Oseltamivir 45 mg
1 INDICATIONS & USAGE Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: β’ 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) β’ Prophylaxis of influenza A and B in patients 1 year and older. (1.2) Limitations of Use: β’ Not a substitute for annual influenza vaccination. (1.3) β’ Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3) β’ 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 β’ 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. β’ 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)]. β’ 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)].
camber pharmaceuticals, inc.
CAPSULE GREY H 32
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16 HOW SUPPLIED/STORAGE AND HANDLING
OSELTAMIVIR PHOSPHATE capsules USP, 30 mg (30 mg free base equivalent of the phosphate salt) are light yellow opaque cap/light yellow opaque body size β4β hard gelatin capsules imprinted with βHβ on cap and β33β on body with blue ink, filled with white to off white granular powder. They are supplied as follows: Carton of 10 (1 x 10) unit-dose capsules NDC 31722-630-31
OSELTAMIVIR PHOSPHATE capsules USP, 45 mg (45 mg free base equivalent of the phosphate salt) are grey opaque cap/grey opaque body size β4β hard gelatin capsules imprinted with βHβ on cap and β32β on body with blue ink, filled with white to off white granular powder. They are supplied as follows: Carton of 10 (1 x 10) unit-dose capsules NDC 31722-631-31
OSELTAMIVIR PHOSPHATE capsules USP, 75 mg (75 mg free base equivalent of the phosphate salt) are light yellow opaque cap/grey opaque body size β2β hard gelatin capsules imprinted with βHβ on cap and β5β on body with blue ink, filled with white to off white granular powder. They are supplied as follows: Carton of 10 (1 x 10) unit-dose capsules NDC 31722-632-31 Storage Store the capsules at 20o to 25ΒΊC (68ΒΊ to 77ΒΊF) [see USP Controlled Room Temperature].
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