Clinical Information
Gen. Code and Des.
63224 oseltamivir phosphate ORAL CAPSULE 45 MG
GCN and Des.
98981 oseltamivir phosphate ORAL CAPSULE 45 MG
Strength
45MG
Dose Form
CAPSULE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
8182800 NEURAMINIDASE INHIBITOR ANTIVIRALS
Active Ingredients
7919 oseltamivir phosphate
Inactive Ingredients
2537 povidone 9003398
2549 gelatin 9000708
These highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE CAPSULES safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE CAPSULES.
OSELTAMIVIR PHOSPHATE capsules , for oral use
Initial U.S. Approval: 1999
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)
DOSAGE AND ADMINISTRATION
Treatment of influenza
Adults and adolescents (13 years and older): 75 mg twice daily for 5 days (2.2)
Pediatric patients 1 to 12 years of age: Based on weight twice daily for 5 days (2.2)
Pediatric patients 2 weeks to less than 1 year of age: 3 mg/kg twice daily for 5 days (2.2)
Renally impaired adult patients (creatinine clearance >30-60 mL/min): Reduce to 30 mg twice daily for 5 days (2.4)
Renally impaired adult patients (creatinine clearance >10-30 mL/min): Reduce to 30 mg once daily for 5 days (2.4)
ESRD patients on hemodialysis: Reduce to 30 mg immediately and then 30 mg after every hemodialysis cycle. Treatment duration not to exceed 5 days (2.4)
ESRD patients on CAPD: Reduce to a single 30 mg dose immediately (2.4)
Prophylaxis of influenza
Adults and adolescents (13 years and older): 75 mg once daily for at least 10 days (2.3)
Community outbreak: 75 mg once daily for up to 6 weeks (2.3)
Pediatric patients 1 to 12 years of age: Based on weight once daily for 10 days (2.3)
Community outbreak: Based on weight once daily for up to 6weeks (2.3)
Renally impaired adult patients (creatinine clearance >30-60 mL/min): Reduce to 30 mg once daily (2.4)
Renally impaired adult patients (creatinine clearance >10-30 mL/min): Reduce to 30 mg once every other day (2.4)
ESRD patients on hemodialysis: Reduce to 30 mg immediately and then 30 mg after alternate hemodialysis cycles for the recommended duration of prophylaxis (2.4)
ESRD patients on CAPD: Reduce to 30 mg immediately and then 30 mg once weekly for the recommended duration of prophylaxis (2.4)
DOSAGE FORMS AND STRENGTHS
Capsules: 30 mg, 45 mg, 75 mg (3)
CONTRAINDICATIONS
Patients with known serious hypersensitivity to oseltamivir or any of the components of oseltamivir phosphate (4).
WARNINGS AND PRECAUTIONS
Serious skin/hypersensitivity reactions such as Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme: Discontinue oseltamivir phosphate and initiate appropriate treatment if allergic-like reactions occur or are suspected. (5.1)
Neuropsychiatric events: Patients with influenza, including those receiving oseltamivir phosphate particularly pediatric patients, may be at an increased risk of confusion or abnormal behavior early in their illness. Monitor for signs of abnormal behavior. (5.2)
ADVERSE REACTIONS
Most common adverse reactions (>1% and more common than with placebo):
Treatment studies �" Nausea, vomiting, headache. (6.1)
Prophylaxis studies �" Nausea, vomiting, headache, pain.(6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
Live attenuated influenza vaccine (LAIV), intranasal:
Avoid administration of LAIV within 2 weeks before or 48 hours after oseltamivir phosphate use, unless medically indicated.(7)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 12/2022
