Proserin (Proserinum)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceNeostigmine methyl sulfateNeostigmine methyl sulfate
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  • Proserin
    solution w / m in / in PC 
    NOVOSIBHIMFARM, OJSC     Russia
  • Proserin
    pills inwards 
    DALHIMFARM, OJSC     Russia
  • Proserin
    solution in / in PC 
    MIKFARM, LLC    
  • Proserin-Darnitsa
    solution in / in PC 
    DARNITSA PHARMACEUTICAL FIRM, CJSC     Ukraine
    • Dosage form: & nbsppills
    Composition:

    Composition per one tablet:

    Active substance: Neostigmine methyl sulfate (proserin) - 0,015 g Excipients: sucrose (sugar) - 0,064 g, potato starch- 0,020 g, calcium stearate monohydrate 0.001 g.

    Description:tablets of white color flat-cylindrical with bevel.
    Pharmacotherapeutic group:cholinesterase inhibitor
    ATX: & nbsp

    S.01.E.B   Parasympathomimetics

    S.01.E.B.06   Neostigmine

    Pharmacodynamics:

    The synthetic inhibitor of cholinesterase, reversibly blocking cholinesterase, leads to the accumulation and enhancement of the action of acetylcholine on organs and tissues and the restoration of neuromuscular conduction. It causes a decrease in the heart rate, increases the secretion of glands (salivary, bronchial, sweat and gastrointestinal tract) and promotes the development of hypersalivation, bronchorrhoea, acidity of the gastric juice, narrows the pupil, causes a spasm of accommodation, reduces intraocular pressure, strengthens the tone of the smooth muscles of the intestine intensifies peristalsis and relaxes sphincters) and bladder, causes spasm of the bronchi, tones the skeletal muscles.

    Pharmacokinetics:

    Being a quaternary ammonium base, poorly penetrates the blood-brain barrier and does not have a central effect. Bioavailability - 1-2 %. Connection with plasma proteins - 15 - 25 %. Half-life 52 min. Metabolism - in the liver with the formation of inactive metabolites. 80 % of the administered dose is excreted by the kidneys during 24 h (of which 50 % - unchanged and 30 % - in the form of metabolites).

    Indications:

    Myasthenia gravis gravis, movement disorders after brain injury, paralysis, recovery period after suffering meningitis, polio, encephalitis.

    Contraindications:

    Hypersensitivity to the drug, epilepsy, hyperkinesis, vagotomy, coronary heart disease, bradycardia, arrhythmia, angina, asthma, marked atherosclerosis, hyperthyroidism, peptic ulcer and 12 duodenal ulcer, peritonitis, mechanical obstruction of the gastrointestinal tract and urinary tract, prostate hyperplasia, a period of acute infection, children under 18 years of age (for a given dosage form), deficiency of sucrase / isomaltase, fructose intolerance, glucose-galactose th malabsorption.

    Carefully:Arterial hypotension, recent coronary occlusion, Addison's disease.
    Pregnancy and lactation:

    The use of the drug during pregnancy and during breastfeeding is contraindicated.

    Dosing and Administration:

    Inside, 30 minutes before eating.

    In myasthenia gravis: a single dose of 15 mg, a daily dose of 50 mg. The course of treatment of myasthenia gravis is prolonged with a change in the way of administration. The course of treatment - 25 - 30 days, if necessary - again, after 3 - 4 weeks. Most of the total daily dose is administered in the daytime, when the patient is most fatigued.

    For motor disorders that occur after meningitis, encephalitis, trauma, central nervous system, as well as paralysis of the facial nerve, a dose of 15 mg 1 to 2 times a day is prescribed, varying the dose depending on the effect and tolerability. The course of treatment on average 2-3 weeks.

    In the treatment of motor disorders that are a consequence of poliomyelitis, Prozerin is used in combination with other measures (therapeutic gymnastics, physiotherapy, balneotherapy, etc.) once a day for 15 mg. Depending on the effectiveness and tolerability of the drug can be administered daily or every other day, for treatment 15-20 receptions. Repeated courses are conducted after 2-3 months.

    Side effects:

    From the gastrointestinal tract: hypersalivation, spastic reduction and enhancement of intestinal peristalsis, nausea, vomiting, flatulence, diarrhea.

    From the cardiovascular system and blood: arrhythmias (brady or tachycardia, atrioventricular block, nodal rhythm), nonspecific changes in the electrocardiogram, cardiac arrest, lowering of blood pressure.

    On the part of the respiratory system: shortness of breath, bronchospasm, respiratory depression, increased secretion of bronchial glands.

    From the nervous system and sensory organs: headache, dizziness, weakness, unconsciousness, drowsiness; miosis, visual impairment, tremor, spasms and twitching of skeletal muscles, including twitching of the muscles of the tongue, cramps, dysarthria, arthralgia; profuse sweating.

    Other: increased frequency of urination; allergic reactions (redness of the face, rash, itching, anaphylaxis).

    Overdose:

    Symptoms: associated with overexcitation of cholinergic receptors (cholinergic crisis): bradycardia, hypersalivation, miosis, bronchospasm, nausea, increased intestinal peristalsis, diarrhea, frequent urination, twitching of the muscles of the tongue and skeletal muscles, gradual development of muscle weakness,lowering of blood pressure. Treatment: reduce the dose or discontinue treatment, if necessary, administer atropine (1 ml of a 0.1% solution), metocinium iodide and other holinoblokatory.

    Interaction:

    When myasthenia is prescribed in combination with glucocorticosteroids and anabolic hormones.

    Atropine, metocinium iodide and other m-holinoblokatory weaken m-cholinomimetic effects (narrowing of the pupil, bradycardia, increased motility of the gastrointestinal tract, hypersalivation, and others).

    With caution appoint a cholin blocker, in patients (with myasthenia) against neomycin, streptomycin, kanamycin and other antibiotics that have antidepolarizing effect, local anesthetics and means for general anesthesia, antiarrhythmic drugs and a number of other drugs that disrupt the cholinergic transmission.

    Special instructions:

    If a miasthenic (with insufficient therapeutic dose) or cholinergic (due to an overdose) crisis occurs during treatment, careful differential diagnosis is required because of the similarity of the symptoms.

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

    During the treatment period, care must be taken when managing transport means and employment of other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Tablets 15 mg.

    For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    2 contour squares, together with instructions for use, are placed in a cardboard pack.

    Packaging:(10) - a contour mesh package (2) / 2 contour packs of 10 tablets together with the instructions for use are placed in a pack of cardboard. / - A pack of cardboard
    Storage conditions:

    In a dry, protected from light place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000692
    Date of registration:30.06.2010
    The owner of the registration certificate:DALHIMFARM, OJSC DALHIMFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp07.08.2015
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