SYMMETREL SUMMARY
SYMMETREL®
(Amantadine Hydrochloride, USP)
Tablets and Syrup
Rx only
SYMMETREL (Amantadine Hydrochloride, USP) is designated generically as amantadine hydrochloride and chemically as 1-adamantanamine hydrochloride.
SYMMETREL is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. SYMMETREL is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.
Influenza A Prophylaxis: SYMMETREL (Amantadine Hydrochloride, USP) 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 SYMMETREL 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, SYMMETREL prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response.
Influenza A Treatment: SYMMETREL 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 SYMMETREL will avoid the development of influenza A virus pneumonitis or other complications in high risk patients.
There is no clinical evidence indicating that SYMMETREL 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: SYMMETREL is 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. In the treatment of Parkinson's disease, SYMMETREL is less effective than levodopa, (-),-3-(3,4-dihydroxyphenyl)-L-alanine, and its efficacy in comparison with the anticholinergic antiparkinson drugs has not yet been established.
Drug-Induced Extrapyramidal Reactions: SYMMETREL is indicated in the treatment of drug-induced extrapyramidal reactions. Although anticholinergic-type side effects have been noted with SYMMETREL 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 Symmetrel (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 Symmetrel (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 Treated Patients to Decrease Prolactin Elevation [Not yet 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.
Study of Amantadine for Weight Stabilization During Olanzapine Treatment [Recruiting]
Weight gain associated with antipsychotic medication use is a major side effect that limits
the tolerability of these drugs. This often significant weight gain adversely affects
health, increasing risks for developing cardiovascular disease, diabetes, sleep apnea,
cancers of the colon, kidneys, uterus, endometrium and esophagus and osteoarthritis.
Beasley and colleagues (1997) reported that 40. 5% of olanzapine-treated patients gained more
than 7% of baseline weight. Much of the olanzapine induced weight gain occurs early in
treatment, and antipsychotic-naïve and young patients (Woods et al., 2002) are particularly
vulnerable to this side effect. One of the most promising medications to aid weight loss in
patients taking olanzapine is amantadine.
Attempts at preventing weight gain are expected to be more successful than attempts to
reverse it once it occurs. It is now common clinical practice to educate all patients
beginning treatment with olanzapine, and other antipsychotics, about healthy eating and the
need for exercise. However, despite this effort, weight gain in this population continues.
Beginning a weight-stabilizing medication after a low threshold of weight gain has occurred
may have significant impact on patients' health and their willingness to continue to take
antipsychotics.
We propose to investigate the efficacy of amantadine as a weight-stabilizing agent in a
population of first-episode psychotic subjects just beginning treatment with antipsychotic
agents. This population is generally young and medically healthy, without contraindications
to amantadine. They are often of normal body mass index and without obesity-related medical
problems. They have much to gain in preventing the weight gain which so often progresses
steadily over the course of treatment, is difficult to reverse and results in significant
morbidity and mortality. Additionally, the first episode psychotic population tends to take
fewer concomitant psychiatric medications. This is important since these medications may
cause weight gain (long term use of mirtazapine, lithium, depakote) or weight loss (short
term use of SSRI's) which could confound the effectiveness of amantadine to combat weight
gain.
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
discontinuation
3. To determine the safety profile of amantadine in patients with disorders of
consciousness
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