Oseltamivir

TAMIFLU is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. Prophylaxis of influenza A and B in patients 1 year and older. Limitations of Use: Not a substitute for annual influenza vaccination. Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. Not recommended for patients with end-stage renal disease not undergoing dialysis.

Oseltamivir is an antiviral drug with activity against influenza virus.

Treatment of influenza Adults and adolescents (13 years and older): 75 mg twice daily for 5 days. Pediatric patients 1 to 12 years of age: Based on weight twice daily for 5 days. Pediatric patients 2 weeks to less than 1 year of age: 3mg/kg twice daily for 5 days. Renally impaired adult patients (creatinine clearance >30-60 mL/min): Reduce to 30 mg twice daily for 5 days. Renally impaired adult patients (creatinine clearance >10-30 mL/min): Reduce to 30 mg once daily for 5 days. ESRD patients on hemodialysis: Reduce to 30 mg immediately and then 30 mg after every hemodialysis cycle. Treatment duration not to exceed 5 days. ESRD patients on CAPD: Reduce to a single 30 mg dose immediately. Prophylaxis of influenza Adults and adolescents (13 years and older): 75 mg once daily for at least 10 days - Community outbreak: 75 mg once daily for up to 6 weeks.

TAMIFLU is contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. Severe allergic reactions have included anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme. Patients with known serious hypersensitivity to oseltamivir or any of the components of TAMIFLU

Serious skin/hypersensitivity reactions such as Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme: Discontinue TAMIFLU and initiate appropriate treatment if allergic-like reactions occur or are suspected. Neuropsychiatric events: Patients with influenza, including those receiving TAMIFLU, particularly pediatric patients, may be at an increased risk of confusion or abnormal behavior early in their illness. Monitor for signs of abnormal behavior.

The following serious adverse reactions are discussed below and elsewhere in the labeling: Serious skin and hypersensitivity reactions Neuropsychiatric events Most common adverse reactions (>1% and more common than with placebo): Treatment studies – Nausea, vomiting, headache. Prophylaxis studies – Nausea, vomiting, headache, pain.

Live attenuated influenza vaccine (LAIV), intranasal: Avoid administration of LAIV within 2 weeks before or 48 hours after TAMIFLU use, unless medically indicated.

Store the capsules at 25ºC (77ºF), excursions permitted to 15º to 30ºC (59º to 86ºF). Storage Store dry powder at 25ºC (77ºF), excursions permitted to 15º to 30ºC (59º to 86ºF). Store constituted oral suspension under refrigeration for up to 17 days at 2º to 8ºC (36º to 46ºF). Do not freeze. Alternatively, store constituted oral suspension for up to 10 days at 25ºC (77ºF), excursions permitted to 15º to 30ºC (59º to 86ºF).