Butacin

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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 Butacin

What is Butacin?

Butacin is a pharmaceutical formulation containing phenylbutazone, a non-steroidal anti-inflammatory drug (NSAID) belonging to the pyrazolone class. It is primarily utilized for its analgesic, anti-inflammatory, and antipyretic properties.

Mechanism of Action

The therapeutic effects of Butacin are achieved through the inhibition of the cyclooxygenase (COX) enzymes. These enzymes are responsible for the synthesis of prostaglandins, which are lipid compounds that act as mediators in the processes of inflammation, pain signaling, and fever induction. By reducing prostaglandin production, Butacin helps to manage symptoms associated with various inflammatory conditions.

Therapeutic Applications

Butacin is indicated for the management of severe inflammatory and painful conditions. Its use is generally reserved for cases where other treatments have proven ineffective. Common applications include:

  • Rheumatoid Arthritis: A chronic inflammatory disorder affecting the joints.
  • Ankylosing Spondylitis: A type of arthritis that primarily affects the spine.
  • Osteoarthritis: A degenerative joint disease.
  • Acute Gouty Arthritis: Severe attacks of pain and inflammation in the joints caused by uric acid crystals.

Due to its potent nature, Butacin is typically intended for short-term use to address acute exacerbations of chronic inflammatory diseases.

What side effects are possible with Butacin?

Possible Side Effects and Safety Information

The safety profile of Butacin (Hyoscine Butylbromide) is primarily defined by its effects as a peripheral anticholinergic agent, which are documented across major System Organ Classes (SOC) in official regulatory labeling. These effects are classified by frequency, ranging from common to those reported in the post-marketing phase.


Adverse Reaction Frequencies

Classification Examples of Documented Adverse Reactions
Common Tachycardia (increased heart rate), Dry mouth, Constipation, Dizziness, Accommodation disorders (impaired eye focus)
Uncommon Skin reactions (e.g., Urticaria, Pruritus), Dyshidrosis (reduced sweating)
Rare Urinary retention
Not Known Anaphylactic shock (including fatal cases), Hypotension, Increased intraocular pressure, Confusion, Hallucinations

Key Safety Restrictions and Considerations

Official prescribing information includes specific constraints for its use. The medicine is contraindicated in patients with untreated narrow angle glaucoma, Myasthenia Gravis, prostatic hypertrophy with urinary retention, and mechanical stenoses or obstructive conditions of the gastrointestinal tract.

Regulatory documents also highlight specific safety considerations for patient groups. Caution is advised for individuals with underlying cardiac disease due to the increased risk of severe adverse effects such as potentially fatal anaphylaxis, tachycardia, and hypotension. Furthermore, due to a lack of sufficient human data, use during pregnancy and lactation is generally not recommended as a precautionary measure. Should accommodation disorders or dizziness occur, the ability to operate machinery or drive may be impaired.

Overdose and Emergency Response

Documented Overdose Manifestations

Overdose with Butacin (Hyoscine Butylbromide) is formally documented in regulatory prescribing information, defining specific manifestations that represent an exaggeration of the drug's peripheral anticholinergic effects. Documented signs include tachycardia (fast heart rate), dry mouth, urinary retention, and transient visual disturbances (accommodation disorders). Further manifestations listed in regulatory sources are reddening of the skin, inhibition of gastrointestinal motility, and drowsiness.

Severe Outcomes and Mandated Actions

The regulatory profile notes that severe or life-threatening outcomes can occur, including respiratory paralysis and Cheyne-Stokes respiration. Isolated reports, typically associated with high-dose parenteral administration, document coma, hallucinations, and dystonia.

Immediate medical attention must be sought if an overdose or a severe adverse reaction is suspected. Management procedures are explicitly documented and include the use of parasympathomimetics as an antidotal treatment. For respiratory paralysis, intubation and artificial respiration are required, and catheterisation may be needed for severe urinary retention. Treatment for oral overdose may involve gastric lavage with activated charcoal.

Therapeutic Uses of Butacin

What Butacin Treats: Main Uses and Benefits

Butacin provides supportive symptomatic relief across various clinical scenarios, often used during phases when symptoms become more noticeable. A primary therapeutic goal of this class of medication is to temporarily relieve discomfort and help ease the overall symptom burden. It is primarily applied in contexts where short-term, focused management of disruptive symptoms is needed to assist with maintaining functional stability.

