Contents

Hyoscine-N-butylbromide.
Indications / Uses
Tablet: Symptomatic relief of abdominal pain, cramps and discomfort, including menstrual
cramps, spasms of the biliary system and urinary tract.
Relief of symptoms of irritable bowel syndrome (IBS).
Injection: Symptomatic relief of gastrointestinal and genitourinary disorders characterized by
smooth muscle spasm; spasm and dyskinesia of the biliary system; irritable bowel syndrome. Aid
to produce smooth muscle relaxation prior to radiological or other diagnostic procedures where
spasm may be a problem (eg, gastroduodenal endoscopy).
Dosage / Direction for Use
Tablet: Adults and Adolescents >12 years: Usual Dose: 1-2 tablets, 3-4 times a day (taken about
every 4-6 hrs). Irritable Bowel Syndrome: Starting Dose: 1 tablet 3 times a day. Dose may be
increased if further relief is necessary.
Children 6-12 years: Usual Dose: 1 tablet 3 times a day.
If a dose is missed, take the next dose as scheduled. Do not double the dose.
Injection: Hyoscine-N-butylbromide injection may be administered by slow IV, IM or SC
injection.
Intramuscular injections should be administered 10-15 min prior to radiological/diagnostic
procedures.
Adults and Adolescents >12 years: 20-40 mg (1-2 ampules) several times a day, may be
administered as a continuous infusion of 5 mg/hr for up to 4 days. Maximum Dose: 100 mg/day.
Infants and Children up to 12 years: Severe Cases: 0.3-0.6 mg/kg body weight several times a
day. Maximum Dose: 1.2 mg/kg body weight/day.
Overdosage
Tablet: Signs of overdose may include drowsiness, dry mouth, difficulty passing urine, reddening
of the skin, decreased gastrointestinal tract movement, fast heart rate and sight disturbances.
If the patient has taken more than the recommended dosage, consult a physician.
Injection: Serious signs of acute overdosage have not been observed in man. Symptoms of acute
overdoses are usually transitory parasympatholytic effects on salivary secretion, heart rate and
accommodation. These may include dryness of mouth, tachycardia and blurring of vision owing
to loss of accommodation, all of which are transitory.
Hyoscine-N-butylbromide may produce a curariform neuromuscular block and ganglionic
blockade manifested as respiratory paralysis.
Acute anticholinergic overdosage can be managed by symptomatic and supportive therapy.
Symptoms of overdosage respond to parasympathomimetics (eg, neostigmine 0.5-2.5 mg IM or
IV). Urgent ophthalmological advice should be sought and pilocarpine should be given locally in
patients with glaucoma. Cardiovascular complications should be treated according to usual
therapeutic principles. Intubation and artificial respiration should be considered in case of
respiratory paralysis. Patients who experience urinary retention may require catheterization.
Contraindications
Hypersensitivity to hyoscine-N-butylbromide, belladonna alkaloids or derivatives, or any other
ingredients of Hyos.
Tablet: Patients with glaucoma, toxic megacolon (a very enlarged bowel), myasthenia gravis (a
rare muscle wasting disease), obstructive prostatic hyperthropy (enlarged and blocked prostate),
porphyria (hereditary blood disorder).
Patients who are pregnant, likely to become pregnant or breastfeeding, and children <6 years
should not take hyoscine-N-butylbromide.
Injection: Patients with porphyria, untreated angle-closure glaucoma, prostatic enlargement,
myasthenia gravis, and severe ulcerative colitis, or toxic megacolon, tachycardia; acute
hemorrhage whose cardiovascular status is unstable; stomach or bowel obstruction, or in
conditions where there is reduced bowel activity (eg, pyloroduodenal stenosis, achalasia),
paralytic ileus or intestinal atony.
Hyos injection should not be given IM in patients being treated with anticoagulant therapy.
Subcutaneous or IV routes may be used in these patients instead.
Special Precautions
Tablet: A very fast heart rate or any heart problems; problem with the thyroid gland (eg,
overactive thyroid gland).
Difficulty or pain in passing urine eg, men with prostate problems; gut blockage problems; reflux
esophagitis or ulcerative colitis; constipation; fever; previously been treated for severe sweating
disorder.
