NEWS HIGHLIGHTSMedia Articles Related to Tamiflu (Oseltamivir)
Sewage Study Reveals Half Of Tamiflu Prescriptions Went Unused During 2009 H1N1 Swine Flu Pandemic Source: Compliance News From Medical News Today [2013.04.20] A new study concludes that approximately half of the prescriptions of Tamiflu during the 2009-10 influenza pandemic went unused in England. The unused medication represents approximately 600,000 courses of Tamiflu at a cost of around 7.8 million pounds to the UK taxpayer...
Roche Agree To Release All Trial Data On Tamiflu Drug Source: Flu / Cold / SARS News From Medical News Today [2013.04.06] The BMJ can reveal that following over three years of talks with pharmaceutical giant Roche, the Cochrane Collaboration is at last being granted access to "all 74 Roche-sponsored trials" of the influenza drug, Tamiflu (oseltamivir). In an email to the Cochrane researchers on 2 April, Roche said they would provide "each CSR [clinical study report]" over the next few months...
FDA Approves Tamiflu for Infants Source: MedicineNet oseltamivir Specialty [2012.12.24] Title: FDA Approves Tamiflu for Infants Category: Health News Created: 12/22/2012 11:00:00 AM Last Editorial Review: 12/24/2012 12:00:00 AM
Does Tamiflu Work? Questions Continue Source: MedicineNet Strep Throat Specialty [2012.11.15] Title: Does Tamiflu Work? Questions Continue Category: Health News Created: 11/15/2012 11:00:00 AM Last Editorial Review: 11/15/2012 12:00:00 AM
Cases of Tamiflu-Resistant Flu Concern Experts Source: MedicineNet amantadine Specialty [2011.12.29] Title: Cases of Tamiflu-Resistant Flu Concern Experts Category: Health News Created: 12/28/2011 6:06:00 PM Last Editorial Review: 12/29/2011 12:00:00 AM
Published Studies Related to Tamiflu (Oseltamivir)
Oseltamivir pharmacokinetics in morbid obesity (OPTIMO trial). [2011.09] BACKGROUND: Detailed pharmacokinetics to guide oseltamivir (Tamiflu(R)) dosing in morbidly obese patients is lacking... CONCLUSIONS: With single and multiple dosing, the systemic exposure to oseltamivir is decreased but that of oseltamivir carboxylate is largely unchanged. Based on these pharmacokinetic data, an oseltamivir dose adjustment for body weight would not be needed in morbidly obese individuals.
Effect of milk on the pharmacokinetics of oseltamivir in healthy volunteers. [2011.09] We previously showed that oseltamivir, a prodrug of the influenza virus neuraminidase inhibitor Ro 64-0802, is a substrate of proton-coupled oligopeptide transporter (PEPT1), and its intestinal absorption in rats is markedly inhibited by administration with milk...
Oseltamivir compared with the Chinese traditional therapy maxingshigan-yinqiaosan in the treatment of H1N1 influenza: a randomized trial. [2011.08.16] BACKGROUND: Observational studies from Asia suggest that maxingshigan-yinqiaosan may be effective in the treatment of acute H1N1 influenza. OBJECTIVE: To compare the efficacy and safety of oseltamivir and maxingshigan-yinqiaosan in treating uncomplicated H1N1 influenza... CONCLUSION: Oseltamivir and maxingshigan-yinqiaosan, alone and in combination, reduced time to fever resolution in patients with H1N1 influenza virus infection. These data suggest that maxingshigan-yinqiaosan may be used as an alternative treatment of H1N1 influenza virus infection. PRIMARY FUNDING SOURCE: Beijing Science and Technology Project and Beijing Nova Program.
Effect of oseltamivir treatment on anticoagulation: a cross-over study in warfarinized patients. [2010.12] AIM: To investigate whether oseltamivir enhances the anticoagulant effect of warfarin and to evaluate any pharmacokinetic (PK) interaction between the agents... CONCLUSION: Concomitant administration of oseltamivir for 4.5 days to volunteers on daily warfarin had little or no effect on warfarin pharmacokinetics and no effect on pharmacodynamics. (c) 2010 The Authors. British Journal of Clinical Pharmacology (c) 2010 The British Pharmacological Society.
Long-acting neuraminidase inhibitor laninamivir octanoate versus oseltamivir for treatment of influenza: A double-blind, randomized, noninferiority clinical trial. [2010.11.15] BACKGROUND: A single administration of laninamivir octanoate, a long-acting neuraminidase inhibitor, against influenza infection has been proven effective in nonclinical studies. This study evaluated the clinical efficacy of laninamivir octanoate for the treatment of adult influenza patients... CONCLUSIONS: A single inhalation of laninamivir octanoate is effective for the treatment of seasonal influenza, including that caused by oseltamivir-resistant virus, in adults. CLINICAL TRIALS REGISTRATION: NCT00803595.
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.
Pharmacokinetics of TamifluŽ (Oseltamivir) in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)and or Continuous Venovenous Hemodialysis (CVVHD) [Recruiting]
Critically ill patients with flu may receive a drug called oseltamivir. They may also
receive medical therapies to support their lung function (extracorporeal membrane
oxygenation; ECMO) and kidney function (continuous venovenous hemodialysis; CVVHD). CVVHD
and ECMO may remove some oseltamivir from the bloodstream. The purpose of this study is to
determine how much oseltamivir gets removed by CVVHD or ECMO in critically ill patients.
A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain [Recruiting]
This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the
efficacy against viral activity, the effectiveness in resolving the disease symptoms, and
the safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza
strain or influenza A are eligible for this study. Patients will be randomized to one of
four treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg
(adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body
weight-adjusted for pediatric patients. The target sample size is 300-500 patients.
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.
Reports of Suspected Tamiflu (Oseltamivir) Side Effects
Abnormal Behaviour (53),
Overdose (49),
Maternal Exposure During Pregnancy (33),
Pneumonia (30),
Influenza (29),
Hallucination (22),
Vomiting (20),
Pregnancy (20),
NO Adverse Event (19),
Acute Respiratory Distress Syndrome (18), more >>
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