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Tamiflu (Oseltamivir Phosphate) - Summary

 



TAMIFLU SUMMARY

TAMIFLU (oseltamivir phosphate) is an antiviral agent indicated for treatment and prophylaxis of influenza.

Treatment of Influenza

TAMIFLU is indicated for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days.

Prophylaxis of Influenza

TAMIFLU is indicated for the prophylaxis of influenza in adult patients and adolescents 13 years and older.

TAMIFLU is not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control's Immunization Practices Advisory Committee.


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NEWS HIGHLIGHTS

Media Articles Related to Tamiflu (Oseltamivir)

Review Questions Tamiflu's Effectiveness
Source: MedicineNet Pneumonia Specialty [2009.12.09]
Title: Review Questions Tamiflu's Effectiveness
Category: Health News
Created: 12/8/2009 4:10:00 PM
Last Editorial Review: 12/9/2009

Tamiflu-Resistant Swine Flu Found in Canadian Father
Source: MedicineNet oseltamivir Specialty [2009.11.12]
Title: Tamiflu-Resistant Swine Flu Found in Canadian Father
Category: Health News
Created: 11/11/2009 4:10:00 PM
Last Editorial Review: 11/12/2009

Tamiflu-Resistant Swine Flu Passed Person-to-Person in U.S.
Source: MedicineNet amantadine Specialty [2009.10.30]
Title: Tamiflu-Resistant Swine Flu Passed Person-to-Person in U.S.
Category: Health News
Created: 10/29/2009 2:10:00 PM
Last Editorial Review: 10/30/2009

Targeted Prevention Measures Stopped Spread Of H1N1 Flu At Alabama Boys Camp, Doctor Says
Source: Flu / Cold / SARS News From Medical News Today [2010.02.04]
Providing preventive Tamiflu and educating and emphasizing the need for repeated hand sanitizer use and disinfectant spray helped stop the spread of H1N1 influenza at a boys' summer camp in northern Alabama, according the co-director of the University of Alabama at Birmingham (UAB) Division of Pediatric Infectious Diseases. David Kimberlin, M.D...

Preventive Steps Helped Summer Campers Avoid Swine Flu (HealthDay)
Source: Y! Health Cold & Flu News [2010.02.01]
HealthDay - MONDAY, Feb. 1 (HealthDay News) -- An Alabama summer camp managed to contain the spread of swine flu by giving preventive Tamiflu to kids at risk and encouraging the use of sanitizers for hands and surfaces, a new report says.

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Published Studies Related to Tamiflu (Oseltamivir)

Oseltamivir oral suspension and capsules are bioequivalent for the active metabolite in healthy adult volunteers. [2009.08]
Aims: The objective of this study was to assess the relative bioavailability of oseltamivir carboxylate (active metabolite) following oral administration of the market suspension, the clinical trial suspension and the market capsule formulations of oseltamivir (prodrug) in healthy subjects...

Pharmacokinetics and tolerability of oseltamivir combined with probenecid. [2008.09]
Oseltamivir is an inhibitor of influenza virus neuraminidase, which is approved for use for the treatment and prophylaxis of influenza A and B virus infections.Alternate-day dosing of oseltamivir plus dosing with probenecid four times daily achieved trough oseltamivir carboxylate concentrations adequate for neuraminidase inhibition in vitro, and this combination should be studied further.

A comparison of the effectiveness of zanamivir and oseltamivir for the treatment of influenza A and B. [2008.01]
OBJECTIVE: To compare the effectiveness of zanamivir with oseltamivir for influenza A and B... CONCLUSION: Zanamivir therapy is more effective than oseltamivir for the treatment of influenza B infection.

Active metabolite from Tamiflu solution is bioequivalent to that from capsule delivery in healthy volunteers: a cross-over, randomised, open-label study. [2006.11.10]
The bioavailability of oseltamivir phosphate and oseltamivir carboxylate were assessed in healthy volunteers when delivered as a solution of the active pharmaceutical ingredient (API) compared with the commercial capsule formulation. The 90% confidence intervals (CIs) for the ratios of the two treatments (capsule versus solution) were within the reference region [0.80-1.25] for area under the curve (AUC(0-infinity): [0.94-0.99]) and maximum observed plasma concentrations (C(max): [0.93-1.08])...

Efficacy of oseltamivir phosphate to horses inoculated with equine influenza A virus. [2006.09]
We investigated the efficacy of the oral administration of oseltamivir phosphate (OP) in horses experimentally infected with equine influenza A virus (H3N8). Nine horses were divided into three horses each of control, treatment and prophylaxis groups... The results indicated that the oral administration of OP to horses affected with equine influenza would contribute to reduce the magnitude of virus excretion, pyrexia and consequent secondary bacterial pneumonia.

more studies >>

Clinical Trials Related to Tamiflu (Oseltamivir)

Evaluation of Alternative Oseltamivir (Tamiflu) Dosing Strategies. [Completed]
Objective 1: Determine the safety and toxicity profile of Tamiflu administered in combination with probenecid in healthy adults. Objective 2: Determine the pharmacokinetic profile of Tamiflu and probenecid in healthy adults.

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.

