Tamiflu capsule
Company: Roche
Approval Status: October 27, 1999
Treatment for: For the treatment of all common strains of influenza
Areas: Immunology/Infectious Diseases
| General Information | Clinical Results | Side Effects | Mechanism of Action | Additional Information |
General Information
The influenza virus is an exceptionally contagious viral infection which attacks the entire body, causing symptoms ranging from muscle aches and sore throat to fever and respiratory complications. An effective treatment is in demand, especially since influenza outbreaks kill 20,000 to 40,000 people in the United States annually.
Tamiflu is a neuraminidase inhibitor designed to attack the
neuraminidase protein, one of the two major surface structures of
the influenza virus. Since the protein receptor sites are nearly
identical in all common strains of influenza, Tamiflu, the first
neuraminidase inhibitor in pill form, is effective in preventing
the spread of both the A and B strains of the virus within
the body. This is contrary to earlier drugs which were effective in
treating only one strain. Furthermore, this pill (along with its
counterpart, Relenza [zanamivir], which has a similar effect, but
is inhaled) also has the advantage of affecting flu virus later in
its life cycle, so is less likely to cause genetic mutations that
lead to drug resistance.
Tamiflu is indicated for the treatment of uncomplicated acute
illness due to influenza infection in adults who have been
symptomatic for no more than two days. The recommended dose is 75
mg twice daily for five days. Although studies indicate that
Tamiflu may contribute to prevention of the virus, researchers
advise that the drug is not a substitute for the influenza vaccine,
but rather a supplement to it. However, for people who cannot be
vaccinated for medical reasons, such as allergies, Tamiflu may be a
viable alternative.
Clinical Results
A total of 1355 patients participated in two phase III,
placebo-controlled, double-blind trials, one inside the United
States and one outside of the United States. Patients qualified for
the study if they had a fever of over 100F accompanied by at least
one respiratory symptom and at least one systemic symptom, and if
their community was currently affected by a circulating influenza
virus. Patients' ages ranged from 18-65 years old. Most were
affected by type A influenza, although some patients had type B,
while others had an unknown strain of the virus.
5-day treatment was started within 40 hours of the onset of
symptoms. At the onset of treatment, participants were asked to
self-assess their symptoms as either "none",
"mild," "moderate," or "severe." Time
to improvement was calculated from the beginning of treatment to
the point at which a patient described his or her symptoms as
"none" or "mild."
Results showed that median time to improvement was 1.3 days (30%) fewer for participants taking Tamiflu than those who were given a placebo. There were no significant differences between the effects on men and women, neither did increased dosage significantly affect results.
Side Effects
The most common side-effects experienced by participants in the
study were nausea and vomiting. These symptoms were mostly mild to
moderate and generally occurred within the first two days of
administration of the drug. Other less-frequent side-effects
included diarrhea, bronchitis, abdominal pain, dizziness, headache,
cough, insomnia, vertigo, fatigue.
Do not take Tamiflu if you are allergic to oseltamivir
phosphate or any other ingredients of Tamiflu. Before
starting treatment, make sure your doctor knows about any other
medications you may be taking, or if you have any form of kidney
disease. The effects of Tamiflu on children (under the age of 18)
and on human pregnancies have not yet been determined.
Mechanism of Action
Oseltamivir is an ethyl ester prodrug requiring ester hydrolysis for conversion to the active form, oseltamivir carboxylate. The proposed mechanism of action of oseltamivir is via inhibition of influenza virus neuraminidase with the possibility of alteration of virus particle aggregation and release. (FDA Label)
Additional Information
For additional information about the influenza virus and
prevention methods, visit the Centers for Disease Control Influenza
Home Page:
www.cdc.gov/ncidod/diseases/flu/fluvirus.htm
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
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