Zanamivir
is a medicationused
to treat and prevent influenza caused by influenza A and B viruses. It is a neuraminidase inhibitor and was developed by the Australian biotech firm Biota Holdings.DRUG CLASS:
Antiviral
Neuraminidase Inhibitor, Influenza A&B Virus
DOSING:
Adult Dose
:Influenza, Viruses Types A and B; Prophylaxis:
Household setting:
10 mg (two 5 mg inhalations) orally once daily (at approximately the same time each day) for 10 days (FDA
dosage
)Community setting:
10 mg (two 5 mg inhalations) orally once daily (at approximately the same time each day) for 28 days (FDA
dosage
)10 mg (two 5 mg inhalations) orally once daily for 7 days following exposure (guideline
dosage
)Long-term care facilities and hospitals:
10 mg (two 5 mg inhalations) orally once daily for a minimum of 2 weeks: continuing up to 1 week after the last known case (guideline
dosage
)Influenza, Virus types A and B:
10 mg (two 5 mg inhalations) orally twice daily (approximately 12 hours apart at about the same time each day) for 5 days
When possible, administer 2
doses
on day 1, at least 2 hours apartPediatric Dose:
Influenza, Viruses Types A and B; Prophylaxis:
Household setting, 5 years or older:
10 mg (two 5 mg inhalations) orally once daily (at approximately the same time each day) for 10 days (FDA
dosage
)Community setting, adolescents:
10 mg (two 5 mg inhalations) orally once daily (at approximately the same time each day) for 28 days (FDA
dosage
)5 years or older:
10 mg (two 5 mg inhalations) orally once daily for 7 days following exposure (guideline
dosage
)Long-term care facilities and hospitals:
10 mg (two 5 mg inhalations) orally once daily for a minimum of 2 weeks: continuing up to 1 week after the last known case (guideline
dosage
)Influenza, Virus types A and B:
7 years or older:
10 mg (two 5 mg inhalations) orally twice daily (approximately 12 hours apart at about the same time each day) for 5 days
When possible, administer 2
doses
on day 1, at least 2 hours apartINDICATIONS:
FDA-Labeled Indications:
Influenza, Viruses Types A and B; Prophylaxis
Influenza, Virus types A and B
MECHANISM OF ACTION
:Zanamivir
is an inhibitor of influenza virus neuraminidase affecting release of viral particlesADVERSE EFFECT:
Common:
Respiratory:
Cough (influenza prophylaxis in pediatric patients: 16%)
Nasal symptom (influenza prophylaxis in pediatric patients: 20%)
Pain in throat (influenza prophylaxis in pediatric patients: 11%)
Respiratory depression
Other:
Fever with chills (influenza prophylaxis: 5%)
Serious
Cardiovascular:
Cardiac dysrhythmia
Dermatologic:
Rash
Immunologic:
Anaphylaxis
Hypersensitivity reaction
Neurologic:
Seizure
Psychiatric:
Abnormal behavior
Delirium
Respiratory:
Bronchospasm
Edema of pharynx
CONTRAINDICATION:
Hypersensitivity to
zanamivir
or any component of the product, including milk proteinsINTERACTION:
Zanamivir
is not a substrate nor does it affect cytochrome P450 (CYP) isoenzymes (CYP1A1/2, 2A6, 2C9, 2C18, 2D6, 2E1, and 3A4) in human liver microsomes. No clinically significant pharmacokinetic drug interactions are predicted based on data from in vitro studies. The concurrentuse
ofZanamivir
with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of potential interference between these products: LAIV should not be administered within 2 weeks before or 48 hours after administration ofZanamivir
, unless medically indicated. The concern about possible interference arises from the potential for antiviral drugs to inhibit replication of live vaccine virus.PHARMACOKINETICS:
Absorption:
Inhalation-Systemic: Bioavailability: 4% to 17%
Distribution:
NA
Metabolism:
NA
Excretion:
Inhalation-Systemic: Renal: unchanged; Fecal: Unabsorbed drug
Elimination:
Inhalation-Systemic: 2.5 to 5.1 h
PRECAUTION:
Administration:
Administration by mechanical ventilator or reconstitution in any liquid for nebulization is not recommended;
use
only with the provided Diskhaler; death due to ventilator obstruction has been reportedConcomitant Use:
Avoid
use
of intranasal live attenuated influenza vaccine (LAIV) within 2 weeks before, or 48 hours after,zanamivir
administration, unless medically necessaryImmunologic:
Allergic-like reactions: including oropharyngeal edema,
Serious skin rashes: and anaphylaxis have been reported; discontinue
use
if an allergic reaction occurs or is suspectedPsychiatric:
Abnormal behavior and delirium leading to injury, primarily in pediatric patients: have been reported; monitoring recommended
Respiratory:
Use
not recommended with underlying airway disease, such as asthma or COPD, due to serious cases of bronchospasm, some fatal; if required, monitoring recommendedSerious and sometimes fatal cases of bronchospasm have been reported in patients with or without history of airway disease; discontinuation recommended if bronchospasm or decline in respiratory function develops
PREGNANCY CATEGORY:
Fetal risk cannot be ruled out.
BREASTFEEDING:
Infant risk cannot be ruled out.
MONITORING:
Symptomatic improvement indicates efficacy in treatment of influenza infection
Respiratory function; in patients with underlying airway disease
HOW TO TAKE OR ADMINISTRATION:
Inhalation:
Administer only with disk haler device provided
Do not reconstitute inhalation powder in any liquid formulation
Do not administer by any nebulizer or mechanical ventilator
If administered concurrently,
use
inhaled bronchodilator firstDOSAGE FORM:
Inhalation Disk:
5 MG/1 Actuation
TREATMENTS:
Management of Mild to Moderate Toxicity:
Treatment is predominantly symptomatic and supportive care.
Management of Severe Toxicity:
Treatment is symptomatic and supportive. Treat agitation with benzodiazepines. Treat seizures with
IV
benzodiazepines; barbiturates or propofol may be needed if seizures persist or recur.TOXICOLOGY:
In clinical trials: oseltamivir oral
doses
up to 1000 mg have resulted only in nausea and vomiting. Intravenousdoses
ofZanamivir
up to 600 mg were well tolerated in healthy volunteers. Additionally, forZanamivir
, up to 1200 mg/dayIV
for 5 days have been given to volunteers with minimal effects.Zanamivir
intranasaldoses
up to 96 mg/day were administered to volunteers with no or minimal adverse effects. Oseltamivir-associated neuropsychiatric symptoms have occurred with high-dose therapy at 150 mg/kg two times daily for 2 days in a patient with influenza.PATIENT COUNSELING OR CLINICAL TEACHING:
Warn patient not to
use
this drug in a nebulizer. It should only beused
with theDiskhaler device provided with the drug product.
This drug may cause diarrhea, nausea, headache, cough, and nasal symptoms.
Advise patient to immediately report signs or symptoms of bronchospasm and respiratory depression.
Instruct patient on proper inhalation technique
Disclaimer:
For the Registered Medical Practitioner Only. We are not recommended for self medication. self medication is may harmful for health. We are only information about medicine.
No comments:
Post a Comment