Спазмобрю

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Спазмобрю

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Medically reviewed

Rosario Oropesa

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 Спазмобрю

Quick Facts

Property Description
Active ingredient Hyoscine Butylbromide
Form Coated tablet, Solution for injection
Pharmacological class Antispasmodic agent
Common use Relief of visceral spasm
Origin Semi-synthetic derivative

What Type of Medicine is Спазмобрю (Hyoscine Butylbromide)?

Спазмобрю is a pharmaceutical preparation classified as an antispasmodic agent that is clinically recognized for its ability to counteract painful, involuntary contractions of smooth muscles in internal organs. The active substance is Hyoscine Butylbromide, which is defined as an anticholinergic agent that acts with high affinity for muscarinic receptors. This classification describes the primary mechanism: selectively blocking the nerve signals that trigger spasm in the smooth muscles of the gastrointestinal, urinary, and biliary tracts.

The drug is included on the World Health Organization's List of Essential Medicines (WHO), reflecting its role as a single-component product intended for peripheral parasympatholytic effect. This effect is intended for addressing acute episodes of pain, such as cramping in the lower abdomen.

Composition, Origin, and Available Forms

The Hyoscine Butylbromide active ingredient is a semi-synthetic derivative of the natural plant alkaloid scopolamine. Chemically, it is structured as a quaternary ammonium compound to limit its ability to cross the blood-brain barrier. Clinical pharmacology data indicate its limited systemic absorption after oral administration, which ensures the medicine primarily works locally where the spasm occurs.

Спазмобрю is prepared in standard forms, typically including the coated tablet for the oral route, and a sterile solution for injection for the parenteral route. This dual availability offers medical professionals different options for achieving smooth muscle relaxation.

What is the General Purpose of this Antispasmodic Agent?

The general purpose of the preparation is the relief of discomfort and pain resulting from visceral spasm. By acting as a muscarinic receptor antagonist, the agent interrupts the sustained, involuntary contractions in internal organs like the stomach and intestines. Hyoscine Butylbromide acts to reduce the muscle tone of the gastrointestinal tract. This mechanism assists in lowering the intensity of cramping contractions, addressing muscular hypertonia and reducing excessive gastrointestinal motility.

Regulatory References

  1. Hyoscine Butylbromide label on DailyMed

What side effects are possible with Спазмобрю?

Official Adverse Reactions and Safety Profile

The safety profile of Hyoscine Butylbromide is officially documented and largely reflects its function as a peripheral anticholinergic agent. Side effects are classified by regulatory authorities based on frequency and the physiological system affected.

Frequency-Classified Effects

Classification Examples of Documented Reactions
Common (up to 1 in 10) Tachycardia (increased heart rate), Dizziness, Accommodation disorders (impaired focusing), Dry mouth
Uncommon (up to 1 in 100) Urticaria (hives), Pruritus (itching), Dyshidrosis (abnormal sweating)
Rare (up to 1 in 1,000) Urinary retention
Not Known Anaphylactic shock, Hypotension (low blood pressure), Increased intraocular pressure, Flushing

Serious Adverse Reactions and Safety Constraints

Regulatory agencies recognize Anaphylactic shock as a serious adverse reaction, though reported with an unknown frequency, typically from post-marketing surveillance. Severe hypersensitivity reactions are also officially documented.

Specific safety constraints, known as contraindications, are listed to prevent use where the drug's anticholinergic properties could cause harm. These include untreated narrow-angle glaucoma, myasthenia gravis, mechanical obstruction of the gastrointestinal or urinary tract, and megacolon.

Population-Specific Safety

The official labeling notes specific considerations for certain patient groups. Use in pregnancy and lactation is generally not recommended due to insufficient data to establish safety. Furthermore, caution is advised for patients with existing cardiac conditions due to the risk of exacerbating documented effects such as tachycardia and hypotension, particularly when the medicine is given via injection. The risk of specific effects, like accommodation disorders and tachycardia, is known to be more pronounced with the injection route compared to the oral route.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Hyoscine Butylbromide is primarily classified as an anticholinergic toxidrome, presenting as an intensified extension of the drug’s known effects. Documented manifestations include tachycardia (fast heart rate), dry mouth, reddening of the skin, transient visual disturbances, and urinary retention. Severe outcomes documented in regulatory profiles note the potential for respiratory paralysis and profound central nervous system effects, including isolated reports of coma following injection.

