Hyoscine Butyl Bromide - A Comprehensive Review About Its Uses, Dosage, Side Effects, Precautions, and Interaction

Overview:

Hyoscine butyl bromide is an anticholinergic medicine used to treat pain and discomfort caused by abdominal cramps, menstrual cramps, or other spasmodic activities. It stops muscle contractions by relaxing the muscles of the stomach, intestine, and bladder. It acts as an antispasmodic drug and eases bloating and spasms associated with the stomach, intestine, and bladder. It is an antispasmodic drug indicated for the treatment of abdominal pain associated with irritable bowel syndrome (IBS) and diverticular disease (digestive condition affecting the large intestine). Hyoscine butyl bromide is available on prescription and may be bought over the counter.

How Does Hyoscine Butyl Bromide Work?

Hyoscine butyl bromide acts by blocking the muscarinic receptors found on the walls of the gastrointestinal tract. The drug blocks the action of acetylcholine on the receptors present within the smooth muscle of the gastrointestinal and urinary tract and reduces contractions.

The onset of action of Hyoscine butyl bromide is seen as early as 15 minutes after oral administration. The drug is rapidly absorbed after intramuscular or subcutaneous administration with effect in approximately 30 minutes. The duration of action may last for four hours. The peak plasma concentration reaches two hours. Hyoscine butyl bromide is mainly eliminated in the feces and very little in the urine. The half-life of elimination is one to five hours.

Uses of Hyoscine Butyl Bromide:

Hyoscine butyl bromide is used in the treatment of pain due to smooth muscle spasms. The drug helps relieve cramps in the muscles of the stomach, intestine, bladder, and ureter. Hyoscine butyl bromide may be used to alleviate the symptoms of irritable bowel syndrome (IBS), and diverticular disease. It also helps to relax the muscles and provides relief from cramps, pain, and discomfort associated with menstruation (monthly periods).

Limitations:

Hyoscine butyl bromide cannot be taken longer than two weeks. The medication cannot be given to children younger than six years of age.

Route of Administration - Oral and injectable.

Dosage Strengths - 10 mg.

Typical Dosage -

Special Considerations:

• Allergy - Hyoscine butyl bromide should not be taken if a person is allergic to the drug or any of its ingredients.

• Pregnancy and Breastfeeding - It is recommended to use Hyoscine butyl bromide with caution during pregnancy, especially in the first trimester. Small amounts of Hyoscine butyl bromide may get into breast milk and may increase the risk of side effects.

• Children - The use of Hyoscine butyl bromide must be avoided in children under the age of six years. The drug should not be given to children below 12 years for treating irritable bowel syndrome.

• Mind Alertness - Hyoscine butyl bromide may cause blurred vision so it is advised to avoid driving or operating machinery while taking the medication.

• Liver or Kidney Disease - Dose adjustments may be required in patients with liver impairment and kidney impairment.

Warnings and Contraindications

Contraindications:

• Hypersensitivity - Hyoscine butyl bromide is contraindicated in people who have demonstrated prior hypersensitivity to the drug or any other component of the products.

• Myasthenia Gravis - Hyoscine butyl bromide is contraindicated for use in myasthenia gravis (neuromuscular disease causing weakness and fatigue) as it can cause adverse effects.

• Mechanical Stenosis - People with a partial or complete blockage in the intestine (mechanical stenosis) should not be given Hyoscine butyl bromide.

• Paralytical or Obstructive Ileus - Hyoscine butyl bromide should not be used in a partial bowel obstruction as the drug may slow gut motility and impede the resolution of partial bowel obstruction.

• Megacolon - The use of Hyoscine butyl bromide is not indicated for use in people affected with megacolon (a complication of severe colon disease) due to the increased risk of colon relaxation and further major side effects.

• Narrow-Angle Glaucoma - The use of Hyoscine butyl bromide should be avoided in people with undiagnosed and untreated glaucoma (caused due to damage to the optic nerve).

Warnings and Precautions:

• Glaucoma - Elevation of intraocular pressure may be produced by the administration of Hyoscine butyl bromide in patients with undiagnosed or untreated narrow-angle glaucoma (when fluid from eyes cannot drain resulting in damage to optic nerve).

• Fructose Intolerance - Hyoscine butyl bromide tablets contain 41.2 mg sucrose and should be avoided in patients with hereditary fructose intolerance and glucose-galactose malabsorption.

