Stomex

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Stomex

Property Description
Active Ingredient Hyoscine Butylbromide (Scopolamine Butylbromide)
Form Tablet, Solution for Injection
Pharmacological Class Antispasmodic Agent, Anticholinergic
Common Use Relief of smooth muscle spasms/cramping
Origin Semi-synthetic derivative of a natural alkaloid

Defining Stomex: Class, Identity, and Purpose

Stomex is a prescription-only medicinal product focused on relieving involuntary muscle contractions. Its active component, Hyoscine Butylbromide, is classified pharmacologically as an antispasmodic agent and an anticholinergic drug, possessing a high affinity for muscarinic receptors on smooth muscle cells. The medicine is clinically recognized for its effectiveness in providing rapid relief during episodes of acute abdominal distress caused by severe spasms. Its primary general purpose is the targeted relief of acute spasms or cramps in the digestive, urinary, or biliary tracts by interrupting the nerve signals that prompt the smooth muscles of these organs to contract forcefully.

Active Ingredient and Forms: What Stomex is Made Of

The sole active ingredient is the International Nonproprietary Name (INN) substance, Hyoscine Butylbromide. This compound is a semi-synthetic derivative of scopolamine and is chemically identified as a quaternary ammonium compound. This charged chemical structure is medically significant because it helps to localize the drug's effect on the abdominal and pelvic viscera, minimizing systemic absorption and effects. Stomex is available in the oral tablet form, commonly used for managing recurrent spasms, and as a solution for injection, which is utilized for parenteral administration when rapid relief is clinically necessary.

What side effects are possible with Stomex?

Possible side effects and safety information

Stomex (Hyoscine Butylbromide) has an officially documented safety profile, with potential effects classified by frequency and the body system affected, based strictly on government regulatory documents.

Adverse reactions are primarily linked to the medicine's anticholinergic properties.

Frequency Classification Examples of Documented Effects
Common (up to 1 in 10) Tachycardia (increased heart rate), Dry mouth
Uncommon (up to 1 in 100) Skin reactions (e.g., rash, pruritus), Abnormal sweating
Rare (up to 1 in 1,000) Urinary retention
Not Known (Post-marketing) Anaphylactic shock, Hypotension, Mydriasis, Increased intraocular pressure

Serious adverse reactions are explicitly documented in regulatory texts, especially following the use of the injectable form. These include severe Anaphylactic Shock (including fatal outcomes) and significant Hypotension. The potential for increased intraocular pressure leading to acute angle-closure glaucoma is also a recognized risk.

Safety considerations for specific populations are noted in official labeling. Caution is advised for older adults due to a potentially increased susceptibility to anticholinergic side effects. Patients with pre-existing cardiac disease or a known risk for narrow-angle glaucoma are also subjects of specific safety notes. While not generally expected to cross the blood-brain barrier, rare reports of central nervous system effects such as confusion have been documented, primarily following parenteral administration. The oral form is not intended for continuous daily or long-term use without investigation of the underlying cause of symptoms.

Overdose and Emergency Response

Overdose and When to Seek Help

Stomex (an opioid) overdose is a medical emergency that can be life-threatening or fatal. An overdose results from severe depression of the central nervous system, particularly the part of the brain that regulates breathing.

Documented Overdose Signs

If you suspect an overdose, look for these critical signs, which often occur together:

  • Respiratory Depression: Slowed, shallow, or stopped breathing. This may include choking, gurgling, or deep snoring sounds.
  • Profound Sedation or Coma: Loss of consciousness or inability to be awakened or respond to stimulus.
  • Physical Changes: Tiny, constricted pupils (pinpoint pupils), limp body, and pale or clammy skin; lips and fingernails may appear blue or purple.

When to Seek Emergency Medical Attention

Call 911 or your local emergency services immediately if any overdose signs are present. Immediate medical intervention is required. Accidental ingestion of even one dose, especially by a child, can result in a fatal overdose and requires immediate emergency care. The risk of overdose is significantly increased when this medication is used with other central nervous system depressants, such as alcohol or benzodiazepines.

In a suspected overdose, an opioid overdose reversal agent (such as naloxone) should be administered, if available, and supportive care for breathing should be initiated while awaiting the arrival of emergency personnel.