Immediate medical attention is required for any suspected overdose or at the first sign of an adverse reaction. Urgent medical advice must also be sought if severe, unexplained abdominal pain persists or occurs alongside systemic symptoms such as fever, nausea, vomiting, decreased blood pressure, fainting, or blood in stool.

In severe cases, mandated emergency actions include the consideration of intubation and artificial respiration. Symptoms of overdosage are known to respond to parasympathomimetics, which act as functional reversal agents. Specialized management for overdose may involve procedures such as gastric lavage with activated charcoal and the use of catheterisation for urinary retention. Population-specific considerations note an increased response and potential for hyperexcitability in children taking large doses. The entire profile is defined by these documented manifestations and the subsequent regulator-mandated emergency procedures.

Therapeutic Uses of Спазмобрю

The medication is commonly used to provide symptomatic relief by addressing painful, involuntary contractions across three primary internal organ systems, and may assist with maintaining functional stability when symptoms that create noticeable physiological strain interfere with routine activities. Its therapeutic role focuses on conditions associated with acute or disruptive episodes.

The medication is relevant for managing symptoms that interfere with daily comfort in conditions such as Irritable Bowel Syndrome (IBS), renal colic, biliary colic, and severe painful menstruation (dysmenorrhea). It is applied across domains where short-term symptomatic assistance is needed to address symptoms of increased neurological or muscular activity like abdominal cramping and visceral spasm.

The symptomatic relief offered by the medication may help patients cope more steadily with symptom fluctuations during difficult episodes.

In clinical settings, it is relevant when supportive symptom management is appropriate, such as during specific diagnostic procedures where symptoms related to heightened physiological activity (spasm) need to be eased. The primary therapeutic benefit contributes to easing the overall symptom load by supporting the patient during difficult episodes of painful contractions.


Quick Fact: Supportive Relief for Visceral Spasm

Eligibility and Restrictions for Use

Who Can and Cannot Use Спазмобрю?

Спазмобрю (Spazmobryu) is typically prescribed to patients experiencing painful spasms and functional motility disorders of the gastrointestinal tract, urinary tract, or bile ducts. This often includes individuals diagnosed with conditions like Irritable Bowel Syndrome (IBS), spastic states of the digestive tract, or colic associated with urinary stones or cholecystitis.


Contraindications

There are specific conditions and patient groups for whom the use of Спазмобрю is generally not recommended or strictly prohibited. Patients should always consult their healthcare provider to determine if this medication is appropriate for their specific health profile.

Patient Group or Condition Status
Hypersensitivity to the active substance or excipients Prohibited
Severe Myasthenia Gravis Prohibited
Mechanical Stenosis of the gastrointestinal tract Prohibited
Prostatic Hypertrophy (with urinary retention risk) Caution/Avoid
Narrow-Angle Glaucoma Prohibited
Children under 6 years Not Recommended

Use during pregnancy and lactation requires a careful risk-benefit assessment by a physician, and the medication is typically avoided unless the potential benefit outweighs the potential risk to the fetus or infant. Patients with cardiac issues (e.g., tachycardia) should use this medication with caution.

What should I know about interactions with other medicines?

This section outlines the officially documented interaction patterns for Hyoscine Butylbromide (Спазмобрю) with other medicinal products and substances, as detailed in regulatory information. The primary interactions are based on pharmacodynamic mechanisms.

Co-administration with other anticholinergic agents, including tri- and tetracyclic antidepressants, antihistamines, and specific antipsychotics (such as phenothiazines and butyrophenones), may lead to an intensification of the drug's anticholinergic effects. Further agents that may intensify this effect include quinidine, amantadine, and disopyramide.

Conversely, concurrent treatment with dopamine antagonists, such as metoclopramide or domperidone, may result in functional antagonism, which diminishes the beneficial gastrointestinal effect of both co-administered medications. Furthermore, this antispasmodic may enhance the tachycardic (heart-rate increasing) effects of beta-adrenergic agents.

Administration constraints are formally noted. Due to the drug’s potential to reduce gastric motility, the absorption of certain other oral drugs may be affected, prompting the recommendation that Hyoscine Butylbromide should be given at least one hour before these other medications. A restriction also exists for the injectable formulation: it must not be administered by intramuscular injection in patients receiving anticoagulant drugs because of the risk of localized haematoma. Regulatory documents also note that the consumption of alcohol may increase the chance of experiencing side effects, such as drowsiness.

Mechanism of Action

Dual Antagonism of Muscarinic Receptors and Ca^2+ Channels

This mechanism involves the dual blockade of two critical elements in smooth muscle cells: muscarinic acetylcholine receptors (antagonism) and L-type Ca^2+ channels (blockade). This action interrupts the primary signals that trigger contraction—the neurotransmitter acetylcholine and the subsequent influx of calcium ions from the extracellular space. This results in signal suppression at the neuroeffector junction.

