Active material: Amantadin
When ATH: N04BB01
CCF: Противопаркинсонический препарат – блокатор глутаматных NMDA-рецепторов
ICD-10 codes (testimony): B02.2, G20, G21
When CSF: 02.06.03
Manufacturer: Merz Pharma GmbH & Co. KGaA (Germany)
Pills, Film-coated orange, round, lenticular, with a notch on one side, without smell.
| 1 tab. | |
| Amantadine sulfate | 100 mg |
Excipients: microcrystalline cellulose, potato starch, gelatin, lactose monohydrate, povidone, talc, magnesium stearate, colloidal silicon dioxide, Croscarmellose sodium, Titanium dioxide, butyl methacrylate copolymer, dye orange yellow.
10 PC. – блистеры (3) – пачки картонные.
Solution for infusion colorless, clear.
| 1 ml | 1 fl. | |
| Amantadine sulfate | 400 g | 200 mg |
Excipients: sodium chloride, water d / and.
500 мл – флаконы полимерные (1) – коробки картонные.
500 мл – флаконы полимерные (2) – коробки картонные.
Blocker of glutamate N-methyl-D-aspartate receptors (NMDA-receptor). Of anti-drug. Amantadine has indirect agonist activity at striatal dopamine receptors. Increases extracellular concentrations of dopamine, through both intensification of its production, and the blockade of dopamine reuptake by presynaptic neurons. At therapeutic concentrations amantadine and slows down the production of acetylcholine, thereby, anticholinergic effects.
Absorption
After administration of a single dose of Cmax It achieved within approximately 2-8 no. Upon receiving a dose of amantadine sulfate 100 mg Cmax is 0.15 ug / ml.
Average plasma concentrations of amantadine sulphate in the / infusion at a dose of 200 mg for 3 h is 0.54 l. At a dose of 200 mg / day average plasma concentration at the end of the 6th day of treatment is 0.76 l.
Distribution
Binding to plasma proteins is 67%. It penetrates through the BBB.
Deduction
T1/2 – 10-30 no, average 10 no. Excreted by the kidneys virtually unchanged (90% single dose); небольшое количество – с калом. Dialysis maloeffyektivyen (about 5% for one procedure).
The total clearance with on / in the introduction of 3.6 l /.
Orally
- Parkinson's disease (muscle rigidity, tremor, Hypo- or akinesia);
- Extrapyramidal disorders, caused by the intake of neuroleptics, or other drugs;
- Neuralgia in opoyasыvayushtem gerpese.
For i / v administration
- Parkinson's disease, Parkinson's syndrome (akynetycheskyy crisis, acute decompensation);
- Violation of vigilance (initiative) in postkomatoznom period;
- Neuralgia in opoyasыvayushtem gerpese.
The drug is administered orally after meals, drinking a small amount of liquid, preferably in the first half of the day. First 3 days appoint 1 tab. / day, then increase the dose to 2 tab. / day, it being possible to further increase the dose to 1 tab. in Week. Typically, an effective dose of 1-3 tab. 2 times / day. The maximum daily dose - 600 mg (6 tab.). In case combination treatment is necessary to determine the dose individually. The last dose is recommended to take in the second half of the day no later 16 no.
In elderly patients, in particular, patients with the condition of excitement and confusion, preddeliriya and delirium, It requires a lower dosage.
B / appoint 500 ml 1-2 times / day. The dose can be increased to 3 time / day of 500 ml. Продолжительность вливания – 3 no (55 drops / min).
The average duration of therapy for neuralgia with herpes zoster is 1 week with a subsequent transition to the reception of the drug inside.
At renal impairment drug administered according to the glomerular filtration rate.
| Glomerular filtration rate | Dose | Interval |
| 80-60 ml / min | 100 mg | 12 no |
| 60-50 ml / min | 200 mg 100 mg alternately | in one day |
| 50-30 ml / min | 100 mg | 24 no |
| 30-20 ml / min | 200 mg | 2 times a week |
| 20-10 ml / min | 100 mg | 3 times a week |
| <10 ml / min | 200 mg 100 mg | weekly and a week later |
The incidence of adverse reactions is classified as follows: Often (>1/10), often (>1/100, <1/10), infrequently (>1/1000, <1/100), rarely (>1/10 000, <1/1000), rarely (<1/10 000, including isolated reports).
