BUSCOLYSIN

 

COMPOSITION:
Hyoscine butylbromide 20 mg/1 ml in one ampoule; 20 mg in 1 ml solution; 5 mg in 5 ml syrup; 7.5 mg in one suppository for children, 10 mg in one suppository for adults; 10 mg in one filmtablet.

ACTION:
Buscolysin is a quaternary ammonium derivative with peripheral anticholinergic action. It inhibits the transmission of nervous impulses in the ganglia and at the same time it has a parasympatholytic action. Buscolysin decreases the smooth muscle tone of the gastrointestinal and urogenital tract, inhibits the secretion of the bronchial, salivary and sudoriferous glands, and in higher doses - the secretion of gastric glands. In the same doses it also blocks the accommodation of the eye.

PHARMACOKINETICS:
Administered orally, it is partially absorbed due to its low lipoid solubility - about 5 %, and after rectal application - about 2 % from the dose. The bioavailability of the preparation is low in all forms of administration. With parenteral administratiopn, the half-life time is about 5 h, 50 % of the administered dose being excreted with urine. A small part of the drug is eliminated unchanged with the bile.

INDICATIONS:
Spastic states of the stomach and duodenum, biliary ducts and urogenital system. Facilitation of endoscopic examinations and functional diagnosis during examination of the gastrointestinal tract. During labor, for accelerating the dilation of cervix uteri.

CONTRAINDICATIONS:
Mechanical stenisis of the gastrointestinal tract. Urine retention due to prostate adenoma, glaucoma, tachycardia and myastenia gravis.

SIDE EFFECTS:
Anticholinergic effects can be observed with higher doses: inhibition of saliva and sudor secretion, disturbances in miction and acceleration of cardiac rhythm. Reactions of hypersensitivity are likely to occur in individual cases: most often - urticaria, and rarely - shock.

DRUG INTERACTIONS:
The anticholinergic effects are enhanced after combined therapy of buscolysin with amantadin, tricyclic antidepressants, quinidine, antihistamine preparations and dizopyramide. Buscolysin intensifies the tachycardia induced by the beta-sympathomimetics.

DOSAGE AND ADMINISTRATION:
Parenterally - intramuscularly or intravenously, slowly. In severe spastic and pain symptoms adults receive 20-40 mg daily depending on the severity of the complaints and the daily dose can reach 100 mg. Little children and breast-fed infants - 5 mg three times daily.
Orally - adults and children above 7 years of age - 1-2 filmtablets 3-4 times daily. Children below 3 years - 5 ml syrup (1 teaspoonful) 3 times daily.
Rectally - children up to 3 years of age - 1 suppository for children 3 times daily; children above 3 years - 1/2 suppository for adults 3 times daily.

MEDICINAL FORM AND PACKAGE:
Packages with 10, 50 and 100 ampoules of 20 mg/1 ml (2 %).
Vials of 10 ml - 2 % solution.
Syrup in vials of 125 ml.
Packages with 6 suppositories.
Packages with 20 filmtablets.

STORAGE:
At moderate temperature (15-30° C) in a place protected from direct sunlight.

EXPIRY:
Ampoules and solution 5 (five) years.
Syrup and suppositories 3 (three) years.
Filmtablets 2 (two) years.