Buscopan® (Buscopan®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceHyoscine butyl bromideHyoscine butyl bromide
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  • Buscopan®
    suppositories rect. 
    Boehringer Ingelheim International GmbH     Germany
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    pills inwards 
    Boehringer Ingelheim International GmbH     Germany
  • Neoscapan
    solution for injections 
    NOVOSIBHIMFARM, OJSC     Russia
    • Dosage form: & nbspcoated tablets
    Composition:
    1 tablet contains 10 mg of the butyl bromide hyoscyline
    Excipients: calcium hydrogen phosphate anhydrous (calcium hydrophosphate) 33 mg; corn starch, dried, 30 mg; corn soluble cornstarch 2 mg; silicon dioxide colloid 4 mg; tartaric acid 0.5 mg; stearic acid 0.5 mg.
    Sheath: povidone (polyvinylpyrrolidone) 0.505 mg: sucrose 41.182 mg; talc 23.671 mg; gum arabian (acacia gum) 2.761 mg; titanium dioxide 1.802 mg; macrogol 6000 (polyethylene glycol) 0.055 mg; wax karnauba 0.012 mg; wax white (wax bee white) 0.012 mg.
    Description:

    White, round, biconvex tablets, covered with sugar shell. The smell is almost imperceptible.

    Pharmacotherapeutic group:M-holinoblokator
    ATX: & nbsp

    A.03.B.B.01   Hyoscine butyl bromide

    Pharmacodynamics:
    Has a local spasmolytic effect on the smooth muscles of the internal organs (gastrointestinal tract, bile ducts, urinary tract), reduces the secretion of digestive glands.The local antispasmodic effect is explained by the ganglioblocking and antimuscarinic activity of the drug.
    Being a quaternary ammonium derivative, hyoscine butyl bromide does not penetrate the blood-brain barrier, therefore, there is no anticholinergic effect on the central nervous system.
    Pharmacokinetics:

    Being a quaternary ammonium derivative and having a high polarity, hyoscine butyl bromide slightly absorbed in the gastrointestinal tract. After application, the absorption of the drug is 8%. The average absolute bioavailability is less than 1%. After a single application of hyoscine butyl bromide inside at doses of 20-400 mg, the average peak plasma concentrations were achieved after about 2 hours and were from 0.11 to 2.04 ng / ml.

    Hyoscine butyl bromide, due to its high affinity for muscarinic and nicotinic receptors, is mainly distributed in the muscle cells of the abdominal and pelvic organs, as well as in the intramural ganglia of the abdominal cavity. The connection with plasma proteins (albumin) is low and is about 4.4%. It was found that the drug (in a concentration of 1 mmol) in vitro interacts with choline transport (1.4 nmol) in epithelial cells of the human placenta.

    The terminal half-life of the drug after a single oral administration at doses of 100-400 mg ranged from 6.2 to 10.6 hours. Metabolism is carried out mainly by hydrolysis of the ester bond. After ingestion, excretion of the drug occurs with feces and urine. After applying the drug inside: renal elimination is from 2 to 5%, elimination through the intestine - 90%. Renal excretion of the metabolites of hyoscine butyl bromide is less than 0.1% of the dose value. After taking the drug inside at doses of 100-400 mg, the average clearance values ​​are from 881 to 1420 liters per minute, whereas the corresponding volumes of distribution for the same dose range vary from 6.13 to 11.3 x 105 l, which can be explained by low systemic bioavailability.

    Metabolites excreted in the urine, weakly bind to muscarinic receptors, so they are not active and do not have pharmacological properties.

