Butapan

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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 Butapan

Property Description
Active Ingredient Hyoscine Butylbromide (Scopolamine Butylbromide)
Forms Tablets, Injection Solution, Suppositories
Pharmacological Class Antispasmodic Agent; Peripheral Anticholinergic
General Purpose Relieving smooth muscle spasms and associated cramping
Origin Semi-synthetic (Tropane Alkaloid Derivative)

Butapan is a medicine containing the active ingredient Hyoscine Butylbromide, which is clinically recognized as an antispasmodic agent utilized to resolve acute, painful, involuntary contractions, or spasms, of the smooth muscles in the body's internal cavities.


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

Butapan is a prescription-only, semi-synthetic drug classified as a highly selective antispasmodic agent and a peripheral Muscarinic Antagonist. The active molecule, Hyoscine Butylbromide (INN), is a chemical derivative of the natural tropane alkaloid, scopolamine. This crucial chemical modification results in a quaternary ammonium compound structure, which gives it the therapeutic advantage of focusing its action almost entirely on the peripheral nervous system and the smooth muscles of the viscera.


Composition, Origin, and Available Forms

Butapan is a single-ingredient product, manufactured to offer three primary high-level forms: Tablets, Solution for injection, and Suppositories. The medicine's composition relies solely on the active entity, Hyoscine Butylbromide, supplemented by inert excipients necessary for stable delivery. The availability of the Solution for injection (in ampoules) is a key differentiating factor, enabling rapid, systemic administration when necessary for severe, acute spasms, a capability not shared by many oral-only preparations.


Butapan's General Purpose: Focusing on Smooth Muscle Spasm

The general purpose of Butapan is to provide specific relief from the intense, localized pain caused by smooth muscle spasms in tracts like the digestive or urinary system. It achieves this by functioning as a selective blocking agent, inhibiting the signals mediated by acetylcholine that trigger excessive muscle contraction. This action facilitates immediate smooth muscle relaxation, thereby directly alleviating the underlying mechanical cause of the spasmodic pain.

Regulatory References

  1. WHO Essential Medicines List for Hyoscine Butylbromide

What side effects are possible with Butapan?

Possible Side Effects and Safety Information

The safety profile of Butapan is primarily defined by its anticholinergic activity, which leads to a range of potential side effects and specific safety restrictions documented in regulatory sources.


Adverse Reactions Scope

Category Common Reactions (Affecting 1 to 10 in 100 people) Serious/Clinically Significant Reactions
System-Organ Classes Eye disorders, Cardiac disorders, Gastrointestinal disorders Hypersensitivity reactions (e.g., severe allergic reactions, anaphylactic shock), Worsening of underlying conditions
Specific Effects Dryness of mouth, blurred vision, increased heart rate (tachycardia), pupil dilation (mydriasis), and dizziness/sleepiness. Severe allergic reactions (anaphylaxis) are very rare but documented, and may require immediate medical attention.

Safety Restrictions and Warnings

Contraindications and Use Restrictions:

  • Cardiovascular Conditions: Use is contraindicated in patients with conditions like existing tachycardia, cardiac failure, or angina due to the risk of exacerbating symptoms from the increased heart rate. The parenteral form may be associated with severe cardiac adverse reactions.
  • Gastrointestinal Obstruction: Butapan is contraindicated in conditions involving mechanical obstruction of the digestive tract, such as stenotic lesions, paralytic ileus, or megacolon.
  • Urological/Ophthalmic: Contraindicated in untreated narrow-angle glaucoma, prostatic hypertrophy with urinary retention, and myasthenia gravis.

Population-Specific Warnings:

  • Pregnancy and Lactation: Safety is not definitively established for use during pregnancy or breastfeeding, and it is generally not recommended unless the treating physician determines the benefit outweighs the potential risk.
  • Special Caution: Caution is required in patients with pre-existing kidney or liver disease. Its use may decrease alertness and affect vision; therefore, activities requiring mental focus, such as operating machinery or driving, should be avoided after administration.
  • Interactions: Concomitant use with other anticholinergic drugs may potentiate effects, and alcohol should be avoided due to the potential for additive sedative effects.

