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NONRXDRUG-DR-XY37802-1pc

HYOS HYOScine N-Butylbromide 10mg Film-Coated Tablet 1's

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Description

Indications/Uses

Tablet: For the symptomatic relief of abdominal pain, cramps and discomfort, including menstrual cramps, spasms of the biliary system and urinary tract.
For the relief of symptoms of irritable bowel syndrome (IBS).
Injection: For the symptomatic relief of: Gastrointestinal and genitourinary disorders characterized by smooth muscle spasm; Spasm and dyskinesia of the biliary system; Irritable bowel syndrome (IBS).
As an aid to produce smooth muscle relaxation prior to radiological or other diagnostic procedures where spasm may be a problem (e.g., gastroduodenal endoscopy.
 

Dosage/Direction for Use

Tablet: See Table 1.



Injection: Hyoscine-N-butylbromide injection may be administered by slow intravenous (IV), intramuscular (IM) or subcutaneous (SC) injection.
IM injections should be administered 10-15 minutes prior to radiological/diagnostic procedures. (See Table 2.)
 


Administration

May be taken with or without food
 

Special Precautions

Anticholinergics such as hyoscine-N-butylbromide should be used with caution in the following conditions: 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 gastric ulcer, gastroesophageal reflux disease or hiatal hernia associated with reflux esophagitis.
Patients with autonomic neuropathy, partial obstructive uropathy and diarrhea.
Those with known or suspected GI infections such as Clostridium difficile-associated diarrhea and colitis, shigellosis and dysentery since the drug may decrease GI 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 their 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.
 

Adverse Reactions

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, decreased blood pressure, loss of taste, headache, nervousness, weakness, flushing, insomnia, urinary retention, dry mouth, nausea, vomiting, and bloated feeling.
 

Action

Pharmacologic Classification: Anticholinergic/Antispasmodic.
Pharmacology: Tablet: This product contains 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) and 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.
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: Bioavailability: Hyoscine-N-butylbromide is rapidly distributed into the tissues after intravenous administration. It is partially metabolized in the liver to inactive compounds. The terminal elimination half-life is approximately 5 hours.
Its main route of excretion is through the kidneys; total body clearance is 1.2 L/minute. 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.
 

MedsGo Class

Antispasmodics

Features

Brand
Hyos
Full Details
Dosage Strength
10mg
Drug Ingredients
  • Hyoscine N-Butylbromide
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Hyoscine N-Butylbromide
Dosage Form
Film-Coated Tablet
Registration Number
DR-XY37802
Drug Classification
Over-The-Counter (OTC)
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