Indication

Amantadine hydrochloride tablets are indicated in the treatment of idiopathic Parkinson’s disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication. It is indicated in those elderly patients believed to develop parkinsonism in association with cerebral arteriosclerosis.

Qualitative Quantitative Composition

Amantadine hydrochloride USP 100 mg

Pharmaceutical Dose Form

Film coat tablet

Dose And Administration

The usual dose of amantadine hydrochloride tablets is 100 mg twice a day.

The initial dose of amantadine hydrochloride tablets is 100 mg daily for patients with serious associated medical illnesses or who are receiving high doses of other antiparkinson drugs. After one to several weeks at 100 mg once daily, the dose may be increased to 100 mg twice daily, if necessary. Occasionally, patients whose responses are not optimal with amantadine hydrochloride tablets at 200 mg daily may benefit from an increase up to 400 mg daily in divided doses. However, such patients should be supervised closely by their physicians.

Contraindications

Amantadine hydrochloride tablets are contraindicated in patients with known hypersensitivity to amantadine hydrochloride or to any of the other ingredients in amantadine hydrochloride tablets.

Special Warnings Precautions

Deaths have been reported from overdose with amantadine hydrochloride. The lowest reported acute lethal dose was 1 gram. Acute toxicity may be attributable to the anticholinergic effects of amantadine. Drug overdose has resulted in cardiac, respiratory, renal or central nervous system toxicity. Cardiac dysfunction includes arrhythmia, tachycardia, and hypertension.

Amantadine hydrochloride can exacerbate mental problems in patients with a history of psychiatric disorders or substance abuse.

Patients with a history of epilepsy or other “seizures” should be observed closely for possible increased seizure activity.

Patients receiving amantadine hydrochloride tablets who note central nervous system effects or blurring of vision should be cautioned against driving or working in situations where alertness and adequate motor coordination are important.

Patients with a history of congestive heart failure or peripheral edema should be followed closely as there are patients who developed congestive heart failure while receiving amantadine hydrochloride tablets.

Amantadine hydrochloride should not be discontinued abruptly in patients with Parkinson’s disease since a few patients have experienced a parkinsonian crisis, i.e., a sudden marked clinical deterioration, when this medication was suddenly stopped.

Interaction

Careful observation is required when amantadine hydrochloride is administered concurrently with central nervous system stimulants.

Agents with anticholinergic properties may potentiate the anticholinergic-like side effects of amantadine.

Coadministration of thioridazine has been reported to worsen the tremor in elderly patients with Parkinson’s disease.

Coadministration of quinine or quinidine with amantadine was shown to reduce the renal clearance of amantadine by about 30%.

License Name

บริษัท สตาดา (ประเทศไทย) จำกัด

Distributor Name

บริษัท ดีเคเอสเอช (ประเทศไทย) จำกัด

Marketing Authorisation Number

1C 2/65(P)