Neoscapan (Neoskapan)

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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  • Neoscapan
    solution for injections 
    NOVOSIBHIMFARM, OJSC     Russia
    • Dosage form: & nbspinjection
    Composition:

    Active substance:

    hyoscine butyl bromide - 20 mg.

    Excipients:

    sodium chloride - 6 mg.

    water for injection - up to 1 ml.

    Description:

    Transparent lightly colored liquid.

    Pharmacotherapeutic group:m-holinoblokator
    ATX: & nbsp

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

    Pharmacodynamics:

    Has spasmolytic effect on the smooth muscles of internal organs (gastrointestinal tract, bile ducts, urinary tract), reduces the secretion of digestive glands. The spasmolytic effect is explained by the ganglion-blocking and m-cholipolitic activity of hyoscine butyl bromide. Being a quaternary ammonium derivative, hyoscine butyl bromide poorly penetrates the blood-brain barrier, so it has no significant effect on the central nervous system.

    Pharmacokinetics:

    Suction and distribution:

    After intravenous administration hyoscine butyl bromide quickly distributed in tissues. Volume of distribution (Vss) -128 l.Binding to blood plasma proteins (albumin) is weak, about 4.4%. Due to the high affinity for m-cholinergic receptors and n-cholinergic receptors, hyoscine butyl bromide is distributed mainly in the muscle cells of the abdominal and pelvic region, as well as in the intramural ganglia of the abdominal cavity. Determined that hyoscine butyl bromide (in a concentration of 1 mmol) in vitro interacts with choline transport (1.4 nmol) in epithelial cells of the human placenta.

    Metabolism and excretion:

    Metabolism is carried out mainly by hydrolysis of the ester bond.

    The terminal elimination half-life is about 5 hours. The total ground clearance is 1.2 l / min. After intravenous injection, 42 to 61% is excreted in the urine (50% unchanged) and from 28.3 to 37% with feces. Metabolites excreted in the urine, weakly bind to m-cholinorecenters, so they are not active and do not have pharmacological properties.

    Indications:

    Renal colic, biliary colic. When carrying out X-ray diagnostic studies, for example, to reduce spasm and pain in pyelography, as well as in endoscopic studies, when smooth muscle spasm and pain can be a cause for difficulty in performing the procedure, for example, gastroduodenoscopy.

    Contraindications:

    • hypersensitivity to hyoscine butyl bromide or any other component of the drug;
    • angle-closure glaucoma;
    • obstruction of the urinary tract (including benign prostatic hypertrophy), urinary retention;
    • violation of patency of the gastrointestinal tract;
    • tachycardia;
    • myasthenia gravis;
    • megacolon;
    • children and adolescents under 18;
    • pregnancy, breast-feeding.

    Intramuscular administration of hyoscine butyl bromide to patients taking anticoagulants is contraindicated because of the possibility of intramuscular hematoma formation. In this case, the drug should be administered intravenously.

    Carefully:

    Use with caution in patients with cardiovascular disease, in which an increase in the heart rate may be undesirable: atrial fibrillation, heart failure, coronary heart disease, mitral stenosis, hypertension;

    with acute bleeding;

    thyrotoxicosis (possibly strengthening tachycardia);

    hyperthermia (body temperature can still increase due to suppression of secretion of sweat glands);

    suspected ileus (including, pyloric stenosis), reflux esophagitis, hiatal hernia, combined with the reflux oesophagitis (decreased motility of the esophagus and stomach and relaxation of the lower esophageal sphincter can help slow gastric emptying and increased gastroesophageal reflux through the sphincter with the broken function); open-angle glaucoma (mydriatic effect may cause some increase in intraocular pressure;

    may require correction of therapy), in patients with possible undiagnosed glaucoma;

    ulcerative colitis (high doses may inhibit intestinal motility, increasing the chance of paralytic ileus);

    autonomic (autonomic) neuropathy - urinary retention and paralysis of accommodation can be exacerbated;

    hypertrophy of the prostate without obstruction of the urinary tract.

    Pregnancy and lactation:

    Application during pregnancy is contraindicated. If you need to use the drug during lactation at the time of treatment should stop breastfeeding.

    Dosing and Administration:
    Intravenous, intramuscular.
    1 ampoule (20 mg) intravenously or intramuscularly. Additional administration of 20 mg (1 ampoule) is possible after 30 minutes. The maximum daily vine is 100 mg.
    Intravenous administration should be slow.
    As a solvent, it is possible to use isotonic 0.9% sodium chloride solution or 5% glucose solution.

