SW Hyoscine

Round, white, film-coated tablet.
Each tablet contains: Hyoscine N-Butylbromide 10 mg.

Pharmacology: The effect of Hyoscine on the heart is to alter the rate. With small doses, the heart rate decreases temporarily and increases with larger doses. It also reduces the motility and tone of the gastrointestinal tract and may even reduce the volume of its various secretions.
The drug will produce mydriasis and paralysis of accommodation (cyclopegia). Hyoscine butylbromide is poorly absorbed from the gastrointestinal tract. In 10 experiments in 3 volunteers, hyoscine butylbromide in single doses of up to 600 mg taken as tablet, appeared to be inactive by mouth, either it remained unabsorbed or it was absorbed more slowly than it was inactivated in the body. After 50 to 100 mg of hyoscine butylbromide was given to 6 male volunteers, by mouth or by intra-intestinal infusion, very little hyoscine butylbromide was absorbed from the upper small intestine, and none appeared in the plasma. About 2% and 90% of the dose appeared in the urine and faeces, respectively. After intravenous administration of 8 mg to 1 volunteer, 42% was eliminated in the urine and 37% in faeces.

It is indicated for gastrointestinal spasm and hypermotility, biliary dyskinesia, and spasm of the urinary tract, delayed relaxation of the lower uterine segment and dysmenorrhoea.

Route of administration: Oral.
Dosage: Adults: One to two tablets, three to four times daily.
Children (6-12 years): One tablet, three times daily.

Symptoms and Treatment for Overdosage and Antidote(s): Overdosage with hyoscine butylbromide may cause disorientation, memory disturbances, dizziness, restlessness, hallucinations, or confusion.
Treatment: Empty the stomach by aspiration and lavage. The use of charcoal to prevent absorption, followed by lavage, has been suggested. Give a purgative, such as 30 g of sodium sulphate in 250 ml of water. Physostigmine salicylate has been advocated to control the central and peripheral effects of hyoscine but is not now generally recommended. Excitement may be controlled by diazepam or a short-acting barbiturate. Supportive therapy may require oxygen and assisted respiration, ice bags or alcohol sponges for hyperpyrexia, especially in children, bladder catheterisation, and the administration of fluids.

Because of the anticholinergic effect of hyoscine, it should not be used in patients with glaucoma, achalasia, prostatic hypertrophy, or obstruction of the bladder neck. It is contraindicated in patients with myasthenia gravis and in patients known to be hypersensitive to hyoscine.

Potentially alarming idiosyncratic reactions may occur with ordinary therapeutic doses of hyoscine butylbromide. Hyoscine should be used with caution in patients with pyloric obstruction or urinary bladder neck obstruction. Hyoscine butylbromide should be used with special caution in the elderly or in individuals with impaired metabolic, liver, or kidney functions, because of the increased likelihood of CNS effects.
Effects on Ability to Drive and Use Machines: Since drowsiness, disorientation, and confusion may occur with the use of hyoscine, patients should be warned of the possibility and cautioned against engaging in activities that require mental alertness, such as driving a motor vehicle or operating dangerous machinery.

Long experience has shown no evidence of ill effects during human pregnancy. However, the usual precautions regarding the use of drugs in pregnancy, especially during the first trimester, should be observed.
Safety during lactation has not been established.

The side effects of hyoscine butylbromide include dryness of the mouth with difficulty in swallowing, thirst, dilatation of the pupils with loss of accommodation and photophobia, increased intra-ocular pressure, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and desire to urinate with the inability to do so, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation. Occasionally, vomiting, giddiness, and staggering may occur.

The anticholinergic effect of tricyclic antidepressants, antihistamines, quinidine, amantadine, and disopyramide can potentiate the anticholinergic effect of Hyoscine butylbromide.
Hyoscine butylbromide enhances tachycardic effects of β-adrenergic agents. Dopamine antagonist, eg, metoclopramide, reduces effects of both drugs on GIT.

Store at or below 30°C. Protect from light.
Shelf-life: 4 years.

Antispasmodics

A03BB01 - butylscopolamine ; Belongs to the class of belladonna alkaloids, semisynthetic, quaternary ammonium compounds. Used in the treatment of functional gastrointestinal disorders.

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