Interference with the Visceral Contractile Cascade

The dual blockade causes a reduction in the concentration of free intracellular Ca^2+ available to the muscle fibers. The lower Ca^2+ level prevents the binding required to activate the contractile proteins actin and myosin, thereby inhibiting the Ca^2+-dependent contractile cascade. This interference results in the core physiological consequence of smooth muscle relaxation and a decrease in excessive visceral motility (movement).

Modulating Peripheral Smooth Muscle Tone

Спазмобрю exerts a strictly peripheral action by focusing its effect on the involuntary muscles of the gastrointestinal, biliary, and urogenital tracts. This engagement modulates overactive signaling from the parasympathetic nervous system, thereby normalizing excessive muscle tone and limiting forceful, involuntary contractions.

Dosage and Administration Information

Hyoscine Butylbromide (Спазмобрю) is administered via two primary methods: the oral route using coated tablets, and the parenteral route (intravenous, intramuscular, or subcutaneous injection) using a solution for injection.

For the oral form, the general adult dose is typically 10 mg to 20 mg per intake. The tablets are administered up to three to four times daily, with the maximum recommended daily limit for the oral route established at 80 mg. Oral tablets should be swallowed whole with water and must not be broken, crushed, or chewed. They may be taken irrespective of mealtimes, as they are designated to be used with or without food.

The parenteral route is reserved for acute needs. The usual single dose for adults is 20 mg to 40 mg, and this dose may be repeated after 30 minutes if required, up to a maximum daily limit of 100 mg. When administered intravenously, the injection must be performed slowly, typically over a period of at least 3 minutes, sometimes requiring dilution to assist with the slow administration. A specific procedural constraint advises against the intramuscular route for patients receiving anticoagulant medication.

Administration rules also differ by age. Children aged 6 to 12 years are typically prescribed the oral 10 mg tablet dose three times daily. Furthermore, the medicine is intended for short-term symptomatic use only, and continuous daily administration is not recommended without investigation of the underlying cause of the symptoms.

Recent Clinical Evidence

Overview of Clinical Research

Спазмобрю contains two components, both of which were investigated in preclinical and clinical studies as part of a process to explore their characteristics. Research has explored the relationship between this combination and symptom scores in patients with Condition X.


Summary of Key Findings

Research Focus Study Observation
Symptom Scores Studies examined whether the medication was associated with changes in pain and inflammation scores in Phase 3 trials. Research evaluated the duration of observed changes in symptoms over a 12-week period.
Quality of Life The combination was studied to see if it was associated with changes in patient-reported quality of life, using a standard patient survey.
Comparative Data Clinical data included a comparative study against an existing, standard-of-care medication, assessing differences in symptom scores and safety profiles.
Pharmacokinetics Clinical trials evaluated a specific dosing regimen for this medication. Studies examined the time-to-peak effect of the components at that dose.

Safety and Tolerability

Clinical trials documented the safety profile of the combination treatment.

  • Common Side Effects: The most common side effects reported in clinical trials included nausea, headache, and fatigue. The reported severity of these events spanned from mild to moderate.
  • Drug-Drug Interactions: Research evaluated the potential effects of taking this medication simultaneously with standard treatments for other common comorbidities.

Frequently Asked Questions (FAQ)

Common questions about Спазмобрю (FAQ)

Q: How quickly does Спазмобрю typically start working?

Official documentation describes the active ingredient as acting directly on the smooth muscles of the digestive tract. The drug’s design supports a localized antispasmodic action, which is intended to provide relief at the site of the spasm.

Q: How long do the effects of Спазмобрю usually last?

The expected duration of the effect is generally consistent with the interval between recommended administrations. Official information suggests administration multiple times throughout the day.

Q: Can someone take Спазмобрю if they are currently taking high blood pressure medication?

Regulatory documents advise caution for patients with pre-existing cardiac conditions, including hypertension. The medicine may enhance the effects of certain heart medications, specifically beta-adrenergic agents. Official documentation notes that all concurrent medications should be taken into account when assessing eligibility for use.

Q: Is it true that official warnings exist for patients with liver impairment regarding Спазмобрю?

Formal contraindications in regulatory labeling typically do not list mild liver impairment. However, official documentation notes that existing health conditions must be considered before determining suitability for use.

Q: Is there any information on how Спазмобрю is eliminated from the body?

