OSELTAMIVIR capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Alembic Pharmaceuticals Inc.

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 not recomm

ملخص المنتج:

Oseltamivir phosphate capsules, USP 30 mg Opaque light yellow cap/opaque light yellow body hard gelatin capsules size “4” having imprinting “A 292” on cap with blue ink filled with white to off-white granular powder. They are available as follows: NDC 62332-413-10                Carton of 10 capsules (1 x 10 unit dose blisters) 45 mg Opaque grey cap/opaque grey body hard gelatin capsules size “4” having imprinting “A 293” on cap with blue ink filled with white to off-white granular powder. They are available as follows: NDC 62332-414-10                Carton of 10 capsules (1 x 10 unit dose blisters) 75 mg Opaque light yellow cap/opaque off white body hard gelatin capsules size “2” having imprinting with “A 294” on cap with blue ink filled with white to off-white granular powder. They are available as follows: NDC 62332-415-10                Carton of 10 capsules (1 x 10 unit dose blisters) Storage Store the capsules at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

OSELTAMIVIR - OSELTAMIVIR CAPSULE
ALEMBIC PHARMACEUTICALS 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
INDICATIONS AND USAGE
Oseltamivir phosphate capsule is an influenza neuraminidase inhibitor
(NAI) indicated for: (1)
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: (1)
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 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)
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) (2)
Pediatric patients 1 to 12 years of age: Based on weight once daily
for 10 days (2.3)