OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION- oseltamivir phosphate powder, for suspension

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

OSELTAMIVIR PHOSPHATE (UNII: 4A3O49NGEZ) (OSELTAMIVIR ACID - UNII:K6106LV5Q8)

Disponibbli minn:

Alvogen Inc.

INN (Isem Internazzjonali):

OSELTAMIVIR PHOSPHATE

Kompożizzjoni:

OSELTAMIVIR ACID 6 mg in 1 mL

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Oseltamivir phosphate for oral suspension is 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. Oseltamivir phosphate for oral suspension is indicated for the prophylaxis of influenza A and B in patients 1 year and older. - Oseltamivir phosphate for oral suspension is 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 for oral suspension [see Microbiology (12.4)] . - Ose

Sommarju tal-prodott:

Oseltamivir Phosphate for Oral Suspension (Supplied as Powder ) Supplied as a white to off-white granular powder in a glass bottle. After constitution, the powder blend produces a white to off-white tutti-frutti–flavored oral suspension. After constitution with 55 mL of water, each bottle delivers a usable volume of 60 mL of oral suspension equivalent to 360 mg oseltamivir base (6 mg/mL) [see Dosage and Administration (2.5)] (NDC 47781-384-26). Storage Store dry powder at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. 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) [See USP Controlled Room Temperature].

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION - OSELTAMIVIR
PHOSPHATE POWDER, FOR SUSPENSION
ALVOGEN INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OSELTAMIVIR PHOSPHATE
FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION.
OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Oseltamivir phosphate for oral suspension 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)
DOSAGE AND ADMINISTRATION
Treatment of influenza
Adults and adolescents (13 years and older): 75 mg twice daily for 5
days (2.2)
Pediatric patients 1 to 12 years of age: Based on weight twice daily
for 5 days (2.2)
Pediatric patients 2 weeks to less than 1 year of age: 3 mg/kg twice
daily for 5 days (2.2)
Renally impaired adult patients (creatinine clearance >30 to 60
mL/min): Reduce to 30 mg twice daily
for 5 days (2.4)
Renally impaired adult patients (creatinine clearance >10 to 30
mL/min): Reduce to 30 mg once daily
for 5 days (2.4)
ESRD patients on hemodialysis: Reduce to 30 mg immediately and then 30
mg after every
hemodialysis cycle. Treatment duration not to exceed 5 days (2.4)
ESRD patients on CAPD: Reduce to a single 30 mg dose immediately (2.4)
Prophylaxis of influenza
Adults and adolescents (13 years and older): 75 mg once daily for at
least 10 days (2.3)
Community outbreak: 75 mg once daily for up to 6 weeks (2.3)
Pediatric patients 1 to 12 years of