Respolin Autohaler

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Salbutamol sulfate 120.525ug Equivalent to 100 µg salbutamol anydrous

Available from:

iNova Pharmaceuticals (New Zealand) Limited

INN (International Name):

Salbutamol sulfate 120.525 µg (Equivalent to 100 µg salbutamol anydrous)

Dosage:

100 mcg/dose

Pharmaceutical form:

Aerosol inhaler, metered dose

Composition:

Active: Salbutamol sulfate 120.525ug Equivalent to 100 µg salbutamol anydrous Excipient: Cryofluorane Dichlorodifluoromethane Sorbitan trioleate Trichlorofluoromethane

Units in package:

Inhaler, metered, 400 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sicor (Societa Italiana Corticosteroidi) Srl

Product summary:

Package - Contents - Shelf Life: Inhaler, metered, - 400 dose units - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1988-09-05

Summary of Product characteristics

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Data Sheet
RESPOLIN™ AUTOHALER
Salbutamol Sulphate BP 120.5 mcg per actuation (equivalent to 100 mcg ex
valve salbutamol free base)
Presentation
RESPOLIN AUTOHALER is a breath activated metered dose inhaler containing an homogenous
aerosol suspension of micronised salbutamol sulphate in fluorocarbon propellants. The suspension is
contained within a pressurised 10 ml aluminium canister closed with a metering valve and fitted with a
plastic oral adaptor. Each actuation delivers salbutamol sulphate equivalent to salbutamol (as the free
base) 100 mcg.
Uses
Actions
Salbutamol is a relatively selective beta-2-adrenoreceptor agonist. Administration by inhalation results in
direct stimulation of beta-2 receptors in bronchial smooth muscle and hence bronchodilation. This is
thought to be due to stimulation of adenyl cyclase by salbultamol, resulting in increased levels of cyclic
AMP within cells. These are thought to inhibit the entry of calcium ions into the cells, thus inhibiting
smooth muscle contraction. High levels of cyclic AMP in mast cells also inhibit the release of histamine
and SRS-A.
Pharmacokinetics
Data on salbutamol pharmocokinetics is limited and can be regarded only as qualitative, but not
quantitative. The following relates to aerosol administration of RESPOLIN AUTOHALER. Following
administration of salbutamol by aerosol, only 10 to 20% of the dose reaches the lungs, the remainder
stays in the mouth, stomach or on the apparatus. Salbutamol reaching the lungs acts rapidly and directly
on bronchial smooth muscle. Initially, salbutamol is undetectable in blood but after 2 to 3 hours, low
concentrations are seen, due pre