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Flumadine (Rimantadine Hydrochloride) - Summary

 
 



FLUMADINE SUMMARY

FLUMADINE® TABLETS
(rimantadine hydrochloride tablets)
FLUMADINE® SYRUP
(rimantadine hydrochloride syrup)

Flumadine® (rimantadine hydrochloride) is a synthetic antiviral drug available as a 100 mg film-coated tablet and as a syrup for oral administration. Each film-coated tablet contains 100 mg of rimantadine hydrochloride plus hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, FD&C Yellow No. 6 Lake and FD&C Yellow No. 6. The film coat contains hydroxypropyl methylcellulose and polyethylene glycol. Each teaspoonful (5 mL) of the syrup contains 50 mg of rimantadine hydrochloride in a dye-free, aqueous solution containing citric acid, parabens (methyl and propyl), saccharin sodium, sorbitol and flavors.

Flumadine is indicated for the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults.

Flumadine is indicated for prophylaxis against influenza A virus in children.

PROPHYLAXIS:   In controlled studies of children over the age of 1 year, healthy adults and elderly patients, Flumadine has been shown to be safe and effective in preventing signs and symptoms of infection caused by various strains of influenza A virus. Early vaccination on an annual basis as recommended by the Centers of Disease Control's Immunization Practices Advisory Committee is the method of choice in the prophylaxis of influenza unless vaccination is contraindicated, not available or not feasible. Since Flumadine 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 outbreak, Flumadine prophylaxis should be considered for the 2 to 4 week time period required to develop an antibody response. However, the safety and effectiveness of Flumadine prophylaxis have not been demonstrated for longer than 6 weeks.

TREATMENT:   Flumadine therapy should be considered for adults who develop an influenza-like illness during known or suspected influenza A infection in the community. When administered within 48 hours after onset of signs and symptoms of infection caused by influenza A virus strains, Flumadine has been shown to reduce the duration of fever and systemic symptoms.


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NEWS HIGHLIGHTS

Published Studies Related to Flumadine (Rimantadine)

A case for rimantadine to be marketed in Canada for prophylaxis of influenza A virus infection. [2003.10]
CONCLUSION: This meta-analysis demonstrates that amantadine and rimantadine are superior to placebo in the prevention of influenza A illness. Both antiviral agents have an increased number of adverse events compared with placebo; however, the use of amantadine is associated with significantly higher numbers of central nervous system events and treatment withdrawals compared with rimantadine. Thus, rimantadine should be the preferred agent in this class for the prevention of influenza A virus infection and should be made available in Canada.

Bioequivalence of two rimantadine tablet formulations in healthy male volunteers after single dose administration. [2001.04]
AIM: The bioequivalence of two rimantadine tablet formulations was determined... CONCLUSION: The two rimantadine formulations were equivalent in both the rate and extent ofbioavailability and they were also well tolerated. This study confirms the findings of other studies showing that for immediate release formulations of drugs with long half-lives shortening the duration over which blood samples are collected improves the economics, is more ethical and does not impair the quality of data.

Pharmacokinetics and therapeutic efficacy of rimantadine in horses experimentally infected with influenza virus A2. [1999.07]
OBJECTIVE: To determine pharmacokinetics of single and multiple doses of rimantadine hydrochloride in horses and to evaluate prophylactic efficacy of rimantadine in influenza virus-infected horses...

Effect of rimantadine treatment on clinical manifestations and otologic complications in adults experimentally infected with influenza A (H1N1) virus. [1998.05]
Susceptible adults (n = 105) were enrolled into a randomized double-blind study of rimantadine treatment of experimental influenza A infection. Subjects were cloistered for 8 days and challenged with a rimantadine-sensitive strain of influenza A H1N1 virus at the end of the first day...

Safety and efficacy of long-term use of rimantadine for prophylaxis of type A influenza in nursing homes. [1995.10]
The safety and efficacy of rimantadine for long-term prophylaxis of influenza A (H3N2) infection were evaluated among elderly residents in 10 nursing homes. Within each nursing home, participating residents were randomly assigned to receive placebo or rimantadine at 100 or 200 mg/day...

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Clinical Trials Related to Flumadine (Rimantadine)

Hepatitis C Rimantadine and Antiviral Combination Therapy [Completed]
Hepatitis C virus is one of the leading causes of liver failure and liver cancer worldwide. Current treatment of hepatitis C infection is only successful in about half of those who are eligible. The current treatment aims to boost the host immune system but does not directly act on the virus. Many drugs are in various stages of development that target the virus

directly - their specific mode of action is confirmed by showing the virus is forced to

adapt in the presence of the drug. As with many viruses, treating with only one specific drug would quickly lead to the virus adapting and becoming resistant. We therefore need to find new combinations of directly acting drugs. Rimantadine has already been shown in the laboratory to target hepatitis C directly. We have designed this study to see if it happens in real life as well. If so, we could use rimantadine to help fight hepatitis c more effectively.

