Usual Adult Dose for Influenza

600 mg IV once as a single dose

Use: For the treatment of acute uncomplicated influenza in patients symptomatic no more than 2 days

Usual Pediatric Dose for Influenza

6 months to 12 years: 12 mg/kg IV once as a single dose

• Maximum dose: 600 mg/dose

Renal Dose Adjustments

Adults and adolescents 13 years or older:

• CrCl at least 50 mL/min: No adjustment recommended.
• CrCl 30 to 49 mL/min: 200 mg IV once
• CrCl 10 to 29 mL/min: 100 mg IV once

• CrCl at least 50 mL/min: No adjustment recommended.
• CrCl 30 to 49 mL/min: 4 mg/kg IV once
• Maximum dose: 200 mg/dose
• CrCl 10 to 29 mL/min: 2 mg/kg IV once
• Maximum dose: 100 mg/dose

• CrCl less than 50 mL/min: Data not available

• CrCl calculated using the Cockcroft-Gault formula.
• The pharmacokinetics (PKs) of this drug have not been studied in pediatric subjects with renal dysfunction; since the PKs in pediatric subjects with normal renal function are comparable to those in adults, the same proportional dose reduction is recommended in pediatric patients at least 2 years of age with renal dysfunction.
• Due to developmental immaturity of renal function in patients younger than 2 years, a recommendation for dose reduction cannot be made for patients 6 months to less than 2 years of age with CrCl less than 50 mL/min.

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:
Known serious hypersensitivity or anaphylaxis to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 6 months.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: Dose should be adjusted based on renal function and administered after dialysis.

Other Comments

Administration advice:

• Administer within 2 days of onset of influenza symptoms.
• Administer via IV infusion for 15 to 30 minutes.
• If diluted solution is refrigerated, allow it to reach room temperature then administer immediately; discard unused diluted solution after 24 hours.

• Vials: Store in original containers at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Diluted solution: If not administered immediately, store refrigerated (2C to 8C [36F to 46F]) for up to 24 hours.

• This drug must be diluted before infusion; the final concentration of diluted solution for administration should be between 1 and 6 mg/mL.
• Maximum infusion volume:
• Age 6 months to 1 year: 25 mL
• Age 1 year and older, weight 5 to less than 10 kg: 25 mL
• Age 1 year and older, weight 10 to less than 15 kg: 50 mL
• Age 1 year and older, weight 15 to less than 20 kg: 75 mL
• Age 1 year and older, weight at least 20 kg: 100 mL
• The manufacturer product information should be consulted.

• Compatible: 0.9% or 0.45% sodium chloride, 5% dextrose, lactated Ringers; materials commonly used for administration (e.g., polyvinylchloride [PVC] bags, PVC-free bags, polypropylene syringes, polyethylene tubing)
• Do not mix or co-infuse with other IV agents.

• Efficacy based on clinical trials of naturally-occurring influenza in which the infections were mostly due to influenza A virus; limited number enrolled who were infected with influenza B virus.
• As influenza viruses change over time, resistant or more virulent mutations may emerge and decrease the efficacy of antiviral drugs; available information on influenza drug susceptibility patterns and treatment effects should be considered when deciding whether to use this drug.
• Efficacy not established in patients with serious influenza requiring hospitalization.

• Psychiatric: For signs of abnormal behavior in patients with influenza

• Seek medical attention at once if an allergic-like reaction occurs/is suspected.
• After receiving this drug, contact physician if signs of abnormal behavior occur.