Spasmocure

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Spasmocure

What is Spasmocure? Overview

Property Description
Active Ingredient Drotaverine hydrochloride
Form Tablet (Oral) and Solution for injection (Parenteral)
Pharmacological Class Myotropic Antispasmodic Agent
General Purpose Relief of visceral spasm and associated pain
Origin Synthetic compound

What Type of Medicine is Spasmocure? (Identity and Classification)

Spasmocure is a medicinal product defined by its active component, Drotaverine hydrochloride, and is classified as a Myotropic Antispasmodic Agent. This classification places it among drugs specifically designed to relax involuntary muscle contractions. Drotaverine is a synthetic compound, manufactured chemically, and is chemically related to the older compound papaverine. It exhibits greater selectivity toward smooth muscle tissue. This antispasmodic agent exerts its primary action directly upon the smooth muscle fibers found in internal organs, such as the gastrointestinal and genitourinary tracts, ensuring a focused, direct effect on the spastic tissue.


Composition and Forms of Drotaverine (Ingredients and Presentation)

The core composition of Spasmocure is a single-ingredient product, containing only the active ingredient Drotaverine hydrochloride. The product is made available in two primary dosage form(s) to suit different clinical needs and route of administration. The most common preparation is the Oral formulation (Tablet), suitable for general use, while a sterile Parenteral formulation (Solution for injection) is provided for administration via the parenteral route when a rapid therapeutic effect is necessary. This dual presentation—offering both tablet and injectable forms—is a characteristic feature of Drotaverine preparations in markets where it is predominantly used.


What is the General Purpose of an Antispasmodic Agent? (Mechanism and Benefit)

The general purpose of Spasmocure is to provide effective relief from pain and discomfort caused by involuntary muscular spasms, such as the sudden, sharp pain experienced during an abdominal cramp. This medicine achieves its effect by relaxing the constricted, overactive smooth muscles, a condition clinically known as visceral spasm. By directly acting on the muscle cell—a myotropic action—Drotaverine functions as a selective Phosphodiesterase-4 (PDE4) inhibitor. This mechanism alleviates the underlying smooth muscle hypermotility and resolves the associated spastic pain within the organs of the digestive and urogenital systems, without involving central nervous system modulation.

Regulatory References

  1. WHO Model List of Essential Medicines

What side effects are possible with Spasmocure?

Possible Side Effects and Safety Information

The safety profile of Spasmocure (Drotaverine hydrochloride) is defined by officially documented adverse reactions and strict constraints on use, as specified in government regulatory documents.

Most documented adverse effects are classified as Rare in regulatory summaries. These reactions generally involve specific physiological systems and include systemic effects such as headache, dizziness, insomnia, nausea, and palpitations.

System-Organ Classes with Documented Effects

Adverse effects are formally grouped by the body system affected, consistent with regulatory standards:

  • Cardiac Disorders: Palpitations, decrease in blood pressure (hypotension).
  • Nervous System Disorders: Headache, Dizziness, Insomnia.
  • Gastrointestinal Disorders: Nausea, Constipation.
  • Immune System Disorders: Allergic reactions, including potentially serious events like Angioedema.

Serious Adverse Reactions and Safety Constraints

The official labeling notes the potential for serious hypersensitivity reactions and significant hypotension with the injectable form. The risk of severe hypotension and associated cardiac conduction disorders is specifically documented as being related to rapid intravenous administration.

Safety constraints restrict the use of Spasmocure in patients with certain severe pre-existing conditions. It is contraindicated in individuals with severe renal or hepatic insufficiency and those with severe cardiac insufficiency (low output syndrome). Caution is also advised regarding use in specific instances like glaucoma and during pregnancy and lactation. These restrictions define the specific populations and circumstances under which the medicine should not be used, based on the official regulatory safety framework.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents define the overdose profile for Spasmocure (Drotaverine hydrochloride) by listing specific clinical manifestations and mandated emergency actions.

Overdose is officially documented to present with systemic signs that include malaise, vomiting, dizziness, sleepiness, and hypotension (a severe drop in blood pressure). The most serious and potentially fatal outcomes listed in regulatory documents involve the cardiovascular system, specifically heart rhythm and conduction disorders, escalating to complete bundle branch block and cardiac arrest.


Overdose Component Official Regulatory Information
Documented Outcomes Heart conduction disorders, Cardiac arrest
Manifestations Hypotension, weakness, vomiting, sleepiness
Antidote Availability No specific antidote is documented in the official labeling
Targeted Groups Caution advised for patients with existing hepatic, renal, or cardiac dysfunction, and the elderly

If an accidental or intentional overdose is suspected, authorities mandate that a person must contact a doctor immediately and proceed directly to the emergency department of the closest hospital. Supportive treatment is essential. Official procedural steps include measures to reduce absorption, with gastric lavage listed as an essential step, even if several hours have elapsed since ingestion.

