandurkar NB, Patil RT, Agrawal SN, Uday RB, Tambe SG. Efficacy and safety of aceclofenac and drotaverine fixed-dose combination in the treatment of primary dysmenorrhoea: a double-blind, double-dummy, randomized comparative study with aceclofenac. Eur J Obstet Gynecol Reprod Biol. 2010 Sep;152(1):86–90.