PC-Merz (PK-Merz)

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: & nbspfilm-coated tablets
    Composition:

    Active substance: amantadine sulfate 100 mg

    Excipients:

    lactose monohydrate 108.4 mg

    cellulose microcrystalline 70 mg

    potato starch 19 mg

    gelatin 10 mg

    Povidone 9 mg

    croscarmellose sodium 6.6 mg talc 6 mg

    silicon dioxide colloid 0.5 mg magnesium stearate 0.5 mg

    Sheath: talc 3.115 mg butyl methacrylate copolymer 2,121 mg titanium dioxide 1,192 mg magnesium stearate 1.055 mg dye sunset sunset yellow (E 110) 0.917 mg

    Description:Round biconvex tablets covered with an orange film shell, odorless, with a notch on one side.
    Pharmacotherapeutic group:An antiparksonic remedy
    ATX: & nbsp

    N.04.B.B.01   Amantadine

    Pharmacodynamics:

    Amantadine has an indirect agonistic effect on steric dopamine receptors. Increases the extracellular concentration of dopamine, both by intensifying its production, and blockade of reuptake of dopamine by presynaptic neurons.In therapeutic concentrations amantadine slows the production of acetylcholine and, thus, has an anticholinergic effect.

    Pharmacokinetics:

    After oral administration, peak plasma concentrations are achieved after 2-8 hours. When taking 200 mg per day, a steady plasma concentration of 400-900 ng / ml is achieved on the 4th-7th day. The total clearance is 17.7 ± 10 l / h on healthy volunteers; the half-life is from 10 to 30 hours, an average of about 15 hours. Amantadine approximately 67% bind to plasma proteins. Penetrates through the blood-brain barrier. It is allocated by the kidneys practically unchanged (90% of a single dose); a small amount of it is excreted with feces. Dialysis is ineffective (about 5% per procedure).

    Indications:

    Parkinson's disease (muscle rigidity, tremor, hypo- or akinesia).

    Extrapyramidal disorders caused by the administration of neuroleptics or other drugs (dyskinesia, akathisia and parkinsonism).

    Neuralgia with herpes zoster (Herpes Zoster).

    Contraindications:

    Hypersensitivity to any of the components of the drug; severe congestive heart failure (grade IV on the scale of the New York Heart Association), cardiomyopathy, myocarditis, atrioventricular blockade II and III degree, a bradycardia with a heart rate of less than 55 beats / min, an interval QT more than 420 ms, ventricular arrhythmia (including ventricular flutter), pregnancy and the period of breastfeeding, a low content of potassium and magnesium in the blood, simultaneous reception with drugs that extend the interval QT, expressed renal insufficiency (creatinine clearance less than 10 ml / min), children's age (under 18 years), hereditary galactose deficiency, lactase deficiency, glucose-galactose malabsorption, phenylketonuria, sucrose-isomaltous insufficiency, hereditary fructose insufficiency, psychoses (in anamnesis).

    Carefully:

    Hyperplasia of the prostate, narrow-angle glaucoma, renal failure of varying severity (there is a risk of cumulation of the drug), agitation, delirium, central nervous system depression, exogenous psychosis (including history), joint intake with memantine, triamterene / hydrochlorothiazide.

    Dosing and Administration:

    Inside, after a meal with a small amount of liquid, preferably in the first half of the day.The first 3 days - 1 tablet a day, then increase the dose to 2 tablets per day, and further increase in the dose per 1 tablet per week is possible. The usual effective dose is 1 to 3 tablets twice a day. The maximum daily dose is 600 mg. In case of combined treatment it is necessary to determine the dose individually. The last dose is recommended in the afternoon no later than 16-00.

    In elderly patients, in particular, patients suffering from a state of agitation and confusion, predilea and delirium, require a lower dosage.