Efficacy Study of Early vs. Late Oseltamivir Administration for Treating and Preventing Influenza [Active, not recruiting]
This study is a randomized, blinded, placebo-controlled clinical efficacy trial to assess the duration and severity of influenza symptoms, duration of viral shedding, and household transmission in influenza patients receiving oseltamivir early and late relative to placebo.

There are four main hypotheses:

1. The duration of influenza symptoms, severity, and duration of viral shedding are reduced in patients who start oseltamivir treatment late (48 to 119 hours after illness onset) compared to those receiving no antiviral therapy;

2. Antiviral effectiveness for reducing infectiousness to household contacts is at least 80% for index cases starting therapy early (<48 hours) compared to those receiving no antiviral therapy;

3. Antiviral effectiveness for reducing infectiousness to household contacts is at least 60% when patients initiate treatment late (48 to 119 hours) compared to those receiving no antiviral therapy;

4. Prior influenza vaccination during the same season reduces the duration of influenza symptoms and symptom severity in patients receiving oseltamivir after adjusting for age and timing of antiviral therapy (early vs. late).

There are two secondary hypotheses:

1. The duration of influenza symptoms, severity, and duration of viral shedding are reduced in patients with influenza who start oseltamivir treatment early (within 48 hours) vs. late (48 to 119 hours);

2. The incidence of secondary complications is lower in patients starting oseltamivir therapy late relative to those receiving no antiviral therapy.

A Study of Tamiflu (Oseltamivir) Treatment in Laboratory-Confirmed Influenza. [Terminated]
This study will evaluate the efficacy and safety of Tamiflu in patients with clinically-diagnosed influenza occurring during an influenza outbreak within the community. Patients will be randomized to receive Tamiflu 75mg bid orally plus support therapy (NSAIDs and antibiotics) or support therapy alone. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Alternative Oseltamivir Dosing Strategies [Active, not recruiting]
This study will determine if oseltamivir (TamifluĀ® (Registered Trademark)) is safe and effective given less frequently than the currently prescribed dose of twice a day for 5 days to people who have the flu, and once a day for up to 6 weeks in people who have been exposed to someone else with flu and want to prevent getting it themselves. This study will see if the drug can be given once every other day instead of daily if given with another medication called probenecid (BenemidĀ® (Registered Trademark) or ProbalanĀ® (Registered Trademark)).

Healthy people 18 years of age and older may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests.

Participants are randomly assigned to one of the following regimens for 2 weeks: 1) 75 milligrams (mg) of oseltamivir once a day; 2) 75 mg of oseltamivir once every other day plus 500 mg probenecid four times a day; or 3) 75 mg of oseltamivir once every other day plus 500 mg probenecid twice a day. All medications are taken by mouth. On study day 0, subjects have the following baseline procedures: measurement of vital signs, review of medical and medication history, physical examination, blood draw and urine test. They also receive the first dose of oseltamivir or oseltamivir and probenecid. In addition, they undergo the following procedures as follows:

- Days 1 and 4: Vital signs; review of clinical symptoms, side effects and medications

taken; urine testing and blood draw.

- Day 8: Same as day 1 plus count of study medication.

- Day 14: Same as day 8 plus pharmacokinetic study to measure the amount of oseltamivir

and probenecid in the blood. For this test, a catheter is inserted into an arm vein and blood samples are collected through the catheter before taking the study medications, at the time the medications are taken, and again at 15 minutes, 30 minutes, 45 minutes and 1, 1. 5, 2, 4, 8 and 12 hours after the medication is taken. The catheter is then removed. This is the last day to take the study medication.

- Day 15: Blood draw for 24-hour (post medication) blood sample.

- Day 16: Blood draw for 48-hour (post medication) blood sample.

- Days 21 and 28: Same as day 1.

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PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 4 ratings/reviews, Tamiflu has an overall score of 7.75. The effectiveness score is 7.50 and the side effect score is 9. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Tamiflu review by 52 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   family flu outbreak
Dosage & duration:   75mg taken twice x a day for the period of 5 days
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   My son came home from college with the flu. Student Health gave him a pack of Tamiflu and he felt better within 24 hours. When I started feeling sick 3 days later, I called my Dr and ask for Tamiflu. I felt almost back to norma lwithin 24 hours.
Side effects:   none
Comments:   Just took the pill and drank fluids

 

Tamiflu review by 51 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   The flu
Dosage & duration:   75mg taken 2 times a day for the period of 5 days
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   I felt better in about 2 days. Maybe I would of felt better with out the drug. Not quite sure if it really helped.
Side effects:   The side effects were the drug made me not able to sleep at night. It gave me restless legs,and insomnia. It also took away my apitete.
Comments:   The treatment was to take 1 tablet orally 2 times a day for 5 days.

 

Tamiflu review by 51 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   The flu
Dosage & duration:   75mg taken 2 times a day for the period of 5 days
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   I felt better in about 2 days. Maybe I would of felt better with out the drug. Not quite sure if it really helped.
Side effects:   The side effects were the drug made me not able to sleep at night. It gave me restless legs,and insomnia. It also took away my apitete.
Comments:   The treatment was to take 1 tablet orally 2 times a day for 5 days.

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Page last updated: 2010-02-04

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