The medication may be considered for managing symptoms related to physical discomfort, symptoms associated with acute or episodic changes, and symptoms that create noticeable physiological strain.


Quick Fact: Relief for Acute Discomfort

Quick Fact: Relief for sudden, intense symptoms that temporarily interfere with daily functioning.


Addressing Symptom Clusters and Episodic Patterns

This area covers conditions characterized by symptoms that appear in recurrent or episodic manifestations. When symptoms intensify and supportive relief is needed, Butacin assists with symptomatic management. It supports the patient during difficult episodes and helps improve day-to-day comfort.


Providing Short-Term Assistance

Butacin is relevant when groups of symptoms cluster into disruptive patterns. It is applied during these phases of increased physiological stress to assist with functional stability and help maintain a sense of stability when symptoms are more noticeable.

Eligibility and Restrictions for Use

Who can and cannot use Butacin?

Eligibility for Butacin (Hyoscine Butylbromide) is strictly defined by regulatory guidelines to ensure patient safety, focusing on absolute prohibitions (contraindications) and age restrictions.


Populations Excluded from Use (Contraindications)

The medicine must not be used by individuals with specific underlying health conditions, as its anticholinergic action could aggravate them. These include known hypersensitivity to the drug, myasthenia gravis, untreated narrow-angle glaucoma, and conditions causing gastrointestinal or urinary obstruction, such as paralytic or obstructive ileus, megacolon, or prostatic hypertrophy with urinary retention. The injectable form is also contraindicated in patients with specific severe cardiac conditions like angina or cardiac failure.


Age and Conditional Use

Use is generally approved for adults. For the oral tablet form, use is typically restricted to children aged 6 years and over. Butacin is not recommended during pregnancy or breastfeeding due to insufficient data for established safety. Furthermore, caution is advised for patients susceptible to narrow-angle glaucoma or urinary outlet obstruction.


Specific Restrictions

Administration via intramuscular (IM) injection is prohibited for patients taking anticoagulant drugs (blood thinners) due to the risk of hematoma, requiring an alternative route.

What should I know about interactions with other medicines?

Butacin's interaction profile is primarily defined by its potential for pharmacodynamic potentiation with other medicines. Co-administration with agents that also possess anticholinergic properties, such as Tricyclic Antidepressants, Antihistamines, Antipsychotics, Quinidine, Amantadine, and Disopyramide, may lead to an intensification of anticholinergic effects.

Conversely, the medicine's effect on gastrointestinal motility may be opposed by Dopamine Antagonists, including Metoclopramide and Domperidone, resulting in a diminution of the effects of both drugs. Caution is also required with Beta-Adrenergic Agents due to the documented potential for enhanced tachycardic effects.

Specific administration constraints exist. Anticoagulant drugs are restricted when Butacin is administered via the intramuscular (IM) injection route due to the documented risk of forming a haematoma at the injection site. Furthermore, to prevent reduced oral absorption, Butacin must be taken at least one hour apart from Antacids and Adsorbent Antidiarrheals. Officially documented notes also advise patients to abstain from alcohol. For patients with pre-existing cardiac conditions, specific monitoring is advised during parenteral administration.

Mechanism of Action

Butacin's action involves disrupting a specific type of nerve signal that drives involuntary contraction in smooth muscle tissues. This mechanism involves highly localized molecular and cellular interference within the peripheral nervous system.

Targeting the Muscarinic Acetylcholine Receptor

The drug operates as a competitive antagonist, physically blocking the M1- M5 muscarinic receptors on peripheral smooth muscle cells. This action prevents the primary parasympathetic neurotransmitter, acetylcholine, from binding, thereby suppressing the nerve signal at the molecular level by acting on the process responsible for initiating contraction.

Inhibiting the Smooth Muscle Contraction Cascade

By blocking the receptor, the drug prevents the subsequent G q-protein cascade and the resulting release of intracellular calcium ( Ca^2+) within the muscle cell. Since calcium is required for the muscle's contractile machinery to engage, the inhibition of this molecular step results in the relaxation of visceral smooth muscle and a reduction in involuntary motility.

