Spastop

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Spastop

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Medically reviewed

Laura Arias

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 Spastop

Property Description
Active ingredient Otilonium Bromide
Form Oral film-coated tablet
Pharmacological class Antispasmodic agent (Spasmolytic)
Common function Relieves smooth muscle spasms in the gut
Origin Synthetic anticholinergic compound

What is Spastop and Its Pharmacological Classification?

Spastop is the specific brand name for a medication whose active ingredient is Otilonium Bromide (OB), and it belongs to the high-level pharmacological class of antispasmodic agents, often called spasmolytics. This compound is a synthetic anticholinergic compound and a quaternary ammonium derivative whose primary pharmacological role is to act on the smooth muscles of the digestive tract.

The classification as a spasmolytic defines the drug's core function: to reduce involuntary contractions and spasms in muscle tissue. Otilonium Bromide is an established synthetic compound that specifically targets muscle overactivity, providing relief from the discomfort associated with spastic states. Research indicates that Otilonium Bromide helps relieve painful spasms by regulating the flow of signals and calcium ions in the muscle cells.


Otilonium Bromide: Composition, Form, and General Purpose

The medication is a single active ingredient product, consisting of Otilonium Bromide alongside standard pharmaceutical solid excipients, delivered as an oral film-coated tablet. The general therapeutic goal of Spastop is to help calm painful, excessive contractions and normalize the rhythmic activity of the lower intestinal tract muscles. A typical neutral use scenario involves taking the tablets to manage sudden onset abdominal cramping.

The function of the medicine is achieved because the active substance acts locally on the smooth muscle of the gastrointestinal wall, where it works to stabilize the muscle cells and reduce their capacity to contract excessively. Due to its chemical structure, Otilonium Bromide is poorly absorbed into the systemic circulation, which contributes to its specialized localized therapeutic effect within the gut. The medication has a targeted, local action in the digestive system, minimizing effects elsewhere.


Is Spastop a Selective Spasmolytic Agent?

Yes, Spastop is distinguished as a highly selective spasmolytic agent due to the active compound, Otilonium Bromide, being structurally engineered for poor systemic absorption. This feature is essential as it ensures that the medication remains concentrated primarily within the walls of the intestines, maximizing its therapeutic benefit where the spasms occur. By targeting the source of the spastic states within the digestive tract, Spastop serves as an established compound used to manage symptoms arising from the abnormal motility of the gut.

What side effects are possible with Spastop?

Possible side effects and safety information

The safety profile of Spastop (Otilonium Bromide) is structured around its classification as a selective antispasmodic with documented low systemic absorption. This characteristic often limits the occurrence of adverse reactions primarily to the gastrointestinal tract and skin, as noted in official regulatory documents.

Official Classification of Adverse Reactions

The regulatory labeling classifies adverse reactions based on their observed frequency in clinical studies. The most common category for documented side effects is Uncommon (occurring in 1/1,000 to < 1/100 patients), indicating a low overall incidence.

System-Organ Class (SOC) Documented Adverse Reactions Typical Frequency
Gastrointestinal Disorders Nausea, Vomiting, Abdominal pain, Constipation Uncommon
Skin and Subcutaneous Tissue Disorders Skin rash, Pruritus (itching), Erythema (redness) Uncommon

Serious Safety Concerns and Contraindications

Post-marketing surveillance has documented rare, serious adverse reactions classified under Immune System Disorders. These Hypersensitivity events, which include Angioedema (swelling) and Urticaria (hives), represent clinically significant allergic responses.

The medication is subject to formal Contraindications that restrict its use based on pre-existing conditions. These restrictions include known Hypersensitivity to the substance, Glaucoma, Prostatic Hypertrophy, and Pyloric Stenosis.

Safety in Specific Populations

Official labeling addresses specific patient groups:

  • Paediatric Population (under 18 years): Use is not recommended due to insufficient clinical data to establish safety and efficacy in this age range.
  • Hepatic or Renal Impairment: No dose adjustment is necessary as a consequence of the drug's limited systemic absorption.

This structure ensures a clear, label-based definition of the medicine's risk profile without providing any instructional or therapeutic advice.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation characterizes the overdose profile for Spastop (Otilonium Bromide) as having an expected low systemic toxicity. Based on comprehensive preclinical data, regulatory authorities state that no specific symptoms of overdose are expected following ingestion of doses substantially higher than the usual therapeutic intake. However, the potential for adverse effects exists; for example, the specific clinical manifestation documented in human cases of acute overdose has been systemic hypotension, characterized by a drop in blood pressure.

Should an overdose be suspected, it is mandated by the official product information that users must seek immediate medical attention without delay. Prompt contact with emergency services or a healthcare professional is required to address any unexpected or severe clinical signs that may be observed.

The definitive management approach is defined by the absence of a specific neutralizing agent. Regulatory authorities state that no specific antidote is known for Otilonium Bromide overdose. Consequently, the official guidance for healthcare providers requires the application of an appropriate symptomatic and supporting therapy to manage any clinical effects, such as hypotension or other observed changes in physiological function. This supportive approach is necessary to ensure patient stabilization.