From the central and peripheral nervous system: часто – тревога, irritability, heteroptics, psychomotor agitation, dizziness, headache, reduced visual acuity, insomnia; очень редко – эпилептические припадки, perifericheskaya neuropathy, temporary loss of vision.
Cardio-vascular system: очень редко – аритмия, tachycardia, ventricular fibrillation, prolongation of the interval QT, development or exacerbation of congestive heart failure, orthostatic hypotension; часто – синдром мраморной кожи в сочетании с отеком лодыжек и голени.
From the digestive system: often - nausea, vomiting, dry mouth, decreased appetite, dyspepsia.
From the urinary system: часто – задержка мочи у больных с гиперплазией предстательной железы; очень редко – полиурия, nocturia.
Dermatological reactions: очень редко – кожные аллергические реакции, dermatosis, photosensitivity.
From the hematopoietic system: leukopenia, thrombocytopenia.
- Severe congestive heart failure (IV functional class NYHA classification);
- Cardiomyopathy;
- Miokardit;
— AV-blockade II and III degrees;
- Bradycardia (HR less 55 u. / min);
- Prolongation of the interval QT more 420 ms;
- Ventricular fibrillation (incl. ventricular flutter);
- Hypokalemia;
- Gipomagniemiya;
- Concomitant use of drugs with, prolonging the QT interval;
- Severe renal insufficiency (CC < 10 ml / min);
- Children's age;
— только для таблеток – наследственная недостаточность галактазы, lactase deficiency, malabsorption syndrome glucose / galactose, lack of sucrase / isomaltase, hereditary fructose intolerance;
- Phenylketonuria;
- Pregnancy;
- Breastfeeding;
- Hypersensitivity to any component of the drug.
FROM caution should be prescribed the drug for benign prostatic hyperplasia, angle-closure glaucoma, renal failure of varying severity (there is a risk of cumulation of the drug), ažitacii, delirium, CNS depression, ékzogennom psychosis (incl. history), when co-administered with memantine, triamterene / hydrochlorothiazide.
The drug is contraindicated in pregnancy and lactation (breast-feeding).
Treatment with PK-Merz can not be stopped suddenly, tk. this can lead to deterioration of the disease.
Patients with cardiovascular disease should be under constant medical supervision in the appointment of PK-Merz.
The treatment is contraindicated alcohol intake.
Effects on ability to drive vehicles and management mechanisms
Precautions should use the drug during the drivers of vehicles and people, skills relate to the high concentration of attention.
Symptoms: nausea, vomiting, tremor, ataxia, reduced visual acuity, lethargic, dysarthria, seizures, arrhythmia.
Treatment: gastric lavage, administration of activated charcoal. Symptomatic therapy.
Concomitant intake of amantadine and drugs, causing an increase in the QT interval, in particular:
- Class I antiarrhythmic drugs A (eg, quinidine, disopyramide, prokaynamyd) and class III (eg, amiodarone and sotalol);
- Antipsychotics (eg, tioridazin, chlorpromazine, pimozid);
- Tricyclic and tetracyclic antidepressants (eg, Amitriptyline);
- Antihistamines (eg, astemizol, terfenadine);
- Macrolide antibiotics (eg, Erythromycin, clarithromycin);
- Gyrase inhibitors (eg, sparfloxacine);
- Azole antifungals;
- Other preparations (bidupin, galofantrin, co-trimoxazole, pentamidine, cisapride and bepridil).
Simultaneous administration of diuretics, representing a combination of triamterene / hydrochlorothiazide may lead to increased concentrations of amantadine in plasma.
At simultaneous reception with other antiparkinsonian drugs (levodopa, bromocriptine, Memantine, trigeksifenidil) it may be necessary to lower the dose of the drug at the same time received, or both drugs in order to avoid unwanted effects, in particular, psychotic reactions.
Anticholinergic agents, sympathomimetic and memantine increase the side effects of amantadine.
Funds, stimulating the central nervous system (incl. psychostimulants), Ethanol increases the risk of side effects of amantadine.
The drug is released under the prescription.
The drug should be stored out of reach of children at or above 25 ° C. Shelf life - 5 years.
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