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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 [Recruiting]
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.

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.

A Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As First Line Treatment For Human Swine Influenza Infection [Recruiting]
The outbreak of respiratory illnesses in Mexico that began in March 2009 was caused by a swine origin influenza A (H1N1) virus (S-OIV) that had not been recognized previously in pigs or humans. As of 17 May 2009, 39 countries have officially reported 8480 cases of influenza A (H1N1) infection.

The H1N1 influenza A virus appears sensitive to oseltamivir and zanamivir in vitro, but resistant to amantadine and rimantadine. This study is to test the oseltamivir, zanamivir and placebo arms as the first line treatment for human swine influenza infection. Through the study, the investigators may have better understanding about the clinical and, biochemical, virological profiles of oseltamivir/zanamivir on the H1N1 virus, and optimizing the treatment strategy among the Chinese population.

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Page last updated: 2006-01-31

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