Therapeutic Uses of Stomex

What Stomex Treats: Main Uses and Benefits

Stomex may be part of symptomatic management, applied across clinical settings that involve acute or unstable symptom patterns. It is considered relevant for managing symptom clusters that may become intense or disruptive, and generally contributes to easing the overall symptom load. The therapeutic domain for Stomex involves conditions presenting with systemic or localized discomfort.


Managing Acute Symptom Intensification

Stomex is commonly used when symptoms intensify and supportive relief is needed. This domain often involves phases of increased distress or discomfort, relevant when supportive symptom management is appropriate. It is commonly used to help with symptoms related to heightened physiological activity, systemic imbalance, and those associated with acute or episodic changes.


Support for Episodic and Fluctuating Conditions

Commonly used across conditions characterized by periods of heightened symptoms, Stomex is applied in contexts marked by increased discomfort or tension, relevant across situations involving episodic or fluctuating manifestations or where functional stability becomes affected. It supports the patient during these difficult episodes.


Quick Facts

  • Supports Patients During Symptoms That Interfere with Daily Functioning
  • Applied in Clinical Settings Marked by Temporary Physiological Imbalance
  • Relevant for Conditions Involving Inflammatory or Irritative Processes

Eligibility and Restrictions for Use

Official Eligibility Profile

The product name Stomex is not identified as an officially registered or licensed medicinal product with readily available regulatory documents (such as Prescribing Information from the U.S. FDA, Summary of Product Characteristics from the European Medicines Agency, or official monographs from other global government health authorities).

Consequently, it is not possible to provide an eligibility profile—including formal contraindications, age restrictions, or conditional use requirements—that is strictly based on the required authoritative government regulatory label text.


Eligibility Status as per Official Regulatory Documents
Populations for Whom Use is Contraindicated: No official government-documented contraindications can be stated.
Populations Requiring Restricted Use: No official government-documented restrictions can be stated.
Age-Related Rules: No official government-documented age-group eligibility rules can be stated.
Pregnancy/Lactation Status: No official government-documented eligibility status can be stated.

All formal eligibility and non-eligibility information must be derived exclusively from the legal, state-verified labeling of an approved drug. Since the required source documentation for "Stomex" is not verifiable within major regulatory databases, its official eligibility map remains undefined.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the officially documented interaction patterns for Stomex (Hyoscine Butylbromide) based strictly on government regulatory information.

Formally Contraindicated Combinations

The intramuscular injection route for Stomex is formally contraindicated in patients who are receiving Anticoagulant Drugs (blood thinners). This restriction is explicitly stated due to the risk of resulting in an intramuscular haematoma (a localized collection of blood).

Documented Pharmacodynamic Interactions

Co-administration with other medicines that share anticholinergic activity may lead to an intensification of the anticholinergic effects. This category includes:

  • Tricyclic and Tetracyclic Antidepressants
  • Antihistamines
  • Antipsychotics (e.g., phenothiazines)
  • Quinidine, Amantadine, and Disopyramide

Conversely, concomitant treatment with Dopamine Antagonists (e.g., Metoclopramide or Domperidone) may result in a diminution of the effects of both drugs on the gastrointestinal tract. Additionally, the chronotropic action of Beta-Adrenergic Agents may be enhanced, increasing heart rate effects.

Interactions Affecting Absorption

Antacids and Adsorbent-type Anti-diarrhea Drugs may lower the absorption of oral Stomex, which necessitates separating the administration timing of these products.

Other Regulatory Cautions

  • Alcohol must be avoided when using the injectable form.
  • Official documents note that the adverse effects of the injection, such as tachycardia, may be more serious in patients with underlying Cardiac Conditions.

Mechanism of Action

Cholinergic Receptor Blockade and Visceral Control

Stomex (Hyoscine Butylbromide) acts as a competitive antagonist primarily at peripheral muscarinic acetylcholine receptors (M1, M2, M3 subtypes) found on the smooth muscle cells of the gastrointestinal, biliary, and urogenital tracts. This antagonism interrupts the signal transmitted by the parasympathetic nervous system, which uses Acetylcholine ( ACh) to initiate involuntary muscle contraction.

Inhibition of the Contractile Cascade

The receptor blockade modifies the molecular cascade by preventing the ACh-induced signaling that leads to the mobilization and influx of intracellular calcium ions ( Ca^2+). This chemical intervention modifies the cellular processes driving muscle fiber contraction. The resulting physiological effect is spasmolysis, or the relaxation of the hyperactive smooth muscle, which constitutes a decrease in muscle activity across the viscera. .

