Oseltamivir 30 MG Oral Capsule
1 INDICATIONS AND USAGE Oseltamivir phosphate capsules are 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) 1.1 Treatment of Influenza 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. 1.2 Prophylaxis of Influenza Oseltamivir phosphate capsules are indicated for the prophylaxis of influenza A and B in patients 1 year and older. 1.3 Limitations of Use 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 recommended for patients with end-stage renal disease not undergoing dialysis [see Dosage and Administration (2.4) and Use in Specific Populations (8.6) ] .
Amneal Pharmaceuticals NY LLC
CAPSULE YELLOW AMNEAL 264
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16 HOW SUPPLIED/STORAGE AND HANDLING
OSELTAMIVIR Phosphate capsules USP, 30 mg are supplied as hard gelatin capsules with yellow ivory opaque cap and yellow ivory opaque body printed “AMNEAL” on cap and “264” on body with blue ink. They are available as follows: Blister pack of 10: NDC 69238-1264-1
OSELTAMIVIR Phosphate capsules USP, 45 mg are supplied as hard gelatin capsules with light gray opaque cap and light gray opaque body printed “AMNEAL” on cap and “265” on body with blue ink. They are available as follows: Blister pack of 10: NDC 69238-1265-1
OSELTAMIVIR Phosphate capsules USP, 75 mg are supplied as hard gelatin capsules with yellow ivory opaque cap and light gray opaque body printed “AMNEAL” on cap and “266” on body with blue ink. They are available as follows: Blister pack of 10: NDC 69238-1266-1 Storage Store the capsules at 20º to 25ºC (68º to 77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].
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