Spasmo-lit® (Spasmo-lyt®)

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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    Madaus, GmbH     Germany
    • Dosage form: & nbspcoated tablets
    Composition:

    1 tablet, coated, contains:

    Active substance: trospy chloride - 20.0 mg.

    Excipients: wheat starch - 19.0 mg, microcrystalline cellulose 16.0 mg, lactose monohydrate 7.0 mg, stearic acid 3.0 mg, povidone (K 29-32) (polyvinylpyrrolidone K25) 2.0 mg, croscarmellose sodium - 2.0 mg, talc - 0.7 mg, silicon dioxide colloidal anhydrous - 0.3 mg.

    Shell: sucrose 39.0 mg, talc 8.062 mg, calcium carbonate (E 170) 6.46 mg, titanium dioxide (E 171) -3.43 mg macrogol 8000 (polyethylene glycol 8000) 1.86 mg, iron dye oxide yellow (E 172) 0.43 mg, sodium carmellose 0.328 mg, silicon dioxide colloidal anhydrous 0.38 mg, beeswax white 0.025 mg, carnauba wax 0.025 mg.
    Description:Round tablets, brownish-yellow, covered with glossy shell.
    Pharmacotherapeutic group:m-holinoblokator
    ATX: & nbsp

    G.04.B.D   Spasmolytics

    G.04.B.D.09   Trospium chloride

    Pharmacodynamics:

    Trospium chloride - a quaternary ammonium base, belongs to the group of m-holinoblokatorov.

    Trospium chloride has a high affinity for muscarinic M receptors1-, M2- them3subtypes and shows little affinity for nicotinic receptors.

    Consequently, the m-holinoblokiruyuschy effect of tropia chloride is to reduce the contractile tone of the smooth muscles of the gastrointestinal tract and urogenital tract.

    It is proved that trospium chloride does not affect cardiac repolarization, but can cause a dose-dependent effect on the heart rate, speeding it up.

    In a prolonged clinical study of trospium chloride at a dose of 20 mg twice daily, an increase QT > 60 ms in 1.5% (3/197) patients. The clinical significance of these results has not been established.
    Pharmacokinetics:
    After oral administration of 20 mg of trospium chloride, the maximum concentration (CmOh) in blood plasma were 4 ng / ml and were achieved in 4-6 hours. Within the study range, 20-60 mg as a single dose, plasma concentrations were proportional to the dose taken. Absolute bioavailability of a single oral dose of trospium chloride 20 mg (1 tablet of spasmodic-lithium® 20 mg) is 9.6 ± 4.5%. Simultaneous eating, especially a diet high in fat, reduces the bioavailability of trospium chloride. After a meal with a high fat content, the average Cmax and the concentration in the blood plasma in time decreased to 15-20% of the values ​​obtained on an empty stomach.

    Most of the systemically available tropia of chloride is excreted by the kidneys unchanged, a smaller part (10% of renal excretion) is excreted in the urine. The limiting half-life is 10-20 hours. Accumulation of trospium chloride does not occur. Binding to plasma proteins - 50-80%.

    Pharmacokinetic data in elderly patients do not imply any significant differences.

    The results of a pharmacokinetic study in patients with mild to moderate hepatic insufficiency did not confirm the need for dose adjustment in patients with hepatic insufficiency, consistent with the limited role of hepatic metabolism in eliminating trospium chloride.

    Indications:

    Symptomatic treatment of bladder dysfunction, namely urinary incontinence / or increased frequency of urination, as well as imperative urging in patients with overactive bladder (idiopathic or neurologic detrusor hyperactivity).

    Contraindications:Trospium chloride is contraindicated patients with a delay in urine, angle-closure glaucoma, slowing the evacuation of food from stomach and condition, predisposing to their development, severe gastrointestinal disorders (including toxic megacolon), severe myasthenia gravis, tachyarrhythmia.
    Trospium chloride is also contraindicated patients with hypersensitivity to active substance or to any auxiliary to the core or tablet shell.
    Not recommended preparation for patients with:
    - a rare hereditary intolerance to galactose, deficiency of Lappase Lactase or glucose-galactose malabsorption;
    - a rare hereditary intolerance to fructose or insufficiency of sugar-isomaltases;
    - an allergy to wheat (excellent from celiac disease). Apart from this, trospia chloride can be used in patients with celiac disease;
    severe function impairments liver, because the data on use of the drug in patients with severe function impairments there are no liver.
    Since data on the use of in children under 18 years of age are absent, the drug is contraindicated this category of patients.
    Carefully:

    Trospium chloride should be use caution in patients with:

    - autonomic neuropathy;

    - hernia of esophageal opening diaphragm, combined with reflux-esophagitis;

    - patients for whom increased heart rate can be undesirable: atrial fibrillation, tachycardia, chronic heart insufficiency, ischemic disease heart, mitral stenosis, arterial hypertension,

    - impaired liver function of moderate severity.

