Composition
Active ingredient:
Amantadine Sulfate 100 mg
Auxiliary substances:
Microcrystalline cellulose,
potato starch,
gelatin,
lactose monohydrate,
povidone,
talc,
magnesium stearate,
colloidal silicon dioxide,
croscarmellose sodium,
titanium dioxide,
butyl methacrylate copolymer,
dye orange yellow
Pharmacological action
PC-Merc – blocker of glutamate N-methyl-D-aspartate receptors (NMDA receptors). Antiparkinsonian drug. Amantadine has an indirect agonistic effect on striatal dopamine receptors. Increases the extracellular concentration of dopamine by both intensifying its production and blocking dopamine reuptake by presynaptic neurons. In therapeutic concentrations, amantadine slows down the production of acetylcholine and, thus, has an anticholinergic effect.
Pharmacokinetics
Suction
After taking a single dose, Cmax is reached within about 2-8 hours. After taking amantadine sulfate at a dose of 100 mg, the Cmax is 0.15 mcg / ml.
The average plasma concentration of amantadine sulfate after intravenous infusion at a dose of 200 mg for 3 hours is 0.54 µl. At a dose of 200 mg/day, the average plasma concentration by the end of the 6th day of treatment is 0.76 µl.
Distribution
Binding to plasma proteins is 67%. Penetrates through the BBB.
Elimination
T1/2 – 10-30 hours, on average 10 hours. It is excreted by the kidneys almost unchanged (90% of a single dose); a small amount – with feces. Dialysis is ineffective (about 5% in one procedure).
The total clearance for intravenous use is 3.6 l/h.
Indications
- Parkinson’s disease (muscle rigidity, tremor, hypo-or akinesia);
- extrapyramidal disorders caused by taking neuroleptics or other drugs;
- neuralgia with herpes zoster.
Contraindications
- severe congestive heart failure (IV functional class NYHA classification);
- cardiomyopathy;
- myocarditis;
- AV-block II and III degree;
- bradycardia (heart rate less than 55 beats/min);
- prolongation of the interval QT more than 420 msec;
- ventricular arrhythmia (including ventricular flutter);
- hypokalemia;
- hypomagnesemia;
- simultaneous use of drugs that lengthen the QT interval;
- renal failure severe (CC < 10 ml/min);
- child;
- only for tablets – a hereditary deficiency galactose, lactase deficiency, a syndrome of malabsorption of glucose/galactose, sucrase/isomaltase, hereditary fructose intolerance;
- phenylketonuria;
- pregnancy;
- lactation;
- hypersensitivity to any component of the drug.
With caution, the drug should be prescribed for prostatic hyperplasia, angle-closure glaucoma, renal failure of varying severity (there is a risk of accumulation of the drug), agitation, delirium, central nervous system depression, exogenous psychosis (including in the anamnesis), when co-administered with memantine, triamterene/hydrochlorothiazide.
Side effects
Mental disorders accompanied by visual hallucinations.
Rarely-motor and mental arousal.
Urinary retention in patients with prostate adenoma.
Heart failure.
Arrhythmia, tachycardia, nausea, dry mouth, dizziness, sleep disorders.
Very rarely — the appearance of bluish coloration of the skin of the upper and lower extremities, decreased visual acuity.
Interaction
Concomitant use of diuretics, which are a combination of triamterene/hydrochlorothiazide, may lead to changes in the concentration of amantadine in plasma.
When combined with other anti-parkinsonism medications, it may be necessary to adjust the doses of other medications or the combination as a whole accordingly, otherwise side effects may increase.
How to take, course of use and dosage
Inside, after eating with a small amount of liquid, preferably in the first half of the day.
The first 3 days – 1 tablet per day, then increase the dose to 2 tablets per day, and it is possible to further increase the dose by 1 tablet per week.
The usual effective dose is 1 to 3 tablets twice daily.
The maximum daily dose is 600 mg.
In the case of combined treatment, it is necessary to determine the dose individually.
The last dose is recommended to be taken in the afternoon no later than 16-00.
Use in elderly patients, in particular in patients suffering from agitation and confusion, pre-delirium and delirium. A lower dosage is required.
Overdose
Symptoms: nausea, vomiting, tremor, ataxia, decreased visual acuity, lethargy, dysarthria, epileptic seizures, arrhythmia.
Treatment: gastric lavage, taking activated charcoal, symptomatic therapy.
Special instructions
Treatment of PC-Merc should not be stopped abruptly, as this may lead to a worsening of symptoms.
Patients suffering from cardiovascular diseases should be under constant medical supervision when prescribing the drug PK-Merz.
Alcohol intake is contraindicated during treatment.
Influence on the ability to drive motor vehicles and work with mechanisms. Use with caution when working for drivers of vehicles and people whose profession is associated with increased concentration of attention.
Form of production
Coated tablets.
Storage conditions
Store at a temperature not exceeding 25°C.
Shelf
life is 5 years.
Active ingredient
Amantadine
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Description
For adults as directed by your doctor
Indications
Mental Disorders, Parkinson ‘s Disease
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Side effects of PK-Merz, pills 100mg, 30pcs.
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