OSELTAMIVIR PHOSPHATE- oseltamivir phosphate capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

OSELTAMIVIR PHOSPHATE

Composition:

OSELTAMIVIR CARBOXYLATE 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oseltamivir Phosphate Capsules, USP 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. Oseltamivir Phosphate Capsules, USP are indicated for the prophylaxis of influenza A and B in patients 1 year and older. - Oseltamivir Phosphate Capsules, USP 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, USP [ see Microbiology (12.4) ] - Oseltamivir Phosphate C

Product summary:

Oseltamivir Phosphate Capsules, USP 30-mg capsules (30 mg free base equivalent of the phosphate salt): Hard Gelatin, White Opaque/White Opaque Capsule, imprinted with black ink "N" on the body and black ink "1008" on the cap. Available in blister packages of 10 (NDC 70710-1008-2). 45-mg capsules (45 mg free base equivalent of the phosphate salt): Hard Gelatin, Light Blue Grey Opaque/ Light Blue Grey Opaque Capsule, imprinted with black ink "N" on the body and black ink "1009" on the cap.   Available in blister packages of 10 (NDC 70710-1009-2). 75-mg capsules (75 mg free base equivalent of the phosphate salt): Hard Gelatin, White Opaque/ Light Blue Grey Opaque Capsule, imprinted with black ink "N" on the body and black ink "1010" on the cap.    Available in blister packages of 10 (NDC 70710-1010-2). Storage Store the capsules at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OSELTAMIVIR PHOSPHATE- OSELTAMIVIR PHOSPHATE CAPSULE
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OSELTAMIVIR PHOSPHATE CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
OSELTAMIVIR PHOSPHATE CAPSULES.
OSELTAMIVIR PHOSPHATE CAPSULES, FOR ORAL USE.
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.2) 04/2018
INDICATIONS AND 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)
DOSAGE AND ADMINISTRATION
Treatment of influenza ( 2.2)
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: 3 mg/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 ( 2.4)
Renally impaired adult patients (creatinine clearance >10-30 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 ( 2.3)
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
Pediatric patients 1 to 12 years of age: Based on weight