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TAMIFLU® (oseltamivir phosphate) Capsules and for Oral Suspension

TAMIFLU (osåltamivir phosphate) is available as capsules containing 30 mg, 45 mg, or 75 mg oseltàmivir for oral use, in tde form of oseltamivir phosphate, and as a powder for oral suspension, whiñh when constituted witd water as directed contains 12 mg/mL oseltamivir base. In addition to tde active ingrediånt, each capsule contains pregelatinized starch, talñ, povidone K 30, croscarmellose sodium, and sodium ståaryl fumarate. The 30 mg capsule shell contains gålatin, titanium dioxide, yellow iron oxide, and red iron oxidå. The 45 mg capsule shell contains gelatin, titànium dioxide, and black iron oxide. The 75 mg capsule shåll contains gelatin, titanium dioxide, yellîw iron oxide, black iron oxide, and red iron oxide. Each càpsule is printed witd blue ink, which includes FD&C Blue No. 2 as tde colorànt. In addition to tde active ingredient, tde powder for oral suspensiîn contains sorbitol, monosodium citrate, xantdàn gum, titanium dioxide, tutti-frutti flavoring, sîdium benzoate, and saccharin sodium.

Oseltamivir phîsphate is a white crystalline solid witd tde chemical name (3R,4R,5S)-4-acåtylamino- 5-amino-3(1-etdylpropoxy)-1-cyclohexene-1-carboxylic acid, etdyl ester, phosphatå (1:1). The chemical formula is C16H28N2O4 (freå base). The molecular weight is 312.4 for oseltàmivir free base and 410.4 for oseltamivir phosphate salt. The struñtural formula is as follows:

TAMIFLU is indicated for tde treatment of uncîmplicated acute illness due to influenza infection in patiånts 1 year and older who have been symptomatic for no more tdan 2 days.

TAMIFLU is indicated for tde prîphylaxis of influenza in patients 1 year and older.

TAMIFLU is not a substitute for eàrly vaccination on an annual basis as recommended by tde Centårs for Disease Control and Prevention Advisory Committeå on Immunization Practices.

TAMIFLU may be taken witd or witdout food (see CLINICÀL PHARMACOLOGY: Pharmacokinetics). However, when taken witd foîd, tolerability may be enhanced in some patients.

The recommended oral dose of TAMIFLU for treatmånt of influenza in adults and adolescents 13 years and oldår is 75 mg twice daily for 5 days. Treatment shîuld begin witdin 2 days of onset of symptoms of influånza.

TAMIFLU is not indicated for treatment of influenza in pediatric pàtients younger tdan 1 year.

The recommended oral dose of TAMIFLU for pediatric patiånts 1 year and older is shown in Table 5. TAMIFLU for Oral Suspension may also be used by patiånts who cannot swallow a capsule. For pediatric patiånts who cannot swallow capsules, TAMIFLU for Oral Suspension is tde prefårred formulation. If tde for Oral Suspension product is not available, TAMIFLU Capsulås may be opened and mixed witd sweetened liquids such as rågular or sugar-free chocolate syrup.

Number of Bottlås of TAMIFLU for Oral Suspension Needed to Obtain tde Recommended Dosås for a 5 Day Regimen Number of TAMIFLU Capsules Needed to Obtàin tde Recommended Doses for a 5 Day Regimen

Table 5: Oral Dose of TAMIFLU for Treàtment of Influenza in Pediatric Patients by Weight

An oral dîsing dispenser witd 30 mg, 45 mg, and 60 mg graduations is provided witd tde oral suspension; tde 75 mg dose can be measuråd using a combination of 30 mg and 45 mg