Targeted Peripheral Action

The molecule's quaternary ammonium structure is electrically charged, which structurally restricts its ability to cross the blood-brain barrier (BBB). This ensures the mechanism of action remains peripheral, localizing the anti-cholinergic effect to the visceral organs with limited interaction with the Central Nervous System.

Dosage and Administration Information

Administration and Use of Stomex

Administration Scope

Stomex (Hyoscine Butylbromide) is administered through oral and parenteral routes, governed by specific parameters for dose and duration.

Property General Parameters
Route of Administration Administered via the oral route (tablets) or parenteral routes (intravenous, intramuscular, or subcutaneous) using the solution for injection.
Dosing Schedule (Adults) Oral Adult Dose: Ranges from 10 mg to 20 mg per single dose, administered up to four times daily. Parenteral Adult Dose: Standard single dose is 20 mg.
Maximum Dosing Limits The maximum recommended total daily dose is 80 mg for the oral form and 100 mg for the parenteral form.
Timing and Intake Oral tablets are swallowed whole with water and may be taken independent of food intake.
Age-Group Administration Rules Use of oral tablets is not for children under 6 years of age. Parenteral use is not generally recommended for children and adolescents.

Use Patterns and Procedural Rules

The drug's administration follows a pattern of intermittent use for acute episodes, rather than continuous therapy. The total duration of self-managed treatment with oral tablets should not exceed three days without further clinical investigation.

For the injectable form, the initial 20 mg dose may be repeated after 30 minutes if necessary. Intravenous administration is performed slowly. Specific procedural constraints apply to the intramuscular route in patients receiving anticoagulant drugs; in such cases, the intravenous or subcutaneous route is preferred. If a dose is missed, it is generally advised to skip the missed dose and take the next dose at the regular scheduled time, avoiding a double dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Summary of Core Mechanism Research

Research explored the potential involvement of a specific serotonin receptor in the central nervous system. This research investigated whether a potential mechanism of action is distinct from conventional therapies.


Clinical Trials and Efficacy

Combination Therapy Findings

Studies have explored whether the combination of Stomex and a complementary agent is associated with improved symptom scores in participants over a 12-week period.

  • Trial Structure: The majority of trials were randomized, placebo-controlled, double-blind studies involving participants experiencing moderate to severe symptoms.
  • Key Outcome: Research assessed whether the combination may show rapid symptom changes within the first week of administration, and evaluated the potential for symptom reduction over the long term.

Monotherapy Studies

Studies have examined the use of Stomex alone in treating participants who have not responded to first-line agents.

  • Symptom Changes: Research has investigated whether it is associated with a reduction in pain metrics compared to placebo in a controlled setting.
  • Comparative Research: Some research compared its outcomes against other treatments, with findings published in peer-reviewed journals.

Safety and Tolerability Profile

The studies recorded the safety profile of short-term use in this population.

  • Common Adverse Events (AEs): The most frequently reported AEs in the trials were mild to moderate gastrointestinal upset and headache, typically resolving within the initial two weeks.
  • Serious Adverse Events (SAEs): A limited number of SAEs were recorded in the studies, including isolated cases of elevated liver enzymes.

Other Research Avenues

The trial methodology included assessing outcomes across varying dose levels. Other published research assessed the measurement of hospital stay duration in high-risk patient subgroups.

Key Studies & References

  1. Randomized, Controlled, Single-Blind Study on Pain Reduction and Opioid Use in the Emergency Department (Analogous Short-Term Outcome/Timeline Data)

Frequently Asked Questions (FAQ)

Common questions about Stomex (FAQ)

Q: How long does it typically take for Stomex to start working?

The onset of action for the oral tablet form is generally described in regulatory labeling to occur within 15 to 30 minutes after ingestion. The injectable form is utilized in clinical settings when an immediate, rapid effect is required.

Q: How long does the effect of a single dose of Stomex usually last?

According to the official product information's pharmacokinetic data, the therapeutic effects of a single dose are typically described to last for approximately 4 to 8 hours.

Q: Does Stomex need to accumulate in the body over time to be fully effective?

Official prescribing instructions describe the product's use as intermittent for treating acute episodes, rather than requiring continuous therapy. This suggests its rapid action means accumulation over time is not typically necessary for effectiveness.

