Oseltamivir Phosphate 6 mg / ml Oral Suspension — Generic For Tamiflu (60 ml Total) — Ajanta Pharma

These highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION.

OSELTAMIVIR PHOSPHATE for oral suspension

Initial U.S. Approval: 1999

Indications And Usage

Oseltamivir phosphate for oral suspension 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)

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: 3mg/kg twice daily for 5 days (2.2)

Renally impaired adult patients (creatinine clearance greater than 30 to 60 mL/min): Reduce to 30 mg twice daily for 5 days (2.4)

Renally impaired adult patients (creatinine clearance greater than 10 to 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)

Pediatric patients 1 to 12 years of age: Based on weight once daily for 10 days (2.3)

Renally impaired adult patients (creatinine clearance greater than 30 to 60 mL/min): Reduce to 30 mg once daily (2.4)

Renally impaired adult patients (creatinine clearance greater than 10 to 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

For oral suspension: 360 mg oseltamivir base supplied as powder (constituted to a final concentration of 6 mg/mL) (3)

Contraindications

Patients with known serious hypersensitivity to oseltamivir or any of the components of oseltamivir phosphate for oral suspension (4)

Warnings And Precautions

• Serious skin/hypersensitivity reactions such as Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme: Discontinue oseltamivir phosphate for oral suspension and initiate appropriate treatment if allergic-like reactions occur or are suspected. (5.1)
• Neuropsychiatric events: Patients with influenza, including those receiving oseltamivir phosphate for oral suspension, 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)

• Serious skin/hypersensitivity reactions such as Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme: Discontinue oseltamivir phosphate for oral suspension and initiate appropriate treatment if allergic-like reactions occur or are suspected. (5.1)
• Neuropsychiatric events: Patients with influenza, including those receiving oseltamivir phosphate for oral suspension, 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)

Serious skin/hypersensitivity reactions such as Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme: Discontinue oseltamivir phosphate for oral suspension and initiate appropriate treatment if allergic-like reactions occur or are suspected. (5.1)

Neuropsychiatric events: Patients with influenza, including those receiving oseltamivir phosphate for oral suspension, 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 (greater than 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 Ajanta Pharma USA, Inc., at 1-855-664-7744 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 for oral suspension use, unless medically indicated. (7)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 8/2025