Localized Peripheral Efficacy

Butacin possesses a quaternary ammonium structure, which confers a positive charge that restricts its ability to traverse the blood-brain barrier. This structural feature ensures the anticholinergic effect is concentrated almost entirely on the targets in the peripheral autonomic nervous system (viscera), ensuring the physiological consequence—a decrease in muscle contractility—is highly localized.

Dosage and Administration Information

How to Use Butacin: Administration Guidelines

Butacin (hyoscine butylbromide) is used as specified to ensure standardized use. The medicine is intended for short-term, intermittent use and should not be taken on a continuous daily basis for extended periods without medical review.


Administration Routes and Dosing

The medication permits administration via the oral route (tablets) or the parenteral routes, including Intravenous (IV), Intramuscular (IM), and Subcutaneous (SC) injection.

Administration Route Standard Adult Dosing Key Frequency Instruction
Oral Tablet (10 mg or 20 mg) 10 mg to 20 mg per dose; up to 80 mg (four times daily) is the maximum single daily regimen. Doses are repeated three to four times daily.
Parenteral Injection (20 mg/mL) A single dose of 20 mg to 40 mg. The dose may be repeated after 30 minutes if necessary, with a maximum total of 100 mg per day.

Procedural and Age-Specific Instructions

Oral tablets must be swallowed whole with water and must not be broken, crushed, or chewed. Intravenous injection must be administered slowly, typically over at least three minutes, and may be diluted with standard solutions like 0.9% sodium chloride.

Age-Specific Use: The oral form is recommended for children over 6 years at a dose of 10 mg three times daily. No specific dose adjustment information is required for older adults, as no age-specific adverse reactions requiring modification have been identified. Usage should be reviewed if the condition does not improve within two weeks.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Hyoscine Butylbromide

The research for Hyoscine Butylbromide focuses on its application in exploring short-term, spasmodic symptoms. The evidence base primarily consists of Randomized Controlled Trials (RCTs) and meta-analyses that explore outcomes related to physical discomfort and patient-reported experiences. These studies help show what has been observed so far under specific research conditions.


Evidence for Acute Visceral Spasm and Cramping

Research has focused on Hyoscine Butylbromide in conditions associated with acute or disruptive episodes of pain. The trials were mostly short-term RCTs that included participants who reported acute abdominal pain, and sometimes included adolescents and children over the age of six in emergency settings. These studies explored short-term changes in reported symptoms by measuring patient-reported outcomes describing perceived discomfort. Findings describe patterns observed in the studies related to measured pain intensity and patient self-reports, compared to placebo or other measured changes. The findings were mixed when Hyoscine Butylbromide was directly compared to standard non-spasmolytic analgesics in certain acute settings. The results apply only to the populations studied, and there is limited information for long-term outcomes.


Research on Episodic Symptoms and Diagnostic Support

Studies in Irritable Bowel Syndrome (IBS) Symptoms

Hyoscine Butylbromide was evaluated in studies focused on conditions characterized by fluctuating or episodic manifestations, such as the cramping pain common in Irritable Bowel Syndrome (IBS). Research highlights changes measured during the study period, focusing on measured changes in the frequency and intensity of pain during periods of heightened symptom activity. A key limitation is that follow-up durations were limited, and the evidence base notes the potential for use to mask symptoms that may require further investigation.

Supportive Use in Endoscopic Procedures

Research has explored the use of Hyoscine Butylbromide as a supportive agent during various diagnostic procedures. Findings describe patterns observed where the medicine was associated with physiological measures in the digestive tract, which may contribute to changes in visualization metrics reported by the medical professional. Evidence quality varies across studies, and some established guidelines indicate that this application is not a universal standard of care.


Study Duration and Long-Term Follow-up Data

The vast majority of research on this medicine is focused on short-term changes in reported symptoms observed during acute or episodic patterns. Consequently, long-term effects are not fully established, and limited information is available on the outcomes or patterns of use for individuals who take the medicine regularly over periods exceeding a few months.

Frequently Asked Questions (FAQ)

Common questions about Butacin (FAQ)


Q: How quickly should I expect Butacin to start working?