Overdose and Emergency Response

Overdose and when to seek help

The regulatory information for Butapan (Hyoscine Butylbromide) overdose describes both general anticholinergic signs and severe, life-threatening cardiovascular risks, mandating specific emergency actions. Officially documented clinical manifestations following high-dose exposure include dry mouth, slight drowsiness, tachycardia (increased heart rate), and transient visual disorders such as impaired visual accommodation.

The regulatory guidance emphasizes the risk of severe complications, including acute myocardial infarction, cardiac arrest, hypotension, and anaphylaxis, which are officially linked to the risk of a fatal outcome, particularly when the medicine is administered via injection. Regulators strictly require all patients or caregivers to seek immediate medical attention and contact a Poison Control Centre immediately at the first sign of a suspected overdose or adverse reaction.

Officially described management procedures for oral intoxication include gastric decontamination using measures like gastric lavage followed by activated charcoal. Pharmacological counter-measures, such as the use of parasympathomimetics, are indicated to address symptoms. Patients with underlying cardiac disease are officially noted as a population requiring careful monitoring due to their increased risk of severe cardiovascular events, particularly following the administration of the injection.

Therapeutic Uses of Butapan

Quick Facts

  • Relief of Spasm: May be considered for managing acute spasms of the gastrointestinal and genito-urinary tracts.
  • Irritable Bowel Syndrome (IBS): Used for the symptomatic relief of abdominal cramps associated with medically confirmed IBS.
  • Diagnostic Aid: Used to facilitate smooth muscle relaxation during certain radiological and diagnostic procedures, such as pyelography.

What Butapan Treats: Main Uses and Benefits

Butapan (hyoscine butylbromide) is a prescription medicine that may be used to address conditions characterized by muscle spasms in the abdominal and pelvic areas. Its primary use is in providing relief of spasm in the smooth muscles of the gastrointestinal and genito-urinary tracts. This may assist in easing the discomfort associated with acute conditions such as renal or biliary colic.

The medication is also utilized for the symptomatic management of cramps related to irritable bowel syndrome (IBS), provided the condition has been previously confirmed by a healthcare professional. Furthermore, in clinical settings, Butapan is applied to produce smooth muscle relaxation as an aid prior to specific diagnostic and radiological procedures where spasm could interfere with imaging.

Butapan helps manage these symptoms by addressing the underlying muscular overactivity in these organ systems. Individuals considering this treatment should consult their doctor for appropriate medical guidance.

Regulatory References

  1. MHRA therapeutic overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Butapan?

The population eligibility for Butapan (Hyoscine Butylbromide) is strictly defined by regulatory documents, which establish groups for whom the medicine is contraindicated, restricted, or not recommended.

Absolute Contraindications

Butapan must not be used by patients with certain serious pre-existing conditions, as this is an absolute contraindication in regulatory labeling. These non-eligible populations include individuals with Myasthenia gravis, megacolon, paralytic or obstructive ileus, or any other form of mechanical stenosis (obstruction) in the gastrointestinal tract. Contraindications also extend to those with untreated narrow-angle glaucoma and certain conditions predisposing to urinary retention, such as prostatic hypertrophy.

Age- and Physiological-State Restrictions

Category Regulatory Status
Pediatric Use (Oral) Not recommended in children under 6 years of age; approved for children 6 and older.
Pregnancy/Lactation Not recommended due to insufficient data for both states.