    Pregnancy and lactation:Clinical data on the use of spasmodic litters ® in pregnant women are absent. In this regard, the use of the drug is permissible, if the intended use for the mother exceeds the potential risk to the fetus or child.
    Dosing and Administration:

    1 tablet twice a day (equivalent to 40 mg of trospium chloride per day). The tablet should be swallowed whole, without chewing, with a glass of water, before eating on an empty stomach.

    For patients with severe renal dysfunction (creatinine clearance 10-30 ml / min / 1.73 m2 ) the recommended dose is one tablet per day or every other day (equivalent to 20 mg of trospium chloride per day or every other day).

    The need for continuation of treatment should be regularly assessed every 3-6 months.

    Side effects:

    - During the treatment of trospium chloride, anticholinergic reactions may occur, such as dry mouth, indigestion and constipation, and abdominal pain.

    - Infrequently (<1%): tachycardia, headache, bloating, diarrhea, chest pain.

    - Rarely (<0.1%): disturbances in urination (for example, the formation of residual urine), disruption of accommodation (this is especially true for patients with hyperopia and patients whose vision can not be appropriately adjusted), shortness of breath, rash, asthenia, urinary retention, painful urination, myalgia, arthralgia, angioedema edema, increased serum aminotransaminase activity, anaphylaxis, dizziness.

    - Very rarely (<0.01%): angioedema.

    Overdose:After taking the maximum single dose of 360 mg of trospium chloride, healthy volunteers exhibited dry mouth, tachycardia and urinary disorders. To date, the manifestations of severe overdose or intoxication was not reported. Presumptive signs of intoxication will be an increase in anticholinergic symptoms.

    In case of intoxication the following measures should be taken:

    - gastric lavage and reduced absorption (eg, Activated carbon);

    - patients with glaucoma are instilled eye drops into the conjunctival sac by 1-2 drops.

    The number of installations can vary depending on the indications and individual sensitivity of the patient.

    Acute attack of glaucoma: during the first hour, pilocarpine solution is instilled every 15 minutes, 2-3 hours every 30 minutes, 4-6 hours every 60 minutes, and further 3-6 times a day, until the seizure occurs.

    - catheterization of the bladder in patients with urinary retention;

    - treatment with parasympathomimetics (for example, neostigmine methylsulfate in case of severe symptoms;

    - use of (3-adrenoblockers in case of insufficient response, severe tachycardia and / or circulatory instability (for example, 1 mg of propranolol intravenously along with ECG and blood pressure monitoring).

    Interaction:Spasmo-lit® can cause an increase in the anticholinergic effect of such drugs as amantadine, tricyclic antidepressants; increased heart rate with simultaneous admission with beta-adrenomimetics; a decrease in the effectiveness of prokinetic agents (eg, metoclopramide).
    Because the trospium chloride can have an effect on the peristalsis and secretion of the gastrointestinal tract, it can not be ruled out that the absorption of other concomitant drugs can not be violated.

    When combined with drugs such as colestramine, colestipol, guar plants, it is impossible to exclude the inhibition of absorption of trospium chloride, so the simultaneous use of these drugs with trospium chloride is not recommended.

    Special instructions:

    Before starting therapy, organic causes of urinary frequency, urinary incontinence and urinary incontinence, for example, such as heart disease, kidney disease, polydipsia, infection or urinary tract tumors, should be excluded.

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

    It is advisable to use caution when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions, as the drug can cause a disruption to accommodation and other side effects that may affect these abilities.

    Form release / dosage:

    The tablets covered with a cover, 20 mg.

    Packaging:

    For 10 tablets coated with a coating, in a blister of PVC / PVDC and aluminum foil. 2 blisters together with instructions for use in a cardboard box.

    Storage conditions:

    Store at a temperature not higher than 25 ° C. Keep out of the reach of children's place.

    Shelf life:

    5 years. Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002038
    Date of registration:02.04.2013
    The owner of the registration certificate:Madaus, GmbHMadaus, GmbH Germany
    Manufacturer: & nbsp
    Madaus, GmbH Germany
    Representation: & nbspROTTAFARM SPAROTTAFARM SPARussia
    Information update date: & nbsp21.10.2015
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