A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy Volunteers [Completed]
This open label, randomized, three-period crossover study will evaluate the effect of co-administration of Tamiflu (oseltamivir) and rimantadine on the pharmacokinetics of Tamiflu and rimantadine. Healthy volunteers will receive multiple oral doses of Tamiflu, rimantadine or Tamiflu plus rimantadine in random order, with a minimum wash-out period of 7 days between treatments. Anticipated time on study is up to 11 weeks.

Chart Review of Antivirals for Influenza in Infants [Completed]
This retrospective study conducted in Canada and the US involves a chart review to assess the safety of oseltamivir (TamifluŽ) compared to alternate antiviral therapy, amantidine or rimantidine, administered to children less than 12 months of age with diagnosed or suspected influenza. The objectives are to describe the frequency of neurological and all other adverse events possibly related to administration of these antivirals in these infants. Investigators will also compare frequency of adverse events at various doses of oseltamivir in these children. Critical endpoints to be collected include frequency and severity of adverse events, particularly those relating to central nervous system complications. A sub-investigator will travel to each of the participating sites to collect data related to each infant's health prior to becoming ill, health status at time of influenza diagnosis, dosing regimen, reported neurological events post-dosing, and all reported adverse events post-dosing.

Basic and Clinical Research on Applying Blood Fix to Treat Critical H1N1 Patients [Active, not recruiting]
The 2009 flu pandemic is a global outbreak of a new strain of influenza A virus subtype H1N1, commonly known as swine flu, that was first identified in April 2009. Large-scale immunization is an essential approach of controlling the pandemic. Vaccines are now becoming available for protection against pandemic influenza A(H1N1) 2009 infection in some countries. In response to the pandemic, novel vaccines against the virus strain A/California/07/2009(H1N1) have been developed and recently were approved for vaccination among specific populations in China. However, the safety and effectiveness of the vaccines is of prime concern to the authorities and the public. This report details the findings of a observational clinical trial of the safety and immunogenicity of a influenza A (H1N1)2009 monovalent vaccine. The virus of Swine Flu H1N1 that outbroke in 2009 is sensitive to neuraminidase inhibitors (Oseltamivir, zanamivir and peramivir) but have drug resistant to adamantanamine derivatives (amantadine and Flumadine), therefore neuraminidase inhibitors are recommended for antiviral therapy against Swine Flu H1N1, effect of which is evidence by the data that such drugs do modify the symptoms and decrease the death rate of H1N1 in America and Mexico. However, clinically, the investigators have encountered that this virus can infect resistant strains of Oseltamivir, which urges for a more effective treatment plan. In view of above situations, seeking for an effective measures against H1N1 flu should be a top priority and will benefit human life and economy globally. This Topic will take the classic strategy of passive immunity to perform basic and clinical researches on applying blood fix to treat critical H1N1 patients and collect blood of healthy persons who are inoculated with specific H1N1 vaccines to cure critical H1N1 patients.

Prophylactic Efficacy of Relenza Against Influenza A and B [Completed]
In response to the European regulatory authorities, GSK is conducting a post-marketing observational study to assess the efficacy of Relenza when used as prophylaxis against influenza. SPECIFIC AIMS 1. Determine the frequency of patients who received Relenza from October 2006 through April 2009, and among them the number who have no concurrent diagnosis of influenza, i. e., those receiving Relenza for prophylaxis, and among these the number who have a family member with a medical visit for influenza within three days preceding the above indentified patient's dispensing of Relenza. This is to determine the feasibility of conducting detailed analysis. 2. If analysis is feasible then tabulate the frequency of influenza-like-illness and respiratory outcomes in users of prophylactic Relenza and their family members and in family members of persons using Relenza for the treatment of influenza (i. e., index cases). 3. If analysis is feasible then estimate the direct effect of prophylactic Relenza on the occurrence of influenza-like-illness and respiratory outcomes, the secondary effect of Relenza treatment of influenza on susceptible family members, and the total effect of Relenza (treatment plus prophylaxis). METHODS Overview of Study Design This is an analysis of the 30-day risk of influenza-like illness and respiratory outcomes in persons for whom some household members (index cases) have had a medical visit associated with a diagnosis of influenza. The exposed individuals to the index case will be categorized into one of four cohorts according to whether the exposed person received prophylactic Relenza or no antiviral treatment and by whether the index family member with a diagnosis of influenza received antiviral treatment. Estimates of the direct effect of Relenza prophylaxis, the indirect effectof preventing disease in susceptible family members, and the total effect of disease reduction when both index cases and susceptible family members are treated will be obtained from different comparisons between cohorts, as outlined below. The research will cover the first three influenza seasons during which Relenza has been indicated for prophylactic use in the United States. These will be from October through April of 2006-2009.

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Page last updated: 2006-01-31

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