Neomidantan (Neomidantan)

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Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAmantadineAmantadine
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    • Dosage form: & nbspcapsules
    Composition:

    Composition of the contents of one capsule:

    active substance: amantadine hydrochloride 100.0 mg;

    Excipients: lactose monohydrate 105.0 mg, potato starch 42.5 mg, stearic acid 2.5 mg.

    The composition of white capsule № 0: titanium dioxide E171 -2%, gelatin - up to 100%.
    Description:Hard gelatin capsules № 0 of white color. The contents of capsules are powder from white to almost white.
    Pharmacotherapeutic group:An antiparksonic remedy
    ATX: & nbsp

    N.04.B.B.01   Amantadine

    Pharmacodynamics:

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

    Pharmacokinetics:

    The drug is well absorbed from the gastrointestinal tract. The maximum concentration in the blood plasma is reached after 3-4 hours. The steady-state concentration at a dose of 200 mg per day is established within 3 days. 60-70% of the active substance binds to plasma proteins. The volume of distribution - from 5 to 10 l / kg, increases in patients of senile age. Amantadine overcomes the blood-brain barrier, placental barrier; penetrates into the mother's milk.

    Amantadine is slightly metabolized in the liver.

    Half-life in patients with normal renal function is about 15 (10-30) h. Elimination slows down in elderly patients and with impaired renal function. 90% are excreted unchanged in urine.

    With renal failure, cumulation is possible.

    Indications:

    Parkinson's syndrome and idiopathic Parkinson's disease.

    Contraindications:

    - Hypersensitivity to the components of the drug,

    - liver failure,

    - chronic renal failure,

    - thyrotoxicosis,

    - epilepsy,

    - angle-closure glaucoma,

    - hyperplasia of the prostate,

    - arterial hypotension,

    - heart failure II-III stages by classification NYHA,

    - pregnancy and the period of breastfeeding,

    - children under 18 years of age,

    - simultaneous administration of memantine, triamterene, hydrochlorothiazide,

    - deficiency of lactase, lactose intolerance, glucose-galactose malabsorption (because the preparation contains lactose).

    Carefully:

    Precautions for prescribing with orthostatic arterial hypotension, allergic dermatitis, alcoholism, mental disorders (including history), including psychosis, agitation, predelly, delirious psychosis, as well as elderly patients.

    Pregnancy and lactation:

    The drug is contraindicated in pregnancy and during breastfeeding, because amantadine penetrates the placental barrier and is found in breast milk.

    Dosing and Administration:

    Inside after eating. Capsules should be swallowed whole, without chewing, squeezed with enough liquid.

    Parkinson's disease. The initial dose is 100 mg (one capsule) per day.After a week, the dose is increased to 100 mg twice a day, usually in combination with other antiparkinsonian agents. Individual patients need an increased dose. The maximum daily dose is 400 mg.

    Patients with renal insufficiency reduce the dose and / or increase the interval between doses (see table).

    Creatinine clearance ml / min

    Dose

    < 15

    The use is contraindicated

    15-35

    100 mg every second - third day

    >35

    100 mg every day

    In elderly patients, reduced doses are used.

    The use of the drug is discontinued gradually, since the abrupt withdrawal of the drug may increase the symptoms of Parkinson's disease.

    If you forget to take the next dose, take the next dose at the usual time. Never take a double dose to replace a missed dose.

    Side effects:

    Impaired nervous system: motor or mental agitation, headache, dizziness, irritability, insomnia, tremor, mental disorders, very rarely - convulsions.

    Disorders from the cardiovascular system: heart failure, tachycardia, orthostatic hypotension, arrhythmogenic action, peripheral edema (shins, ankles).

    Disorders from the gastrointestinal tract: often - dyspeptic disorders (dry mouth, nausea, vomiting, diarrhea, constipation), lack of appetite.

    Disorders from the kidneys and urinary tract: acute urinary retention (often in patients with prostatic hypertrophy), polyuria, nocturia.

    Disturbances on the part of the organ of sight: rarely - blurred vision.

    Disturbances from the skin and subcutaneous tissue: dermatosis, the appearance of a bluish color of the skin of the upper and lower extremities ("marble skin").

    Overdose:

    Symptoms: nausea, vomiting, tremor, movement coordination disorders, dilated pupils (weakly responsive to light), urinary retention, acute psychosis with disorientation, hallucinations and aggressive behavior, blurred vision, respiratory disorders and arrhythmia.

    Treatment: gastric lavage, symptomatic therapy: measures for maintenance of vital functions. Only a small amount of the drug is excreted during hemodialysis.

    Interaction:

    Medicines that stimulate the central nervous system and ethanol, increases the risk of side effects. Strengthens the action of levodopa, psychostimulants.Compatible with central anticholinergics and other antiparkinsonian means.

    Neomidantan and

    - bupropion: the risk of side effects increases (with a special caution bupropion should be used in patients with a known low seizure threshold).

    - memantine: the toxic effect of amantadine on the central nervous system is intensified (simultaneous use is contraindicated).

    - Methyldopa: the risk of developing extrapyramidal side effects increases.

    - metoclopramide: increased risk of developing extrapyramidal by-products effects.

    - tetrabenazine: the risk of developing extrapyramidal side effects increases.

    Special instructions:

    The sudden cessation of the treatment of patients who simultaneously use neuroleptic drugs may lead to the development of a malignant neuroleptic syndrome.

    The therapeutic effect of antiparkinsonian drugs develops gradually.

    Information on the effectiveness in the treatment of extrapyramidal disorders against the background of treatment with antipsychotic drugs (drug parkinsonism) is contradictory.Patients with a tendency to cardiovascular failure with the appearance of accelerated palpitation, dizziness and loss of consciousness should immediately stop using the drug and consult a doctor.

    Treatment with amantadine should be stopped immediately if there is an accelerated heart beat, dizziness and / or fainting. The patient should be observed in 24 hours for longer interval QT. If QT the interval is not extended, the treatment can be continued, taking into account contraindications and interactions of amantadine with other drugs.

    In patients taking Neomidantan for a long time, a liveno net (blue-violet skin color) is often observed.

    In patients with congestive heart failure with prolonged use of amantadine peripheral edema may form (usually no sooner than 4 weeks later). This can occur before or during the live mesh. Please consult with your doctor, as it may be necessary to reduce the dose or stop treatment with Neomidantan.

    In patients with renal insufficiency, intoxication (poisoning) can develop.Patients who have trouble urinating, should consult a doctor.

    Treatment can not be stopped suddenly, because possibly sharp exacerbation of the disease.

    The use of alcohol during 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 managing motor vehicles and practicing potentially dangerous activities that require increased concentration of attention and quick reaction.

    Form release / dosage:

    Capsules of 100 mg.

    Packaging:

    10 capsules per contour cell packaging made of polyvinylchloride film and aluminum foil.

    For 5 contour mesh packages together with instructions for use in a pack of cardboard.

    Storage conditions:

    Store in a dry, dark 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 expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001462
    Date of registration:26.01.2012
    Expiration Date:26.01.2017
    Date of cancellation:2017-02-10
    The owner of the registration certificate:Olainfarm, AOOlainfarm, AO Latvia
    Manufacturer: & nbsp
    Representation: & nbspOLAINFARM JSC OLAINFARM JSC Latvia
    Information update date: & nbsp19.06.2018
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