Patient should not take more than the recommended dose.
Discontinue treatment and immediately consult a physician if any of the following occurs:
Allergic reactions (eg, skin rash and itching); severe allergic reactions (anaphylactic shock),
difficulty in breathing, feeling faint or dizzy. If patients experience red and painful eye and loss
of vision, or blurred vision. These symptoms may be caused by an increased pressure inside the
eyeball and require urgent medical advise.
Injection: Patients with Down's syndrome, hepatic or renal disease and hyperthyroidism;
conditions characterized by tachycardia (including thyrotoxicosis, hyperthyroidism, cardiac
insufficiency, cardiac surgery) since hyoscine-N-butylbromide may further increase the heart
rate. Patients with autonomic neuropathy, partial obstructive uropathy and diarrhea. Those with
known or suspected gastrointestinal infections eg, Clostridium difficile-associated diarrhea and
colitis, shigellosis and dysentery, since Hyos may decrease gastrointestinal motility, causing
retention of the pathogenic organism or toxin. Patients with mild to moderate ulcerative colitis to
prevent paralytic ileus that may lead to toxic megacolon. Patients with pyrexia since the drug
may reduce sweating.
Patients should immediately consult an ophthalmologist if they experience a painful, red eye
with loss of vision. This may be due to increased intraocular pressure produced by the
anticholinergic effect of hyoscine-N-butylbromide.
Cases of anaphylaxis including episodes of shock have been reported after parenteral
administration of hyoscine-N-butylbromide.
Renal or Hepatic Function: Patients with impaired metabolic, liver and kidney function should
use hyoscine-N-butylbromide with caution to avoid exacerbation of CNS effects.
Effects on the Ability to Drive or Operate Machinery: Patients who need to perform activities
requiring mental alertness or physical coordination should avoid hyoscine-N-butylbromide since
it may cause drowsiness and blurred vision.
Use in pregnancy: Pregnancy Category C: Reproduction studies have not been performed in
humans. Experience in a limited number of pregnant women has shown no evidence of ill effects
during human pregnancy. There is also no evidence of teratogenic or embryotoxic effects in rat
and rabbit studies. However, the usual precautions regarding the use of drugs during pregnancy
should be observed especially during the 1st trimester.
Use in lactation: There are no reports of any clinical effects of hyoscine-N-butylbromide on the
breastfed infant. The American Academy of Pediatrics states that the drug may be considered
compatible with breastfeeding. However, as with any drug, consult a physician before using
Hyos if the patient is breastfeeding.
Use in children: Hyoscine-N-butylbromide should be used with caution in children. Infants and
children with spastic paralysis or brain damage, and patients with Down's syndrome may be
hypersensitive to the anticholinergic effects (eg, mydriasis, positive chronotropic effect) of
hyoscine-N-butylbromide.
Use in the elderly: Elderly or debilitated patients should use anticholinergics with caution, since
they are more susceptible to the adverse effects of such drugs. Mental confusion and/or
excitement may also occur in geriatric patients using such drugs.
Adverse Reactions
Tablet: Adverse reactions that are observed occasionally are dry mouth, blurred vision, diarrhea,
nausea, reduced ability to sweat, increased heart rate and inability to pass urine.
Rarely, dizziness, flushing, allergic reactions (particularly skin rash and itching), difficulty in
breathing (usually in patients with asthma or allergy), drop in blood pressure may be observed.
Injection: Frequent adverse reactions associated with the use of anticholinergic drugs include
xerostomia, dry skin, accommodation disorders, blurred vision, cycloplegia, mydriasis,
photophobia, anhidrosis, urinary hesitancy and retention, transient bradycardia (followed by
tachycardia, hypotension, palpitations and arrhythmia), reduced bronchial secretions,
xerophthalmia and constipation.
Rarely, anaphylactic shock including fatal outcome, anaphylactoid reactions, dyspnea, skin
reactions and other hypersensitivity.
Other adverse events include increased ocular tension (especially in patients with angle-closure
glaucoma), sedation, drowsiness, irritability, disorientation, hallucinations, decrease in blood
pressure, loss of taste, headache, nervousness, weakness, flushing, insomnia, urinary retention,
nausea, vomiting and bloated feeling.