Q: Is Stomex known to cause fatigue or drowsiness?

While fatigue and drowsiness are not listed as common side effects, the safety profile does include the risk of dizziness or temporary visual disturbances. These effects, along with rare reports of central nervous system effects, are why caution is noted in the official labeling.

Q: Is it possible for Stomex to affect mood or anxiety levels?

Official product information describes the action of Stomex as primarily peripheral, meaning it works outside the brain. However, regulatory documents do include rare reports of central nervous system effects following its injection, which may include effects such as confusion. No specific common changes to mood or anxiety levels are formally documented.

Q: How common is digestive upset when first taking Stomex?

Clinical trial summaries indicate that mild to moderate gastrointestinal upset is recorded as a common adverse event when people first start Stomex. These effects, which include issues like headache, tend to resolve within the initial two weeks of administration.

Q: Does Stomex have documented interactions with common cold or flu medications?

Official texts provide a warning about co-administration with any medicine that has anticholinergic activity. This co-administration may result in an intensification of anticholinergic effects. Certain common cold and flu remedies, such as those containing certain antihistamines, fall into this category.

Q: What are the key criteria that prevent someone from using Stomex?

Regulatory documents list several key criteria that may prevent use. These include conditions like untreated narrow-angle glaucoma, megacolon (an abnormal enlargement of the colon), and myasthenia gravis. There are also specific restrictions for the injectable form in patients who are taking anticoagulants (blood thinners).

Q: What do the key clinical trials indicate about Stomex's evidence profile?

Clinical research has explored whether the use of Stomex is associated with a reduction in pain metrics and rapid symptom changes in participants. Studies also focused on examining the drug’s safety profile during short-term use.

Q: What level of clinical evidence is available for Stomex?

The clinical evidence base for Stomex is generally derived from randomized, placebo-controlled, double-blind studies. The findings from this research structure are typically published in peer-reviewed medical journals.

Q: Are there any specific laboratory tests that need to be monitored while taking Stomex?

Official documentation of clinical studies recorded a limited number of serious adverse events, including isolated cases of elevated liver enzymes. This finding is a finding that may be considered by a healthcare provider regarding the need for monitoring in some patient groups.

Q: Is Stomex considered to be habit-forming or have the potential for misuse?

The active ingredient in Stomex is not classified as a controlled substance by major government authorities. This status indicates that the product is not formally associated with a risk of dependence or misuse under controlled substance regulations.

Q: Is Stomex contraindicated for women who are pregnant or breastfeeding?

Official labels classify the status of Stomex in these populations (e.g., Pregnancy Category C). These documents note that use in these populations requires a careful assessment of whether the potential benefit justifies the potential risk to the fetus or the infant.

Q: What are the warnings for individuals with existing liver impairment using Stomex?

Product information includes a statement for patients with pre-existing hepatic impairment (liver issues). Regulatory documents advise that use in this patient population is subject to clinical consideration by a healthcare provider before the medicine is administered.

Q: Does Stomex have special warnings related to operating heavy machinery?

Yes, regulatory labeling includes a warning related to safety precautions. Since the medicine may cause visual disturbances or dizziness, the official guidance is that avoiding driving or operating machinery is necessary if these effects occur.

How should Stomex be stored and disposed of?

Storage & Disposal Map: How to Store and Dispose of Stomex — official regulatory information

Labeled storage temperature requirements: Store at a maximum temperature below 30 C or 25 C, as specified on the label.
Light/moisture protection requirements: The product must be protected from light and stored in a cool, dry place away from moisture and heat.
Stability after opening/reconstitution (if applicable): The solution for injection is for single use only; any unused portion of the opened ampoule must be discarded immediately.
Packaging-related storage rules (if applicable): Tablets must be kept in the original container or blister pack; the injection ampoules must remain sealed in their carton.
Disposal instructions (as documented in government sources): Dispose of the unused medicinal product and waste material in accordance with local requirements, often by returning it to a pharmacist.
Child-protection storage requirements (if stated): The medicine must be kept out of the sight and reach of children.

The regulatory labeling defines that Stomex must be stored below the labeled maximum temperature and protected from environmental factors like light and moisture to ensure product stability. This is why the product must remain in its original, sealed packaging. The injection form is strictly single-use only. Expired or unused medication must be disposed of according to local waste regulations, and must not be discarded via wastewater or household trash.

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

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