AMANTADINE SUMMARY
AMANTADINE HYDROCHLORIDE ORAL SOLUTION USP
50 mg/5mL
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.
Parkinson's Disease/Syndrome
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.
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NEWS HIGHLIGHTS
Published Studies Related to Amantadine
Effects of amantadine in children with impaired consciousness caused by acquired brain injury: a pilot study. [2009.07]
OBJECTIVE: To conduct a pilot study of amantadine in children with impaired consciousness caused by acquired brain injury, to establish design feasibility, and to assess the effect on level of arousal and consciousness... CONCLUSIONS: This study suggests that amantadine facilitates recovery of consciousness in pediatric acquired brain injury and provides important information necessary to design future more definitive studies.
Placebo-controlled trial of 400 mg amantadine combined with peginterferon alfa-2a and ribavirin for 48 weeks in chronic hepatitis C virus-1 infection. [2008.11]
CONCLUSION: In this large placebo-controlled multicenter study, amantadine even at a dose of 400 mg/day did not improve virological response rates of peginterferon alfa-2a and ribavirin in patients with chronic genotype HCV-1 infection.
Placebo-controlled trial of 400 mg amantadine combined with peginterferon alfa-2a and ribavirin for 48 weeks in chronic hepatitis C virus-1 infection. [2008.06.19]
The impact of amantadine on virologic response rates of interferon-based treatment of chronic hepatitis C is controversial. The aim of this study was to compare virological response rates in patients with chronic hepatitis C virus (HCV)-1 infection treated with 400 mg amantadine or placebo in combination with peginterferon alfa-2a (40 kD) and ribavirin for 48 weeks...
Efficacy of amantadine on quality of life in patients with chronic hepatitis C treated with interferon-alpha and ribavirin: results from a randomized, placebo-controlled, double-blind trial. [2007.08]
AIM: The aim of this study was to investigate whether amantadine reduces deterioration of quality of life in patients with chronic hepatitis C during and after treatment with interferon-alpha (IFN-alpha) and ribavirin... CONCLUSION: The addition of amantadine to IFN-alpha plus ribavirin combination therapy may reduce deterioration of depression, fatigue, and vigor during treatment but does not affect quality of life after treatment.
Interferon and ribavirin with or without amantadine for interferon non-responders with chronic hepatitis C. A randomized, controlled pilot study. [2007.07.28]
BACKGROUND/AIMS: Treatment options for interferon-non-responders (INF-NR) with chronic hepatitis C are limited. Our aim was to compare efficacy and tolerability of an interferon-alfa-2a (INF), ribavirin (RIBA) and amantadine (AMA) combination with those of an INF and RIBA combination... CONCLUSION: Although similarly tolerated triple combination with INF, RIBA and AMA does not seem to offer relevant efficacy advantages over double combination with INF and RIBA in INF non-responders with chronic hepatitis C.
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]
Amantadine for Treatment of Symptoms of the Post-Traumatic Confusional State [Active, not recruiting]
Patients with traumatic brain injury often experience a period of acute confusion that may
include agitation as they recover from their injuries. While this confusion generally
resolves with time, patients may pose increased risk of injury to themselves or others during
this period. Their behavior may also increase stress for family members and interfere with
their ability to benefit from rehabilitation therapies. A number of different medications
have been used to treat confusion to decrease agitation, decrease risk of injury, and improve
participation in rehabilitation therapies. To this point, there has not been a research or
scientific basis for knowing which medication is the best for a specific patient. The
overall goal of this study is to conduct a scientific investigation to help determine which
medication works best to treat confusion.
Study hypothesis: Amantadine will reduce the severity and number of symptoms of acute
confusion after traumatic brain injury.
Peginterferon Alfa-2a, Ribavirin, Amantadine/Placebo in Hepatitis C Virus (HCV)-Genotype-1-Infection (PRAMA) [Active, not recruiting]
This was a randomized, multi-center, partially placebo-controlled Phase IV study to compare
the efficacy and tolerability of a 48-week combined therapy with pegylated interferon
alpha-2a, ribavirin and amantadine sulphate versus placebo in untreated patients with chronic
hepatitis C virus-genotype-1-infection. The hypothesis was that there will be an increase in
sustained response rate for triple therapy compared to current standard treatment.
Triple Therapy With Peg-Interferon Alfa-2b/Ribavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2b/Ribavirin for Previous Hepatitis C Virus (HCV) Non Responders [Terminated]
Triple antiviral therapy with peg-interferon-alfa/ribavirin+amantadine was suggested to
increase sustained virological response (SVR) rates in HCV non-responders to a standard
interferon/ribavirin combination.
Patients with hepatitis C virus infection were eligible if they had failed to respond to a
single previous 24 week cycle of interferon/ribavirin combination therapy. Non-response was
defined as persistent HCV RNA in the serum during the last month of treatment.
This study tested the efficacy and safety of pegylated interferon alfa-2b with ribavirin and
amantadine or a placebo for 48 weeks.
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