Indication
Busconil® is mainly indicated in the following cases:
- Gastrointestinal tract spasm (including pylorospasm).
- Hypermotility and postoperative vomiting and spastic constipation.
- Spasm and dyskinesia of the biliary system.
- Genito-urinary tract spasm.
- Spastic pain in dysmenorrhoea and nocturnal enuresis.
- Delayed relaxation of the lower uterine segment.
- Peptic ulcer in conjunction with antacids or H2-receptor antagonists.
Composition
Each film coated tablet of Busconil® 10 contains:
- Hyoscine N butylbromide 10 mg
Each 5 ml of Busconil® oral solution contains:
- Hyoscine N butylbromide 5 mg
Dosage
Adults:
- 1- 2 tablets of Busconil® tablet three to five times a day as needed.
Children:
- depending on age, the daily children dosage of Busconil® oral solution is recommended as follows:
-Children Over 6 years:
- 10 ml 3- 4 times daily.
-Children 1- 6 years:
- 5- 10 ml three times daily.
-Infants less than 1 year:
- 5 ml three times daily.
¤ Busconil® can be taken both on empty and full stomach.
- Hyoscine N butylbromide has a peripheral anticholinergic action which results from a ganglion-blocking action within the visceral wall as well as from an anti-muscarinic activity. Consequently, it exerts a spasmolytic action on the smooth muscles of the gastrointestinal, biliary and genito-urinary tracts.
- As a quaternary ammonium derivative, Hyoscine N butyl-bromide does not readily pass the blood-brain barrier; therefore, anticholinergic side effects at the central nervous system do not occur when used in therapeutic doses.
Each film coated tablet of Busconil® 10 contains:
- Hyoscine N butylbromide 10 mg
Each 5 ml of Busconil® oral solution contains:
- Hyoscine N butylbromide 5 mg
Busconil® is mainly indicated in the following cases:
- Gastrointestinal tract spasm (including pylorospasm).
- Hypermotility and postoperative vomiting and spastic constipation.
- Spasm and dyskinesia of the biliary system.
- Genito-urinary tract spasm.
- Spastic pain in dysmenorrhoea and nocturnal enuresis.
- Delayed relaxation of the lower uterine segment.
- Peptic ulcer in conjunction with antacids or H2-receptor antagonists.
Busconil® is contraindicated in the following cases:
- Hypersensitivity to Hyoscine N butyl bromide or any anticholinergic drugs.
- Myasthenia gravis and megacolon.
- Tachycardia and myocardial Ischemia.
- Narrow angle glaucoma, adhesions between the Iris and lens.
- Gastrointestinal obstructive disease, paralytic ileus, ulcerative colitis and hepatic diseases.
- Obstructive uropathy and renal diseases.
- The effect of Busconil® may be enhanced by concomitant administration of other drugs with antimuscarinic properties such as: Amantadine, Tricyclic antidepressants, Quinidine, some Antihistamines, Phenothiazine and Antipsychotics.
- Concomitant treatment with Dopamine antagonist such as Metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract.
- Caution is recommended in pregnancy especially during the first trimester.
- Safety during lactation has not yet been established.However, adverse effects on the new born have not been reported.
- The side effects are dose-related and usually reversible when therapy is discontinued.
At therapeutic doses, adverse effects include:
- dryness of mouth and skin, thirst, flushing, dilated pupils with loss of accommodation and photophobia, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition.
Over-dosage:
¤ In case of over-dosage, anti-cholinergic symptoms as
- urinary retention, dry mouth, reddening of the skin, tachycardia and transient visual disturbances may occur.
Treatment of the over-dosage:
- gastric lavage with medicinal charcoal should be followed by magnesium sulfate (15%). In addition, appropriate supportive therapy should be given as required.
Adults:
- 1- 2 tablets of Busconil® tablet three to five times a day as needed.
Children:
- depending on age, the daily children dosage of Busconil® oral solution is recommended as follows:
-Children Over 6 years:
- 10 ml 3- 4 times daily.
-Children 1- 6 years:
- 5- 10 ml three times daily.
-Infants less than 1 year:
- 5 ml three times daily.
¤ Busconil® can be taken both on empty and full stomach.
Busconil® needs to be used with caution in:
- Patients prone to narrow angle glaucoma;
- Patients susceptible to intestinal or urinary outlet obstructions;
- In those inclined to tachyarrhythmia.
- Busconil® tablet : Blister of 10 tablets, pack of two Blisters.
- Busconil® oral solution : bottles of 60 ml / 100 ml.
¤ Hospital packs of different sizes.
- Store in a dry place at a temperature not exceeding 25°C.