Therapeutic Uses of Spastop

Quick Facts: Spastop

  • Therapeutic Scope: Symptomatic relief for abdominal conditions.
  • Primary Application: Manages symptoms associated with Irritable Bowel Syndrome (IBS).
  • Relief Targets: Intended to address colicky abdominal pain, cramps, and spasms.
  • Associated Symptoms: May assist in addressing persistent non-specific diarrhea, with or without alternating constipation, and flatulence related to these conditions.

What Spastop Treats: Main Uses and Benefits

Spastop, which contains the active substance mebeverine hydrochloride, is utilized for the symptomatic management of the Irritable Bowel Syndrome (IBS) and related conditions. The therapeutic focus is on addressing the discomfort and painful episodes that may be associated with these functional bowel disorders.

This medication is commonly used to provide relief from the core symptoms of IBS, which include episodes of abdominal pain and cramps. It is also indicated for the management of other conditions typically included in this grouping, such as chronic irritable colon and spastic constipation.

Mebeverine may offer a contribution to managing associated complaints of these conditions, such as persistent, non-specific changes in bowel habits, which may include diarrhea or alternating constipation, as well as the presence of flatulence. The goal of treatment is the alleviation of symptoms to support daily comfort.

Eligibility and Restrictions for Use

Who Can and Cannot Use Spastop?

Eligibility for Spastop (Mebeverine Hydrochloride) is defined by regulatory bodies, establishing specific patient groups who are permitted to use the medicine and those who are excluded.

Populations Contraindicated for Use

Use is strictly contraindicated for individuals with known hypersensitivity to Mebeverine Hydrochloride or any of the inactive ingredients (excipients). Furthermore, the medicine must not be used by patients diagnosed with specific conditions, including paralytic ileus, or hereditary metabolic disorders such as rare galactose intolerance, total lactase deficiency, and glucose-galactose malabsorption.

Age and Physiological Restrictions

  • Age-Group Eligibility: The medicine is intended for use by adults. It is not recommended for use in children and adolescents below 18 years due to a lack of sufficient data establishing safety and efficacy for this age group.
  • Pregnancy and Lactation: Spastop is not recommended during pregnancy and should not be used by women who are breast-feeding, as the impact on the foetus or the excretion of the substance in human milk is not fully established by regulatory evidence.

Regarding organ function, no specific dosage adjustment is deemed necessary for adult patients with pre-existing hepatic or renal impairment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The officially documented interaction profile for the active ingredient in Spastop (Drotaverine hydrochloride in many formulations) details specific pharmacodynamic effects when taken with certain medicinal products.

Documented Interaction Categories and Constraints

Interacting Medicine Category Specific Interaction Consequence (Official Regulatory Statement)
Antiparkinsonian Agents (e.g., Levodopa) Concomitant use may result in a reduction of the anti-Parkinsonian effect, potentially leading to increased muscle rigidity and tremor.
Vasodilators / Antihypertensives (e.g., Nitrates, sGC Stimulants) Combination may lead to the enhancement of the vasodilatory or antihypertensive effect, which could result in severe hypotension (very low blood pressure).
Other Papaverine Derivatives Possible additive antispasmodic effects, which requires clinical consideration.
Certain Dyes (e.g., Patent Blue) May lead to a decrease in the therapeutic efficacy of this product.

Interaction-Related Restrictions

The most clinically significant constraints in the official regulatory documentation relate to the co-administration with Levodopa, requiring careful patient management due to the potential for the product to counteract the efficacy of Levodopa. Separating the administration time of this product and other interacting agents, particularly Nitrates and sGC stimulants like Riociguat (a soluble Guanylate Cyclase stimulant), is essential to mitigate the risk of adverse cardiovascular consequences. This profile is explicitly based on published regulatory information detailing changes in effect when combined with the listed agents.

Mechanism of Action

How Spastop Works: Mechanism of Action

Blocking Contraction Signals at the Cellular Level

The mechanism of action is defined by the multi-target action of Otilonium Bromide (OB), primarily by acting as a non-competitive blocker of voltage-gated L-type and T-type calcium channels on smooth muscle cells. This action limits the necessary influx of calcium ions ( Ca^2+), an ion required for the initiation of smooth muscle contraction. By suppressing this foundational molecular step, the drug directly modulates the cell's capacity for contraction.

Modulating Nerve Input and Gut Tone

OB also engages in receptor antagonism by interfering with the excitatory input from the enteric nervous system. It blocks muscarinic receptors (anticholinergic action) and modulates Neurokinin-2 ( NK2) receptors. The interference at the nerve and ion channel levels modulates the signals that govern muscle contraction, resulting in a decrease in muscle tone and contractility within the intestinal wall.

Mechanism Constraints: Highly Localized Action

Due to its chemical structure, OB is poorly absorbed into the general circulation, meaning its mechanism is largely physiologically constrained to the peripheral smooth muscle and nerve endings within the gastrointestinal wall. This localized action maintains the multi-target effect within the gut, concentrating the inhibition of muscle contraction signals in the intestinal wall.