• Myasthenia Gravis - The use of Buscopan is contraindicated in myasthenia gravis as it may exacerbate the symptoms.

• Intestinal Obstruction - Hyoscine butyl bromide must not be used when there is a blockage in the stomach or bowel or in conditions where there is reduced bowel activity.

• Cardiac Insufficiency - Buscopan, a Hyoscine butyl bromide, must be administered with caution in patients with cardiac failure as it may further accelerate the heart rate.

For Patients

What Is Irritable Bowel Syndrome?

It is a gastrointestinal disorder that mainly affects the large intestine. Intestinal bowel syndrome is also known as spastic colon, irritable colon, spastic colitis, and mucous colitis. The condition may be caused due to acidity, stress, carbonated foods and beverages, irregular hormone levels, irregular eating or drinking habits, allergies, and intolerance to certain food or medicines.

Symptoms of Irritable Bowel Syndrome:

• Abdominal pain occurs between the chest and pelvic region.

• Cramping.

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• Bloating and gas.

• Constipation.

• Diarrhea.

Why Is Hyoscine Butyl Bromide Prescribed for Irritable Bowel Syndrome?

Hyoscine butyl bromide relaxes the cramping muscles of the bowel. The drug relieves painful stomach cramps. The antifoaming effect of the drug decreases bloating and gas.

Facts One Should Know About Hyoscine Butyl Bromide:

• Hyoscine butyl bromide is also known as Scopolamine butyl bromide.

• Hyoscine butyl bromide relieves stomach pain by relaxing the gut. The drug stops painful spasms by targeting smooth muscles in the digestive tract.

• It relieves painful cramps within 15 minutes of administration.

• Hyoscine butyl bromide is available with a prescription and over-the-counter.

• The most common side effects are dry mouth, constipation, and blurred vision.

• Avoid consuming alcohol while taking Hyoscine butyl bromide.

• There is no report of a habit-forming tendency with Hyoscine butyl bromide.

How Should One Take Hyoscine Butyl Bromide?

• Take Hyoscine butyl bromide only when one has stomach cramps or period pain.

• The usual dose of Hyoscine butyl bromide is one or two tablets of 10 mg per day. The maximum dose is six tablets per day.

• The tablets may be taken with or without food and with a glass of water.

• For injection, the usual dose is 10 mg to 20 mg given intramuscular, intravenous, or subcutaneously. The maximum daily dose is 100 mg.

• It is advised not to take Hyoscine for more than two weeks.

• Avoid taking this medicine after it expires. Check for the expiry on the back of the medicine pack.

• In case of a missed dose, take it soon after one remembers. However, do not take two tablets together as it may cause adverse reactions. Always space the doses at least eight hours apart.

Information Be Given to the Doctor Before Taking Hyoscine Butyl Bromide:

• Allergy - Hyoscine butyl bromide should not be taken if one has had an allergic reaction to it or any similar medication.

• Medical History - Before using Hyoscine butyl bromide, inform the doctor of medical history and drug history. Inform the doctor of prescription drugs, non-prescription, supplements, or herbal products.

• Pregnancy and Breastfeeding - Talk to the doctor before taking the medication in case the person is pregnant, breastfeeding, or planning to become pregnant.

• Children - Hyoscine butyl bromide should be started in low doses in children aged six years or older. The drug is not studied for safety and effectiveness in children younger than six years.

Safety of Hyoscine Butyl Bromide:

Hyoscine butyl bromide injections may contain inactive ingredients that can cause serious allergic reactions or adverse events including increased heart rate and low blood pressure. The drug is generally well tolerated as it is barely absorbed and detectable in the blood

Effectiveness of Hyoscine Butyl Bromide:

Hyoscine butyl bromide acts directly in the abdomen and targets to relieve the cause of abdominal pain, such as reducing the contractions of the muscles in the walls of the stomach, bowel, and bladder. It has a fast onset of action (15 minutes).

Side Effects Expected With Hyoscine Butyl Bromide:

Hyoscine butyl bromide can cause mild or severe side effects when taken in normal doses. These may include,

• Blurred vision.

• Constipation.

• Decreased ability to sweat.

• Diarrhea.

• Dizziness.

• Dry mouth.

• Fast heartbeat.

• Flushing.

• Nausea and vomiting.

The serious side effects may include

• Difficulty urinating.

• Dizziness.

• Shortness of breath.

• Skin rash.

• Itching.

• Vision changes.

