OSELTAMIVIR PHOSPHATE · HETERO LABS LTD III

Absorption and Bioavailability Oseltamivir is absorbed from the gastrointestinal tract after oral administration of oseltamivir phosphate and is extensively converted predominantly by hepatic esterases to oseltamivir carboxylate. At least 75% of an oral dose reaches the systemic circulation as oseltamivir carboxylate and less than 5% of the oral dose reaches the systemic circulation as oseltamivir (see Table 6 ).

Table 6Mean (% CV) Pharmacokinetic Parameters of Oseltamivir and Oseltamivir Carbo...

14.1 Treatment of Influenza Adults Two randomized, placebo-controlled, double-blind clinical trials of oseltamivir phosphate were conducted in adults between 18 and 65 years old, one in the U.S. and one outside the U.S., for the treatment of acute uncomplicated influenza. Eligible subjects had fever of at least 100ºF, accompanied by at least one respiratory symptom (cough, nasal symptoms, or sore throat) and at least one systemic symptom (myalgia, chills/sweats, malaise, fatigue, or headache), and influenza virus was known to be circulating in the community. Subjects were randomized to receive...

The following serious adverse reactions are discussed below and elsewhere in the labeling: Serious skin and hypersensitivity reactions [see Warnings and Precautions (5.1) ] Neuropsychiatric events [see Warnings and Precautions (5.2) ] Most common adverse reactions (> 1% and more common than with placebo): Treatment studies – Nausea, vomiting, headache. ( 6.1 ) Prophylaxis studies – Nausea, vomiting, headache, pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1...

Oseltamivir phosphate for oral suspension 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 [see Warnings and Precautions (5.1) ] . Patients with known serious hypersen...

Serious skin/hypersensitivity reactions such as Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme: Discontinue oseltamivir phosphate for oral suspension and initiate appropriate treatment if allergic-like reactions occur or are suspected. ( 5.1 ) Neuropsychiatric events: Patients with influenza, including those receiving oseltamivir phosphate for oral suspension, particularly pediatric patients, may be at an increased risk of confusion or abnormal behavior early in the...

7 DRUG INTERACTIONS Live attenuated influenza vaccine (LAIV), intranasal: Avoid administration of LAIV within 2 weeks before or 48 hours after oseltamivir phosphate for oral suspension use, unless medically indicated. ( 7 ) 7.1 Influenza Vaccines Live Attenuated Influenza Vaccine The concurrent use of oseltamivir phosphate with live attenuated influenza vaccine (LAIV) intranasal has not been evalu...