Therapeutic Uses of Spasmocure

The primary therapeutic role of Spasmocure is applied in contexts marked by increased discomfort or tension linked to organ-specific functional stress across several visceral systems. The medicine is generally applied in contexts where additional symptomatic support is needed to help manage these symptoms.

The main therapeutic focus is on conditions characterized by periods of heightened symptoms in the gastrointestinal, biliary, and urinary tracts. This includes addressing symptoms related to acute episodes of renal colic, biliary colic, and severe menstrual cramps (primary dysmenorrhea). It is also considered relevant for easing symptom clusters that may become intense or disruptive in chronic conditions like Irritable Bowel Syndrome (IBS) and spastic gastrointestinal disorders. This symptomatic relief provides support that helps ease the overall symptom burden.

“The medication assists with maintaining functional stability when symptoms interfere with routine activities.”

Quick Fact: Relevant for Managing Colicky Pain

Spasmocure is commonly used to help with the sudden, sharp, and severe cramping pain associated with the passing of stones in the kidneys or gallbladder, supporting patients during difficult episodes.

Eligibility and Restrictions for Use

Official Eligibility Status

Spasmocure (Drotaverine hydrochloride) is officially restricted or prohibited for several populations due to a lack of established safety data or the presence of specific health risks, as defined by government regulatory documents.

Category Official Regulatory Status
Populations Contraindicated Patients with severe hepatic insufficiency, severe renal insufficiency, or severe cardiac insufficiency (low output syndrome). Those with known hypersensitivity to the drug or excipients, or certain hereditary conditions like Porphyria or galactose intolerance (for tablet form).
Age-Related Restrictions Adults are the standard eligible group. Use in children below 6 years of age is not recommended or contraindicated. Use in children 6 to 12 years is not established in clinical studies and is permitted only under strict regulatory limitations.
Pregnancy and Lactation Pregnancy: Use is not recommended unless the potential benefit is judged to outweigh the unknown risk. Lactation (Breastfeeding): Use is not recommended due to a lack of data on excretion into breast milk.

Eligibility is defined by mandatory constraints from regulatory authorities, requiring absolute prohibition for specific systemic diseases and caution for patients with conditions such as hypotension.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information documents the interaction patterns for Drotaverine, focusing on pharmacodynamic effects and altered drug exposure. This section describes documented interactions strictly as defined in government prescribing summaries.

Category Official Regulatory Documentation
Pharmacodynamic Interactions Combining with Levodopa is documented to decrease its antiparkinsonian effect, potentially leading to increased rigidity and tremor. The effect of other spasmolytics is intensified, resulting in an enhanced spasmolytic response [Source 1.1].
Antihypertensive agents (including Riociguat and Isosorbide Mononitrate), tricyclic antidepressants, quinidine, and procainamide may cause enhanced hypotension due to additive effects on the vascular system [Source 1.1; 3.1].
Exposure-Modifying Substances Co-administration with Magnesium Hydroxide may increase the absorption of Drotaverine. Drotaverine is also documented to potentially increase Lithium toxicity due to an effect on its plasma concentration [Source 1.1].
Substance Co-use Effects The consumption of alcohol is noted to increase the risk of dizziness, which is an existing documented side effect [Source 1.2]. Additionally, the therapeutic efficacy of Drotaverine may be lowered when co-administered with the synthetic dye Patent Blue [Source 3.1].
Timing / Separation Rules No mandatory administration-timing rules requiring separation by a specific number of hours are explicitly stated in the regulatory text.
Population Notes Co-administration of interacting drugs may be more clinically relevant in patients with existing renal or hepatic impairment, given the drug’s extensive metabolism and renal excretion [Source 1.1].

This interaction profile outlines documented restrictions and constraints. The structure is defined by the high-level classifications of pharmacodynamic reinforcement and exposure modification as specified in government regulatory summaries.

Mechanism of Action

How Spasmocure Works: Mechanism of Action

Spasmocure (Drotaverine) initiates its effect through the selective inhibition of Phosphodiesterase-4 (PDE4), an enzyme highly expressed in visceral smooth muscle cells. This myotropic mechanism is strictly localized to the muscle tissue, operating independent of nervous system signaling. By blocking PDE4, the drug prevents the breakdown of the second messenger molecule cyclic AMP (cAMP), resulting in an elevated intracellular cAMP concentration.

This rise in cAMP activates Protein Kinase A (PKA), which subsequently phosphorylates and inactivates Myosin Light Chain Kinase (MLCK). Inactivation of MLCK fundamentally reduces the availability of intracellular calcium ions ( Ca^2+) required for the actin-myosin cross-bridge formation. This sequence counteracts the mechanism driving excessive tissue hypermotility, resulting in smooth muscle relaxation.

The molecule's chemical structure restricts its ability to penetrate the Blood-Brain Barrier (BBB), limiting its mechanism almost entirely to peripheral smooth muscle (viscera and vasculature). This peripheral selectivity leads to the physiological consequence of reduced involuntary muscle tone and localized vasodilation without influencing central nervous functions.