Dosage and Administration Information

How to Use Spastop (Otilonium Bromide)

The usage of Spastop, containing the active substance Otilonium Bromide, is based on instructions concerning its route, dose, and administration timing. The medication is an oral preparation provided as a single-strength 40 mg film-coated tablet.

Administration Guidelines

Administration Scope Instruction
Route and Form Oral intake of the 40 mg film-coated tablet.
Standard Adult Dose One 40 mg tablet, taken two to three times daily.
Timing in Relation to Meals Should be taken preferably 20 minutes before a meal.
Ingestion Method The tablet must be swallowed whole with water, and must not be crushed or chewed.

Usage Patterns and Specific Populations

Treatment with Otilonium Bromide does not have a defined limitation on duration; the course of use is managed according to the underlying condition and its clinical progression. If a dose is missed, it is standard practice to continue with the next scheduled dose and not take a compensatory double dose.

Usage restrictions are noted for the pediatric population. The medication is not recommended for children and adolescents under 18 years of age due to a lack of established safety and efficacy data in this group. No specific dose adjustment is typically required for older adults or those with existing hepatic or renal impairment.

Recent Clinical Evidence

Research evidence / Overview of studies for Spastop

This overview summarizes the type of research that has been conducted on the active ingredient in Spastop, Otilonium Bromide. The aim is to describe what the scientific studies have explored, what patterns were observed in the research populations, and what still remains uncertain, based on official regulatory and peer-reviewed sources.


Evidence for Use in Irritable Bowel Syndrome (IBS)

Research for Otilonium Bromide has focused predominantly on its evaluation for Irritable Bowel Syndrome (IBS) and conditions involving periods of heightened symptoms in the lower digestive tract. The primary evidence was evaluated in multiple Randomized Controlled Trials (RCTs). These short- to intermediate-term studies typically compared the medication against an inactive treatment (a placebo) in adult populations diagnosed with IBS.

The key outcomes research examined included patient-reported outcomes describing perceived discomfort, such as the Global Assessment of Relief, and measurements related to the frequency and intensity of symptoms such as abdominal pain and bloating (distension).

Studies report that individuals receiving the active medication frequently described patterns in their perceived discomfort that varied compared to those receiving placebo, and the research contributes to understanding how symptoms evolved in the observed populations. Study results apply only to the populations studied, meaning findings describe group patterns, not personal outcomes.


Long-Term Studies and Follow-up Data

Studies have monitored patient responses over defined time intervals, with the major efficacy trials typically running for periods up to 15 weeks. Research has also examined what happens after the medication is discontinued. These post-treatment follow-up studies monitored the risk of symptom recurrence or relapse. The long-term status of symptoms is not well characterized over many months, and long-term effects of continuous use are not fully established by available RCTs.


What is Still Uncertain About the Research for Spastop

Research highlights that the long-term status of symptoms is not well characterized, as follow-up durations were limited in the primary controlled studies. Data for certain groups remain limited. Specifically, research concerning the use of Otilonium Bromide in pediatric populations (children and adolescents) is very limited, and subgroup findings are uncertain regarding specific, detailed effects on bowel habits.

Key Studies & References

  1. Submission for the classification of Otilonium bromide - 40 mg - Medsafe (Regulatory Document)

Frequently Asked Questions (FAQ)

Common questions about Spastop (FAQ)


Q: What is the risk of low blood sugar (hypoglycemia) when taking sitagliptin?

A: According to official regulatory documents, the risk of low blood sugar, or hypoglycemia, is generally low when sitagliptin (the active ingredient in Spastop) is taken on its own. However, this risk increases significantly when sitagliptin is combined with other medicines known as an insulin secretagogue (like a sulfonylurea) or with insulin. The product information notes that when sitagliptin is used with these types of medications, dose adjustments to the insulin secretagogue or insulin may be necessary.


Q: What are the common side effects of sitagliptin?

A: Official product information, based on clinical trials, indicates that the most commonly reported side effects include upper respiratory tract infection, nasopharyngitis (which is inflammation of the nose and throat), and headache. Other side effects that may occur include nausea, stomach pain, or diarrhea. A comprehensive list of reported side effects can be found in the official drug safety information.


Q: Is sitagliptin safe for children to use?

A: Regulatory information specifies that sitagliptin (the active ingredient in Spastop) is not indicated for use in children and adolescents under 18 years of age. Studies have not been conducted in children under 10 years of age, and the medication showed insufficient benefit in adolescents between the ages of 10 and 17. The medication's use is limited to the approved adult patient population as specified in the labeling.

How should Spastop be stored and disposed of?

How to Store and Dispose of Spastop

Storage Requirements

Spastop tablets must be stored at a temperature not above 30 C and should be protected from direct sunlight to maintain product stability. Consistent with official labeling, the medication must be kept out of the sight and reach of children.

Disposal Instructions

Official regulatory documents state that unused or expired Spastop should not be thrown away in household trash or disposed of via wastewater. Disposal should follow established environmental regulations, and patients are typically instructed to consult a pharmacist or use an approved drug take-back program.

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

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