Oseltamivir Phosphate

OSELTAMIVIR PHOSPHATE- oseltamivir phosphate capsule
RPK Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

1.1 Treatment of Influenza

Oseltamivir Phosphate capsule USP is 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 capsule USP is indicated for the prophylaxis of influenza A and B in patients 1 year and older.

1.3 Limitations of Use

• Oseltamivir Phosphate capsule USP is 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 Capsule USP [see Microbiology (12.4)].
• Oseltamivir Phosphate capsule USP is 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)].

2 DOSAGE AND ADMINISTRATION

2.1 Dosage and Administration Overview

Administer Oseltamivir Phosphate capsule for the treatment of influenza in patients 2 weeks of age or older [see Dosage and Administration (2.2)] or for prophylaxis of influenza in patients 1 year and older [see Dosage and Administration (2.3)] using:

• Oseltamivir Phosphate capsule

The capsules may be taken with or without food; however, tolerability may be enhanced if Oseltamivir Phosphate capsule USP is taken with food.

Adjust the Oseltamivir Phosphate capsule dosage in patients with moderate or severe renal impairment [see Dosage and Administration (2.4)]

For patients who cannot swallow capsules, Oseltamivir Phosphate for oral suspension is the preferred formulation. When oseltamivir phosphate for oral suspension is not available from wholesaler or the manufacturer, Oseltamivir Phosphate capsules may be opened and mixed with sweetened liquids such as regular or sugar-free chocolate syrup, corn syrup, caramel topping, or light brown sugar (dissolved in water). During emergency situation and when neither the oral suspension or the age-appropriate strengths of Oseltamivir Phosphate capsules to mix with sweetened liquids are available, then a pharmacist may prepare an emergency supply of oral suspension from Oseltamivir Phosphate 75 mg capsules [see Dosage and Administration (2.6)].

2.2 Recommended Dosage for Treatment of Influenza

Initiate treatment with Oseltamivir phosphate capsule within 48 hours of influenza symptom onset.

Adults and Adolescents (13 years of age and older)

The recommended oral dosage of Oseltamivir phosphate capsule for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily (one 75mg capsule twice daily) for 5 days.

Pediatric Patients (2 weeks of age through 12 years of age)

Table 1 displays the recommended oral dose of Oseltamivir phosphate capsule for treatment of influenza in pediatric patients 2 weeks of age through 12 years of age and provides information about prescribing the capsule.

2.3 Recommended Dosage for Prophylaxis of Influenza

Initiate post-exposure prophylaxis with Oseltamivir phosphate capsule within 48 hours following close contact with an infected individual. Initiate seasonal prophylaxis with Oseltamivir phosphate capsule during a community outbreak.

Adults and Adolescents (13 years of age and older)

The recommended dosage of oseltamivir phosphate capsule USP for prophylaxis of influenza in adults and adolescents 13 years and older is 75 mg orally once daily (one 75 mg capsule once daily) for at least 10 days following close contact with an infected individual and up to 6 weeks during a community outbreak. In immunocompromised patients, Oseltamivir phosphate capsule may be continued for up to 12 weeks [see Use in Specific Populations (8.9)]. The duration of protection lasts for as long as Oseltamivir phosphate capsule dosing is continued.

Pediatric Patients (1 to 12 years of age)

Table 1 displays the recommended oral dose of Oseltamivir phosphate capsule for prophylaxis of influenza in pediatric patients 1 to 12 years of age based on body weight and provides information about prescribing the capsule. Prophylaxis in pediatric patients is recommended for 10 days following close contact with an infected individual and up to 6 weeks during a community outbreak [see Use in Specific Populations (8.4) and Clinical Studies (14.2)].

Table 1 Oseltamivir phosphate capsules Dosage Recommendations in Pediatric Patients for Treatment and Prophylaxis of Influenza

* The recommended duration for post-exposure prophylaxis is 10 days and the recommended duration for community outbreak (seasonal/pre-exposure) prophylaxis is up to 6 weeks (or up to 12 weeks in immunocompromised patients). The amount supplied (e.g., number of bottles or capsules) for seasonal prophylaxis may be greater than for post-exposure prophylaxis. † Oseltamivir phosphate for oral suspension is the preferred formulation for patients who cannot swallow capsules.
Weight	Treatment Dosage for 5 days	Prophylaxis Dosage for 10 days *	Number of Capsules to Dispense (Strength) †
Patients from 2 Weeks to less than 1 Year of Age
Any weight	3 mg/kg twice daily	Not applicable	Not applicable
Patients 1 to 12 Years of Age Based on Body Weight
15 kg or less	30 mg twice daily	30 mg once daily	10 Capsules (30 mg)
15.1 kg to 23 kg	45 mg twice daily	45 mg once daily	10 Capsules (45 mg)
23.1 kg to 40 kg	60 mg twice daily	60 mg once daily	20 Capsules (30 mg)
40.1 kg or more	75 mg twice daily	75 mg once daily	10 capsules (75 mg)