OSELTAMIVIR PHOSPHATE- oseltamivir phosphate capsule

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Asclemed USA, Inc.

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Oseltamivir Phosphate capsule 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 capsule is indicated for the prophylaxis of influenza A and B in patients 1 year and older. - Oseltamivir Phosphate capsule 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 Capsule [see Microbiology (12.4)]. - Oseltamivir Phosphate capsule is not recommend

उत्पाद समीक्षा:

Oseltamivir phosphate capsules USP 75-mg capsules (75 mg free base equivalent of the phosphate salt): White to off white powder filled in size "2" hard gelatin capsule with cream cap and brown body printed OP on cap and 75 on body in black. Available in blister packages of 10  NDC 76420-597-10 (relabeled from NDC 64380-799-01) Store at 20° to 25°C (68° to 77°F); Excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

OSELTAMIVIR PHOSPHATE - OSELTAMIVIR PHOSPHATE CAPSULE
ASCLEMED USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OSELTAMIVIR PHOSPHATE
CAPSULE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
OSELTAMIVIR
PHOSPHATE CAPSULE.
OSELTAMIVIR PHOSPHATE CAPSULE, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Oseltamivir Phosphate capsule 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)
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: 3mg/kg twice
daily for 5 days (2.2)
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)
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 age: Based on weight once daily
for 10 days (2.3)
Communi