oseltamivir phosphate

FDA Drug Profile — Oseltamivir Phosphate, oseltamivir phosphate, OSELTAMIVIR PHOSPHATE, Oseltamivir phosphate, Tamiflu

Drug Details

Generic Name
oseltamivir phosphate
Brand Names
Oseltamivir Phosphate, oseltamivir phosphate, OSELTAMIVIR PHOSPHATE, Oseltamivir phosphate, Tamiflu
Application Number
ANDA212739
Sponsor
Lannett Company, Inc.
NDC Codes
35
Dosage Forms
CAPSULE, POWDER, FOR SUSPENSION, POWDER, SUSPENSION, FOR SUSPENSION
Routes
ORAL
Active Ingredients
OSELTAMIVIR PHOSPHATE

Indications and Usage

1 INDICATIONS & USAGE Oseltamivir phosphate 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. (1.1) • Prophylaxis of influenza A and B in patients 1 year and older. (1.2) Limitations of Use: • Not a substitute for annual influenza vaccination. (1.3) • Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3) • Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3) 1.1 Treatment of Influenza Oseltamivir phosphate capsules are indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. 1.2 Prophylaxis of Influenza Oseltamivir phosphate capsules are indicated for the prophylaxis of influenza A and B in patients 1 year and older. 1.3 Limitations of Use • Oseltamivir phosphate capsules are not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices. • Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate capsules [ see Microbiology ( Error! Hyperlink reference not valid. • Oseltamivir phosphate capsules are not recommended for patients with end-stage renal disease not undergoing dialysis [see Dosage and Administration (2.4) and Use in Specific Populations ( 8.6)].