NEODOSE

INDICATIONS

Treatment of Influenza :

• Treatment of confirmed or suspected influenza virus for patients who have severe, complicated, or progressive illness, patients at higher risk of influenza complications (eg, age or underlying medical condition) or who are hospitalized. Early antiviral treatment can shorten the duration of fever and clinical illness, may reduce the risk of complications (eg, otitis media, pneumonia, respiratory) and death, and shorten the duration of hospitalization .Those patients with severe, complicated or progressive illness and those who are hospitalized may also derive benefit even if oseltamivir is started after 48 hours of illness onset.
• Treatment should not wait for laboratory confirmation of influenza, but instead be initiated as soon as possible after the onset of symptoms, including patients seeking medical attention more than 48 hours after onset of symptoms. The duration of therapy is 5 days, but a longer treatment duration may be considered in patients who remain severely ill after 5 days of treatment. Unless an alternative diagnosis is made, a full treatment course should be completed by patients with suspected influenza regardless of negative initial test results. Oseltamivir has been used in term and preterm infants in the NICU setting for treatment and prophylaxis of influenza A virus (H1N1) with no reported safety concerns.
• Neuraminidase inhibitors reduced the mortality rate (odds ratio, 0.36 (95% CI, 0.16 to 0.84), particularly if mechanical ventilation was required, in children (median age 6 years (0 to 17 years)) in the intensive care unit with laboratory-confirmed influenza in a retrospective study (n=784). Early treatment (3 days vs 5 days) was associated with decreased mortality.

PRECAUTIONS

• Concomitant use: Concomitant use with intranasal live attenuated influenza vaccine (LAIV) not recommended within 2 weeks before or 48 hours after oseltamivir phosphate administration unless medically necessary.
• Dermatologic: Serious skin reactions such as toxic epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme may occur; discontinue use if allergic-like reaction occurs.
• Fructose intolerance: One dose delivers 2 g of sorbitol and may cause dyspepsia or diarrhea in patients with hereditary fructose intolerance.
• Immunologic:
  • Anaphylaxis has been reported; discontinue use if allergic-like reaction occurs.
  • Secondary bacterial infections may occur.
• Psychiatric: Abnormal behavior and delirium leading to potentially fatal injuries have been reported, primarily in pediatric patients.
• Renal: Renal impairment (ESRD not undergoing dialysis); use not recommended

ADVERSE EFFECTS

• Most common adverse events reported in pediatric patients are nausea and vomiting.
• Mild rash and gastrointestinal signs, and transient rise in transaminases have been reported in neonates receiving oseltamivir; no abnormal neurologic manifestations were reported.

ADMINISTRATION

May be given with or without food. Food may increase tolerability in some patients.

MONITORING

Closely monitor patients with influenza for neurologic symptoms or abnormal behavior