ARCHIVED: Appendix 2: The Management of the National Antiviral Stockpile: Options Report - Summary of antivirals contained and proposed for the NAS

 

APPENDIX 2: SUMMARY OF ANTIVIRALS CONTAINED AND PROPOSED FOR THE NAS
*Prophylaxis dosages are summarized in the Glossary of this Report, and can be found along with further technical information in CPIP, Annex E, or in the appropriate product monograph.
Antiviral Manufacturer Formulation(s) Standard Treatment Dose* Shelf-Life (stability) Patent Status

Oseltamivir/
Tamiflu®

Hoffman-La Roche

Capsules (30mg, 45mg, 75mg)

Packaging: 10 capsules per blister pack

Powder for oral suspension (12 mg/ml when reconstituted): 900 mg per bottle (volume of 75 ml in a 100-ml glass bottle)

Adults:  75mg twice daily for 5 days (10 capsules)

Children:
15 kg or less: 30mg twice daily for 5 days (10 capsules)
>15-23kg: 45mg twice daily for 5 days (10 capsules)
>23-40kg: 60mg twice daily for 5 days (given as two 30mg capsules) (20 capsules)
>40 kg: 75mg twice daily for 5 days (10 capsules)
Adolescents 13 years+: 75mg twice daily for 5 days (10 capsules)

Emergency compounding: 75 mg capsules with Ora-Sweet is permitted to obtain paediatric final concentration 15 mg/ml.

Capsules: 7 years for new gov’t purchases after 2008 (formerly 5 years)

Powder: 2 years stability once reconstituted, 10 days in refrigerator (at 2-8OC)

 

 

 

 

 

 

 

 

 

 

Compounded: stable for 5 weeks when stored at 25OC

Patent expires 2016

Zanamivir/
RelenzaR

                         

GlaxoSmith-Kline

ROTADISK consisting of a circular foil disk with four blisters each containing 5mg of zanamivir.  A DISKHALER inhalation device is provided to administer the medication (through inhalation).

 

Packaging: one box contains 5 disks (equals one treatment course)

Adults: 2 inhalations (10mg) twice daily for 5 days

Children: only indicated for children aged 7+: 2 inhalations (10mg) twice daily for 5 days

5 years

 

 

(note: GSK has guaranteed 7 years of shelf-life on government purchases by replacing expiring stock – see discussion in Current Context – Regulatory Considerations of this Report)

Patent expires Dec 2014

Amantadine/ Gen-AmantadineR

Genpharm

(generic Amantadine manufacturer that supplies the F/P/T stockpiles)

Capsules (100mg/capsule)

Packaging: one bottle contains 100 capsules

 

Syrup (10mg/ml)
Packaging: one bottle contains 500 ml

Used in combination therapy.  Dosages are stated for those with no renal impairment

1-9 years or <40kg: 5mg/kg/day once daily, or divided twice daily. Total daily dose not to exceed 150mg
Aged 10-64 years: 200mg  once daily, or divided twice daily. Reduced to 100mg/day for persons with seizure disorder.

65+: 100mg once daily

Capsules: 3.5 to 4 years depending on manufacturer.

 

 

 

Syrup: 2 years.

Generics available

 

Page details

Date modified: