Rx Item-Oseltamivir 6MG-ML 60 ML Suspension by Teva Pharma USA Gen Tamiflu

Rx Item-Oseltamivir 6MG-ML 60 ML Suspension by Teva Pharma USA , Clinical Information:
Generic Code And Description: 67561 Oseltamivir Phosphate Oral Suspension After Reconsitution 6 Mg/Ml
Strength: 6 Mg/Ml
Dose Form: Suspension Reconstituted Oral (Ml)
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 8182800 Neuraminidase Inhibitor Antivirals
Active Ingredients: 7919 Oseltamivir Phosphate
Inactive Ingredients: 2332 Sodium Citrate 68042
2468 Propylene Glycol 57556
2599 Sorbitol 50704
2600 Saccharin 81072
3192 Benzyl Alcohol 100516 Drug Class: Drug Class: 8182800 Neuraminidase Inhibitor Antivirals , OMP Family: , Temparature Zone: 10 Room Temperature, Unit Dose Indicator: NO, Item Size: 60ML, Brand Label Flag: GENERIC , Storage Temperature Zone: 10 Room Temperature, Item Size Code:60ML, Item Strength Code:6MG-ML , Item Abbreviation: Oseltamivir , Generic Form: SUS

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
RECENT MAJOR CHANGES
Warnings and Precautions (5.2) 04/2018
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 (2.2)

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: 3 mg/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 (2.4)
Renally impaired adult patients (creatinine clearance >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 (2.3)

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 (2.4)
Renally impaired adult patients (creatinine clearance >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 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 Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 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 and FDA-approved patient labeling.

Revised: 10/2022

Rx Item-Oseltamivir 6MG-ML 60 ML Suspens
Item No. RX886457, 886457, NDC No.: 00093-8180-64, 00093-180-64, 0009318064, 00093818064, 8180-64, 818064 UPC No. 3-00938-18064-6, 300938-180646, 300938180646

Rx Item-Oseltamivir 6MG-ML 60
Item No. RX886457, 886457, NDC No.: 00093-8180-64, 00093-180-64, 0009318064, 00093818064, 8180-64, 818064 UPC No. 3-00938-18064-6, 300938-180646, 300938180646

Rx Item-Oseltamivir 6MG-ML 60 ML Suspens
Rx items can only be ordered by a valid licence holder in scope of practice by-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physica

Rx Item-Oseltamivir 6MG-ML 60 ML Suspens
Item No. RX886457, 886457, NDC No.: 00093-8180-64, 00093-180-64, 0009318064, 00093818064, 8180-64, 818064 UPC No. 3-00938-18064-6, 300938-180646, 300938180646