• Severe allergic reactions such as hives, difficulty breathing, and swelling of the face, mouth, tongue, or throat.

Tips to Cope With Side Effects of Hyoscine Butyl Bromide:

• In case of excessively dry mouth, a person can chew sugar-free gum or candy.

• Adding more fiber to the diet, such as fresh fruits, vegetables, and cereals can relieve constipation. Drinking plenty of water, and exercising regularly also helps to keep the gut healthy.

• Avoid driving or operating heavy machinery until the vision is cleared. Hyoscine can blur vision and will return to normal in a few days.

• Avoid consumption of alcohol, smoking, and heavy meals. Try to take the medication when one can sit or lie down till the symptoms, such as a fast heart rate settles down.

Can One Stop Taking Hyoscine Butyl Bromide Suddenly Without the Doctor's Approval?

• Never stop taking medicines without talking to the doctor. The doctor will decrease the dose gradually.

• Do not take the drug more than advised by the doctor.

• Hyoscine butyl bromide must be taken only when necessary and should be stopped when the symptoms settle (within two weeks).

Dietary Restrictions to Consider When Taking Hyoscine Butyl Bromide:

1. Alcohol - It is advised to avoid drinking alcohol while taking Hyoscine butyl bromide as it may aggravate the side effects.

2. Caffeinated Drinks - It is advised to avoid caffeine, fizzy drinks, and fried foods when taking Hyoscine butyl bromide as it may trigger cramps.

Storage of Hyoscine Butyl Bromide:

• Keep Hyoscine Butyl Bromide medicine in their original packaging and a tightly closed container.

• Store at room temperature between 15 to 30 degrees.

• Direct contact with heat, air, and light may damage the medicines. Therefore, keep the medicines away from moisture, direct light, and heat.

• Always keep the medicines out of reach of children and pets. Always lock the safety caps of the medication to protect small children from poisoning themselves.

Disposal of Hyoscine Butyl Bromide Medicines:

• Do not keep outdated medicines or medicines that are no longer needed. Discard any unused portion of the solution 30 days after the opening of the bottle.

• Likewise, unneeded Hyoscine Butyl Bromide tablets should not be disposed of by flushing or throwing them out with regular garbage.

• Dispose of the medicine through the local medicine take-back program, which can be accessed or learned more about through the local pharmacist.

• Some people may not have access to a drug take-back program. Ask the local pharmacist about any other drug disposal options available.

Overdose:

• In case of an overdose, call the poison control helpline.

• Call the emergency services if the person has collapsed, has a seizure, or has trouble breathing.

• Overdose symptoms include drowsiness, dry mouth, difficulty passing urine, reddening of the skin, or fast heart rate.

• Supportive treatment is initiated following the patient's clinical signs and symptoms.

For Doctors

Indications:

• Hyoscine butyl bromide is prescribed to relieve abdominal cramps and irritable bowel syndrome pain, cramps, and discomfort.

• The drug is used for diagnostic and therapeutic medical procedures where spasms might be a problem, such as gastroduodenal endoscopy, and to produce smooth muscle relaxation prior to radiological procedures, like pyelography (imaging of the renal pelvis).

• The drug is used to treat period pain by relaxing the muscles.

Pharmacology of Hyoscine Butyl Bromide:

Description - Hyoscine butyl bromide stops muscle contractions by relaxing the stomach, intestines, and bladder muscles.

Components of Tablets -

Active Ingredients - Hyoscine butyl bromide.

Inactive Ingredients -

• Calcium hydrogen phosphate.

• Maize starch.

• Soluble starch.

• Colloidal silica.

• Tartaric acid.

• Stearic acid.

• Sucrose.

• Talc.

• Acacia.

• Titanium dioxide.

• Macrogol 6000.

• Carnauba wax.

• White beeswax.

• Povidone.

Composition of Injection -

Active Ingredients - Hyoscine Butyl bromide.

Nonmedicinal Ingredients -

• Sodium chloride.

• Water for injection.

Clinical Pharmacology:

Mechanism of Action - Hyoscine butyl bromide exerts a spasmolytic action on the smooth muscles of the gastrointestinal, biliary, and genitourinary tracts. Hyoscine butyl bromide does not enter the central nervous system as a quaternary ammonium derivative. Therefore, anticholinergic side effects in the central nervous system do not occur. Peripheral anticholinergic action results from a ganglion-blocking action within the visceral wall as well as from an antimuscarinic activity.

