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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  • PC-Merz
    solution d / infusion 
    Merz Pharma GmbH & Co. KG. KGaA     Germany
    • Dosage form: & nbspsolution for infusions
    Composition:

    1 bottle of solution for infusion volume of 500 ml contains:

    Active substance:

    Amantadine sulfate 200 mg.

    Excipients:

    sodium chloride 4500 mg;

    water for injection up to 500 ml.

    Description:

    Transparent solution, from colorless to brownish-yellow in color.

    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:

    The average plasma concentration of amantadine sulfate after its infusion in an amount of 200 mg for 3 hours is 0.54 μl. At a dosage of 200 mg per day, the average plasma concentration at the end of the 6th day of treatment is 0.76 μl.The total ground clearance is 3.6 l / h; the half-life is 10 to 30 hours, an average of about 10 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, Parkinson's syndrome (akinetic crisis, acute decompensation). Violation of vigilance (initiative) in the post-coma period.

    Neuralgia with 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, bradycardia with a heart rate of less than 55 beats / min, lengthening 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 failure (creatinine clearance less than 10 ml / min), children's age.

    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:

    Intravenous, 1-2 times a day for 500 ml; the dose can be increased up to 3 times a day for 500 ml. Duration of infusion 3 hours (55 drops per minute). The average duration of therapy for neuralgia with herpes zoster is 1 week, followed by a transition to oral administration of the drug.

    Glomerular filtration rate (GFR) ml / min

    Dosage

    (mg)

    Dosing interval (H)

    80-60

    100

    12

    60-50

    200 and 100 alternately

    Every second day

    50-40

    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, sense organs and psyche: Often: anxiety, irritability, visual hallucinations, psychomotor agitation, dizziness, headache, decreased visual acuity, insomnia. Rarely: epileptic seizures, peripheral neuropathy, temporary loss of vision.

    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, vomiting, dry mouth, decreased appetite, indigestion.

    Other: Often: urinary retention in patients with prostate adenoma. Rarely: skin allergic reactions, dermatosis, photosensitivity, polyuria, nocturia, leukopenia, thrombocytopenia.

    Overdose:

    Symptoms: nausea, vomiting, tremor, ataxia, decreased visual acuity, lethargic state, dysarthria, depression, epileptic seizures, cardiac arrhythmia. Treatment is symptomatic (use of sedative, anticonvulsant and antiarrhythmic drugs).

    Interaction:

    Contraindicated simultaneous administration of amantadine and drugs, causing an increase in the range of RT, in particular:

    - some antiarrhythmic drugs class IA (for example, 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, 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:
    Solution for infusions, 200 mg / 500 ml.
    Packaging:500 ml per bottle of low density polyethylene, equipped with a special attachment for fastening. The bottle is hermetically sealed with a high-density polyethylene lid. The upper part of the lid is covered with aluminum foil. 2 bottles are placed in a cardboard box with instructions for use.
    Shelf life:5 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:П N015091 / 01
    Date of registration:16.07.2010 / 23.12.2016
    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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