Active substanceDrotaverineDrotaverine
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  • Dosage form: & nbsppills
    Composition:

    Composition for one tablet.

    Drotaverina hydrochloride 80.0 mg.

    Excipients: lactose monohydrate, microcrystalline cellulose, corn starch, croscarmellose sodium, silicon dioxide colloidal anhydrous, talc, magnesium stearate.

    Description:

    Tablets from light yellow with a greenish shade to yellow with a greenish tint of color, flat-cylindrical, with a risk on one side and a facet. Marble is allowed.

    Pharmacotherapeutic group:Spasmolytic agent
    ATX: & nbsp

    A.03.A.D.02   Drotaverine

    Pharmacodynamics:Drotaverin is a myotropic antispasmodic, chemical structure and pharmacological properties close to papaverine, but it has a stronger and longer acting effect.Reduces the intake of calcium ions in the smooth muscle cells. Reduces the tone of the smooth muscles of internal organs and intestinal motility, dilates the blood vessels. Does not affect the autonomic nervous system, does not penetrate the central nervous system. Immediate influence on smooth muscles makes it possible to use it as an antispasmodic, when drugs from the group of M-cholinoblockers are contraindicated (closed-angle glaucoma, prostatic hypertrophy).
    Pharmacokinetics:

    When taken orally, absorption is high. Bioavailability is 100%. Evenly distributed on the tissues, penetrates into the smooth muscle cells. The maximum concentration in the blood reaches after 2 hours. Connection with blood plasma proteins - 80 - 90%. The half-life is 7-12 hours. Drotaverine is actively metabolized in the liver, is excreted mainly by the kidneys, to a lesser extent with bile. Does not penetrate the blood-brain barrier.

    Indications:

    With spasms and pain (of a spastic nature) that occur with the following conditions:

    - spasm of smooth muscles of internal organs (renal colic, biliary colic, intestinal colic),

    - with dyskinesia of the biliary tract and gallbladder hyperkinetic type, with cholecystitis, postcholecystectomy syndrome;

    - pyelite;

    - with spastic constipation, spastic colitis, proctitis, tenesmus; pilorospazme, gastroduodenitis, peptic ulcer of stomach and duodenum (in the phase of exacerbation, as part of complex therapy - to relieve the pain syndrome of a spastic nature);

    - with endarteritis,

    - spasm of peripheral, coronary arteries, as well as spasm of cerebral arteries accompanied by headaches;

    - algodismenorea;

    - to reduce excitability of the uterus during pregnancy (threatening miscarriage, threatening premature birth); spasm of the throat of the uterus during labor, prolonged opening of the throat, postnatal fights.

    To prevent the occurrence of spasm:

    - with some instrumental studies, cholecystography.
    Contraindications:

    Hypersensitivity, expressed renal and hepatic insufficiency, chronic heart failure, atrio-ventricular blockade of II and III degree, cardiogenic shock, arterial hypotension. This dosage form is not prescribed for children under 12 years of age.

    Spasmonet forte tablets contain lactose, so patients with congenital intolerance to galactose, lactose deficiency, or glucose-galactose malabsorption should not take the drug.

    Carefully:Pronounced atherosclerosis of the coronary arteries, angle-closure glaucoma, prostatic hyperplasia.
    Pregnancy and lactation:

    The appointment of the drug during pregnancy and lactation is not contraindicated. Be wary appoint during pregnancy (I trimester) and during lactation.

    Dosing and Administration:

    Inside, with a small amount of liquid.

    Adults and children over 12 years - 1 tablet 2-3 times a day (160-240 mg drotaverina).
    Side effects:

    Nausea, dizziness, palpitation, a feeling of heat, increased sweating, lowering blood pressure, allergic skin reactions.

    Overdose:

    Symptoms: in high doses violates atrioventricular conduction, reduces the excitability of the heart muscle, can cause heart failure and respiratory center paralysis.

    Interaction:

    With simultaneous application drotaverine can weaken the antiparkinsonian effect of levodopa.

    Strengthens the effect of papaverine, bendazole and other antispasmodics (including M-holinoblokatorov), lowers arterial pressure caused by tricyclic antidepressants, quinidine and procainamide. Phenobarbital increases the severity of spasmolytic action of drotaverine.

    Drotaverine reduces the spasmogenic activity of morphine.

    Special instructions:

    In the treatment of gastric ulcer and duodenal ulcer drug is used in combination with other antiulcer drugs.

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

    During the period of application of the drug it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Tablets, 80 mg.

    Packaging:

    For 10 tablets in Contour mesh packaging made of a combined material (polyamide / foil aluminum / polyvinyl chloride) and foil of aluminum printed lacquered. By 2 or 10 contour cellular Packaging together with the instructions for use are placed in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C, in the original packaging.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-003585/07
    Date of registration:06.11.2007 / 29.01.2016
    Date of cancellation:2018-02-09
    The owner of the registration certificate:KRKA-RUS, LLC KRKA-RUS, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
    Information update date: & nbsp09.02.2018
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