oseltamivir phosphate capsule
1 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 ) Important 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 )].
lupin pharmaceuticals, inc.
CAPSULE YELLOW 30mg LU
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oseltamivir phosphate capsule
lupin pharmaceuticals, inc.
oseltamivir phosphate capsule
lupin pharmaceuticals, inc.
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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): size '4' hard gelatin capsules with light yellow cap imprinted with '30 mg' in blue ink and light yellow body imprinted with 'LU' in blue ink containing white to off white granular powder. Available in HDPE bottle pack of 10 (NDC 68180-675-10) and blister packages of 10 (NDC 68180-675-11). 45-mg capsules (45 mg free base equivalent of the phosphate salt): size '4' hard gelatin capsules with grey opaque cap imprinted with '45 mg' in blue ink and grey opaque body imprinted with 'LU' in blue ink containing white to off white granular powder. Available in HDPE bottle pack of 10 (NDC 68180-676-10) and blister packages of 10 (NDC 68180-676-11). 75-mg capsules (75 mg free base equivalent of the phosphate salt): size '2' hard gelatin capsules with light yellow cap imprinted with '75 mg' in blue ink and grey opaque body imprinted with 'LU' in blue ink containing white to off white granular powder. Available in HDPE bottle pack of 10 (NDC 68180-677-10) and blister packages of 10 (NDC 68180-677-11). Storage Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].
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