What is Drotaverine Hydrochloride?
Drotaverine hydrochloride belongs to the benzylisoquinoline chemical family and serves as a powerful antispasmodic medication to treat smooth muscle spasms. This medication serves as a treatment for multiple spastic disorders, including gastrointestinal issues, dysmenorrhea, biliary dyskinesia, and urological diseases. The structural similarity between drotaverine and papaverine results in enhanced antispasmodic effects through PDE4 inhibition that promote smooth muscle relaxation with minimal cardiovascular consequences.
Alfa Chemistry offers high-quality drotaverine hydrochloride for pharmaceutical applications, ensuring rigorous quality standards and reliable supply chains.
| Catalog | Product Name | |
| ACM985126 | Drotaverine hydrochloride | Inquiry |
How Does Drotaverine Hydrochloride Work?
Drotaverine hydrochloride works mainly by selectively blocking PDE4 enzyme activity that breaks down cyclic adenosine monophosphate (cAMP). Drotaverine triggers smooth muscle relaxation by boosting levels of intracellular cAMP. The non-specific suppression of PDE enzyme activity lessens calcium entry into muscle cells, which boosts its antispasmodic properties. The drug targets smooth muscles throughout the gastrointestinal, biliary, and genitourinary systems to provide relief from spasms linked to irritable bowel syndrome (IBS), renal colic, and dysmenorrhea.
Therapeutic Applications of Drotaverine Hydrochloride
- Gastrointestinal Disorders
Drotaverine hydrochloride serves as a standard treatment option for spasmodic gastrointestinal pain. Research has proven that this treatment effectively reduces both pain and discomfort in the abdominal area for patients with irritable bowel syndrome. An IBS patient treated with drotaverine for four weeks showed significant reduction in pain frequency and severity as well as stool frequency through a randomized, double-blind, placebo-controlled study[1].
- Dysmenorrhea
The medication works to relieve menstrual cramps through the relaxation of uterine smooth muscle. This medication relieves primary dysmenorrhea symptoms through non-hormonal pain treatment options.
- Biliary and Renal Colic
Drotaverine hydrochloride provides treatment for both biliary and renal colic by diminishing spasms in the biliary and urinary tracts, which helps to relieve pain caused by gallstones and kidney stones.
- Obstetric Applications
Drotaverine helps to alleviate cervical muscle spasms during labor, which assists with cervical opening and decreases discomfort from labor. Pregnant women must undergo a thorough evaluation of the risk-benefit balance before using this medication because of possible risks to the fetus.
Fig.1 Effects of drotaverine on spontaneous phasic contractions, cch-induced contractions, and nerve-mediated excitatory responses of circular and longitudinal muscles compared with vehicle (DMSO)[2].
Dosage and Administration of Drotaverine Hydrochloride
| Patient Group | Recommended Dosage | Frequency |
| Adults | 40-80 mg | 1-3 times daily |
| Children (1-6 years) | 10-20 mg | 1-2 times daily |
| Children (>6 years) | 20-40 mg | 1-2 times daily |
*The above data is for reference only.
Prescription dosages must be tailored according to both symptom severity and patient response. Following medical advice helps prevent adverse effects while achieving the best therapeutic results.
What Are the Potential Side Effects of Drotaverine Hydrochloride?
Drotaverine hydrochloride usually causes no severe reactions, but patients may experience mild to moderate side effects such as:
- Gastrointestinal: Nausea, constipation, indigestion
- Nervous System: Headache, dizziness, insomnia
- Cardiovascular: Palpitations, hypotension
- Immune System: Rash, pruritus, angioedema
Patients who face severe or ongoing side effects need to contact a healthcare professional immediately.
Fig.2 Data reference: Proportion of patients reporting abdominal pain, cramping, or discomfort[3].
Drug Interactions of Drotaverine Hydrochloride
Drotaverine hydrochloride may interact with several medications, altering their therapeutic effects:
- Isosorbide Mononitrate: The drug functions as a nitrate medication, which helps treat angina. The combination of drotaverine tablets with this medication enhances vasodilatory activity.
- Riociguat: The drug falls under the soluble guanylate cyclase (sGC) stimulant category and serves as a treatment for adults with chronic thromboembolic pulmonary hypertension. The combination of drotaverine tablets with riciguat enhances the antihypertensive properties of riciguat.
- Patent Blue: This synthetic blue dye serves as a food coloring agent throughout Europe. Patent Blue serves as the coloring agent for lymphatic vessels during sentinel lymph node biopsies and lymphangiography preceding imaging procedures in hospitals. When taken with Drotaverine tablets, the effects of Drotaverine may be reduced.
Medical providers need to evaluate possible drug interactions prior to prescribing drotaverine.
| Catalog | Product Name | |
| ACM16051777 | Isosorbide mononitrate | Inquiry |
| ACM3536490 | Patent blue v | Inquiry |
Is Drotaverine Hydrochloride Safe During Pregnancy?
The use of drotaverine during pregnancy remains controversial. Research on animals indicates possible fetal dangers, especially during early pregnancy stages. The drug should be administered only when the anticipated medical advantages surpass possible adverse effects. Alfa Chemistry advises that pregnant users of drotaverine seek medical advice from a healthcare professional before use.
What Precautions Should Be Taken When Using Drotaverine Hydrochloride?
- Those who have previously shown hypersensitivity to drotaverine or similar substances must stay away from this medication.
- Patients suffering from hypotension need to proceed with care because the treatment could cause additional decreases in their blood pressure.
- Patients who suffer from severe liver or kidney impairment require medical supervision.
- The medication should not be used beyond its expiration date.
Frequently Asked Questions (FAQs)
(1) Is drotaverine hydrochloride safe for children?
Children can receive drotaverine under medical supervision with dosages customized according to their age and weight.
(2) Is drotaverine hydrochloride approved by the FDA?
Although the FDA has not approved drotaverine hydrochloride, it remains in regular use throughout several nations, including Thailand.
(3) Is drotaverine an antibiotic?
No, drotaverine is not an antibiotic. This antispasmodic drug works by blocking PDE4 and stopping cAMP from attaching to PDE4. This leads to smooth muscle relaxation. It does not treat infections.
(4) Is drotaverine hydrochloride a pain reliever?
Drotaverine hydrochloride functions as a pain reliever specifically designed to treat pain caused by smooth muscle spasms. The antispasmodic effects of the drug reduce muscle cramps and spasms, which results in pain relief and muscle relaxation.
(5) Is it safe to combine mefenamic acid with drotaverine hydrochloride?
Mefenamic acid administration is compatible with drotaverine hydrochloride usage. Doctors often prescribe the combination because it delivers dual antispasmodic and analgesic benefits. The combination works to relieve symptoms of spasmodic dysmenorrhea, which includes menstrual pain as well as colic pain from various sources, including ureteric and biliary colic and intestinal colic.
References
- Rai R. R., et al. Efficacy and Safety of Drotaverine Hydrochloride in Irritable Bowel Syndrome: A Randomized Double-Blind Placebo-Controlled Study. Saudi J Gastroenterol (2014).
- Traserra S., 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).
- Eder P., et al. Self-Medication with Drotaverine among Patients with Common Abdominal Symptoms and Treatment Efficacy from the Perspectives of Patients and General Practitioners - An Observational, Retrospective, Cross-Sectional Study Using Real-World Data. J. Clin. Med. (2022).