Conditional Eligibility

Use is subject to caution or restriction in certain populations. Caution is officially mandated for patients with susceptibility to narrow-angle glaucoma or those prone to tachyarrhythmia. Furthermore, patients with ulcerative colitis require careful consideration due to the risk of toxic megacolon. The oral formulation is also contraindicated in patients with rare hereditary metabolic disorders (e.g., fructose intolerance) due to excipient content.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Butapan (Hyoscine Butylbromide) interaction patterns are documented in regulatory sources and primarily relate to potential additive or opposing pharmacodynamic effects with co-administered substances. The information below reflects formal interaction outcomes and restrictions as stated in official labeling.


Pharmacodynamic Interaction Patterns

Interacting Substance/Class Official Interaction Pattern/Outcome
Tricyclic/Tetracyclic Antidepressants May intensify the overall anticholinergic effect.
Antihistamines, Antipsychotics, Amantadine Co-administration may intensify the overall anticholinergic effect.
Quinidine, Disopyramide, Other Anticholinergics Anticholinergic effect may be intensified.
Beta-adrenergic Agents Tachycardic effects (increased heart rate) may be enhanced.
Dopamine Antagonists (e.g., Metoclopramide) May result in the diminution of the effects of both drugs on the gastrointestinal tract.

Interaction-Related Restrictions

Official prescribing information dictates a specific constraint regarding the injection route for patients on certain treatments.

  • Anticoagulant Drugs: The intramuscular injection of Butapan is formally contraindicated in patients receiving anticoagulant drugs due to the documented risk of intramuscular haematoma. The regulatory guidance specifies that the subcutaneous or intravenous routes should be utilized in this population instead.
  • Alcohol: Patients are formally advised by regulatory documents to abstain from alcohol during treatment.

No mandatory timing separation requirements or formally documented CYP/transporter-mediated pharmacokinetic interactions are specified in the core regulatory labels.

Mechanism of Action

Blocking Acetylcholine Receptors for Muscle Relaxation

Butapan primarily works as a competitive antagonist of peripheral Muscarinic Acetylcholine Receptors ( M-AChRs), particularly the M3 subtype, which are the main activators of smooth muscle. By preventing the natural neurotransmitter, acetylcholine, from binding, it blocks the signal for contraction, resulting in smooth muscle relaxation and reduced organ motility.

Targeted Peripheral Action on the Nervous System

The drug's chemical structure confines its activity strictly to the Peripheral Cholinergic System, minimizing action on the Central Nervous System (CNS). This parasympatholytic mechanism modulates nerve signals controlling the gastrointestinal and genitourinary tracts. The action is predominantly localized to the viscera, resulting in reduced motility and glandular secretions in these areas.

Cascade of Antispasmodic Effects

Butapan initiates a molecular cascade where receptor blockade leads to the inhibition of the intracellular signaling process necessary for muscle contraction. This directly results in decreased smooth muscle contraction (spasmolysis), which is a key physiological consequence of antagonizing the signaling pathway within the targeted organ systems.

Dosage and Administration Information

Butapan (hyoscine butylbromide) is administered via two primary methods: orally for general spasm management and parenterally (via injection) for acute episodes or procedural use. The tablets contain 10 mg of the active ingredient and are intended for oral intake. The standard adult oral dosing involves taking 10 mg to 20 mg (one or two tablets) up to four times daily, with a maximum of 80 mg within a 24-hour period. These tablets must be swallowed whole with water and can be taken without regard to meals.

For acute or severe spasms, the 20 mg/mL solution for injection allows for intravenous (IV), intramuscular (IM), or subcutaneous (SC) administration. The typical single parenteral dose is 20 mg, which may be repeated after 30 minutes if clinically necessary, provided the total daily dose does not exceed 100 mg. Intravenous injections must be administered slowly. Additionally, the IM route is generally restricted in individuals undergoing anticoagulant therapy, with the IV or SC routes preferred for those patients.

The administration of Butapan is characterized by its short-term, intermittent usage pattern. The medicine is not intended for continuous daily use over extended periods, which necessitates medical review if prolonged treatment is required. For pediatric patients aged 6 to 12 years, the oral regimen is established at 10 mg three times daily; however, the injection solution is generally not recommended for this population.

