PK-Merz

PK-Merz

amantadine

Manufacturer:

Merz

Distributor:

Zuellig
Concise Prescribing Info
Contents
Amantadine sulphate
Indications/Uses
Treatment of symptoms of Parkinson's as well as movement disorders similar to Parkinson's disease caused by certain medicinal products (neuroleptics & medicinal products w/ similar mechanism of action); extrapyramidal symptoms eg, early dyskinesia, akathisia & parkinsonism.
Dosage/Direction for Use
100 mg once daily for the 1st 4-7 days, followed by a once-wkly increase in daily dose of 1 tab until the maintenance dose is reached. The usual effective dose is 1-3 tab bid (equiv to 200-600 mg/day). Patient w/ renal impairment w/ GFR 60-80 mL/min 100 mg every 12 hr, 50-60 mL/min 200 mg & 100 mg on alternate days, 30-50 mL/min 100 mg once daily, 20-30 mL/min 200 mg twice a wk, 10-20 mL/min 100 mg 3 times a wk, <10 mL/min & haemodialysis patients 200 mg & 100 mg once a wk or once every 2 wk.
Administration
Should be taken with food: Preferably taken in the morning & afternoon w/ a little liqd. The last daily dose should not be taken later than 4 pm.
Contraindications
Hypersensitivity to amantadine compd & yellow-orange S (E110). Severe decompensated heart failure (NYHA class IV), cardiomyopathies & myocarditis, 2nd or 3rd degree AV block, existing bradycardia under 55 bpm, known prolonged QT interval (Bazett QTc >420 ms) or discernible U-waves or congenital QT syndrome in the family anamnesis, history of serious ventricular arrhythmias including Torsade de pointes. Simultaneous treatment w/ budipine or other drugs that prolong the QT interval. Reduced levels of K or Mg in the blood.
Special Precautions
Avoid or discontinue treatment in patients showing baseline QTc values above 420 ms, an increase in QTc of >60 ms during treatment. Risk of electrolyte imbalances. Discontinue in case of palpitations, dizziness or syncope & check for QT prolongation of patient w/in 24 hr. Patients w/ cardiac pacemakers. Not for the prevention & treatment of flu A infection. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Perform ultrasonography if therapy is carried out during 1st trimester of pregnancy. May impair ability to drive or operate machinery. Pregnancy & lactation. Childn.
Adverse Reactions
Dizziness; sleep disturbances, motor & psychiatric agitation, paranoid exogenous psychoses accompanied by visual hallucinations; urinary retention in case of prostatic hypertrophy; livedo reticularis (marble skin), sometimes associated w/ lower-leg & ankle oedema; nausea, dry mouth; orthostatic dysregulation.
Drug Interactions
QT interval prolongation w/ certain antiarrhythmic agents of class I A (eg, quinidine, disopyramide, procainamide) & certain class III (eg, amiodarone, sotalol), certain antipsychotics (eg, thioridazine, chlorpromazine, haloperidol, pimozide), certain tricyclic & tetracyclic antidepressants (eg, amitriptyline), certain antihistamines (eg, astemizole, terfenadine), certain macrolide antibiotics (eg, erythromycin, clarithromycin), certain gyrase inhibitors (eg, sparfloxacin), azole antimycotics & other drugs eg, budipine, halofantrine, co-trimoxazole, pentamidine, cisapride & bepridil. Enhancement of confusion & hallucinations of anticholinergics (eg, trihexyphenidyl, benzatropine, scopolamine, biperiden, orphenadrine). Potentiation of the central effects of amantadine w/ indirectly CNS-active sympathomimetics. Lowering of alcohol tolerance. Mutual potentiation of therapeutic action w/ levodopa. Potentiated effect & undesirable effects w/ memantine. Decreased plasma clearance leading to toxic plasma conc w/ diuretics of the triamterene/hydrochlorothiazide combination.
MIMS Class
Antiparkinsonian Drugs
ATC Classification
N04BB01 - amantadine ; Belongs to the class of adamantane derivative dopaminergic agents. Used in the management of Parkinson's disease.
Presentation/Packing
Form
PK-Merz FC tab 100 mg
Packing/Price
30's
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