    For violations of kidney function:

    Glomerular speed

    Dosage

    Dosing interval

    filtering (GFR) ml / min

    (mg)

    (H)

    80-60

    100

    12

    60-50

    200 and 100 alternately

    in one day

    50-30

    100

    24

    30-20

    200

    2 times per week

    20-10

    100

    3 times a week

    <10

    200 and 100

    weekly and weekly
    Side effects:

    Often

    (≥1/10)

    Often

    (≥1/100, <1/10)

    Infrequently

    (≥1/1000, < 1/100)

    Rarely

    (≥1/10000, < 1/1000)

    Rarely

    (<1/10000), including individual messages

    From the nervous system, the senses and the psyche: Often: insomnia, psychomotor agitation, paranoid exogenous psychosis, accompanied by visual hallucinations (in predisposed elderly patients), dizziness, decreased visual acuity. Rarely: epileptic seizures (usually after taking a dose exceeding recommended), peripheral neuropathy, temporary loss of vision, myoclonia.

    From the cardiovascular system: Rarely: arrhythmia, tachycardia, ventricular fibrillation, lengthening of the interval QT, development or aggravation of heart failure, orthostatic hypotension. Often: syndrome of marble skin in combination with edema of the ankles and lower leg.

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

    Other: Often: urinary retention in patients with prostate adenoma. Rarely: skin allergic reactions, photosensitivity, leukopenia, thrombocytopenia, corneal edema, reversible after discontinuation of the drug.

    Overdose:

    Symptoms: nausea, vomiting, increased excitability, tremor, ataxia, decreased visual acuity, lethargic state, depression, dysarthria, epileptic seizures, arrhythmia.

    Treatment: gastric lavage, reception of activated charcoal, symptomatic therapy.

    Interaction:

    Contraindicated simultaneous administration of amantadine and drugs that cause an increase in the RT interval, in particular:

    - some antiarrhythmic drugs of class IA (eg, kynidine, disopyramide, procainamide), and class III (for example, amiodarone and sotalol);

    - some antipsychotics (for example, thioridazine, chlorpromazine, pimozide);

    - some tricyclic and tetracyclic antidepressants (for example, amitriptyline);

    - some antihistamines (for example, astemizole, terfenadine);

    - some macrolide antibiotics (for example, erythromycin, clarithromycin);

    - some inhibitors of gyrase (eg sparfloxasin);

    - antifungal agents of the azole group, and other drugs, in particular, bidupine, halofantrine, co-trimoxazole, pentamidine, cisapride and bepridil.

    The simultaneous administration of diuretics, which are a combination of triamterene / hydrochlorothiazide, can lead to an increase in the concentration of amantadine in the plasma. With simultaneous admission with other antiparkinsonian drugs (such as levodopa, bromocriptine, memantine, trihexyphenidyl), it may be necessary to lower the dose of the concomitantly taken drug, or both drugs in order to avoid undesirable consequences, in particular, psychotic reactions.Anticholinergics, sympathomimetics and memantine: enhance side effects. Means that stimulate the central nervous system (including psychostimulants), ethanol increase the risk of side effects.

    Special instructions:Treatment of PK-Merz should not be discontinued suddenly, as this can lead to worsening of the symptoms. Patients suffering from cardiovascular diseases should be under constant medical supervision when prescribing PK-Merz. Against the background of treatment, alcohol intake is contraindicated.
    Effect on the ability to drive transp. cf. and fur:

    With caution apply during work drivers of vehicles and people whose profession is associated with increased concentration of attention.

    Form release / dosage:Tablets of 100 mg.
    Packaging:

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

    Storage conditions:

    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.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015091 / 02
    Date of registration:14.07.2010 / 10.04.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:Merz Pharma GmbH & Co. KG. KGaAMerz Pharma GmbH & Co. KG. KGaA Germany
    Manufacturer: & nbsp
    Representation: & nbspMERZ PHARMA LLCMERZ PHARMA LLCRussia
    Information update date: & nbsp03.05.2018
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