Oseltamivir 30 MG Oral Capsule
1 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 ) 1.1 Treatment of Influenza 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. 1.2 Prophylaxis of Influenza Oseltamivir Phosphate Capsules, USP are indicated for the prophylaxis of influenza A and B in patients 1 year and older. 1.3 Limitations of Use 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 Capsules, USP are not recommended for patients with end-stage renal disease not undergoing dialysis [ see Dosage and Administration (2.4) and Use inSpecific Populations (8.6) ].
Zydus Pharmaceuticals (USA) Inc.
CAPSULE WHITE 1008 N
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16 HOW SUPPLIED/STORAGE AND HANDLING
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].
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