Airomir
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
03-09-2007
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Active ingredient:
Salbutamol sulfate 120ug equivalent to 100 µg salbutamol
Available from:
iNova Pharmaceuticals (New Zealand) Limited
INN (International Name):
Salbutamol sulfate 120 µg (= 100 µg salbutamol)
Dosage:
100 mcg/dose
Pharmaceutical form:
Aerosol inhaler, metered dose
Composition:
Active: Salbutamol sulfate 120ug equivalent to 100 µg salbutamol Excipient: Ethanol Norflurane Oleic acid
Units in package:
Inhaler, metered, 200 dose units
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Sicor (Societa Italiana Corticosteroidi) Srl
Product summary:
Package - Contents - Shelf Life: Inhaler, metered, - 200 dose units - 24 months from date of manufacture stored at or below 30°C
Authorization date:
1970-01-01
Summary of Product characteristics
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Data Sheet
AIROMIR™ Inhaler
Salbutamol sulphate. 120 mcg per actuation (equivalent to 100 mcg ex valve
salbutamol base)
Presentation
AIROMIR Inhaler contains microcrystalline salbutamol sulphate suspended in norflurane (HFA-134a)
propellant in a pressurised aluminium container closed with a metering valve fitted to a plastic oral
adaptor. Norflurane propellant is not a chlorofluorocarbon (CFC). Excipients include oleic acid and
ethanol. Each actuation delivers salbutamol sulphate equivalent to 100 mcg ex-valve of salbutamol base.
Uses
Actions
Salbutamol is a relatively selective beta-2 adrenoreceptor stimulant. Administration by inhalation results
in direct stimulation of beta-2 receptors in bronchial smooth muscle, and as a result bronchodilation.
This is thought to be due to stimulation of adenyl cyclase by salbutamol, resulting in increased levels of
cyclic-AMP within cells. This action results in reduction of the entry of calcium ions into the cells and
consequent inhibition of smooth muscle contraction. High levels of cyclic-AMP in mast cells also inhibit
the release of histamine and SRS-A. It is generally considered that the release of histamine and SRS-A,
in response to a Type 1 hypersensitivity reaction, is a primary trigger of allergic asthma.
Pharmacokinetics
Following inhalation of AIROMIR Inhaler the mean time to onset of a 15% increase in FEV
1
was
measured at 6 minutes, with a mean duration of effect, as measured by a 15% increase in FEV
1
, of 3
hours. With administration of salbutamol by aerosol, only 10 to 20% of the dose reaches the lungs, the
remainder stays in the mouth, stomach or in the actuator
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