Posology : מינונים

4.2    Posology and method of administration
Posology

Patients should use a bronchodilator before each dose of Cayston. Short acting bronchodilators can be taken between 15 minutes and 4 hours and long acting bronchodilators can be taken between 30 minutes and 12 hours prior to each dose of Cayston.

For patients taking multiple inhaled therapies, the recommended order of administration is as follows: 
1.     bronchodilator
2.     mucolytics
3.     and lastly, Cayston.

Adults and children 6 years and older
The recommended dose for adults is 75 mg three times per 24 hours for 28 days.

Doses should be taken at least 4 hours apart.

Cayston may be taken in repeated cycles of 28 days on therapy followed by 28 days off Cayston therapy.

The dosing in children aged 6 years and older is the same as for adults.

Elderly
Clinical studies of Cayston did not include Cayston-treated patients aged 65 years and older to determine whether they respond differently from younger patients. If Cayston is to be prescribed to the elderly then the posology is the same as for adults.

Renal impairment

Aztreonam is known to be excreted renally and therefore administration of Cayston in patients with renal impairment (serum creatinine > 2 times upper limit of normal) should be undertaken with caution. No dose adjustment is necessary in cases of renal impairment since the systemic concentration of aztreonam following inhaled administration of Cayston is very low (approximately 1% of the concentration resulting from a dose of 500 mg aztreonam for injection).

Hepatic impairment

There are no data on the use of Cayston in patients with severe hepatic impairment (ALT or AST greater than 5 times the upper limit of normal). No dose adjustment is necessary in cases of hepatic impairment.

Paediatric population

The safety and efficacy of Cayston in children younger than 6 years of age have not been established.
Method of administration

For inhalation use.

Cayston should only be used with the Altera Nebuliser Handset and Altera Aerosol Head connected to an eBase Controller or an eFlow rapid Control Unit. For instructions on reconstitution of the medicinal product before administration, see section 6.6.