Spasmox® (Spasmex®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTrospium chlorideTrospium chloride
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  • Spasmox®
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    Dr. R.PPleger, chemical factory GmbH     Germany
  • Spasmox®
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    Dr. R.PPleger, chemical factory GmbH     Germany
  • Spasmo-lit®
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    Madaus, GmbH     Germany
    • Dosage form: & nbspfilm-coated tablets
    Composition:

    Each tablet contains:

    active substance:

    trospium chloride

    Excipients:

    15.0 mg

    30.0 mg

    lactose monohydrate

    100.00 mg

    100.00 mg

    microcrystalline cellulose

    75.0 mg

    60.0 mg

    corn starch

    44.0 mg

    41.0 mg

    sodium carboxymethyl starch

    10.00 mg

    10.00 mg

    stearic acid

    2.00 mg

    5.00 mg

    povidone-25 thousand.

    1.00 mg

    1.00 mg

    Silica colloidal dioxide shell:

    3.00 mg

    3.00 mg

    hypromellose

    6.24 mg

    6.24 mg

    titanium dioxide

    1.44 mg

    1.44 mg

    microcrystalline cellulose

    0.96 mg

    0.96 mg

    stearic acid

    0.96 mg

    0.96 mg

    tablet weight:

    259.60 mg

    259.60 mg
    Description:

    Round, biconvex tablets, covered with a film coat, white or almost white, with a risk. At the break, the core and the film shell are white or almost white in color.

    Pharmacotherapeutic group:m-holinoblokator
    ATX: & nbsp

    G.04.B.D   Spasmolytics

    G.04.B.D.09   Trospium chloride

    Pharmacodynamics:

    Trospium chloride is a quaternary ammonium base, belongs to the group of m-holinoblokatorov. It is a competitive antagonist of acetylcholine on the receptors of postsynaptic membranes of smooth muscles. Has a high affinity for m1- them3- holinoretseptoram.Reduces the increased activity of detrusor of the bladder.

    Has spasmolytic and some ganglioblokiruyuschee effect. Does not have central effects.

    Pharmacokinetics:

    The maximum concentration of trospium chloride in the blood plasma (CmOh) is achieved 4-6 hours after oral administration of trospium chloride; the half-life (T%) is an average of 5-18 hours, not cumulative. Binding to plasma proteins is 50-80%. The concentration of trospium chloride in the blood plasma at a single intake of 20-60 mg is proportional to the dose taken. The predominant amount of tropia chloride is excreted by the kidneys in unchanged form, a smaller part (about -10%) - in the form of spiroalcohol-metabolite, formed during the hydrolysis of ester bonds.

    Indications:

    - Bladder hyperactivity, accompanied by urinary incontinence,

    imperative urge to urinate and increase the frequency of urination (with idiopathic hyperactivity detrusor non-hormonal and inorganic etiology);

    - mixed forms of urinary incontinence;

    - spastic neurogenic disorders of the bladder (with neurogenic hyperactivity (hyperreflexia) detrusor: diffusesclerosis, spinal trauma, congenital and acquired spinal cord diseases, strokes, parkinsonism);

    - detrusor-sphincter-dissynergy against intermittent catheterism;

    - pollakiuria, nocturia;

    - night and daytime enuresis;

    - in the complex therapy of cystitis, accompanied by imperative symptoms.

    Contraindications:

    Hypersensitivity to drug components, narrow-angle and zakratougolnaya glaucoma, tachyarrhythmia, myasthenia gravis, urinary retention, slowing evacuation of food from the stomach and conditions predisposing to their development, renal failure requiring dialysis (creatinine clearance <10 ml / min / 1, 73 m2), galactose intolerance, lactase deficiency, glucose-galactose. malabsorption, children's age (up to 14 years).

    Carefully:

    - Diseases of the cardiovascular system, in which an increase in heart rate may be undesirable: atrial fibrillation, tachycardia, chronic heart failure (CHF), ischemic heart disease (CHD), mitral stenosis, hypertension, acute bleeding;

    - thyrotoxicosis (tachycardia may be worse);

    - increased body temperature (may still increase due to suppression of activity of sweat glands);

    - reflux-esophagitis, hernia of the esophageal opening of the diaphragm, combined with reflux esophagitis (decreased esophageal and gastric motility and relaxation of the lower esophageal sphincter may contribute to slowing the emptying of the stomach and enhancing gastroesophageal reflux through the sphincter with impaired function);

    - diseases of the gastrointestinal tract (GIT), accompanied by obstruction: achalasia and stenosis of the pylorus (there may be a decrease in motor and tone, leading to obstruction and retention of stomach contents);

    - atony of the intestine in elderly patients or weakened patients (possibly development of obstruction), paralytic ileus (possible development of obstruction);

    - diseases with increased intraocular pressure: open-angle glaucoma (mydriatic effect may cause some increase in intraocular pressure, correction of therapy may be required), age over 40 (risk of undiagnosed glaucoma);

    - ulcerative colitis (high doses can inhibit intestinal peristalsis, increasing the likelihood of paralytic intestinal obstruction, and possibly the manifestation or exacerbation of such a serious complication as a toxic megacolon);

    - dry mouth (prolonged use may cause further intensification of xerostomia);

    - Kidney failure (risk of side effects due to reduced excretion);

    - chronic lung diseases, especially in children and weakened patients (a decrease in bronchial secretion can lead to thickening secret and formation of congestion in the bronchi);

    - myasthenia gravis (the condition may worsen due to inhibition of the action of acetylcholine);

    - autonomic neuropathy (urinary retention and paralysis of accommodation may be aggravated), prostatic hyperplasia without urinary tract obstruction, urinary retention or predisposition to it, or diseases accompanied by obstruction of the urinary tract (including the bladder neck due to prostatic hypertrophy) ;

    - gestosis (hypertension is possible);

    - brain diseases in children, (effects from the central nervous system may be intensified);

    - Down's disease (possibly unusual pupil dilated and increased frequency cardiac contractions);

    - central paralysis in children (reaction to anticholinergic drugs can be most pronounced);

    - liver failure.