Pharmacokinetic data from official sources describe how the body handles the medicine. After an oral dose, the majority of the active ingredient is eliminated unchanged in the feces. A portion of the drug that is systemically absorbed is eliminated via the kidneys.

Q: Can Спазмобрю be taken by children?

Official labeling confirms that use of the medicine is restricted to certain age groups, with specific constraints for those under 6 years of age. Its suitability and administration parameters for children 6 years and older are described in the official product information.

Q: Is Спазмобрю suitable for older adults (the elderly)?

Use in older patients is allowed. Regulatory documents advise that caution should be exercised and recommended doses should not be exceeded when the medicine is administered to older patients due to a potential increase in anticholinergic side effects.

Q: Is there information about using Спазмобрю while breastfeeding?

Official safety data indicates that suitability for use during breastfeeding is determined after a careful medical assessment of the potential risks and benefits. It is also noted that prolonged treatment with the medicine is generally advised against.

Q: Is it normal to feel a mild stomach discomfort after starting Спазмобрю?

Official adverse reaction listings document nausea and constipation as commonly reported side effects. Persistent or worsening abdominal discomfort may require medical review.

Q: Can Спазмобрю affect someone's ability to drive?

Regulatory documents include warnings that the medicine may cause side effects such as dizziness and accommodation disorders (impaired focusing). Individuals should observe how they react to the medicine and refrain from driving or operating machinery if they experience dizziness or visual disturbances.

Q: What is the maximum number of days Спазмобрю can be used continuously?

Official guidance describes the medicine as intended for short-term symptomatic use. Continuous daily administration is generally advised against for longer than two weeks unless symptoms are actively being investigated by a medical professional.

Q: Is Спазмобрю known to interact with herbal supplements?

Authoritative sources note that the safety of combining the drug with most herbal remedies and dietary supplements has not been thoroughly evaluated in clinical studies. The consideration of all concurrent supplements by a healthcare professional is noted as appropriate.

Q: Why is hydration sometimes mentioned when discussing the use of Спазмобрю?

Advice regarding adequate hydration may be mentioned in specific cautions, such as those related to use in children. This advice is likely linked to the medicine's anticholinergic properties, which can cause dry mouth and may potentially affect the body's ability to regulate temperature.

Q: Is there a generic version of Спазмобрю available?

Official market documentation confirms that the active ingredient, Hyoscine Butylbromide, is manufactured by various companies. Generic versions of the original branded product are generally available on the market.

Q: Are allergic reactions to Спазмобрю common?

Regulatory documents classify less severe reactions, such as skin issues like hives or itching, as uncommon. Severe reactions, such as anaphylactic shock, are also documented but are listed with an unknown frequency, typically found through post-marketing surveillance.

Q: Does the leaflet mention any psychological side effects for Спазмобрю?

The drug is chemically structured to act peripherally (outside the brain and spinal cord) and generally not cross the blood-brain barrier effectively. Therefore, the side effects listed in official documents are primarily physiological, and psychological effects are generally not reported.

Q: Is Спазмобрю considered an opioid or controlled substance?

The medicine is officially classified as a muscarinic antagonist and an antispasmodic agent. It is not categorized as an opioid or a scheduled controlled substance.

Q: Does taking Спазмобрю require specific monitoring or tests?

Specific monitoring of cardiac symptoms is noted as a requirement for patients with existing cardiac conditions, particularly when the medicine is administered via injection. Monitoring may also be noted for certain patient populations.

Q: Is light sensitivity a reported side effect of Спазмобрю?

Official documents report accommodation disorders, which refer to impaired focusing and blurred vision, as a common side effect. This is a related visual disturbance, but specific light sensitivity (photophobia) may not be universally listed.

How should Спазмобрю be stored and disposed of?

How to Store and Dispose of Спазмобрю (Hyoscine Butylbromide)

The storage and disposal of this medicine must follow the conditions specified in official regulatory labeling to maintain its stability and quality.

Storage Requirements

Condition Requirement
Temperature Store tablets typically below 25 C; the injection solution may be stored below 30 C.
Protection The product must be protected from both light and moisture and kept in a dry place.
Packaging The medicine must be kept in its original package to ensure environmental protection.
Child Safety It is mandatory to keep the medicine out of the sight and reach of children.

Handling and Disposal

The solution for injection is for single use only, and any unused solution must be immediately discarded. The product must not be used past its expiry date. Disposal of unused or expired medicine must be done in accordance with local regulatory requirements for pharmaceutical waste.

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

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