PK-Merz 100 mg 30 tablets

PK-Merz 100 mg 30 film-coated tablets

Composition

Active ingredient: Amantadine sulfate — 100 mg

Description

PK-Merz contains amantadine sulfate, which acts on dopaminergic and glutamatergic neurotransmission and is effective in treating Parkinson’s disease. It enhances dopamine release, blocks NMDA receptors, and shows mild anticholinergic activity, improving motor function and reducing parkinsonian symptoms.

Indications for Use

Treatment of Parkinson’s disease of various origins.

Dosage and Method of Administration

Swallow the tablet whole without chewing or splitting.

Initial dose: 1 tablet/day for the first 3 days, then increase to 2 tablets/day. The dose can be gradually increased up to a maximum of 6 tablets/day under medical supervision.

Elderly patients or those with agitation/confusion: start with a lower dose.

Renal impairment: dose adjustment required (see table in original text).

Do not abruptly discontinue treatment.

Contraindications

-Hypersensitivity to amantadine or excipients, 

-severe heart failure (NYHA IV), 

-cardiomyopathy, myocarditis, 

-AV block II–III degree, 

-bradycardia < 55 bpm, 

-long QTc interval (> 420 ms), 

-congenital long QT syndrome, 

-ventricular arrhythmias, 

-psychotic disorders, 

-angle-closure glaucoma, 

-pregnancy

Precautions

-ECG monitoring before treatment, at weeks 1 and 3, and then annually. 

-Avoid in patients with QTc > 480 ms or visible U-waves. 

-Use cautiously in renal insufficiency, electrolyte imbalance, CNS disorders, seizures, cardiovascular disease, and concurrent use of memantine or neuroleptics.

-Taper off slowly. Increased risk of suicide ideation in depressed patients.

Side Effects

Common: insomnia, nervousness, motor agitation, urinary retention, skin mottling (livedo reticularis), nausea.

Rare: hallucinations, seizures, corneal clouding, arrhythmias, elevated liver enzymes, rash, photosensitivity.

Pregnancy and Breastfeeding

Contraindicated in pregnancy. Amantadine is excreted in breast milk; monitor infant or discontinue breastfeeding if necessary.

Storage Conditions

Store below 25 °C, in original packaging, out of reach of children.

Packaging

Carton box containing 3 blisters of 10 tablets each and a package insert.