    Pregnancy and lactation:

    During pregnancy and breastfeeding period, the drug should be used if the expected benefit to the mother outweighs the potential risk to the fetus or child.

    Dosing and Administration:

    Inside, before eating, without chewing and drinking with sufficient water. Adults and children from 14 years of drug administered individually, depending on the clinical picture and severity of the disease.

    Dosing regimen of tablets coated with a film membrane, 15 mg.

    The drug is taken 1 tablet 3 times a day (45 mg) at intervals of 8 hours.

    Dosage regimen of tablets coated with a film coat, 30 mg.

    The drug is taken by 1/2 tablet 3 times daily or 1 tablet in the morning and evening 1/2 tablet (45 mg).

    In patients with renal insufficiency (creatinine clearance 10-30 ml / min / 1.73 m2) The daily dose of the drug should not exceed 15 mg.

    On average, the duration of treatment is 2-3 months. If a longer treatment is required, the doctor continues to review the issue of continuing treatment every 3-6 months.
    Side effects:

    Frequency of occurrence of side effects (number of cases: number of observations): often - more than 1: 100; infrequently -1: 100-1000; rarely - less than 1: 1000.

    From the cardiovascular system: infrequently - tachycardia; rarely - chest pain, fainting, tachyarrhythmia, hypertensive crisis.

    From the gastrointestinal tract: often - dry mouth, indigestion, constipation, nausea, abdominal pain; infrequently - diarrhea, bloating; rarely - gastritis.

    From the respiratory system: infrequently - shortness of breath.

    From the nervous system: rarely confusion, hallucinations.

    From the musculoskeletal system: rarely - acute necrosis of skeletal muscles.

    From the side of the organ of vision: infrequently - a violation of accommodation.

    From the urinary system: infrequently - impaired emptying of the bladder; rarely - urine retention.

    From the hepatobiliary system: rarely - a slight or moderate increase in the activity of transaminases.

    From the immune system: infrequent skin rash; rarely - anaphylactic reactions, Stevens-Johnson syndrome.

    Overdose:

    Signs of an overdose are increased anticholinergic symptoms, such as: visual impairment, tachycardia, dry mouth and hyperemia of the skin.

    Treatment: gastric lavage and intake of adsorbents (Activated carbon etc.), instillation pilocarpine - patients with glaucoma, catheterization of the bladder - with a delay in urine.

    In severe cases, appoint cholinomimetics (neostigmine methylsulfate). With insufficient effect, severe tachycardia and / or instability of blood circulation, intravenous beta-blockers are administered intravenously under ECG and arterial pressure.

    Interaction:

    With the simultaneous application of trospium chloride strengthens m-cholinoblocking effect of amantadine, tricyclic antidepressants, quinidine and disopyramide, antihistamines, as well as a positive chronotropic effect of beta-adrenomimetics (see the section "Contraindications").

    Trospium chloride weakens the effect of prokinetics (metoclopramide and cisapride); has an effect on the motor and secretory functions of the gastrointestinaltract, changing the absorption of concomitantly used drugs.

    With the simultaneous administration of drugs containing substances such as guar, colestramine and colestipol, possibly reducing the absorption of trospium chloride.

    There was no interaction between trospium chloride and cytochrome P450 isoenzymes (CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, 3A4), since trospium chloride they are metabolized only in a small amount, and the hydrolysis of esters is the main pathway of its metabolism.

    Special instructions:Taking the drug in case of a violation of the internal sphincter function of the urethra or detrusor of the bladder should be accompanied by its complete release by catheterization. In vegetative disorders of the bladder, the cause of dysfunction should be determined before the treatment, organic
    causes of pollakiuria, nocturia and incontinence, such as: heart failure, polydipsia, the possibility of urinary tract infection     and cancer bladder, as they require the appointment of etiotropic therapy.
    Effect on the ability to drive transp. cf. and fur:At the beginning of treatment, with an increase in the dose of the drug, the replacement of the drug, as well as,interaction with alcohol may impair vision, which should be taken into account when driving and working with moving machinery.
    Form release / dosage:Tablets, film-coated, 15 mg and 30 mg.
    Packaging:

    Tablets, film-coated, 15 mg.

    For 10 tablets, film-coated, in a blister of PVC / aluminum foil. For 3 or 5 blisters together with the instructions for use are placed in a cardboard box.

    Tablets, film-coated, 30 mg.

    For 10 tablets, film-coated, in a blister of PVC / aluminum foil. For 3 blisters together with instructions for use are placed in a cardboard box.

    Storage conditions:In a dry, dark place at a temperature of 15-25 ° C.

    Keep out of the reach of children!

    Shelf life:

    5 years.

    Do not use after the expiration date!

    Terms of leave from pharmacies:On prescription
    Registration number:П N016196 / 02
    Date of registration:04.03.2010
    The owner of the registration certificate:Dr. R.PPleger, chemical factory GmbHDr. R.PPleger, chemical factory GmbH Germany
    Manufacturer: & nbsp
    Information update date: & nbsp21.10.2015
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