Amantadine STADA

Amantadine STADA

amantadine

Manufacturer:

Jubilant Generics Ltd

Distributor:

DKSH

Marketer:

Stada
Concise Prescribing Info
Contents
Amantadine HCl
Indications/Uses
Idiopathic parkinson's disease (paralysis agitans), post-encephalitic & symptomatic parkinsonism. Elderly believed to develop parkinsonism in association w/ cerebral arteriosclerosis.
Dosage/Direction for Use
Adult Parkinsonism 100 mg bid as monotherapy. Patient w/ serious associated medical illnesses or receiving high doses of other antiparkinson drugs Initially 100 mg daily. May be increased to 100 mg bid after 1 to several wk. Patient whose responses is not optimal at 200 mg daily dose May be increased up to 400 mg daily in divided doses. Patient initially benefiting from amantadine HCl tab commonly experience fall-off of effectiveness after few mth May be increased to 300 mg daily. Concomitant therapy w/ levodopa: Hold dose at 100 mg daily or bid while levodopa dose is gradually increased. Renal impairment w/ CrCl 30-50 mL/min/1.73 m2 200 mg on 1st day & 100 mg each day thereafter, 15-29 mL/min/1.73 m2 200 mg on 1st day followed by 100 mg on alternate days, <15 mL/min/1.73 m2 & patient on hemodialysis 200 mg every 7 days.
Administration
May be taken with or without food.
Special Precautions
Not to be given to patients w/ untreated angle closure glaucoma. Not to be discontinued abruptly in patients w/ parkinson's disease. Deaths due to drug accumulation; cardiac, resp, renal or CNS toxicity. Suicide attempts & suicidal ideation in patients w/ & w/o prior history of psychiatric illness. Parkinsonian crisis ie, sudden marked clinical deterioration, when medication is suddenly stopped. NMS; blurry vision &/or impaired mental acuity. Mood/mental changes, swelling of extremities, difficulty urinating &/or shortness of breath. Patients w/ history of psychiatric disorders or substance abuse, & recurrent eczematoid rash; being treated w/ drugs having CNS effects; w/ & history of CHF or peripheral edema; w/ orthostatic hypotension; psychosis psychoneurosis not controlled by chemotherapeutic agents. Closely observe patients w/ history of epilepsy or other seizures for possible increased seizure activity; when dose is reduced abruptly or discontinued, especially if receiving neuroleptics. Consider dose reduction or stopping medication if patient develops intense urges to gamble & spend money uncontrollably, increased sexual urges, & other intense urges during treatment. Frequently monitor patients for melanomas & on regular basis during treatment for any indication. Perform periodic skin exam. Avoid excessive alcohol usage; getting up suddenly from sitting or lying position. Concomitant use w/ anticholinergic drugs. May impair ability to drive or operate machinery. Renal impairment. Liver disease. Pregnancy. Not recommended in lactation. Newborn infants & infants <1 yr. Elderly ≥65 yr.
Adverse Reactions
Nausea, dizziness (lightheadedness), insomnia. Coma, stupor, delirium, hypokinesia, hypertonia, delusions, aggressive behavior, paranoid & manic reaction, involuntary muscle contractions, gait abnormalities, paresthesia, EEG changes, tremor, delirium, agitation, delusions, hallucinations, paranoid reaction, anxiety, depression, slurred speech; cardiac arrest, arrhythmias including malignant arrhythmias, hypotension, tachycardia; acute resp failure, pulmonary edema, tachypnea; dysphagia; leukocytosis, agranulocytosis; keratitis, mydriasis; pruritus, diaphoresis; NMS, allergic reactions including anaphylactic reactions, edema, fever; elevated CPK, BUN, serum creatinine, alkaline phosphatase, LDH, bilirubin, γ-glutamyl transpeptidase, SGOT & SGPT.
Drug Interactions
Concomitant use w/ CNS stimulants. Potentiated anticholinergic-like side effects w/ agents w/ anticholinergic properties. Worsened tremor in elderly w/ parkinson's disease w/ thioridazine. Higher plasma conc w/ Dyazide (triamterene/hydrochlorothiazide). Reduced renal clearance w/ quinine or quinidine.
MIMS Class
Neurodegenerative Disease 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
Amantadine STADA tab 100 mg
Packing/Price
3 × 10's
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