    Side effects:

    To assess the frequency of adverse reactions, the following criteria were used: very often (>1/10); often (>1/100, <1/10): infrequently (>1/1000, <1/100); rarely (> 1/10000. <1/1000); very rarely (<1/10000). including individual messages. Many of the side effects described below may be associated with the anticholinergic properties of hyoscine butyl bromide, which are mostly mild and pass on their own.

    From the immune system: rarely anaphylactic shock, anaphylactic reactions, dyspnea, skin reactions (eg urticaria, rash, erythema, pruritus) and other manifestations of hypersensitivity.

    From the cardiovascular system: often - orthostatic hypotension, tachycardia; rarely - fainting, vasodilation.

    From the digestive system: very often - dry mouth, constipation, nausea, vomiting; often - anorexia,abdominal pain, dyspepsia; rarely - dehydration, weight loss, peripheral edema, dysphagia, stomatitis, biliary spasm.

    From the side of the rut and subcutaneous tissues: rarely - dyshidrotic eczema.

    From the urinary system: often - urinary retention.

    From the side of the organ of vision: often - disorders of accommodation, mydriasis, increased intraocular pressure

    General reactions and reactions at the site of administration: Pain at the injection site after intramuscular injection.

    Overdose:

    Symptoms: Cases of severe intoxication caused by an overdose of hyoscine butyl bromide in humans have not been described. Possible overdose symptoms associated with the anticholinergic effects of hyoscine butyl bromide include: dilated pupils with no response to light, dry mouth, hoarseness, difficulty swallowing, tachycardia, urinary retention, fever.

    Treatment: forced diuresis, repeated injections of physostigmine (every 1 / 2-1 hour) or galantamine (every 1-2 hours). to eliminate paresis of the intestine and tachycardia, it is possible to introduce proserin, with excitation and convulsions - sodium oxybutyrate, oxygen therapy, artificial ventilation.

    Patients with glaucoma are prescribed pilocarpine in drops locally, urgent consultation of the ophthalmologist is necessary.

    Symptomatic means for maintaining the function of the cardiovascular and respiratory systems. When paralysis of the respiratory musculature shows intubation, artificial ventilation of the lungs. In the case of urinary retention, the bladder is catheterized.

    Interaction:

    Hyoscipa butyl bromide enhances the anticholinergic action of tricyclic and tetracyclic antidepressants, antihistamines, antipsychotics (eg phenothiazim and butyrofion derivatives), quinidine, amantadine, disopyramide and other anticholinergics (eg, tiotropium, atropropic atropine-like compounds).

    Simultaneous administration of the butyl bromide hyoscyline and dopamine antagonists, for example metoclopramide, results in a weakening of both drugs on the gastrointestinal tract.

    Hyoscine butyl bromide may enhance tachycardia caused by beta-adrenomimetic agents.

    Special instructions:

    In the event that severe pain in the abdomen persists or builds up, or is accompanied by symptoms such as fever, nausea, vomiting,changes in peristalsis, muscle tension of the anterior abdominal wall, lowering of arterial pressure, loss of consciousness or blood in the stool, it is necessary to take appropriate diagnostic measures to clarify the diagnosis.

    When there is an injection of vessels of the sclera with soreness and a violation of the clearness of vision after the administration of the drug, consultation of the ophthalmologist is necessary.

    After parenteral administration of the drug, single cases of anaphylaxis, including cases of anaphylactic shock, were observed. In this regard, patients receiving the injection of the drug should be under the supervision of a doctor.


    Effect on the ability to drive transp. cf. and fur:

    It is recommended to avoid driving a car and practicing other potentially dangerous activities that require increased attention and speed of psychomotor reactions.

    Form release / dosage:Solution for injection 20 mg / ml
    Packaging:

    1 ml per ampoule of neutral glass.

    For 10 ampoules with instructions for use and a knife for opening ampoules or a scarifier ampullum will be placed in a box of cardboard for consumer containers. For 5 or 10 ampoules are placed in a contour mesh package made of a polyvinyl chloride film or tapepolyethylene terephthalate and aluminum foil or paper with polyethylene coating or without foil, or without paper.

    For 1 or 2 contour packs with instructions for use and a knife for opening ampoules or a scarifier ampullum is placed in a pack of cardboard.

    When you pack the ampoules with a break ring or break point, the ampoule opener or ampoule scapper is not put in.

    Storage conditions:

    In the dark place at a temperature of 2 to 25 ° C. Keep out of the reach of children.

    Shelf life:3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003195
    Date of registration:14.09.2015
    The owner of the registration certificate:NOVOSIBHIMFARM, OJSC NOVOSIBHIMFARM, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspNOVOSIBHIMFARM, OJSCNOVOSIBHIMFARM, OJSC
    Information update date: & nbsp15.12.2015
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