Treatment Studies in Adult Patients

A total of 1171 patients who participated in adult phase III controlled clinical trials for the treatment of influenza were treated with TAMIFLU. The most frequently reported adverse events in these studies were nausea and vomiting. These events were generally of mild to moderate degree and usually occurred on the first 2 days of administration. Less than 1% of subjects discontinued prematurely from clinical trials due to nausea and vomiting.Adverse events that occurred with an incidence of ≥ 1% in 1440 patients taking placebo or TAMIFLU 75 mg twice daily in adult phase III treatment studies are shown in Table 3. This summary includes 945 healthy young adults and 495 “at risk” patients (elderly patients and patients with chronic cardiac or respiratory disease). Those events reported numerically more frequently in patients taking TAMIFLU compared with placebo were nausea, vomiting, bronchitis, insomnia, and vertigo.

Prophylaxis Studies in Adult Patients

A total of 4187 subjects (adolescents, healthy adults and elderly) participated in phase III prophylaxis studies, of whom 1790 received the recommended dose of 75 mg once daily for up to 6 weeks. Adverse events were qualitatively very similar to those seen in the treatment studies, despite a longer duration of dosing (see Table 3). Events reported more frequently in subjects receiving TAMIFLU compared to subjects receiving placebo in prophylaxis studies, and more commonly than in treatment studies, were aches and pains, rhinorrhea, dyspepsia and upper respiratory tract infections. However, the difference in incidence between TAMIFLU and placebo for these events was less than 1%. There were no clinically relevant differences in the safety profile of the 942 elderly subjects who received TAMIFLU or placebo, compared with the younger population.
Drug Uses
Tamiflu is used for the treatment of uncomplicated acute illness due to influenza infection.
How Taken
You may take Tamiflu with or without food. However, when taken with food, your tolerability to Tamiflu may be enhanced. The recommended oral dose of Tamiflu is 75 mg twice daily for 5 days. You should begin treatment within 2 days of onset of symptoms of influenza.
Warnings/Precautions
Tamiflu is not a substitute for a flu vaccination. You should continue receiving an annual flu vaccination. It is not known whether this medicine is excreted in human milk. You should therefore, use this drug only if the potential benefit justifies the potential risk to the breast-fed infant.
Missed Dose
If you miss a dose, use it as soon as you remember. If it is near the time for the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Possible Side Effects
You may experience some common, less serious side effects: nausea (without vomiting), vomiting, diarrhea, abdominal pain, dizziness, headache, cough, insomnia, fatigue.
Storage
Store Tamiflu under refrigeration at 36º to 46ºF (2º to 8ºC). Do not freeze.
Overdose
Symptoms of a Tamiflu overdose are nausea and/or vomiting. Seek medical attention if an overdose is suspected.
More Information
You should begin treatment with Tamiflu as soon as possible from the first appearance of flu symptoms. Similarly, prevention should begin as soon as possible after exposure, at the recommendation of a physician.
Disclaimer
This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.