Official drug information indicates that Butacin is designed to act quickly, particularly when administered as an injection. The medicine is rapidly distributed throughout the body's tissues, which is the physiological basis for its intended quick onset of action on the target muscles.

Q: Can Butacin be taken long-term for chronic conditions?

No. Regulatory warnings state that Butacin is not intended for continuous, long-term use. Official guidance advises that the medicine should not be taken on a continuous daily basis or for extended periods without medical supervision.

Q: Does Butacin make you sleepy or drowsy?

Official labeling lists dizziness as a common side effect of Butacin. Although the medicine's action is primarily concentrated outside the brain (peripheral), official sources note that if accommodation disorders or dizziness occur, the ability to operate machinery or drive may be impaired.

Q: What is the expected duration of treatment with Butacin?

The medicine is intended for short-term, intermittent use to manage acute spasms. For self-medication, official patient guidance generally recommends not to use the medicine for longer than two weeks unless advised otherwise. This time constraint is in place to ensure that persistent or underlying causes for the symptoms are identified, as the medicine is for acute use.

Q: Is Butacin safe for people who have kidney issues?

Butacin is partly eliminated from the body through the urine. While regulatory information may not always define specific dose adjustments for all types of kidney impairment, caution is usually advised due to this elimination pathway. Consultation with a health professional is generally needed to assess the suitability of Butacin when kidney impairment is present.

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

Official pharmacokinetic data, which describes how the body handles the medicine, indicates that the terminal elimination half-life is around five hours after intravenous administration. This means that the majority of the drug is eliminated from the body within approximately 24 hours via both urine and faeces.

Q: Is Butacin considered a controlled substance?

In major regulatory systems, such as the US, Butacin (Hyoscine Butylbromide) is not typically listed as a scheduled or controlled substance when it is marketed as a single-ingredient product.

Q: Are there any known interactions between Butacin and herbal remedies?

Official interaction profiles mainly focus on known prescription drug classes. However, some regulatory materials advise that there is not enough information available to definitively confirm whether all complementary medicines, herbal remedies, and supplements are safe to take with Butacin. For all supplements, including herbal remedies, official guidance recommends consultation with a health professional before use.

Q: Can Butacin make existing stomach issues worse?

Butacin works by relaxing smooth muscles in the gut, and it is contraindicated (must not be used) in serious conditions involving gastrointestinal obstruction. Furthermore, official documents commonly list constipation as a potential side effect. A health professional can determine the medicine's suitability when a patient has underlying stomach issues.

Q: Is Butacin ever used in children?

Yes, the oral tablet form is officially recommended for use in children who are aged 6 years and over, following defined dosing instructions. Use in children under the age of six years is generally not recommended in official guidelines.

Q: Are there any specific populations where Butacin is studied less?

Official documents highlight that there is a lack of sufficient human data regarding the medicine’s use during pregnancy and lactation, which is why its use in these populations is generally not recommended. Additionally, most studies have focused on short-term changes in symptoms, meaning data on long-term effects is limited.

Q: Is Butacin safe for people who have liver problems?

Regulatory data on how the body processes the medicine indicates that minimal metabolism by the liver is generally required for its elimination. Because of this, official labels do not commonly define a specific dose adjustment for liver impairment.

Q: If I miss a dose of Butacin, what is the guidance?

Official patient guidance describes that the missed dose should be taken as soon as it is remembered. However, if it is already nearly time for the next scheduled dose, the missed dose should be skipped. The guidance is to then continue with the regular schedule, and notes advise against taking a double dose to compensate for a skipped one.

How should Butacin be stored and disposed of?

Storage and Disposal of Butacin

Official regulatory guidelines mandate specific conditions to maintain the stability of Butacin (Hyoscine Butylbromide). Tablets must be stored below 30 C and kept in their original container to ensure protection from both light and moisture. The injection solution requires storage below 25 C in a cool, dry area, and any unused portion of an opened ampoule must be discarded immediately.

Child Safety and Disposal

All forms of Butacin must be stored out of the sight and reach of children.

For disposal, the medicine is not on the list of products recommended for flushing; unused or expired Butacin and its packaging must be disposed of in accordance with local pharmaceutical waste regulations.

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

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