Pharmacodynamics - Hyoscine butyl bromide is a muscarinic antagonist which acts to prevent acetylcholine-stimulated contraction of smooth muscle in the gastrointestinal tract. As a quaternary ammonium component, Hyoscine butyl bromide is partially absorbed following oral administration (8 %).

Pharmacokinetics

• The Mean Cmax- 0.11 ng/ml and 2.04 ng / 2.04 ng/ml.

• Median Tmax- Two hours.

[Cmax- Maximum concentration a drug achieves in the blood, cerebrospinal fluid, or target organ after administration of a dose].

[Tmax- Time taken for a drug to reach the highest concentration after administration of a dose].

• The presence of food did not significantly affect the extent of absorption.

Pharmacokinetic Changes-

A. Distribution

• Steady-state Plasma Levels - Varies from 0.37 to 10.7 ng h / ml.

• Mean Absolute Bioavailability - Less than 1 %.

• Plasma Protein Bound - 4.4 %.

• Time to Approach Steady-state Levels - Five hours.

• Mean Volume of Distribution - 6.13 to 11.3.

B. Metabolism

• Metabolic Processes- The main metabolic pathway is the hydrolytic cleavage of the ester bond. Orally administered Hyoscine butyl bromide is excreted in the feces and the urine. Studies have shown that two to five percent of radioactivity can be found in the feces after oral administration. The urinary excretion is less than 0.1 percent of the dose.

C. Elimination -

• Elimination Half-life - One to five hours.

Drug Interactions:

• Antidepressants - The use of antidepressants, such as Amitriptyline increases the risk of side effects of Hyoscine butyl bromide when combined.

• Antihistamines - Taking Hyoscine butyl bromide with antihistamines, such as Cetirizine, Doxylamine, or Diphenhydramine can increase the risk of side effects.

• Motion Sickness Medicines - Combining Hyoscine butyl bromide with motion sickness medicines, such as Domperidone and Metoclopramide should be avoided. This is because both drugs cancel and alter the working of each other. Metoclopramide increases gut motility while Hyoscine butyl bromide reduces it.

• MAO Inhibitors - Combining monoamine oxidase inhibitors (MAO) with Hyoscine butyl bromide can result in intensified anticholinergic side effects of the drug.

• Antacids - These medications can lower the absorption of Hyoscine butyl bromide. The healthcare professional advises taking them at least one hour before taking hyoscine butyl bromide.

What Have Clinical Trials Shown About Hyoscine Butyl Bromide?

Trial 1:

Objective - To study the effect of Hyoscine butyl bromide in shortening the first stage of labor in primiparous (pregnant for the first time) women.

A randomized, double-blind, controlled trial was conducted with 97 primiparous pregnant women in spontaneous labor who received either Hyoscine butyl bromide or placebo intramuscularly once the women entered the active phase of labor.

Primary Outcome Measure - Duration of the first stage of labor.

Second Outcome Measure - Duration of the second and third stages of labor, blood loss at delivery, rate of cesarean section, and Apgar scores (that show how well the baby is doing after birth) for the neonates.

Result - The mean duration of the first stage in the control was 215 minutes, compared with 165 minutes in the study group, representing a decrease of 23.3 %. There was no significant difference in the duration of the second or third stage of labor, and blood loss or Apgar scores. No difference was seen in the Cesarean section rate too. However, there was a 60 % reduction in opioid analgesic use in the Hyoscine butyl bromide group.

Hence, Hyoscine butyl bromide is effective in reducing the duration of the first stage of labor and is not associated with any apparent adverse maternal or neonatal outcomes.

Trial 2:

Objective - To determine whether Hyoscine butyl bromide was superior to Acetaminophen for children with nonspecific colicky abdominal pain.

Randomly selected children aged 8 to 11 with nonspecific colicky abdominal pain received Hyoscine butyl bromide 10 milligrams orally, or Acetaminophen 15 milligrams per kilogram given orally.

Primary Outcome Measure - Self-reported pain at 80 minutes to be 13 mm on a 100 mm visual analog scale.

Secondary Outcome Measure - Administration of rescue analgesics, adverse effects, and pain score less than 30 mm at 80 minutes.

Results - No significant difference in rates of adverse effects between Hyoscine butyl bromide and Acetaminophen was observed. Hyoscine butyl bromide was not superior to Acetaminophen in the setting. Both agents were associated with pain reduction.