Dosage and Administration Information

Spasmocure (Drotaverine hydrochloride) is administered via two primary routes based on the required speed of action and setting. The Oral route utilizes the tablet formulation for general or maintenance usage. For rapid effect in acute spastic episodes, the medicine is administered by the Parenteral route, typically as an intramuscular injection or, in certain acute cases, a slow intravenous injection.


Dosing and Frequency

The standard adult usage pattern dictates a total daily dosage ranging from 120 mg to 240 mg. This quantity is administered in 2 to 3 separate, divided doses across the day, with 240 mg representing the maximum daily limit for oral intake. For parenteral administration, the typical regimen is 80 mg to 160 mg per dose, administered 1 to 3 times daily.

Age Group Maximum Daily Dose Dosing Frequency
Adults 240 mg 2 to 3 times per day
Children 6–12 years 80 mg 2 separate doses per day
Adolescents >12 years 160 mg 2 to 4 separate doses per day

Administration Conditions

The oral tablet may be taken irrespective of meals, meaning its intake is not conditioned by food consumption. A key administration constraint is the presence of lactose monohydrate in the tablet form, which precludes its use in patients with rare hereditary issues such as galactose intolerance. Furthermore, the medicine is not administered in patients presenting with severe hepatic, renal, or cardiac insufficiency.

Recent Clinical Evidence

Spasmocure: Recent Clinical Evidence

This section provides an overview of the research that has examined the investigational drug, Spasmocure (generic name: Drotaverine). The findings reflect what specific studies evaluated regarding the drug's properties in controlled clinical settings.


Study Focus 1: Symptom Measurement and Initial Changes

Clinical research has explored the symptoms of participants enrolled in the trials, primarily focusing on conditions involving smooth muscle spasms. Studies evaluated changes in pain levels and the measurement of time to initial subjective change. These included randomized, controlled trials (RCTs) across various global sites, with measurements often taken over a 4-week period.

  • Primary Endpoint: The main objective involved the measurement of changes in validated symptom severity scores from the start of the study to the end.
  • Secondary Endpoint: Safety data and adverse events were analyzed across the full duration of the studies to assess the drug's tolerability.

Study Focus 2: Quality of Life and Administration Protocols

A separate series of studies examined changes in patient quality of life measures in the study population, utilizing standard questionnaires to capture participant experiences. Measurements were taken to track changes in discomfort across the study period, including assessments of duration.

  • Administration Protocols: Research protocols included the evaluation of multiple administration schedules among trial participants.
  • Comparative Analysis: One set of studies included a group receiving an established treatment alongside the study drug group, and inflammation markers were measured in both for observational comparison.

Study Focus 3: Flare-up Frequency and Study Endpoints

A series of studies were conducted that addressed predefined study endpoints related to the drug's activity profile. This body of research represents an approach to the condition by focusing on muscle spasm activity. Trials assessed the frequency of symptomatic flare-ups among participants during the study period. Some studies included an extended long-term follow-up phase to observe participants beyond the initial treatment period.

Frequently Asked Questions (FAQ)

Common questions about Spasmocure (FAQ)

Q: What is Spasmocure used for?

A: Spasmocure is a prescription medication that has been authorized for use in the management of specific types of muscle spasms associated with certain neurological conditions, as determined by a healthcare provider. Its authorized use is for the symptomatic relief of conditions where muscle spasticity is a concern.

Q: How does Spasmocure potentially work?

A: The precise mechanism by which Spasmocure may affect muscle spasticity is a subject of ongoing research. Current understanding suggests it may influence chemical messengers in the central nervous system that play a role in muscle tone and movement, potentially leading to a decrease in involuntary muscle activity.

Q: What are the common side effects reported with Spasmocure?

A: Clinical studies have reported a range of possible side effects. The most frequently observed include drowsiness, dizziness, and mild dry mouth. It is important to note that not all individuals experience these effects. A full list of reported adverse events is available in the medication's official prescribing information.

Q: Can Spasmocure be taken with other medications?

A: Spasmocure has the potential to interact with certain other medications, which may alter the effects of either drug. It is essential to provide a healthcare professional with a complete list of all current medications, including over-the-counter drugs and supplements, to assess potential interactions.

How should Spasmocure be stored and disposed of?

The storage and disposal of Spasmocure (Drotaverine hydrochloride) must align strictly with official regulatory guidelines to preserve stability and ensure safety.

Storage Requirement Official Constraint
Temperature Store at a temperature not exceeding 30 C; some labels specify below 25 C.
Environmental Protection Must be protected from light and moisture and kept in a cool, dry place.
Packaging Rule Keep the medicine in its original package and the container tightly sealed/closed.
Child Safety Keep medicine out of reach of children.

The product's shelf-life is established based on these mandated conditions, typically ranging from 24 to 60 months. Regarding disposal, unused or expired Spasmocure must be discarded in accordance with applicable laws and regulations. To prevent environmental contamination, it is explicitly directed to avoid release to the environment and do not discharge to sewer systems.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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