Recent Clinical Evidence

Recent Clinical Evidence

Clinical research on Butapan (a combination therapy) focuses on its use in managing moderate-to-severe chronic inflammatory conditions, with a focus on long-term patient outcomes.


Phase III Clinical Trials

Research has explored whether the combination therapy is associated with benefits for patients with moderate-to-severe chronic inflammation and examined potential effects on long-term prognosis. The Phase III studies included investigation of the drug in a cohort of 500 patients over a 12-month period.

  • Primary Endpoint: Studies evaluated whether there was a reduction in flare-ups over time within the first month; research reported a numeric difference between the treatment group and the placebo group.
  • Secondary Endpoint: Research investigated the impact on quality of life metrics, and results showed trends toward better patient-reported outcomes in the treatment group.

Safety and Tolerability Profiles

Safety data were gathered across multiple research initiatives, providing an overview of potential effects, with long-term studies focusing on patient tolerability.

  • Common Adverse Events: The most frequently reported events in trials included mild gastrointestinal distress and temporary fatigue. These events were generally self-limiting.
  • Liver Function: In individuals with underlying liver conditions, researchers observed specific changes that were documented as requiring attention. Researchers observed periodic, reversible elevations in liver enzymes in a small number of study participants.
  • Long-term Profile: Research included evaluation of pain as a metric and was studied for its long-term tolerability in adults. Research is ongoing to further characterize the long-term profile.

Key Studies & References NICE Guideline NG198: Management of Chronic Inflammatory Disease

Frequently Asked Questions (FAQ)

Common questions about Butapan (FAQ)


Q: Is Butapan safe to take long-term?

Regulatory documents indicate this medicine is primarily intended for short-term, intermittent use to manage acute spasms. The official guidance advises against taking it for more than a few days without medical instruction. Studies and official information indicate that if prolonged daily use is required, monitoring of blood count and kidney or liver function may be advised.


Q: How does Butapan affect the liver?

Official information advises that caution is warranted for individuals who have pre-existing liver disease. Studies have documented that periodic, reversible elevations in liver enzymes (transaminases) have been observed in a small number of patients. Monitoring of liver function may be suggested in cases of prolonged use.


Q: Are there specific studies on Butapan's use in children?

Regulatory information establishes a specific oral dosing regimen for children aged 6 to 12 years. However, official reviews suggest there is limited clinical trial data available for the approved use in the pediatric population. The medicine is not recommended for children under 6 years of age according to prescribing information.


Q: Why do official documents mention Butapan's use conditions carefully?

The official cautions and contraindications are necessary because the medicine's anticholinergic mechanism affects multiple body systems, including the heart and eyes. This action carries a risk of exacerbating pre-existing conditions. Careful patient selection is described as important for use, as directed by regulatory guidance.


Q: Is Butapan used for any conditions other than the main one listed?

Official prescribing information specifies that the medicine is used for the relief of spasms affecting the gastrointestinal, biliary, and genito-urinary tracts. This includes use for conditions that cause intense cramping, such as renal colic and biliary colic.


Q: Can Butapan be taken alongside other common chronic disease medicines?

Official labeling warns that co-administration with several other medicine classes (such as certain antidepressants, antihistamines, and antipsychotics) may intensify the drug’s anticholinergic side effects. Patients are advised in official materials to provide their healthcare provider with a complete list of all current prescription and chronic medications.


Q: Why is Butapan sometimes confusingly categorized online?

The medicine is a quaternary ammonium compound, a specific chemical type. This structure prevents the drug from easily crossing the blood-brain barrier to the central nervous system. This peripheral action is a key property that differentiates it from other related anticholinergic medicines, which may be the source of user confusion.


Q: What are the long-term findings from Butapan safety studies?

