PK-Merz

PK-Merz

amantadine

Manufacturer:

Merz

Distributor:

Jacobson Medical
Concise Prescribing Info
Contents
Amantadine sulfate
Indications/Uses
Parkinson's disease of varying origin, senile parkinsonism, residual symptoms & disturbances after stereotactic operations.
Dosage/Direction for Use
Initially 1 tab/day on the 1st 3 days, to be increased to a regular dosage of 2 tab/day. Possible to raise dosage by wkly increases of 1 tab/day. Max daily dose: 6 tab.
Administration
Should be taken with food: Take preferably in the morning & afternoon. Last daily dose should not be taken after 4 pm.
Contraindications
Hypersensitivity. Severe non-compensated cardiac insufficiency (NYHA IV), cardiomyopathy, myocarditis, grade II or III AV block, existing bradycardia (<55 beats/min), congenital QT syndrome in personal or family history, history of serious ventricular arrhythmias including torsades de pointes, simultaneous treatment w/ budipine or other drugs that prolong the QT interval, reduced levels of K or Mg in the blood, prostate hypertrophy, narrow-angle glaucoma, renal impairment, states of agitation or confusion, delirious syndromes or exogenous psychosis in personal or family history. Simultaneous treatment w/ memantine.
Special Precautions
Perform baseline & periodic ECG. Monitor electrolyte balance in patients at risk of electrolyte imbalances. Discontinuation in case of palpitations, dizziness or syncope (check QT prolongation for 24 hr). Patients w/ cardiac pacemakers. Avoid abrupt discontinuation in patients treated simultaneously w/ neuroleptic drugs & amantadine. Seizure-prone patients or those w/ organic brain lesions. Pregnancy & lactation. Elderly.
Adverse Reactions
Common: Dizziness, sleep disturbances, motor & psychiatric agitation, paranoid exogenous psychoses accompanied by visual hallucination, urinary retention in case of prostatic hypertrophy, livedo reticularis sometimes associated w/ lower leg and ankle edema, nausea, dry mouth, orthostatic dysregulation. Rare: Blurred vision. Very rare: Epileptic fits, myoclonus, symptoms of peripheral neuropathy, cardiac arrhythmias eg ventricular tachycardia, ventricular fibrillation, torsade de pointes, QT prolongation, temporary loss of vision, increased photosensitivity, corneal edema, reversible after discontinuation, leukopenia, thrombocytopenia.
Drug Interactions
Drugs known to cause QT prolongation eg quinidine, disopyramide, procainamide, amiodarone, sotalol, thioridazine, chlorpromazine, haloperidol, pimozide, amitriptyline, astemizole, terfenadine, macrolides, sparfloxacin, azole antifungals, budipine, halofantrine, co-trimoxazole, pentamidine, cisapride, bepridil. Anticholinergics, alcohol, indirect CNS-active sympathomimetics, memantine, triamterene/hydrochlorothiazide-type diuretics.
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
5 × 20's
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