    Indications:
    Renal colic, biliary colic, spastic discenezia of bile ducts and gall bladder, cholecystitis, intestinal colic, pylorospasm, peptic ulcer of stomach and duodenum in the phase of exacerbation (as part of complex therapy), algodismenorea.
    Contraindications:
    Hypersensitivity to hyoscine hyoscine butyl bromide or any other other component of the drug.
    Myasthenia gravis, megacolon.
    Children under 6 years.
    Pregnancy, lactation.
    The tablet of Buskopan contains 41.2 mg of sucrose. The maximum recommended daily dose (10 tablets) contains 411.8 mg sucrose. Patients with rare hereditary impairments (fructose intolerance), such as glucose-galactose malabsorption or insulinase malaris deficiency, should not take the drug.
    Carefully:
    Caution is advised to prescribe the drug in the following clinical
    situations: suspicion of intestinal obstruction (including stenosis of the pylorus); obstruction of the urinary tract (including benign prostatic hyperplasia), tachyarrhythmias
    (including ciliary tachyarrhythmia), angle-closure glaucoma.
    In cases where abdominal pain of unknown origin continues or worsens, or when symptoms such as fever, nausea, vomiting, changes in stool consistency and frequency of stools, sensitivity of the abdomen, lowering blood pressure, fainting, or blood in the feces are simultaneously noted, it is necessary to immediately seek medical advice.
    Pregnancy and lactation:

    Data on the use of the drug at pregnancy and penetration drug and its metabolites in the breast milk is limited.

    Studies on the effect of the drug on fertility have not been conducted.

    As a precaution, the use of the drug during pregnancy and during lactation is not recommended.

    Dosing and Administration:
    Inside.
    If the doctor is not assigned otherwise, the following dosing regimen is recommended:
    Adults and children over 6 years: 1 - 2 tablets 3-5 times a day, washed down with water. The drug should not be applied daily for more than 3 days without consulting a doctor.
    Side effects:
    Many of these unwanted effects may be associated with the anticholinergic properties of the drug. Anticholinergic side effects are usually poorly expressed and pass on their own.
    From the immune system:
    Anaphylactic shock, anaphylactic reactions, dyspnea, skin reactions (eg urticaria, rash, erythema, pruritus) and other manifestations of hypersensitivity
    From the cardiovascular system:
    Tachycardia
    From the digestive system:
    Dry mouth
    From the skin and subcutaneous tissues:
    Dyshidrotic eczema
    From the urinary system:
    Retention of urine.
    Overdose:Until now, cases of overdose BUSKOPAN not described, so the following symptoms and recommendations are of a theoretical nature.
    Symptoms
    Possible anticholinergic symptoms: urinary retention, dry mouth, redness of the skin, tachycardia, suppression of the motility of the gastrointestinal tract, as well as transient visual impairment.
    Treatment
    Overdose Symptoms of Buskopan stop
    holinomimetikami. Patients with glaucoma are prescribed pilocarpine in the form of eye drops. If necessary holinomimetiki introduce systemically, for example, neostigmine 0.5 - 2.5 mg intramuscularly or intravenously. Cardiovascular complications are treated according to the usual therapeutic rules. When paralysis of the respiratory musculature shows intubation, artificial ventilation of the lungs. In the case of urinary retention, the bladder is catheterized. Supportive therapy is conducted.
    Interaction:
    Buscopan can enhance the anticholinergic effect of tricyclic and tetracyclic antidepressants, antihistamines, antipsychotics, quinidine, amantadine and disopyramide
    and anticholinergic drugs (eg, tiotropium bromide, ipratropium bromide, atropine-like compounds). Simultaneous application of Buscopan and dopamine antagonists, for example, metoclopramide, leads to a weakening of both drugs on the gastrointestinal tract.
    Buscopan can strengthen tachycardia caused by beta-adrenergic agents.
    Effect on the ability to drive transp. cf. and fur:Studies on the effect of the drug on the ability to drive vehicles and control mechanisms have not been conducted.
    Form release / dosage:
    The tablets covered with a cover of 10 mg.
    Packaging:For 10 or 20 tablets in a contour mesh box (blister) made of PVC / A1-foil. 1 or 2 blisters with instructions for use in a cardboard box.
    Storage conditions:
    At a temperature of no higher than 25 ° C.
    Keep in a safe place out of the reach of children!
    Shelf life:
    5 years
    Do not use after the expiration date.
    Terms of leave from pharmacies:Without recipe
    Registration number:П N014393 / 01
    Date of registration:15.08.2008 / 01.06.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Boehringer Ingelheim International GmbHBoehringer Ingelheim International GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspBERINGER INGELCHAIM INTERNATIONAL GmbH BERINGER INGELCHAIM INTERNATIONAL GmbH Germany
    Information update date: & nbsp13.03.2017
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