Recommended Topic Related To:

Relenza

"Are you aware that colds, flu, most sore throats, and bronchitis are caused by viruses? Did you know that antibiotics do not help fight viruses? It's true. Plus, taking antibiotics when you have a virus may do more harm than good. Taking antibio"...

Relenza

Indications
Dosage
How Supplied

INDICATIONS

Treatment of Influenza

RELENZA® (zanamivir) Inhalation Powder is indicated for treatment of uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients aged 7 years and older who have been symptomatic for no more than 2 days.

Prophylaxis of Influenza

RELENZA is indicated for prophylaxis of influenza in adults and pediatric patients aged 5 years and older.

Important Limitations on Use of RELENZA

  • RELENZA is not recommended for treatment or prophylaxis of influenza in individuals with underlying airways disease (such as asthma or chronic obstructive pulmonary disease) due to risk of serious bronchospasm [see WARNINGS AND PRECAUTIONS].
  • RELENZA has not been proven effective for treatment of influenza in individuals with underlying airways disease.
  • RELENZA has not been proven effective for prophylaxis of influenza in the nursing home setting.
  • RELENZA is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control's Immunization Practices Advisory Committee.
  • Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RELENZA.
  • There is no evidence for efficacy of zanamivir in any illness caused by agents other than influenza virus A and B.
  • Patients should be advised that the use of RELENZA for treatment of influenza has not been shown to reduce the risk of transmission of influenza to others.

DOSAGE AND ADMINISTRATION

Dosing Considerations

  • RELENZA is for administration to the respiratory tract by oral inhalation only, using the DISKHALER device provided [see WARNINGS AND PRECAUTIONS].
  • The 10-mg dose is provided by 2 inhalations (one 5-mg blister per inhalation).
  • Patients should be instructed in the use of the delivery system. Instructions should include a demonstration whenever possible. If RELENZA is prescribed for children, it should be used only under adult supervision and instruction, and the supervising adult should first be instructed by a healthcare professional [see PATIENT INFORMATION].
  • Patients scheduled to use an inhaled bronchodilator at the same time as RELENZA should use their bronchodilator before taking RELENZA [see PATIENT INFORMATION].

Treatment of Influenza

  • The recommended dose of RELENZA for treatment of influenza in adults and pediatric patients aged 7 years and older is 10 mg twice daily (approximately 12 hours apart) for 5 days.
  • Two doses should be taken on the first day of treatment whenever possible provided there is at least 2 hours between doses.
  • On subsequent days, doses should be about 12 hours apart (e.g., morning and evening) at approximately the same time each day.
  • The safety and efficacy of repeated treatment courses have not been studied.

Prophylaxis of Influenza

Household Setting
  • The recommended dose of RELENZA for prophylaxis of influenza in adults and pediatric patients aged 5 years and older in a household setting is 10 mg once daily for 10 days.
  • The dose should be administered at approximately the same time each day.
  • There are no data on the effectiveness of prophylaxis with RELENZA in a household setting when initiated more than 1.5 days after the onset of signs or symptoms in the index case.
Community Outbreaks
  • The recommended dose of RELENZA for prophylaxis of influenza in adults and adolescents in a community setting is 10 mg once daily for 28 days.
  • The dose should be administered at approximately the same time each day.
  • There are no data on the effectiveness of prophylaxis with RELENZA in a community outbreak when initiated more than 5 days after the outbreak was identified in the community.
  • The safety and effectiveness of prophylaxis with RELENZA have not been evaluated for longer than 28 days' duration.

HOW SUPPLIED

Dosage Forms and Strengths

Blister for oral inhalation: 5 mg. Four 5-mg blisters of powder on a ROTADISK for oral inhalation via DISKHALER. Packaged in carton containing 5 ROTADISKs (total of 10 doses) and 1 DISKHALER inhalation device [see HOW SUPPLIED/Storage and Handling].

RELENZA is supplied in a circular double-foil pack (a ROTADISK) containing 4 blisters of the drug. Five ROTADISKs are packaged in a white polypropylene tube. The tube is packaged in a carton with 1 blue and gray DISKHALER inhalation device (NDC 0173-0681-01).

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature). Keep out of reach of children. Do not puncture any RELENZA ROTADISK blister until taking a dose using the DISKHALER.

GlaxoSmithKline Research Triangle Park, NC 27709.December 2011.

Last reviewed on RxList: 1/12/2012
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Relenza - User Reviews

Relenza User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Relenza sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.