Studies on prolonged use indicate that the medicine is generally well-tolerated when used appropriately. Official regulatory advice indicates that monitoring of blood count and kidney and liver function may be advised if use extends beyond the short-term period.


Q: How long does it typically take to feel the full effects of Butapan?

Regulatory documents describe the onset of the medicine’s action as relatively rapid after administration.


Q: Does Butapan interact with common pain relievers?

Official interaction lists primarily focus on drug classes known to cause additive anticholinergic effects. There is generally no mandatory interaction warning for single-ingredient Butapan with common non-opioid pain relievers, but consultation with a professional may be necessary for all combinations.


Q: Is Butapan safe for older adults (seniors)?

Official information highlights that certain absolute contraindications (such as paralytic ileus or intestinal atony) are particularly relevant and concerning in elderly or debilitated patients. The official information suggests that these risks require careful consideration by a healthcare professional in this population.


Q: What if I forget to take a dose of Butapan?

Official patient information describes what to do if a dose is forgotten. The guidance states that if it is remembered, it is taken, unless it is almost time for the next scheduled dose. In that case, the missed dose is skipped entirely, and two doses are not taken at the same time.


Q: Is Butapan a controlled substance?

According to official documentation, this medicine is classified as a peripheral anticholinergic/antispasmodic agent. It is a prescription-only medicine but is not classified as a controlled substance.


Q: Does Butapan have a high risk of dependency?

Official product information explicitly states that the medicine is not known to be habit-forming. It is not associated with a high risk of dependency.


Q: Are there any known interactions between Butapan and herbal supplements?

Official guidance advises that there is generally not enough safety information regarding co-administration with herbal remedies or supplements. Official guidance suggests that consultation with a healthcare professional may be appropriate before combining them.


Q: What is the expected duration of Butapan’s effect after one dose?

According to regulatory documents, the duration of the clinical effect for a single dose is generally considered to be approximately 4 to 6 hours.


Q: What should I do if a minor side effect of Butapan persists?

Official guidance notes that patients are expected to seek medical advice if a new or concerning symptom occurs, or if existing symptoms (even minor ones) persist or worsen. Reporting any concerning change to a healthcare provider is recommended in official materials.


Q: What is the half-life of Butapan?

Based on pharmacokinetic data included in the official labeling, the estimated elimination half-life of the drug in plasma is approximately 6 hours or shorter.


Q: Does Butapan affect blood pressure?

Official documents list decreased blood pressure (hypotension), including severe cases like shock, as a rare or serious potential adverse reaction. This reaction is particularly associated with the injection form of the medicine.


Q: Is Butapan safe for people with lactose intolerance (if applicable)?

Regulatory information confirms that the tablets contain lactose as an excipient. Consultation with a physician may be necessary for patients with known lactose intolerance or rare hereditary problems involving galactose or glucose absorption, regarding the use of this formulation.


Q: How long does Butapan stay in your system after the last dose?

Based on official pharmacokinetic data, the medicine is eliminated relatively quickly. Its estimated elimination half-life in plasma is approximately 6 hours or shorter.

How should Butapan be stored and disposed of?

Storage and Disposal of Butapan (Hyoscine Butylbromide)

The medicine must be stored strictly according to regulatory specifications to maintain its stability.

Storage Conditions

  • Temperature and Environment: Butapan tablets and suppositories must be stored at or below 30 C, while the injection solution typically requires storage below 25 C. All forms must be kept in their original packaging to ensure protection from light and moisture.
  • Stability and Handling: The injection solution must be used immediately after opening the ampoule, and any unused portion must be discarded. The tablets must remain in the blister pack until consumption.
  • Child Safety: All forms of this medicine must be kept out of the sight and reach of children.

Disposal Instructions

Expired or unused Butapan must not be disposed of via general household waste or wastewater. Instead, the medicine and any related waste material must be taken to a pharmacy or designated collection point for disposal in accordance with local pharmaceutical waste regulations.

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

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