Piramal Dry Powder for Oral Suspension

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. …

• Treatment of influenza
• Adults and adolescents (13 years and older): 75 mg twice daily for 5 days
• Pediatric patients 1 to 12 years of age: Based on weight twice daily for 5 days
• Pediatric patients 2 weeks to less than 1 year of age: 3mg/kg twice daily for 5 days Renally impaired adult patients (creatinine clearance >30 to 60 mL/min): Reduce to 30 mg twice daily for 5 days Renally impaired adult patients (creatinine clearance >10 to 30 mL/min): Reduce to 30 mg once daily for 5 days ESRD patients on hemodialysis: Reduce to 30 mg immediately and then 30 mg after every hemodialysis cycle
• Treatment duration not to exceed 5 days ESRD patients on CAPD: Reduce to a single 30 mg dose immediately Prophylaxis of influenza
• Adults and adolescents (13 years and older): 75 mg once daily for at least 10 days Community outbreak: 75 mg once daily for up to 6 weeks
• Pediatric patients 1 to 12 years of age: Based on weight once daily for 10 days Community outbreak: Based on weight once daily for up to 6 weeks Renally impaired adult patients (creatinine clearance >30 to 60 mL/min): Reduce to 30 mg once daily Renally impaired adult patients (creatinine clearance >10 to 30 mL/min): Reduce to 30 mg once every other day ESRD patients on hemodialysis: Reduce to 30 mg immediately and then 30 mg after alternate hemodialysis cycles for the recommended duration of prophylaxis ESRD patients on CAPD: Reduce to 30 mg immediately and then 30 mg once weekly for the recommended duration of prophylaxi …

Oseltamivir Phosphate for Oral Suspension: 6 mg per mL (final concentration when constituted) White to light yellow powder blend for constitution. For oral suspension: 360 mg oseltamivir base supplied as powder (constituted to a final concentration of 6 mg/mL) ( 3 )

• Treatment of Influenza The safety and efficacy of oseltamivir phosphate
• For the treatment of influenza
• Pediatric patients 2 weeks old to 17 years of age has been established [see Dosage and Administration , Clinical Pharmacology , and Clinical Studies ] and is based on: 13 to 17 years of age: Safety and efficacy in adolescent patients 13 to 17 years of age was supported by adequate and well-controlled trials
• Adults and adolescents and younger
• Pediatric patients and safety data in adolescents treated with oseltamivir phosphate in a study of treatment and prophylaxis. …

Treatment of Influenza Of the 4,765 adults in clinical trials of oseltamivir phosphate for the treatment of influenza, 948 (20%) were 65 years and older, while 329 (7%) were 75 years and older. In three double-blind, placebo-controlled trials in the treatment of influenza in patients at least 65 years old, that enrolled 741 subjects (374 received placebo and 362 received oseltamivir phosphate), no overall differences in safety or effectiveness we …

• Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
• Serious Skin/Hypersensitivity Reactions Advise patients and/or caregivers of the risk of severe allergic reactions (including anaphylaxis) or serious skin reactions
• Instruct patients and/or caregiver to stop oseltamivir phosphate for oral suspension and seek immediate medical attention if an allergic-like reaction occurs or is suspected [ see Warnings and Precautions ] . …

• Oseltamivir phosphate for oral suspension is contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product
• Severe allergic reactions have included anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme [see Warnings and Precautions ]
• Patients with known serious hypersensitivity to oseltamivir or any of the components of oseltamivir phosphate for oral suspension

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 ) 7.1 Influenza Vaccines Live Attenuated Influenza Vaccine The concurrent use of oseltamivir phosphate with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for oseltamivir phosphate to inhibit replication of live vaccine virus and possibly reduce the efficacy of LAIV, avoid administration of LAIV within 2 weeks before or 48 hours after oseltamivir phosphate administration, unless medically indicated. …

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. …

The following serious adverse reactions are discussed below and elsewhere in the labeling: Serious skin and hypersensitivity reactions [see Warnings and Precautions (5.1) ] Neuropsychiatric events [see Warnings and Precautions (5.2) ] 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 Lannett Company, Inc. …

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with oseltamivir phosphate for oral suspension in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Available published epidemiological data suggest that oseltamivir phosphate for oral suspension, taken in any trimester, is not associated with an increased risk of birth defects. …

Reports of overdoses with oseltamivir phosphate have been received from clinical trials and during postmarketing experience. In the majority of cases reporting overdose, no adverse reactions were reported. Adverse reactions reported following overdose were similar in nature to those observed with therapeutic doses of oseltamivir phosphate for oral suspension [see Adverse Reactions (6) ] .

Storage Store dry powder at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Preserved in well closed container. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.