International generic name
Drug form and composition
Solution for injection. One ampoule of 1 ml contains 20 mg Hyoscine butylbromide
(20 mg/ml). Coated tablets. One coated tablet contains 10 mg Hyoscine butylbromide.
In gastrointestinal diseases - stomach and duodenal ulcer; esophageal and cardia
spasms; pylor spasm; vomiting; biliary colic; biliary dyskinesia; cholecystitis.
Diseases of the urogenital system - renal colic; urinary bladder tenesmus; spasm
in urolithiasis. In obstetrics and gynecology - spastic dysmenorrhoea; as an additional
medicine in incipient and incomplete abortion; spasms of the delivery pathways during
the parturition; manual extraction of the placenta.
Dosage and administration
Ampoules: In case of acute spastic pain, in adult patients 10-20 mg of preparation
is injected intramuscularly or intravenously 2-4 times daily. Intravenously the
preparation may be used as an infusion, diluted in some parenteral solution. Maximal
dose in adults is 100 mg/24 h. In children older than 6 years Buscolysin is administered
intramuscularly and intravenously in dose 5-10 mg, 2-4 times daily. Coated tablets:
Recommended daily dose in adults and children older than 12 years is 1-2 tablets,
3-4 times daily (1-2 tablets). In children older than 6 years - 1 tablet, 3 times
Hypersensitivity to the preparation; myasthenia gravis.
Special warnings and precautions
Buscolysin should be used with care in patients with rhythm disorders, as a risk
of development of high frequency tachycardia and tachyarrhythmia exists, although
the preparation, compared with atropine, possesses more weak cholinolytic effect
on the heart. Although the preparation exerts weaker anticholinergic effect, compared
with atropine, it should be administered with care in patients with glaucoma and
fever. Buscolysin is used carefully in persons with xerostomia, rhinitis sicca,
hypertension, and hyperthyroidism. It is advisable the preparation to be used in
children over 6 years. In elderly patients, patients with metabolite, liver, and
renal function disorders it should be used with care. Buscolysin passes the placentar
barrier, so it should be administered with care in pregnant women during the first
trimester. The preparation may reduce the mother milk secretion, and it is partially
secreted in the milk, so for nursing women it should be used only in case of exceptional
indications. Buscolysin is used with care in drivers, because it may cause mydriasis
and cycloplegia, with resultant close distance vision disorders.
M-cholinolytic action of Buscolysin is antagonised by cholinergic preparations,
including pylocarpine and anti-cholinesterase agents (galantamine, fisostigmine,
pyridostigmin), due to the functional antagonism. The preparation enhances anti-cholinergic
effects of amantadine, chinidine, three- and fourcycled antidepressants, neuroleptics,
antihistamine and antiparkinson preparations. Buscolysin, depressing gastrointestinal
motor function, increases absorbtion and serum concentration of digoxin (by 1/3),
and may lead to relative overdosage. Combined administration of corticosteroids
(locally or systemic) and Buscolysisn leads to an increase of the risk of elevation
of the ocular pressure and glaucoma development. Excretion of the preparation may
be retarded by urine alkalizing agents - antiacid preparations, citrate, etc. Concomitant
administration of Buscolysin and ketoconazole or metoclopramide may lead to a reduction
of the therapeutic activity of the later.
Buscolysin depresses secretion of the endocrine glands. This is clinically manifested
by xerostomia and skin redness. Buscolysin causes accommodation disorders - mydriasis
and cycloplegia. It may provoke a glaucoma attack, because of elevation of the intraocular
pressure. Following CNS manifestations may be seen: anxiety and hallucinations.
Such symptoms are more frequent in case of overdosage, and in children and elderly
patients. Occasionally Buscolysin may cause tachycardia or tachyarrhythmia, as well
as hypersensitivity manifestations - rush, urticaria. Frequent side effects are
miction disorders and urine retention, particularly in elderly men with prostatic
Buscolysin, being a scopolamine derivative, belongs to the group of the M-cholinolytic
agents influencing the vegetative system. It possesses a prominent spasmolytic action
on the smooth muscle of the gastrointestinal tract, biliary and urinary tract. Buscolysin
blocks predominantly the peripheral pre- and postsynapse muscarine receptors, whereas
nicotine cholinergic receptors are less influenced. Buscolysin exerts some N-cholinolytic
effect on the parasympathetic and sympathetic ganglia. Its effects on the salivary
glands, the heart, and the eye are comparatively weak. Compared with atropine, the
preparation depresses slightly degestive glands secretion - in parenteral application
reduces slightly hydrochloric acid secretion in the stomach, as well as the pathologic
night secretion of the stomach glands. Due to the quaterner nitric atom existence,
the preparation does not pass hematoencephal barrier, and has no effect on the CNS.
10 or 100 ampoules of 1 ml (20 mg). 20 or 800 coated tablets of 10 mg.
Solution for injection - 5 years. Coated tablets - 3 years.