Antiviral Agent

Treatment of uncomplicated acute illness due to influenza virus in adults and adolescents 12 years of age or older. Treatment should only be initiated in patients who have been symptomatic for no more than 2 days.

B

Zanamivir has been shown to cross the placenta in animal models, however, no evidence of fetal malformations has been demonstrated. Zanamivir has been shown to be excreted in the milk of animals, but its excretion in human milk is unknown. Caution should be used when zanamivir is administered to a nursing mother.

Hypersensitivity to zanamivir or any component of the formulation

Patients must be instructed in the use of the delivery system. No data are available to support the use of this drug in patients who begin treatment after 48 hours of symptoms, as a prophylactic treatment for influenza, or in patients with significant underlying medical conditions. Use with caution in patients with underlying respiratory disease - bronchospasm may be provoked. Not a substitute for the flu shot. Consider primary or concomitant bacterial infections.

Most adverse reactions occurred at a frequency which was equal to the control (lactose vehicle)

Central nervous system: Headache (2%), dizziness (2%)

Gastrointestinal: Nausea (3%), diarrhea (3%), vomiting (1%)

Respiratory: Sinusitis (3%), bronchitis (2%), cough (2%)

Miscellaneous: Infection (ear, nose and throat) (2%)

<1.5%: Malaise, fatigue, fever, abdominal pain, myalgia, arthralgia, and urticaria

Information is limited, and symptoms appear similar to reported adverse events from clinical studies.

No clinically significant pharmacokinetic interactions are predicted.

Store at room temperature (25°C) 77°F; do not puncture blister until taking a dose using the Diskhaler®

Zanamivir inhibits influenza virus neuraminidase enzymes, potentially altering virus particle aggregation and release.

Absorption: 4% to 17% of the inhaled dose

Distribution: Plasma protein binding <10%

Metabolism: None

Half-life, serum: 2.5-5.1 hours

Elimination: In urine, as unchanged drug

Adolescents greater than or equal to 12 years and Adults: 2 Inhalations: (10 mg total) twice daily for 5 days. Two doses should be taken on the first day of dosing, regardless of interval, while doses should be spaced by approximately 12 hours on subsequent days.

Inhalation: Must be used with Diskhaler® delivery device. Patients who are scheduled to use an inhaled bronchodilator should use their bronchodilator prior to zanamivir.

No information available to require special precautions

No effects or complications reported

Use delivery device exactly as directed; complete full 5-day regimen, even if symptoms improve sooner. If you have asthma or COPD you may be at risk for bronchospasm; see prescriber for appropriate bronchodilator before using zanamivir. You may experience dizziness or headache (use caution when driving or engaging in hazardous tasks until response to drug is known). Report unresolved diarrhea, vomiting, or nausea; acute fever or muscle pain; or other acute and persistent adverse effects. Breast-feeding precautions: Consult prescriber if breast-feeding.

Powder, for inhalation (Rotadisk®): 5 mg per blister

Majority of patients included in clinical trials were infected with influenza A, however a number of patients with influenza B infections were also enrolled. Patients with lower temperature or less severe symptoms appeared to derive less benefit from therapy. No consistent treatment benefit was demonstrated in patients with chronic underlying medical conditions.