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 BRAND NAMES
 MECHANISM OF ACTION
Scopolamine butylbromide (hyoscine butylbromide) is a quaternary ammonium anticholinergic agent. It exerts its effects by acting as a competitive antagonist at muscarinic acetylcholine receptors, specifically M1 receptors located on the smooth-muscle cells of the GI tract. Its anticholinergic action exerts a smooth-muscle relaxing/spasmolytic effect.
As a quaternary ammonium compound with low lipid solubility, it cannot pass the blood/brain barrier easily and only rarely causes the central nervous system side effects associated with atropine and hyoscine.
- Spasm of the gastrointestinal and genitourinary systems. (tablets)
- Acute genitourinary or gastrointestinal spasm (e.g., renal or biliary colic), or to produce smooth muscle relaxation prior to radiological procedures or other diagnostic procedures where spasm may be a problem (e.g., gastro-duodenal endoscopy). (injection)
Individual response to Scopolamine butylbromide may vary and doses should be adjusted accordingly.
Recommended Dose and Dosage Adjustment
- Tablets: One to two 10 mg tablets per day up to a maximum of 6 tablets per day. In prolonged illness which requires repeated dosing, 1 tablet 3 to 5 times a day is recommended. Tablets should be swallowed whole with a glass of water
- Ampoules: One half (10 mg/0.5mL) to one ampoule (20 mg/1mL) administered parenterally by intramuscular, subcutaneous, or intravenous routes, at an injection rate of 1 mL/min. No dilution of the ampoule is necessary prior to administration. The maximum dose should not exceed 100 mg/day (5 ampoules). Scopolamine butylbromide ampoules may also be used intramuscularly 10-15 minutes before radiological examinations of the stomach to slow peristaltic movements.
 DOSAGE FORMS AND STRENGTHS
- Tablets: Containing 10 mg of Scopolamine butylbromide.
- Ampoules: Containing 20 mg of Scopolamine butylbromide in 1 mL aqueous solution.
- known hypersensitivity to scopolamine butylbromide or to any of the excipients
- prostatic hypertrophy with urinary retention
- obstructive disease of the gastrointestinal tract
- paralytic ileus
- intestinal atony of the elderly or debilitated patient
- pathological tachyarrhythmias, angina and cardiac failure(injection)
- toxic megacolon
- myasthenia gravis.
- patients with porphyria
- By intramuscular injection, it is contraindicated in patients being treated with anticoagulant drugs as intramuscular haematoma may occur. In these patients, the subcutaneous or intravenous routes may be used.
 WARNINGS AND PRECAUTIONS
- Scopolamine butylbromide should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.
- In case severe, unexplained abdominal pain persists or worsens, or occurs together with symptoms like fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, decreased blood pressure, fainting or blood in stool, medical advice should immediately be sought.
- Effects on ability to drive and use machines/Ophthalmologic: as a quaternary ammonium compound with low lipid solubility, Scopolamine butylbromide cannot cross the blood/brain barrier easily and only rarely causes the central nervous system side effects associated with atropine and hyoscine. However, patients should be advised that they may experience undesirable effects such as accommodation disorder or dizziness during treatment with Scopolamine butylbromide ampoules. Therefore, patients with visual accommodation disturbances should not drive or operate machinery until vision has normalised.
- Glaucoma: Elevation of intraocular pressure may be produced by the administration of anticholinergic agents such as Scopolamine butylbromide in patients with undiagnosed and therefore untreated narrow-angle glaucoma. Patients should be advised to seek urgent ophthalmological advice if they develop a painful, red eye with loss of vision after an injection of Scopolamine butylbromide.
- Prostatic enlargement: Scopolamine butylbromide tablets and ampoules should be used with caution in patients with prostatic enlargement, as it may precipitate or aggravate urinary retention
- Cardiovascular: As large doses of anticholinergics/systemic antispasmodics may cause an increase in heart rate, due care is necessary in patients with cardiac disease, especially cardiac arrhythmias, congestive heart failure, coronary artery disease and mitral stenosis.
- Anticholinergics may aggravate hiatal hernia associated with reflux esophagitis, myasthenia gravis or pyloric obstruction.
- After parenteral administration, cases of anaphylaxis including episodes of shock have been observed. As with all drugs causing such reactions, patients receiving Scopolamine butylbromide by injection should be kept under observation.
|Can potentiate the anticholinergic effect.|
|Antihistamines||Can potentiate the anticholinergic effect.|
|Amantadine||Can potentiate the anticholinergic effect.|
|MAO inhibitors||May result in intensified anticholinergic side effects|
|Anticholinergics (e.g. tiotropium, ipratropium, atropine-like compounds)||May intensify anticholinergic effects|
|Dopamine antagonists such as Metoclopramide.||May result in diminution of the effects of both drugs on the gastrointestinal tract.|
|Beta-adrenergic agents (e.g. (Salbutamol,||May enhanced tachycardic effects.|
 PREGNANCY AND LACTATION
There is limited data from the use of hyoscine butylbromide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
There is insufficient information on the excretion of Scopolamine butylbromide and its metabolites in human.
As a precautionary measure, it is preferable to avoid the use of Scopolamine butylbromide during pregnancy and lactation.
 SIDE EFFECTS
Undesirable anticholinergic are generally mild and self-limited. Accumulated clinical and postmarketing experience indicates that the following adverse reactions can be expected with the use of Scopolamine butylbromide ampoules and tablets: Xerostomia (dry mouth), dyshidrosis, visual accomodation disorders, mydriasis, increased intraocular pressure, tachycardia, dyspnea, and urinary retention.
There have been rare reports of dizziness, blood pressure decreased and flushing.
Skin reactions (e.g. urticaria, rash, erythema, pruritus) and other hypersensitivity, angioedema and fixed drug eruptions have been reported rarely.
There have been very rare reports of anaphylactic reactions and anaphylactic shock including fatal outcome.