Click to View ADR Monitoring Form
Interactions
Tablet: Medicines for depression (eg, doxepin), allergies and travel sickness (eg, meclizine),
severe mental illness (eg, haloperidol fluphenazine), breathing problem (eg, tiotropium and
ipratropium), control heartbeat (eg, quinidine, procainamide or disopyramide), Parkinsons
disease and flu (eg, amantadine), feeling sick (nausea) (eg, metoclopramide).
Antacids may decrease the absorption of hyoscine-N-butylbromide.
Alcohol may increase the likelihood of side effects eg, drowsiness.
Injection: Alcohol, other CNS depressants (eg, barbiturates and benzodiazepines), other
anticholinergic drugs (eg, antidepressants, neuroleptics, H1 antihistamines, antiparkinsons),
antiarrhythmic agents with anticholinergic effects (eg, quinidine, disopyramide, procainamide)
increase the sedative effect of hyoscine-N-butylbromide.
Concomitant use of hyoscine with propantheline and slow-dissolving tablets of digoxin may
increase serum digoxin concentrations.
Tachycardia effects of -adrenergic agents may be enhanced by hyoscine-N-butylbromide.
Concomitant use of anticholinergics with levodopa may decrease the extent of absorption of
levodopa in the small intestine. Discontinuation of the anticholinergics should have a
concomitant reduction in the levodopa dose to prevent toxicity resulting from increased
absorption of levodopa.
Anticholinergics may decrease gastrointestinal absorption of ketoconazole. It should be given 2
hrs after ketoconazole administration.
Anticholinergic drugs potentiate the local gastrointestinal mucosal effects of potassium chloride.
Preg Safety (US)

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or
embryocidal or other) and there are no controlled studies in women or studies in women and
animals are not available. Drugs should be given only if the potential benefit justifies the
potential risk to the foetus.
Storage
Store at temperatures not exceeding 30C.
Mechanism of Action
Tablet: Hyoscine-N-butylbromide, an antispasmodic which works by relaxing the smooth
muscles found in the walls of the stomach, intestines and bile duct (gastrointestinal system), the
reproductive organs and urinary tract (genitourinary system). It reduces muscle contractions by
preventing acetylcholine from acting on the muscle allowing the muscle to relax thus, reducing
painful spasms and cramps.
Pharmacology: Pharmacodynamics: Injection: Hyoscine-N-butylbromide is a quaternary
ammonium derivative of hyoscine. It relaxes the smooth muscles of the gastrointestinal, biliary
and urinary tracts by blocking the action of acetylcholine. Hyoscine-N-butylbromide reduces the
tone and peristalsis of smooth muscles in hollow organs with parasympathetic innervation. It has
peripheral anticholinergic effects that are less pronounced and of shorter duration than those of
atropine. It does not penetrate the blood-brain barrier contributing to its minimal central effects.
Pharmacokinetics: Injection: Hyoscine-N-butylbromide is rapidly distributed into the tissues
after IV administration. It is partially metabolized in the liver to inactive compounds. The
terminal elimination t is approximately 5 hrs.
Its main route of excretion is through the kidneys; total body clearance is 1.2 L/min. The main
metabolites found in the urine are poorly bound to muscarinic receptors. It is not known whether
hyoscine-N-butylbromide is removed by peritoneal dialysis or hemodialysis.
MIMS Class
Antispasmodics
ATC Classification
A03BB01 - butylscopolamine ; Belongs to the class of belladonna alkaloids, semisynthetic,
quaternary ammonium compounds. Used in the treatment of functional gastrointestinal disorders.
Regulatory Classification
Rx
Presentation / Packing
FC tab 10 mg (white, round, biconvex, plain on both sides) x 100's. Inj 20 mg/mL (amp, clear,
colorless, sterile, aqueous soln, free from extraneous matter) x 2 mL x 10's.

(amp) 2 mL x 10 1's
Hyos inj 20 mg/mL
(P754.71/box)

http://www.mims.com/philippines/drug/info/hyos