Бускопан®
Producer: Boehringer Ingelheim Pharma (Beringer Ingelkhaym Pharma) Germany
Code of automatic telephone exchange: A03BB01
Release form: Firm dosage forms. Suppositories rectal.
General characteristics. Structure:
Active ingredient: 10 mg of hyoscine of butylbromide in 1 suppository.
Excipients: the water purified solid W45 fat.
Has spasmolytic effect on smooth muscles of internals, reduces secretion of digestive glands.
Pharmacological properties:
Pharmacodynamics. Has local spasmolytic effect on smooth muscles of internals (digestive tract, biliary tract, urinary tract), reduces secretion of digestive glands. Local spasmolytic action is explained by ganglioblokiruyushchy and antimuskarinovy activity of drug. Being quarternary ammonium derivatives, hyoscine butylbromide does not get through a blood-brain barrier therefore anticholinergic influence on TsNS is absent.
Pharmacokinetics. Being quarternary ammonium derivatives and having high polarity, hyoscine butylbromide is slightly soaked up in digestive tract. After rectal use absorption of drug makes 3%. Average absolute bioavailability makes less than 1%. Hyoscine butylbromide owing to high affinity to muskarinovy and nicotinic receptors is distributed mainly in muscle cells of abdominal organs and a small pelvis, and also in intramural gangliya of abdominal organs. Communication with proteins of plasma (albumine) — low also makes about 4,4% Is established that drug (in concentration of 1 mmol) in vitro interacts with sincaline transport (1,4 nmol) in epithelial cells of a human placenta.
After rectal use of drug renal elimination makes 0,7-1,6%; elimination happens generally through intestines. Renal excretion of metabolites of hyoscine of butylbromide makes less than 0,1% of dose size. The metabolites which are excreted with urine poorly contact muskarinovy receptors therefore they are not active and have no pharmacological properties.
Indications to use:
Renal colic, bilious colic, spastic dyskinesia of biliary tract and gall bladder, cholecystitis, intestinal colic, pylorospasm, peptic ulcer of a stomach and duodenum in an aggravation phase (as a part of complex therapy), альгодисменорея.
Route of administration and doses:
Rektalno. If the doctor it is not appointed differently, the following mode of dosing is recommended: adults and children are more senior than 6 years: rektalno on 1-2 suppositories of 3-5 times a day. Suppositories should be extracted from packaging and to enter the pointed end into a rectum. Drug should not be used daily more than 3 days without consultation of the doctor.
Features of use:
Fertility, pregnancy and lactation. Data on use of drug at pregnancy and about penetration of drug and its metabolites into breast milk are limited. Researches about influence of drug on fertility were not conducted.
It is necessary to appoint with care drug in the following clinical situations: suspicion on intestinal impassability (including a pyloric stenosis): obstruction of urinary tract (including prostate hyperplasia), tachyarrhythmias (including ciliary tachyarrhythmia), closed-angle glaucoma.
When the abdominal pain of an unknown origin proceeds or amplifies or when such symptoms as fever, nausea, vomiting, changes of a consistence a calla and frequencies of defecations, morbidity of a stomach, a lowering of arterial pressure, a faint or blood in Calais are at the same time noted, it is necessary to address for medical consultation immediately.
Influences on ability to control of motor transport and to use of mechanisms. Researches about influence of drug on ability to driving of motor transport and to control of mechanisms were not conducted.
Side effects:
Many of the listed undesirable effects can be connected with anticholinergic properties of drug. Anticholinergic side effects are usually expressed poorly and pass independently.
From immune system: acute anaphylaxis, anaphylactic reactions, asthma, skin reactions (for example, urticaria, rash, erythema, itch) and other types of hypersensitivity.
From cardiovascular system: tachycardia.
From the alimentary system: dryness in a mouth.
From skin and hypodermic fabrics: disgidrotichesky eczema.
From an urinary system: ischuria.
Interaction with other medicines:
Buskopan can strengthen anticholinergic effect of tricyclic and tetracyclic antidepressants, antihistaminic, antipsychotic drugs, quinidine, an amantadin and Disopyramidum and anticholinergic drugs (for example a bromide tiotropiya, an ipratropiya of bromide, atropinopodobny connections). Simultaneous use of a buskopan and antagonists of a dopamine, for example, of Metoclopramidum, leads to weakening of effect of both drugs on digestive tract.
Buskopan can strengthen the tachycardia caused by beta and adrenergic means.
Contraindications:
- Myasthenia гравис, megacolon.
- Hypersensitivity to hyoscine to butylbromide or any other component of drug.
- Children up to 6 years.
- Pregnancy, lactation period.
Overdose:
So far cases of overdose of BUSKOPANOM are not described therefore the following symptoms can be connected with its pharmacological effect.
Symptoms. Possible anticholinergic symptoms: an ischuria, dryness in a mouth, erubescence, tachycardia, oppression of motility of digestive tract, and also passing vision disorders.
Treatment. Symptoms of overdose by Buskopan are stopped by cholinomimetics. To patients with glaucoma locally appoint Pilocarpinum in the form of eye drops. If necessary cholinomimetics enter systemically, for example, неостигмин 0,5 - 2,5 mg intramusculary or intravenously. Cardiovascular complications treat according to usual therapeutic rules. At paralysis of respiratory muscles the intubation, artificial ventilation of the lungs is shown. In case of an ischuria catheterize a bladder. The maintenance therapy is carried out.
Storage conditions:
In the dry place at a temperature not above 25 °C. To store in the place, unavailable to children! Period of validity of 5 years. Not to use after expiry date.
Issue conditions:
Without recipe
Packaging:
Suppositories rectal on 10 mg. On 5 suppositories in strips from aluminum foil. On 2 strips in a cardboard pack with the application instruction.