Active substanceAmantadineAmantadine
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  • Dosage form: & nbspcoated tablets
    Composition:

    For one tablet:

    active substance: amantadine hydrochloride - 100,000 mg;

    Excipients: Lactose monohydrate - 105,000 mg, corn starch, partially pregelatinized (starch 1500) - 10,575 mg Sodium croscarmellose - 15,000 mg talc - 7,270 mg, stearic acid - 2,480 mg, potato starch - to the average weight of the core tablet 250.000 mg Opadry II Series 85F 32554 (yellow) - 12,000 mg. Ingredients Opadry II 85F series 32554 (Yellow): polyvinyl alcohol, partially hydrolyzed - 40,000%, macro goal 3,350 - 20,200% talc - 14,800 Dokrashivayuschy pigment (titanium dioxide E 171 -22.320%, based on the aluminum lake of quinoline yellow E 104 - 2,430%, iron oxide yellow E 172 - 0,250%) - 25,000%.

    Description:
    Round biconvex tablets, film-coated, yellow. Two layers are visible on the cross-section.
    Pharmacotherapeutic group:An antiparksonic remedy
    ATX: & nbsp

    N.04.B.B.01   Amantadine

    Pharmacodynamics:

    Antiparkinsonian means, tricyclic symmetric adamantamine. Blocks glutamate NMDA-receptors (incl.in a black substance), thereby reducing the excessive stimulating effect of cortical glutamate neurons on the neostriatum, developing against the background of insufficient isolation of dopamine. Reducing the flow of ionized Ca2 + into neurons, reduces the possibility of their destruction. Mostly affects the stiffness (rigidity and bradykinesia).

    Pharmacokinetics:

    After oral administration, it is well absorbed in the gastrointestinal tract. Maximum concentration in blood plasma after 5 hours; the half-life of amantadine sulfate is 12-13 hours of amantadine hydrochloride - 30 hours. It is excreted by the kidneys in an unchanged form.

    Indications:

    Parkinson's disease, Parkinson's syndrome.

    Contraindications:

    Hypersensitivity, hepatic insufficiency, chronic renal failure, psychoses (in the anamnesis), thyrotoxicosis, epilepsy, zakratougolnaya glaucoma, prostatic hyperplasia, arterial hypotension, heart failure II-III Art. excitation, predelly, delirious psychosis, pregnancy (I trimester), lactation period, simultaneous administration of triamterene and hydrochlorothiazide.

    Carefully:

    Orthostatic arterial hypotension, allergic dermatitis, pregnancy (II-III trimester), elderly age, alcoholism, mental disorders (in the city in the anamnesis).

    Dosing and Administration:

    Inside, after eating. With Parkinson's disease, the initial dose is 100 mg / day with an interval of 6 hours (the last dose before dinner) for 3 days; from 4 to 7 days - 200 mg / day; for 2 weeks - 300 mg / day: from the 3rd week, depending on the patient's condition, 300-400 mg / day. The maximum dosage is 600 mg / day.

    PIn violation of renal function, the dose reduces and increases the intervals between doses at a glomerular filtration rate of 80-60 ml / min - 100 mg every 12 hours, 60-50 ml / min - dosages of 200 mg and 100 mg alternate every other day. 30-20 ml / min - 200 mg 2 times a week. 20-10 ml / min - 100 mg 3 times a week, less than 10 ml / min - 200 mg once a week and 100 mg every second week. In elderly patients, reduced doses are used.

    Side effects:

    From the nervous system: motor or mental arousal, convulsions, headache, dizziness, irritability, insomnia, tremor, mental disorders, accompanied by visual hallucinations.

    From the side of the cardiovascular system: heart failure, tachycardia, orthostatic hypotension, arrhythmogenic action.

    On the part of the organs of the gastrointestinal tract: dry mouth, nausea, anorexia, dyspepsia.

    From the urinary system: acute urinary retention in patients with prostatic hyperplasia, polyuria. nocturia.

    Other: dermatosis, the appearance of bluish coloration of the skin of the upper and lower extremities, reduced visual acuity.

    Interaction:Medicines that stimulate the central nervous system and ethanol increase the risk of side effects. Enhances the action of levodopa. psychostimulants. Compatible with central anticholinergics and other antiparkinsonian means.
    Special instructions:

    Information on the effectiveness in the treatment of extrapyramidal disorders against the background of treatment with antipsychotic drugs (drug parkinsonism) is contradictory. Therapy can not be stopped suddenly, because possibly sharp exacerbation of the disease.

    The use of ethanol against the background of taking the drug is contraindicated.

    Effect on the ability to drive transp. cf. and fur:During the treatment period it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities,requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:
    Tablets, film-coated, 100 mg.
    Packaging:10 tablets per contour mesh package made of polyvinyl chloride film or unplasticized PVC film and flexible packaging on the basis of aluminum foil or aluminum foil or a combination material based on foil. For 100 tablets in cans of glass with a screw neck, sealed with screw caps, or in cans of polymeric, capped polymeric screw caps, or in cans of polymeric, clamped polymeric clamping lids. Each jar or 2, 5 or 10 contour mesh packages together with a medical instruction is placed in a pack of cardboard.
    Storage conditions:List B. In a dry place, at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:
    3 years. Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-000721
    Date of registration:04.08.2010 / 05.04.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC Republic of Belarus
    Manufacturer: & nbsp
    Information update date: & nbsp24.04.2018
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