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:

A-S Medication Solutions

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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. Oseltamivir phosphate capsules are indicated for the prophylaxis of influenza A and B in patients 1 year and older. • 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 ( 12.4)]. • Oseltamivir phosphate capsules are no

उत्पाद समीक्षा:

Product: 50090-6099 NDC: 50090-6099-0 10 CAPSULE in a BLISTER PACK / 1 in a CARTON

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

OSELTAMIVIR PHOSPHATE - OSELTAMIVIR PHOSPHATE CAPSULE
A-S MEDICATION SOLUTIONS
----------
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 (5.4) 06/2016
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 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(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
• Pe