AMANTADINE HYDROCHLORIDE ORAL SOLUTION USP
Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride.
Amantadine hydrochloride syrup is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.
Influenza A Prophylaxis
Amantadine hydrochloride is indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection when early vaccination is not feasible or when the vaccine is contraindicated or not available. In the prophylaxis of influenza, early vaccination on an annual basis as recommended by the Centers for Disease Control's Immunization Practices Advisory Committee is the method of choice. Because amantadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine prophylaxis should be considered for the 2 to 4 week time period required to develop an antibody response.
Influenza A Treatment
Amantadine hydrochloride is also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with amantadine will avoid the development of influenza A virus pneumonitis or other complications in high risk patients.
There is no clinical evidence indicating that amantadine is effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains.
Amantadine is indicated in the treatment of idiopathicParkinson'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. In the treatment of Parkinson's disease amantadine is less effective than levodopa, (-)-3-(3,4-dihydroxyphenyl)-L-alanine, and its efficacy in comparison with theanticholinergic antiparkinson drugs has not yet been established.
Drug-Induced Extrapyramidal Reactions
Amantadine hydrochloride is indicated in thetreatment of drug-induced extrapyramidal reactions. Although anticholinergic-type side effects have been noted with amantadine when used in patients with drug-induced extrapyramidal reactions, there is a lower incidence of these side effects than that observed with the anticholinergic antiparkinson drugs.
Published Studies Related to Amantadine
Assessment of treatment algorithms including amantadine, metformin, and zonisamide for the prevention of weight gain with olanzapine: a randomized controlled open-label study. [2011.05.17]
CONCLUSIONS: Pooled treatment algorithm results were not significantly different from olanzapine monotherapy in mitigating weight gain. However, participants who received treatment with metformin with possible progression to amantadine and then zonisamide had significantly less mean weight gain than participants treated with olanzapine alone. Progression of some participants through the algorithm indicated that a single therapy solution may not be adequate for every patient. Patients treated with olanzapine should receive regular weight monitoring. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00401973. (c) Copyright 2011 Physicians Postgraduate Press, Inc.
Amantadine for dyskinesias in Parkinson's disease: a randomized controlled trial. [2010.12.31]
BACKGROUND: Dyskinesias are some of the major motor complications that impair quality of life for patients with Parkinson's disease. The purpose of the present study was to investigate the efficacy of amantadine in Parkinson's disease patients suffering from dyskinesias... CONCLUSIONS: Results from the present study demonstrated that amantadine exhibited efficacious effects against dyskinesias in 60-70% of patients. TRIAL REGISTRATION: UMIN Clinical Trial Registry UMIN000000780.
Amantadine versus methylphenidate in children and adolescents with attention deficit/hyperactivity disorder: a randomized, double-blind trial. [2010.12.08]
Objective The aim of the present study was to further evaluate, under double blind and controlled conditions, the efficacy of amantadine for attention-deficit/hyperactivity disorder (ADHD) in children and adolescents as compared to methylphenidate.Methods This was a 6-week randomized clinical trial...
Amantadine versus methylphenidate in children and adolescents with attention deficit/hyperactivity disorder: a randomized, double-blind trial. [2010.11]
OBJECTIVE: The aim of the present study was to further evaluate, under double blind and controlled conditions, the efficacy of amantadine for attention-deficit/hyperactivity disorder (ADHD) in children and adolescents as compared to methylphenidate... CONCLUSION: The results of this study indicate that amantadine significantly improved symptoms of ADHD and was well tolerated and it may be beneficial in the treatment of children with ADHD. Nevertheless, the present results do not constitute proof of efficacy. Copyright (c) 2010 John Wiley & Sons, Ltd.
Effects of amantadine on tardive dyskinesia: a randomized, double-blind, placebo-controlled study. [2010.11]
OBJECTIVE: The objective of the study was to demonstrate whether the N-methyl-D-aspartate antagonist, amantadine, can safely ameliorate tardive dyskinesia (TD) without deteriorating the mental state of the patients... CONCLUSIONS: Amantadine may be an effective and safe treatment for TD. The severity of TD movements in patients receiving amantadine improved significantly more than in those receiving placebo, as measured by the AIMS score.
Clinical Trials Related to Amantadine
Safety and Pharmacokinetic Effects of Oseltamivir Alone or in Combination With Amantadine [Completed]
This study is designed to assess the safety and pharmacokinetic effects of oseltamivir
administration alone or in combination with amantadine in healthy volunteers.
Utility of Amantadine Hydrochloride in the Treatment of Post-Traumatic Irritability [Completed]
Study of Amantadine for Risperidone Consta or Paliperidone Treated Patients to Decrease Prolactin Elevation [Recruiting]
The purpose of this study is to show that amantadine might help to reduce the side effect of
the medications which are prescribed to treat schizophrenia or schizoaffective disorder.
High level of hormone prolactin, or hyperprolactinemia, is one of the side effects which
might be developed in patients treated with the paliperidone ER or risperidone Consta.
High level of prolactin might stimulate breast development, might decrease sexual desire
(libido). The goals of this study are to demonstrate that amantadine lowers prolactin
levels, decreases side effects, and improves psychiatric symptoms.
Effectiveness of Amantadine Hydrochloride for Treatment of Severe Traumatic Brain Injury (TBI) [Recruiting]
This is a controlled trial of amantadine to improve level of function following severe
traumatic brain injury.
The purpose of this study is:
1. To determine whether amantadine hydrochloride, given in a dose of 200-400 mg, improves
functional recovery from the vegetative and minimally conscious states
2. To determine whether amantadine-related gains in function persist following drug
3. To determine the safety profile of amantadine in patients with disorders of
Dextromethorphan, Amantadine and Glucose Homeostasis in Diabetes Subjects [Recruiting]
The purpose of this trial is to demonstrate that dextromethorphan (DXM) and amantadine
compared to placebo exert blood glucose (BG) lowering effects following an oral glucose
tolerance test (OGTT) in male subjects with T2DM.